How to temperature map cold chain equipment and storage areas

HOW TO TEMPERATURE MAP COLD CHAIN EQUIPMENT AND STORAGE AREAS WHO/IVB/19.09 ORIGINAL: ENGLISH DISTRIBUTION: GENERAL December 2019 EVM Setting a standard for the vaccine supply chain The Department of Immunization, Vaccines and Biologicals thanks the donors whose unspecified financial support has made the production of this document possible. This document was produced by the Expanded Programme on Immunization of the Department of Immunization, Vaccines and Biologicals Ordering code: WHO/IVB/19.09 Printed: 2019 This document is available on the Internet at: https://www.who.int/immunization/programmes_systems/supply_chain/evm/en/ Copies may be requested from: World Health Organization Department of Immunization, Vaccines and Biologicals CH-1211 Geneva 27, Switzerland Fax: +41 22 791 4227 Email: vaccines@who.int WHO/IVB/19.09 ORIGINAL: ENGLISH DISTRIBUTION: GENERAL December 2019 EVM Setting a standard for the vaccine supply chain HOW TO TEMPERATURE MAP COLD CHAIN EQUIPMENT AND STORAGE AREAS © World Health Organization 2019 Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo). 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Design and layout by Paprika (Annecy, France) Table of Contents Acknowledgements ........................................................ vi Acronyms ........................................................................ vii Background .................................................................... viii The problem ................................................................... viii The solution ................................................................... viii The importance of temperature mapping ................... viii The temperature-mapping process .............................. ix A simplified process ........................................................ ix How to use this guide ...................................................... ix Equipment and material required for temperature mapping ......................................................1 Hardware requirements ...................................................................1 Requirements specific to the three WHO-pre-qualified temperature-monitoring devices .........1 Software requirements ................................................................... 2 Getting started .................................................................4 Section A. File management ............................................5 Section B. Measuring the storage unit to be temperature mapped .......................................................8 Section C. Preparing the temperature-mapping application ......................................................................13 Section D. Transferring data from the Measurement Form to the temperature- mapping application ......................................................14 Section E. Guide on the use of the different types of sensors ....................................................................... 26 Preparing and configuring the LogTag® sensors ................27 Preparing and configuring the Q-tag® sensors ...................33 Preparing and configuring the Libero® sensors ..................34 Section F. Positioning the sensors ............................... 35 Positioning the 12 mandatory sensors ...................................35 Identifying risk zones for placement of optional sensors ................................................................................................37 Positioning the optional sensors ...............................................38 Section G. Removing sensors and downloading temperature readings to the temperature- mapping application ......................................................41 Downloading recorded data from LogTag® sensors ..........41 Downloading recorded data from Q-tag® sensors .............43 Downloading recorded data from Libero® sensors ............45 Importing the temperature data to the main Temperature Mapping tool ...........................................................49 Section H. Obtaining the Temperature Mapping Report ............................................................. 54 Section I. Making decisions and taking action ........... 55 Section J. Managing logos .............................................61 Section K. Repeating temperature mapping for the same equipment or identical equipment .............. 62 Repeating temperature mapping of the same storage units .....................................................................................62 Repeating temperature mapping for identical equipment ..........................................................................................62 Section L. Estimating hold-over time of the storage unit .................................................................... 63 Annex 1: When to conduct temperature mapping after modifications or major repairs ........................... 64 Annex 2: LogTag® temperature data logger ................ 65 Annex 3: Sample door sign for temperature mapping 68 Annex 4: Error messages .............................................. 69 References ..................................................................... 70 How to Temperature Map Cold Chain Equipment and Storage Areas iii List of Tables Table 1. WHO pre-qualified temperature-monitoring devices compatible with the Temperature Mapping tool .....1 Table 2. Temperature Mapping Source: main and sub-folders ..................................................................................................... 3 Table 3. List of temperature mapping activity sections ................................................................................................................... 4 Table 4. Quick reference guide for placement of 12 mandatory sensors ...............................................................................37 Table 5. Guide for placement of optional sensors in cold rooms ...............................................................................................38 Table 6. Guide for placement of optional sensors in freezer rooms..........................................................................................39 Table 7. Guide for placement of optional sensors in dry stores ..................................................................................................39 Table 8. Description of the variables in the “Data” table of Temperature Mapping tool....................................................51 Table 9. List of options for recommended actions on use of the mapped equipment or dry store. ............................59 List of Figures Figure 1. Temperature-monitoring devices (sensors) .......................................................................................................................1 Figure 2. Temperature Mapping tool: main page ................................................................................................................................ 2 Figure 3. Temperature Mapping Source: main folder ........................................................................................................................ 5 Figure 4. Equipment to be temperature mapped ............................................................................................................................... 6 Figure 5. Sample of equipment-specific Temperature Mapping tool “Source” folders ...................................................... 6 Figure 6. Sample of an auto-generated, equipment-specific Temperature Mapping tool .................................................7 Figure 7. Table 1 of the Measurement Form: general information .............................................................................................. 8 Figure 8. Table 2 of the Measurement Form: internal dimension ................................................................................................ 8 Figure 9. Table 3 of the Measurement Form: door ............................................................................................................................. 9 Figure 10. Table 4 of the Measurement Form: evaporators .........................................................................................................10 Figure 11. Guide to measuring storage shelves ................................................................................................................................ 11 Figure 12. Table 5 of the Measurement Form: shelves .................................................................................................................. 11 Figure 13. Table 6 of the Measurement Form: sensors .................................................................................................................12 Figure 14. Main menu of the equipment-specific Temperature Mapping tool .....................................................................13 Figure 15. Selecting worksheet for storage specifications .......................................................................................................... 14 Figure 16. Sample of a completed storage specification table ..................................................................................................15 Figure 17. Selecting worksheet for door specification ...................................................................................................................16 Figure 18. Sample of a completed door specification worksheet ............................................................................................. 17 Figure 19. Manual specification of door location .............................................................................................................................18 Figure 20. Sample of manually relocated door in the diagrams ................................................................................................19 Figure 21. Selecting worksheet for evaporators specifications .................................................................................................19 Figure 22. Sample of a completed evaporators specification worksheet ..............................................................................20 Figure 23. Selecting worksheet for shelves specification ............................................................................................................21 Figure 24. Sample of a completed shelves specification worksheet .......................................................................................22 Figure 25. Selecting the two worksheets relevant for sensors specification .......................................................................23 Figure 26. Sensors specification worksheet ......................................................................................................................................24 Figure 27. Sample of a completed test worksheet ..........................................................................................................................25 Figure 28. Numbering sensors.................................................................................................................................................................26 Figure 29. LogTag® Analyzer main window .........................................................................................................................................27 Figure 30. LogTag® interface connected to a computer ...............................................................................................................28 How to Temperature Map Cold Chain Equipment and Storage Areas iv Figure 31. Connection points for LogTag® interface and sensor ...............................................................................................28 Figure 32. Recognition of a sensor in the LogTag® Analyzer .......................................................................................................29 Figure 33. Setting sensor’s profile in the LogTag® Analyzer ........................................................................................................29 Figure 34. LogTag® Analyzer window for configuring sensor profile ........................................................................................29 Figure 35. Browser for selecting the correct profile for the configuration process ...........................................................30 Figure 36. ”LogTag® profile” to be added to the LogTag® Analyzer program, located in the Temperature Mapping “Common files” sub-folder ......................................................................................................................................................30 Figure 37. LogTag® sensor profile added into the LogTag® Analyzer’s sensor “Configuration profiles” ....................31 Figure 38. Using the <again> button for configuring remaining sensors ..............................................................................32 Figure 39. Proper way of stacking sensors .........................................................................................................................................33 Figure 40. Location of start/stop button of Q-tag® sensor .........................................................................................................33 Figure 41. Location of start button of Libero® sensor ...................................................................................................................34 Figure 42 (a-f). Correct positioning of the 12 mandatory sensors in a cold chain equipment or dry store ............36 Figure 43. Quick guide for identifying risk zones ..............................................................................................................................38 Figure 44. Start button to be pushed to activate the LogTag® sensors .................................................................................40 Figure 45. Sample of graphed temperature readings ....................................................................................................................42 Figure 46 (a-d). How to save temperature data from the LogTag® sensor to the LogTag® Analyzer .........................42 Figure 47. Clicking <Hibernate...F5> will delete all temperature data from the sensor ....................................................43 Figure 48. Stopping the Q-tag® sensor from recording temperatures ...................................................................................44 Figure 49. Check mark appears on Q-tag® sensor when successfully connected to a computer ..............................44 Figure 50. Sample of an automatically created file with a “.txt” extension ...........................................................................45 Figure 51. Connecting the Libero® sensor to the computer ........................................................................................................46 Figure 52. Selecting the “Libero” virtual drive in the computer ..................................................................................................46 Figure 53. Sample of a file in “.pdf” format generated by “Libero”, which contains recorded temperature data ...46 Figure 54. Creating a new text file within the sensor folder ........................................................................................................47 Figure 55. Location of “add file(s)” in the ElproViewer application ............................................................................................48 Figure 56. Window showing retrieved temperature data from the data table .....................................................................48 Figure 57. Location of the “logged data” worksheet for importing temperature data in the equipment-specific Temperature Mapping tool ................................................................................................................................49 Figure 58. Importing recorded temperature data to the equipment-specific Temperature Mapping tool ..............50 Figure 59. Sample of data table auto-filled with temperature-recording information imported from the sensors .......................................................................................................................................................................................................51 Figure 60. Sample of a “Sketch” worksheet showing sensor detecting fluctuations in temperature reading within a cold room .........................................................................................................................................................................53 Figure 61. Sample of the “Report” worksheet in the Temperature Mapping tool ................................................................54 Figure 62. Flow chart to guide decision-making and actions .....................................................................................................56 Figure 63. Sample of filled in Table A: actions should be based on detailed recorded information ............................57 Figure 64. Sample of filled in Table B: actions should be based on detailed recorded information for three horizontal layers. .............................................................................................................................................................................................58 Figure 65. Sample of filled in Table C: actions should be based on detailed recorded information for 4 vertical corners. ...............................................................................................................................................................................................58 Figure 66. Sample of Sections D and E, indicating recommendations and comments based on the results of the temperature mapping......................................................................................................................................................................60 Figure 67. The date of next temperature mapping: indicated in “cell H95” ...........................................................................60 Figure 68. Temperature Mapping logo ..................................................................................................................................................61 How to Temperature Map Cold Chain Equipment and Storage Areas v Acknowledgements This document was developed by the Expanded Programme on Immunization (EPI) of the World Health Organization (WHO) Department of Immunization, Vaccines and Biologicals, and was written by Mojtaba Haghgou, an independent consultant. The following individuals contributed to the production of the document and their inputs are acknowledged with sincere gratitude: y Souleymane Kone and Maricel de Quiroz-Castro (WHO Headquarters); y Oleg Benes (WHO EURO) y Nora Lucia Rodríguez (PAHO) y Adama Sawadogo Serge Ganivet, Soloman Chandrasegarar and Srihari Dutta (UNICEF) The WHO EPI also acknowledges the support and contributions of: y Dr Ida Molina, EPI Manager, and José Trinidad Martínez, Cold Chain Manager, Honduras, for field testing the application in Tegucigalpa and other provinces in Honduras y Alejandro Ortega, Logistics Manager, Nicaragua, for field testing the application in Managua, Nicaragua y Dr Erida Nelaj, EPI Manager, Albania, for field testing the application in Uzbekistan y Mr Mudher Momen Soubhey, Logistics Manager, EPI Iraq for testing the application in Iraq and Syria How to Temperature Map Cold Chain Equipment and Storage Areas vi Acronyms 2D Two-dimensional 3D Three-dimensional EPI Expanded Programme on Immunization EVM Effective vaccine management LED Light-emitting diodes MKT Mean kinetic temperature MS Microsoft PAHO Pan American Health Organization PDF Portable document format PQS Performance, Quality and Safety TM Temperature Mapping UN United Nations UNICEF United Nations Children’s Fund USB Universal Serial Bus WHO World Health Organization How to Temperature Map Cold Chain Equipment and Storage Areas vii Background The central-level cold room of any country may hold millions of dollars’ worth of vaccines.1 In highly populated countries this may also be the case for provincial- and even district- level cold rooms. The WHO Effective Vaccine Management (EVM) Initiative sets standards for safe vaccine handling and storage to ensure that heat and freezing temperatures do not damage vaccines.2 The standards require all vaccine cold and freezer rooms to be temperature mapped routinely every two years. This document provides guidance for undertaking the process. The first temperature mapping should take place at the time of the storage unit’s commissioning, and then should be performed when the cold and freezer rooms, as well as associated storage units (refrigerators and freezers), undergo any modifications or major repairs. Annex 1 provides further information on conducting temperature mapping after modifications or major repairs. Temperature mapping is not limited to vaccine cold and freezer rooms. Temperatures in refrigerators, freezers and dry stores – where diluents, injection equipment and other pharmaceuticals are kept – should also be temperature mapped. The problem The high cost of vaccines justifies the routine temperature mapping of all vaccine cold and freezer rooms and vaccine storage units. That said, EVM assessments completed to date by national immunization programmes have not shown thorough documentation of effective temperature distribution within cold rooms. There are several reasons for this, including: y lack of trained immunization programme managers and store managers, and the lack of a simple tool to facilitate carrying out a temperature mapping exercise; y cost of hiring external consultants to carry out these studies; and y cost of compliance with the technical requirements and standards for temperature mapping. For example, temperature mapping requires at least 48  hours of continuous temperature recording with an appropriate 1 A 40 m3 cold room may house approximately US$ 2.5 million worth of vaccines when fully loaded. 2 WHO (2016). WHO/UNICEF Joint Statement. Achieving immunization targets with the comprehensive effective vaccine management (EVM) framework. 10 March 2016. WHO Reference WHO/IVB/16.09. Available at: http://apps. who.int/iris/bitstream/10665/254717/1/WHO-IVB-16.09-eng.pdf?ua=1. number of temperature sensors (pre-qualified by WHO) placed accurately within empty and fully stocked storage units. The solution One practical solution is to empower and equip field-level Expanded Programme on Immunization (EPI) programme staff, especially store managers, to conduct temperature mapping. This can be achieved through several simple, well-defined, clearly explained and step-by-step actions, assisted by an open-access, user-friendly, computer- based application. In response to this need, WHO has developed a Temperature Mapping tool which aids the process of mapping temperatures in various types of cold chain equipment and dry stores. The Temperature Mapping tool is a computer-based application in Microsoft (MS) Excel® available in official United Nations (UN) languages. The tool and this guidance are downloadable from the EVM Initiative website: www.who.int/ immunization/programmes_systems/supply_chain/evm/en/. The importance of temperature mapping Temperature mapping is the process of recording and mapping temperatures within three-dimensional (3D) spaces, such as cold and freezer rooms, dry storage areas, and refrigerator and freezer units. Temperatures will not be the same everywhere within the storage area. Whether in a small refrigerator, a well-designed cold or freezer room, or, particularly, in a large warehouse, temperatures can vary by as much as 10°C from one location to another within the same unit. Temperatures in the corners will most likely be different from those measured in the centre or close to cooling units. In dry stores, the temperatures close to the ceiling tend to be higher than those close to the floor. There are also specific areas within the cold rooms where the temperature will differ. For example, temperature will be at its coldest next to the cooling fans and likely to be at its warmest close to the doors. Temperature mapping and temperature monitoring are integral to the appropriate storage conditions for pharmaceuticals. Good manufacturing practice for pharmaceutical products recommends regular temperature mapping in all types of warehouses.3 3 See Clause 3.19 of Pharmaceutical Inspection Co-operation Scheme (PIC/s) (2017) Guide to Good Manufacturing Practice for Medicinal Products. Available at: https://www.picscheme.org/en/publications?tri=gmp How to Temperature Map Cold Chain Equipment and Storage Areas viii The temperature-mapping process Temperature mapping consists of several key steps. 1. Decide when to perform temperature mapping. 2. Place an appropriate number of sensors in different areas, particularly areas that might go above or below specified safe temperature ranges. Generally, 20 sensors are used to temperature map a medium-sized cold storage unit, with an additional sensor to measure the ambient temperature. Temperatures need to be recorded at specified regular intervals, continuously, for at least 48 hours. 3. Read and transfer recorded temperatures (minimum, maximum, mean and mean kinetic4) to a 3D sketch of the storage vessel to be temperature mapped. This can include cold and freezer rooms, dry storage areas, and equipment, such as refrigerators and freezers. 4. Identify areas where vaccines and thermo-sensitive pharmaceutical products should not be stored. 5. Implement actions to prevent and reduce the exposure of vaccines and pharmaceuticals to incorrect temperatures. A simplified process The Temperature Mapping tool automatically develops a simple 3D sketch of a storage area based on data input on the actual dimension of the equipment to be mapped, be it a cold room, freezer room, refrigerator/freezer or a dry store. It requires specifying the unit’s length, width and height, as well as: y number, location and dimensions of door(s), evaporators and shelves y number and location of sensors. This information is entered into the application which includes a Measurement Form designed for recording the temperature data. Using this form simplifies taking measurements and transferring them to the application. The process calls for the placement of an appropriate number of sensors in pre-specified locations within the 3D sketch, which provides a guide for placing the sensors in the correct spots within the storage area or unit to be mapped. The application guides the placement of 12 required sensors in pre-specified positions, beginning with three sensors in each of the four corners of the unit to be temperature 4 Mean kinetic temperature (MKT) is a simplified way of expressing the overall effect of temperature fluctuations during storage or transit of perishable goods. The MKT is widely used in the pharmaceutical industry. mapped. There is also the option of positioning an additional 28 sensors in places that might be considered risky areas for storing specific items, such as vaccines. After completing the temperature recording over a period of at least 48 – but up to 72 – hours, the application imports temperature records (converted to Excel®). It ascribes the temperature readings to the location of the sensors, and colour codes the areas where temperatures fall outside the desired range using the 3D diagram. The application produces a report based on the summarized temperature recording data that includes a summary of key findings. A standard template is provided to facilitate the preparation of reports. Users need to use their judgment: i) to decide whether the storage room or equipment tested is adequate for storing specific items (vaccines and other pharmaceutical products), and ii) to identify safe and risky areas within the unit. The application takes care of the most complicated part – by creating a sketch of the unit scaled to fit an A4 sheet for printing. The most critical part of the mapping calls for taking accurate 3D measurements of a minimum of eight places in the unit.5 This task is explained in detail with pictorial aids in Section B. How to use this guide This guide provides a step-by-step approach to temperature mapping of storage areas or equipment. The application it presents can be used for temperature mapping of cold and freezer rooms, refrigerators and freezers, and dry stores. Systematic follow-up of the steps provided in this guide is essential for successful temperature mapping. Once you have completed the initial exercise, you will have learned how to perform temperature mapping. The instructions provided in this guide have been developed for those with limited computer knowledge. Users familiar with MS Excel® and other computer programmes will learn the temperature mapping method faster. Note: Users should save this guide for future reference. 5 The number of measurements to be recorded depends on the size of the unit, number of cooling units, the number of doors and the number of shelves. How to Temperature Map Cold Chain Equipment and Storage Areas ix

Equipment and material required for temperature mapping Hardware requirements The following items are required for temperature mapping, using this application: 1. minimum of 21 temperature monitoring sensors (temperature data loggers) 2. computer with Windows® and MS Excel® installed 3. tape measure 4. clipboard for recording information on the Measurement Form 5. warm clothes for working in the cold and freezer rooms. Three brands of temperature-monitoring devices – tested and approved by WHO – are compatible with this version of the temperature-mapping application: LogTag®, Q-tag® and Libero®. Table 1. WHO pre-qualified temperature-monitoring devices compatible with the Temperature Mapping tool Brand name Model PQS Number Software requirement for the device User interface LogTag® TRIX-8 E06/006 LogTag® Analyzer_24r4 LogTag® interface Q-tag® CLm doc LR E06/016 None USB Libero® Ti1-L E06/024 elproVIEWER USB Figure 1. Temperature-monitoring devices (sensors) LogTag® (TRIX-8) with interface Q-tag® (CLm doc LR) Libero® (Ti1-L) Requirements specific to the three WHO-pre-qualified temperature-monitoring devices LogTag®. This sensor needs at least one interface for configuring the sensors and for transferring data from the sensors (loggers) to the computer. See Annex 2 LogTag® Temperature Data Logger for compatibility between the temperature data logger LogTag® - 8TRIX and your computer’s operating system. Q-tag® and Libero®. These sensors are equipped with a Universal Serial Bus (USB) interface. Of note, the Libero® and LogTag® sensors require specific software, whereas the Q-tag® sensor has no software requirement. How to Temperature Map Cold Chain Equipment and Storage Areas 1 Software requirements Download the required software application from the WHO Effective Vaccine Management Initiative website: who. int/immunization/programmes_systems/supply_chain/evm/en/. The site, as shown in Figure 2, also includes links to the following relevant document and applications: y electronic copy of this guideline y Elpro Viewer software application y LogTag® Analyzer software application. Figure 2. Temperature Mapping tool: main page Note: The actual appearance of the Temperature Mapping tool main page may be different from the above image due to version upgrade. Before downloading the temperature-mapping application, create a folder that will serve as your “main folder” in one of the computer’s drives. All the files and sub-folders that are automatically created by the application will be saved in this “main folder”. Then, download the “Temperature Mapping Source” zip folder, and unzip the contained files into the “main folder”. Note: To ensure smooth execution, it is recommended to download the application onto one of the computer drives, not to the desktop. Additionally, if you are using LogTag®, download the “LogTag® Analyzer” software”; if you are using Libero®, download the “elproVIEWER” software. You do not need to download anything if you are using Q-tag® devices. Once downloading is complete, you should have the files and sub-folders in the “Temperature Mapping Source” as listed in Table 2. How to Temperature Map Cold Chain Equipment and Storage Areas 2 Table 2. Temperature Mapping Source: main and sub-folders Common Files DOC EnablingMacros.docx XLS MeasurementForm.xlsx Profile_Logtag.ltp Option_Logtag.asxml Source Device Outputs Ambient Sensor 1 Sensor 2 Sensor 3 Sensor 4 Sensor 5 Sensor 6 Sensor 7 Sensor 8 Sensor 9 Sensor 9 Sensor 10 Sensor 11 Sensor 12 Sensor 13 Sensor 14 Sensor 15 Sensor 16 Sensor 16 Sensor 17 Sensor 18 Sensor 19 Sensor 20 Logo Images 3 logo files XLS Source.xlsm XLS TM Manager.xlsm How to Temperature Map Cold Chain Equipment and Storage Areas 3 Getting started This guide contains 12 sections (A to L), with each section divided into several steps (see Table 3). Table 3. List of temperature mapping activity sections Sections Descriptions A File management B Measuring the storage unit to be temperature mapped C Preparing the temperature-mapping application D Transferring data from the Measurement Form to the temperature-mapping application E Preparing and configuring the sensors y LogTag® y Q-tag® y Libero® F Positioning the sensors G Removing the sensors and downloading temperature readings to the temperature-mapping application y LogTag® y Q-tag® y Libero® H Preparation of the report I Decision-making J Management of logos K Repeat temperature mapping and temperature mapping of identical equipment y Repeating temperature mapping at subsequent times y Temperature mapping of identical equipment L Estimation of hold-over time How to Temperature Map Cold Chain Equipment and Storage Areas 4 Section A. File management This section describes how to configure the software and prepare the materials needed to start temperature mapping. It outlines three simple steps to use <TM Manager.xlsm> for the different sensors and for mapping various storage units. It also provides important information about what to do – and what not to do – with the application’s files. Step A.1 Check if application has been installed correctly. Once the Temperature Mapping Source application has been copied or downloaded into the computer, you will have the files and folders listed in Figure 3. Figure 3. Temperature Mapping Source: main folder Common Files Source XLS TM Manager.xlsm Click on <TM Manager.xlsm> to open the temperature-mapping application. When using this application for the first time, you may see this warning message. If you see this message, it means that macros are disabled! You must enable macros before using this Application. For more information and to enable macros please refer to “EnableMacros” document in the main folder or click on below link. Enabling Macros Help Document The warning message means that you should enable macros in the computer before starting to use the application. As the method to enable macros differs across operating systems, instructions to enable macros are provided in detail in several languages in the file <EnableMacros>, which is found in the “Common Files” sub-folder of the Temperature Mapping Source main folder. Step A.2 Select the number of units to be mapped for each type of cold chain equipment and dry store using the drop-down menu, as illustrated in Figure 4. How to Temperature Map Cold Chain Equipment and Storage Areas 5 Figure 4. Equipment to be temperature mapped The application will generate a source file for each equipment and storage space indicated. The filenames of these newly generated folders start with a “.TM” and include a number that corresponds to the quantity of the same-type equipment to be temperature mapped. You should, therefore, assign a number for each piece of equipment and storage space to be temperature mapped to ensure the input data is entered to the corresponding Temperature Mapping tool, which will be auto-generated by the application. This will be further discussed in Section C. For example, if you select two cold rooms and one freezer room, three folders will be added automatically in the “main folder” as illustrated in Figure 5. Figure 5. Sample of equipment-specific Temperature Mapping tool “Source” folders TM Cold-room 1 TM Cold-room 2 TM Freezer-room 1 Common Files Source XLS TM Manager.xlsm Note: You should NOT move, open or use files outside of their designated folders. This is very important! How to Temperature Map Cold Chain Equipment and Storage Areas 6 Step A.3 Click on the first unit (e.g. either equipment or dry store) to be temperature mapped. Using the example given in Figure 5, click on “.TM Cold-room 1”. A folder consisting two sub-folders and one Excel® file will appear as follows: Figure 6. Sample of an auto-generated, equipment-specific Temperature Mapping tool TM Freezer-room 1 Device Outputs Logo Images XLS Cold-room 1.xlsm How to Temperature Map Cold Chain Equipment and Storage Areas 7 Section B. Measuring the storage unit to be temperature mapped This section presents the eight steps required for completing the Temperature Mapping Measurement Form. It explains what data should be entered for all the required dimensions within the unit that is being temperature mapped. Once complete, this form will be used to transfer the measurements to the equipment-specific Temperature Mapping tool (which is further illustrated in Section D). Step B.1 Print the Measurement Form <TM MeasurementForm.xlsx> found in the “Common Files” sub-folder. Note: Make sure to bring the hard copy of the Measurement Form with you when you go to the area to be mapped. Step B.2 Insert the specifications, codes and essential measurements in Table 1 of the General Information section located in the upper part of the Measurement Form. Figure 7 presents an example of a completed Table 1 of the form. Figure 7. Table 1 of the Measurement Form: general information Step B.3 Take the unit’s internal measurements for length (L), width (W) and height (H). Begin with the unit’s front side, where the entrance door is located. Then, measure the internal dimensions of the unit’s other sides. Fill in Table 2 of the Measurement Form accordingly, as shown in Figure 8. Figure 8. Table 2 of the Measurement Form: internal dimension How to Temperature Map Cold Chain Equipment and Storage Areas 8 Step B.4 Go to the Specific Measurements section of the Measurement Form. Specify the number of doors, their positions and their dimensions as shown in Figure 9. If the unit to be measured has only one door, which is the normal case, complete only one of the tables. Figure 9. Table 3 of the Measurement Form: door Step B.5 Specify the number and the position of evaporators inside the equipment. Bigger cold rooms may have several evaporators. Measure the dimensions of each evaporator and enter them in Table 4 of the Measurement Form, as illustrated in Figure 10. Note: If you are temperature mapping a refrigerator, freezer or dry store, skip Step B.5 and proceed to Step B.6. How to Temperature Map Cold Chain Equipment and Storage Areas 9 Figure 10. Table 4 of the Measurement Form: evaporators Step B.6 Specify the number and the position of shelves inside the unit to be temperature mapped. Use the instructions provided in Figure 11, which are also found in the Measurement Form. Then, complete Table 5 accordingly, as illustrated in Figure 12, Ignore this step if shelves are not relevant for this exercise or if the unit does not have any shelves. If the distances between shelves are not equal, calculate and use the average of the distance between shelves. How to Temperature Map Cold Chain Equipment and Storage Areas 10 Figure 11. Guide to measuring storage shelves Figure 12. Table 5 of the Measurement Form: shelves Step B.7 Determine the number of optional sensors to be used per each unit of equipment to be temperature mapped. Section B4 of the Measurement Form only requires information on the position of optional sensors. Recommended positions for fixed sensors are discussed separately in Section F. The total number of sensors to be used in recording the internal temperatures depends on the size of the cold chain equipment or dry store to be measured. However, 12 sensors are mandatory for temperature mapping all types of cold chain equipment and dry stores. Note: Do not reduce the number of mandatory sensors in fixed locations or change their positions. How to Temperature Map Cold Chain Equipment and Storage Areas 11 The optional sensors may not be required to temperature map refrigerators or freezers. When temperature mapping cold rooms and freezer rooms, WHO recommends using 20 compulsory sensors.6 In this case, 12 mandatory sensors are placed in 12 fixed positions and 8 optional sensors are placed in 8 additional positions. Section F of this document provides specific guidelines on the placement of both the mandatory and optional sensors. Section B4 of the Measurement Form provides further guidance for taking correct measurements. Up to 28 optional sensors can be placed in positions of your choice. Position the optional sensors where you think it is important to record temperatures or you suspect the temperature is outside of the safe range (also referred to as “risk zones”). In other words, you should place the optional sensors in critical locations. Temperature mapping a very large or drive-in cold room, or very large dry stores will require 40 sensors.7 Once the number of optional sensors and their desired locations in the equipment or dry store are identified, take the coordinates of each of the sensors based on instructions given in the Measurement Form. Then complete Table 6 of the Measurement Form, as shown in Figure 13. Figure 13. Table 6 of the Measurement Form: sensors Step B.8 Check the completed Measurement Form to determine whether any item or measurement has been left out. Once you are satisfied that all the information has been collected and the related tables are completed, proceed to Section C. 6 More information about WHO’s recommendations can be found at: https://www.who.int/immunization_standards/vaccine_quality/pqs_e01_ cr_fr01_vp1_2.pdf. 7 More information about WHO’s recommendations can be found at: https://www.who.int/medicines/areas/quality_safety/quality_assurance/ TS-mapping-storage-areas-final-sign-off-a.pdf. How to Temperature Map Cold Chain Equipment and Storage Areas 12 Section C. Preparing the temperature-mapping application In Section A, you were asked to indicate the number and types of equipment and storage spaces that will be temperature mapped. This action will have generated new sub-folders for each type of equipment in the Temperature Mapping “main folder”, as shown in Figure 5. Each sub-folder contains an Excel file (see example shown in Figure 6) with a label bearing the type of equipment and a number representing the quantity. Even if there are identical pieces of equipment to be mapped, the tool can only be used for the specified equipment. This section explains how to complete – in two simple steps – the information required in the Excel® sheet labelled “Room”, which is one of the worksheets in the equipment-specific tool. Step C.1 Open the Temperature Mapping “main folder”. Then, open the folder <.TM Cold-room 1> to find the E cel® workbook <Cold-room 1.xlsm>, which is specific for this location. Step C.2 Click on <Cold-room 1.xlsm> to open the equipment-specific Temperature Mapping tool, which is illustrated in Figure 14. Figure 14. Main menu of the equipment-specific Temperature Mapping tool How to Temperature Map Cold Chain Equipment and Storage Areas 13 Section D. Transferring data from the Measurement Form to the temperature-mapping application In Sections B and C, respectively, you calculated and added the dimensions and measurements of the unit being temperature mapped to the Measurement Form. Now, in Section D, you transfer that information to the application. Figure 15. Selecting worksheet for storage specifications Step D.1 Once the application is opened, click on <Storage Specifications> from the “Main Menu” (see Figure 15). Fill in the “storage specification” table, as shown in the example in Figure 16. Start by completing the information in cells C3 and D3, using the dropdown menus. Note: Cells in the table with yellow background are mandatory fields that should be completed. The cells with white backgrounds are optional. How to Temperature Map Cold Chain Equipment and Storage Areas 14 Figure 16. Sample of a completed storage specification table Step D1.1. Selecting temperature range Select the storage room or equipment type in C3 and notice the information in cells C4 and C5 will be automatically generated. If you select “Between +2° to +8°C”, “2” and “8” will appear automatically in C4 and C5, respectively. This means that +2°C is the lower alert range designated in C4 and +8°C is the upper alert range designated in C5. Likewise, if you select “Below 0°C” in C3, then “-25” and “-15” will appear in C4 and C5, respectively. Further, when selecting “Ambient temperatures (degree C)” for dry store, “5” and “32” will appear in C4 and C5, respectively. Step D1.2. Selecting type of storage or equipment Select the type of storage equipment in cell D3. The options on the dropdown menu in cell D3 are dependent on the selection done in C3. If you select “Between +2° to +8°C” in C3, you can only select either “Cold room” or “Refrigerator” in cell D3. Similarly, if you select “Below 0°C” in C3, you can only select either “Freezer room” or “Freezer”. However, if you select “Ambient temperatures (degree C)” in C3, you have only one choice, which is “Dry Store”. Step D1.3. Indicating installation date Indicate the installation date of the equipment in cell D10. If you do not know the installation date, select “Not known” from the dropdown menu in cell C10. How to Temperature Map Cold Chain Equipment and Storage Areas 15 Step D.2 Fill in cells C19 to C21 based on the room dimension recorded in Table 2 of the Measurement Form. The unit of measurement is in meters. In cells C13, C14 and C15, specify the number of doors, number of cooling units (evaporators) and number of shelves, respectively. The tool allows you to specify up to 3 doors, 6 sets of shelves and 8 cooling units. If the storage unit is a dry store (ambient temperatures), the dropdown menu in cell C14 will be disabled and you will see 0 in this cell. Cells C23 to C25 are automatically filled in, based on the information entered in cells C19 to C21. y Cell C23 presents the gross volume. This is the product of the multiplication of the three dimensions entered in cells C19, C20 and C21. y Cell C24 is the net volume. The volume indicated will depend on the number of shelves, the distance between them and their dimensions (length and width). These dimensions are specified in the “Shelves” worksheet. y Cell C25 represents the grossing factor. If “0” (meaning no shelves) is the value entered in cell C3 of the “Shelves” worksheet, the net volume will be estimated using grossing factors, which are based on WHO recommendation. The grossing factor increases with the size of the equipment. Step D.3 Go back to the “Main Menu” and select <Doors specifications> as shown in Figure 17. Figure 17. Selecting worksheet for door specification Step D.3.1. Creating the diagram to show exact location and dimension of doors In the “Doors” worksheet, the number of door specification options depends on the information indicated in cell C3. Fill in column D of the worksheet using the data on door dimension recorded in Table 3 of the Measurement Form. Each door requires data input on its position, distance from the left wall, height and width. After indicating How to Temperature Map Cold Chain Equipment and Storage Areas 16 all information, click on <draw plan> and a diagram will appear in which the door is placed to the corresponding position in both the two-dimensional (2D) or horizontal diagram and the 3D diagram. This is illustrated in Figure 18. Figure 18. Sample of a completed door specification worksheet Step D.3.2. Using the “get real position” feature of the tool This feature of the tool enables manual relocation of the position of the door. This is optional and used only when the auto-generated 2D and 3D diagrams do not properly reflect the door’s correct position. The process involves clicking on the <Relocate on plan> in column E next to the door that requires a position correction. When you click on <Relocate on plan>, the door on the 2D diagram will be highlighted, and it can then be moved to the left or to the right and its width can be adjusted (see Figure 19). Once the desired location is determined, click on <Get real positions>. How to Temperature Map Cold Chain Equipment and Storage Areas 17 Figure 19. Manual specification of door location By clicking on <Get real positions>, a message will appear showing the measurement of the location and width of the selected door. If you click on <yes> in the message box, the 3D diagram will be updated to reflect the door location. Note that the value for door height may be missing. If you indicate an estimated door height and click on <Draw Plan>, the information will be reflected in the 3D diagram. Notice the difference in the door size and location between Figure 18, which is the original, and Figure 20, which is how it appears after using the <relocate on plan> option. How to Temperature Map Cold Chain Equipment and Storage Areas 18 Figure 20. Sample of manually relocated door in the diagrams Once the data for all doors is entered, click on <Back to Main Menu>. Step D.4 Click on <Evaporators Specifications> in the “Main Menu” (Figure 21). Figure 21. Selecting worksheet for evaporators specifications How to Temperature Map Cold Chain Equipment and Storage Areas 19 The number of evaporators or cooling units is automatically indicated in cell C3 of the “Evaporators” worksheet. The number of options for the location and dimensions of the evaporators is equal to the number specified in cell C14 in the “Room” worksheet. See the example in Figure 16. Transfer the data on the location and dimension of each evaporator from Table 4 of the Measurement Form to the corresponding cells in column D of the “Evaporators” worksheet. Then, click on <draw plan> to create 2D and 3D diagrams as shown in Figure 22. Figure 22. Sample of a completed evaporators specification worksheet If the location of the evaporators is not correctly reflected in the 2D and 3D diagrams, you can reflect their proper locations in the diagrams using the <relocate on plan> option. Follow the same procedures as described in Step D.3.2 for door size and location. Once the data transfer is completed, click <Back to Main Menu>. How to Temperature Map Cold Chain Equipment and Storage Areas 20 Step D.5 Click on <Shelves Specifications> sheet as shown in Figure 23. Figure 23. Selecting worksheet for shelves specification Examine Section B3 and Table 5 of the Measurement Form for the way shelves are numbered. Note: The number of options for locations and dimensions of shelves is equal to the number specified in cell C15 on the “Room” worksheet. Transfer the data on shelves’ locations and specifications recorded in Table 5 of the Measurement Form to cells in column D of the “Shelves” worksheet, as shown in Figure 24. How to Temperature Map Cold Chain Equipment and Storage Areas 21 Figure 24. Sample of a completed shelves specification worksheet If the location of the shelves is not correctly reflected in the 2D and 3D diagrams, you can reflect their proper location in the diagrams using the <relocate on plan> option. Follow the same procedures as described in Step D.3.2 for door size and location. Once the data transfer is completed, click <Back to Main Menu>. How to Temperature Map Cold Chain Equipment and Storage Areas 22 Step D.6 Specify the number of sensors to be used. Before opening the “Sensors” worksheet, go to the ”Test” worksheet and, in cell C16, specify the total number of sensors that will be used for temperature mapping. Figure 25. Selecting the two worksheets relevant for sensors specification As explained in Step B.7, the Temperature Mapping tool calls for 12 mandatory sensors with an addition of up to 28 optional sensors. Sensors numbered 1 to 12 are fixed at three specific levels in each of the four corners of the storage unit to be mapped. Selecting “12” indicates that you do not require any sensors other than the minimum mandatory sensors placed in fixed positions. If you wish to use optional sensors, then the value to be indicated in cell C16 in the “Test” worksheet should be the sum of the 12 mandatory sensors plus the optional sensors. The maximum number allowed by the tool is 40 sensors. The guidance for identifying the correct number of mandatory and optional sensors to be used for different types of equipment is found in Step B7. Correctly identifying the number of sensors helps improve accuracy of temperature mapping. However, regardless of the number of optional sensors placed, the location of the first 12 mandatory sensors should not be altered. After indicating the total number of sensors, click on <Back to Main Menu>, and then click on the <Sensor Specifications> option. How to Temperature Map Cold Chain Equipment and Storage Areas 23 Step D.7 Record the specific positions (coordinates) of both mandatory and optional sensors that will be placed within the storage unit to the corresponding cells in column C of the “Sensors” worksheet. The data on optional sensors coordinates is found in Table 6 of the Measurement Form. Click on <Draw Plan> to determine whether the optional sensors are in the correct positions or not. The position of the optional sensors can be freely moved on both the horizontal and vertical planes in the 3D diagram. If the desired location of the sensors is not correctly reflected in the 2D and 3D diagrams, you can adjust their location in the diagrams using the <relocate on plan> option. Follow the same procedures as described in Step D.3.2 for the door position. Figure 26. Sensors specification worksheet Once the “Sensors” worksheet is completed, click on <Back to Main Menu>. How to Temperature Map Cold Chain Equipment and Storage Areas 24 Step D.8 Go back to the “Test” worksheet and specify in cells E5, F5, G5, I5 and J5 the start date and time of the temperature mapping test. Then, complete cells E6, F6, G6, I6 and J6 with the end date and the time of the test as shown in Figure 27. You can always go back to this worksheet to modify both the start and end dates in case of delay in the implementation. Figure 27. Sample of a completed test worksheet The accurate specification of start and end dates and times is very important – and should match the exact dates and times of the reading of the sensors. An error message will appear if they do not match. Note: You can postpone this step and fill in only the required start and end dates and times once the sensors are removed from the storage unit and temperature records have been downloaded to “Device Output”. This is further detailed in Section G. Complete the rest of the information from cells C8 to C19 and D20. This will not include cell C16, as you already specified the number of sensors in the earlier steps. How to Temperature Map Cold Chain Equipment and Storage Areas 25 Section E. Guide on the use of the different types of sensors This section describes how to prepare and configure the temperature-recording sensors required for recording internal temperatures of different areas inside the equipment or storage unit for a minimum of 48 and up to 72 hours. The number of steps required to complete this depends on the type of the temperature recording sensor used. Using LogTag® devices require more steps compared to using Q-tag® and Libero® devices. Note: It is not necessary to read the steps for all three types of temperature recording devices. Read only the steps related to the device you are using for temperature mapping. Make sure you prepare one extra sensor, which will be used to measure ambient temperature surrounding the cold chain equipment. Using the example as shown in Figure 27, 20 sensors are indicated but the total number of sensors to prepare should be 21. Step E.1. Labelling the temperature-recording sensors When using the sensors for the first time, number each one from 1 to 20, or a higher number up to 40. Then, mark the extra sensor that will be used for ambient temperature monitoring with the last number. Use a felt pen with permanent ink. Figure 28 is an example of marked LogTag® sensors. Q-tag® or Libero® sensors are marked in the same way. Note: These sensors can be re-used a few times. For temperature mapping requiring additional sensors, just continue marking new sensors from the last number of the old ones. Figure 28. Numbering sensors Using the example given in Figure 27, label the extra sensor as number 21. If you are mapping temperature in very large cold rooms (e.g. drive-in cold rooms) where up to 40 sensors are required, sensor number 40 should be used for measuring ambient temperature. How to Temperature Map Cold Chain Equipment and Storage Areas 26 Step E2. Preparing and configuring temperature sensors Step E.2.1. Preparing and configuring the LogTag® sensors Download and install the LogTag® Analyzer software from the Temperature Mapping tool main page (see Figure 2). Note: For smooth execution, the software should be installed at <C:\Program Files \LogTag® Recorders\ LogTag® Analyzer\>. Step E.2.1a Go to <C:\Program Files \LogTag® Recorders\LogTag® Analyzer> to open the program and click on <LogTag® Analyzer.exe>. The LogTag® Analyzer main window will appear as shown in Figure 29. A shortcut icon can be placed on the computer desktop or pinned in the task bar for easy access. Figure 29. LogTag® Analyzer main window Step E.2.1b Connect the LogTag® interface (Figure 30) to the computer where the LogTag® Analyzer application was installed. How to Temperature Map Cold Chain Equipment and Storage Areas 27 Figure 30. LogTag® interface connected to a computer Step E.2.1c Insert sensor number 1 into the LogTag® interface, as shown in Figure 30. Ensure that the three connection circles are in contact with the three connection spheres inside the groove of the interface (see Figure 31). Figure 31. Connection points for LogTag® interface and sensor A window with a message indicating recognition of sensor 1 will appear (Figure 32). Allow the application to complete reading and connecting to sensor 1. How to Temperature Map Cold Chain Equipment and Storage Areas 28 Figure 32. Recognition of a sensor in the LogTag® Analyzer Step E.2.1d Open the <Configuration Profiles> window by clicking on the <LogTag®> option, as shown in Figure 33, and select <Profile>. If this is the first time the LogTag® Analyzer has been used, the “configuration profile” window may be empty as shown in Figure 34. Figure 33. Setting sensor’s profile in the LogTag® Analyzer Figure 34. LogTag® Analyzer window for configuring sensor profile How to Temperature Map Cold Chain Equipment and Storage Areas 29 Step E.2.1e Select the correct file containing the LogTag® profile by clicking on browse key < ... > located in the lower right corner of the “Configuration Profile” window (see Figure 35). Figure 35. Browser for selecting the correct profile for the configuration process Note: The LogTag® profiles are found in the “Common Files” sub-folder. Step E.2.1f Go to the “Common Files” sub-folder and select <Profile_LogTag®.ltp>, then click on <Open> (see Figure 36). This will allow the profile to be added to the list of available LogTag® configuration profiles as shown in Figure 37. Figure 36. ”LogTag® profile” to be added to the LogTag® Analyzer program, located in the Temperature Mapping “Common files” sub-folder How to Temperature Map Cold Chain Equipment and Storage Areas 30 Figure 37. LogTag® sensor profile added into the LogTag® Analyzer’s sensor “Configuration profiles” Step E.2.1g Select this LogTag® profile from the list and click on <Configure loggers>. This step will complete the configuration process for LogTag® sensor 1. Remove sensor 1 from the interface. It will begin to record temperatures 20 minutes after the sensor’s start button is pushed. The configuration is successfully completed and the sensor is ready for use once the two light-emitting diodes (LEDs) on the sensor blink. Although the sensor is ready for use, it will not detect and record temperatures until the sensor’s start button has been pushed. See Step F.4. This profile will configure the sensor for the following specifications. y The sensor will not record temperatures until 20 minutes after the start button is pushed. y The sensor records temperatures at regular 10-minute intervals. y The temperature is recorded for a maximum of 3 days (72 hours), which thus provides a maximum of 432 readings. Note: You should only use the profile provided for this application! Do not change the profile! Any change to the profile may disrupt the application’s functionality and you may not be able to obtain a report, or a correct and accurate result. Step E.2.1h To configure sensor number 2, insert the sensor to the LogTag® interface and repeat step E.2.1g by clicking on the <Again> key as shown in Figure 38. You do not have to repeat the other prior steps in this section. Repeat the actions done for sensor 2 to configure all the remaining sensors, including the one for measuring and recording the ambient temperature. How to Temperature Map Cold Chain Equipment and Storage Areas 31 Figure 38. Using the <again> button for configuring remaining sensors Step E.2.1i After you finish configuring all the sensors, stack them as shown in Figure 39, with the first 12 sensors in 4 stacks of 3 sensors each, as follows: y sensors 1 to 3 together y sensors 4 to 6 together y sensors 7 to 9 together y sensors 10 to 12 together Then, stack optional sensors 13 to 20. When optional sensors are used, they should be stacked all together, up to 40. One additional sensor (e.g. sensor number 21 or 40) is needed for recording ambient temperatures. Keep it separate from the other sensors but make sure it has been configured like the other sensors. How to Temperature Map Cold Chain Equipment and Storage Areas 32 Figure 39. Proper way of stacking sensors Step E.2.2. Preparing and configuring the Q-tag® sensors Step E.2.2a Enumerate the sensors as explained in Step E.1 for the LogTag® sensors. Step E.2.2b Press and hold the <START / STOP> button for five seconds (see Figure 40). The number 00:30 will start to blink and will count down. Once it reaches 00:00, the device is ready to record temperatures. This delay provides time to place the sensors inside the equipment or storage area to be temperature mapped. Figure 40. Location of start/stop button of Q-tag® sensor Note: Contrary to LogTag®, Q-tag® does not require any configuration or lengthy preparation. Step E.2.2c Repeat Step E.2.2b for all Q-tag® sensors. How to Temperature Map Cold Chain Equipment and Storage Areas 33 Step E.2.2d After configuring all of the Q-tag® sensors, stack them as explained in Step E.2.1i. Step E.2.3. Preparing and configuring the Libero® sensors Step E.2.3a Enumerate the sensors as explained in Step E.1 for the LogTag® sensor. Step E. 2.3b Press and hold the <START Transit> button for three seconds (see Figure 41). The word “Transit” will appear and “Logging” will blink on the unit’s digital screen. This means the sensor is ready and can be positioned for temperature mapping. Figure 41. Location of start button of Libero® sensor Step E.2.3c Repeat Step E.2.3b for all Libero® sensors. Step E. 2.3d After configuring all of the Libero® sensors, stack them as explained in Step E.2.1i. How to Temperature Map Cold Chain Equipment and Storage Areas 34 Section F. Positioning the sensors This section explains how to position the sensors in the correct locations inside the storage unit to be temperature mapped. This is done once all the sensors have been numbered and configured according to the directions in Section E. Once the sensors and the application are prepared, the sensors can be positioned in their assigned place inside the storage unit that is to be temperature mapped. Recall that there should be: y 12 sensors in fixed positions y up to 28 optional sensors which can be placed in critical areas inside the storage unit y 1 sensor for measuring and recording ambient temperatures. Step F.1. Positioning the 12 mandatory sensors Step F.1.1 Bring the 12 mandatory sensors to the storage unit that is to be temperature mapped. Step F.1.2 Refer to the Measurement Form specific to the storage unit that is to be temperature mapped (see Step B.3). Note the height of the storage unit as listed in Table 2 in the Temperature Mapping Measurement Form. Divide the height by two (h/2) and note the result. For example, if the height is 2.2 meters, the result will be 1.1 meters. Step F.1.3 Begin by correctly placing sensor 2 (see Figure 42a) which will serve as the point of reference for placing the rest of the 12 mandatory sensors. Figures 42 (b-f) illustrate the sequential recommended placement of the mandatory sensors. y Place sensor 2 in the front left corner attached to the wall at mid-height of the storage unit. y Place sensor 1 directly below sensor 2 in the front left corner on the floor or attached to the wall close to the floor. y Place sensor 3 in the front left corner, attached to the wall close to the ceiling. y Place sensor 4 in the rear left corner on the floor or attached to the wall close to the floor. y Place sensor 5 at mid-height in the rear left corner, at the same level as sensor 2. y Place sensor 6 in the rear left corner, attached to the wall close to the ceiling. y Place sensor 7 in the rear right corner on the floor or attached to the wall close to the floor. y Place sensor 8 at mid-height in the rear right corner, at the same level as sensors 2 and 5. y Place sensor 9 in the rear right corner, attached to the wall close to the ceiling. y Place sensor 10 in the front right corner on the floor or attached to the wall close to the floor. y Place sensor 11 at mid-height in the front right corner, at the same level as sensors 2, 5 and 8. y Place sensor 12 in the front right corner, attached to the wall close to ceiling. After placement of all 12 mandatory sensors, place the sensor designated to measure ambient temperature just outside of the cold chain equipment, at a mid-height of the equipment. A summary of recommended sensors location is presented in Table 4. Note: It is very important that the 12 fixed sensors are in their correct positions in the unit’s four corners at the correct level (floor, mid-height and ceiling). How to Temperature Map Cold Chain Equipment and Storage Areas 35 Figure 42 (a-f). Correct positioning of the 12 mandatory sensors in a cold chain equipment or dry store h/2 h/2 Position of sensor Front 2 a. Correct placement of sensor 2. b. Position of sensors 1, 2 and 3 c. Position of sensors 4, 5 and 6 d. Position of sensors 7, 8 and 9 e. Position of sensors 10, 11 and 12 f. Properly placed mandatory sensors How to Temperature Map Cold Chain Equipment and Storage Areas 36 Table 4. Quick reference guide for placement of 12 mandatory sensors Sensor number Position of fixed sensors Side Corner Level Fixed sensors 1 Front Left Close to floor 2 Front Left Mid-height 3 Front Left Close to ceiling 4 Rear Left Close to floor 5 Rear Left Mid-height 6 Rear Left Close to ceiling 7 Rear Right Close to floor 8 Rear Right Mid-height 9 Rear Right Close to ceiling 10 Front Right Close to floor 11 Front Right Mid-height 12 Front Right Close to ceiling 21 (or whichever number is the last) Immediately outside of the cold chain equipment at a mid-height of the equipment Ambient Step F.2. Identifying risk zones for placement of optional sensors Identify the risk zones for each piece of cold chain equipment or store room to be temperature mapped (Figure 43). The presence of risk zones determines the ideal placement of the optional sensors. Considerations for identifying risk zones The definition of risk zones varies depending on the type of storage unit and the nature of the items to be stored in the storage unit. y If temperature mapping a cold room for storing freeze-sensitive vaccines, the risk zones are areas where the temperatures are below +2°C or above +8°C. y If the equipment is a freezer, the risk areas are where temperatures are above -10°C. y For the dry stores, all areas where the temperature is below +5°C and above +35°C are inappropriate areas for storing pharmaceutical items and diluents. How to Temperature Map Cold Chain Equipment and Storage Areas 37 Figure 43. Quick guide for identifying risk zones Dangerous zone for freeze-sensitive and heat-sensitive vaccines and other pharmaceuticals y Below 0°C for more than 60 consecutive minutes y Below +2°C for a relatively long time y Above +8°C for a relatively long time Cold-rooms and Refrigerators Dangerous zone for lyophilized vaccines at national and sub-national levels y Above -15°C for a relatively long time y Very inappropriate areas above 0°C Freezer-rooms and Freezers Dangerous zone for pharmaceuticals and diluents y Above +35°C for a relatively long time y Below +5°C Dry Stores Step F.3. Positioning the optional sensors Place the remaining sensors (sensor 13 onwards) on the shelves (if any) or in identified/suspected risk zones inside the equipment or store room. Step F.3.1. Positioning the optional sensors in the cold rooms Place the optional sensors anywhere inside the cold room where you think the temperatures may be outside the range of +2 to +8°C. It is advisable to place one sensor close to the door. Table 5 describes the suggested positions for the optional sensors inside a cold room. Table 5. Guide for placement of optional sensors in cold rooms Sensor number Position of optional sensors 13 Up to 10 centimetres from the front of evaporator 1 at the same level of the air flow or on the top shelves Optional sensors 14 Up to 10 centimetres from the front of evaporator 2 at the same level of the air flow or on the top shelves 15 In the middle of the lowest shelf in front of evaporators 16 On shelf close to the door 17–40 Wherever there might be a risk area for freeze and heat sensitive products. How to Temperature Map Cold Chain Equipment and Storage Areas 38 Step F.3.2. Positioning the optional sensors in freezer rooms Place the optional sensors anywhere inside the freezer room where you think the temperatures may be above -15°C or the warmest area inside the unit to be temperature mapped. It is advisable to place one sensor close to the door. Table 6 shows the suggested positions for the optional sensors inside a freezer room. Table 6. Guide for placement of optional sensors in freezer rooms Sensor number Position of optional sensors Remarks 13 At the centre of the unit close to the ceiling Optional sensors 14 Close to the ceiling and near the door 15 On the shelf close to the door’s higher level 16 On the shelf close to the door’s lower level 17 Wherever there might be a risk that the temperature might be above freezing point18 19 20 …. …. 40 Step F.3.3. Positioning the optional sensors in dry stores Place the optional sensors anywhere inside the dry store where the temperature might be above +35°C, or the warmest area inside the store room. It is advisable to place one sensor inside the unit, close to the door. Table 7 shows the suggested positions for 8 optional sensors inside a dry store. Table 7. Guide for placement of optional sensors in dry stores Sensor number Position of fixed sensors Remarks 13 At the centre of the store close to the ceiling Optional sensors 14 Close to the ceiling and near the door 15 Close to the ceiling and near the door 16 On shelf close to the door higher level 17 Wherever there might be a risk that the temperature may be outside the acceptable range18 19 20 …. …. 40 Note: While the number of mandatory sensors cannot be change, the number of optional sensors can be reduced for smaller storage rooms and equipment. How to Temperature Map Cold Chain Equipment and Storage Areas 39 Step F.4. Activating LogTag® sensors Once all LogTag® sensors are in their correct positions, activate them by pushing and holding for a few seconds the <Start> button on each sensor (see Figure 44). This is an important step and can easily be forgotten. This process does not apply to Q-tag® and Libero® sensors. Figure 44. Start button to be pushed to activate the LogTag® sensors Step F.5 Close the storage unit’s door(s) and leave the sensors there for 48 to 72 hours without opening the unit in between. The minimum period for temperature mapping is 48 hours and the maximum is 72 hours. Very important: Put a highly visible sign in appropriate language(s) on the door to warn that there is a temperature mapping in progress. A sample sign, which warns to NOT open the door, touch the thermostat or turn off the machine, is available in Annex 3. Step F.6 Place the last sensor – prepared for recording the ambient temperatures – just outside the unit to be temperature mapped. See Table 4 for sensors’ recommended placement. How to Temperature Map Cold Chain Equipment and Storage Areas 40 Section G. Removing sensors and downloading temperature readings to the temperature-mapping application This section explains how to remove the sensors positioned inside the store room or equipment after the pre- determined period of time, and how to transfer the recorded temperature information to the equipment-specific Temperature Mapping tool. If several storage units have been temperature mapped, make sure data are entered into each unit’s corresponding Temperature Mapping tool. Step G.1 Remove all the sensors from the storage equipment or storage room and stack them in order, from the first to the last sensor. Keep the ambient temperatures sensor separate from the other sensors. Step G.2 Download and save the recorded temperature data from the sensors. The following steps (G.2.1 G.2.2, and G.2.3) present the steps for recording data from the three types of sensors. It is not necessary to read the steps for all three types. Read only the steps related to the device you are using for temperature mapping. Step G.2.1. Downloading recorded data from LogTag® sensors Download and save the recorded temperature data from LogTag® sensors. Open the <Common files> sub-folder of the Temperature Mapping source folder. Double click on the <Option_LogTag®. asxml> file to download the recorded temperature data from the LogTag® sensors. Step G.2.1a Connect the LogTag® interface to the computer where the LogTag® Analyzer is downloaded (see Step E.2.1b “Preparing and configuring the LogTag® sensors”). Then, open the LogTag® Analyzer application (see Step E.2.1a). Step G.2.1b Insert sensor 1 in the LogTag® interface (see Step E.2.1c). Allow the application to complete reading and connecting to sensor 1 (Figure 32). A graph of the temperature reading will then appear on the screen as shown in Figure 45. How to Temperature Map Cold Chain Equipment and Storage Areas 41 Figure 45. Sample of graphed temperature readings Step G.2.1c Save the temperature data recorded in the sensors to the LogTag® Analyzer. To describe the necessary actions for correctly saving the recorded temperature data in the sensors, use “sensor 1” which contains temperature data take in “cold room 1”. The following set of procedures is illustrated in Figure 46. a. First, go to <File> and select <Save as>. b. When the <Save as> window opens, click on the following folders in a sequential manner: <Documents>, <Temperature Mapping>, <.TM Cold-room 1>, <Device Outputs> and <sensor 1>. c. Then, within the “save as” window, just below the <File name>, check the options for “save as type” from the dropdown list. Select <Text (tab delineated)>. This procedure is very important. d. Check the <Include Summary> tick box. e. Finally, click on <save>. Figure 46 (a-d). How to save temperature data from the LogTag® sensor to the LogTag® Analyzer Documents Temperature Mapping .TM Cold-room 1 Device Outputs Sensor1 a. “save as” must be used b. Sequential actions to save data to the right “sensor” folder How to Temperature Map Cold Chain Equipment and Storage Areas 42 c. Choosing the correct sensor folder to save data d. Saving data to the LogTag® Analyzer Note. <.TM Cold-room 1> in Figure 46 is used only as an example. This could be any storage room or equipment. Step G.2.1d Once the file is saved, click on <LogTag® > and select <Hibernate ... F5> as shown in Figure 47. This turns off the sensor and deletes all temperature readings. Note: Perform step G.2.1d only when you are certain the recorded temperature data is saved on the LogTag® Analyzer, because you will NOT be able to retrieve the data if they are not saved. Figure 47. Clicking <Hibernate...F5> will delete all temperature data from the sensor Step G.2.1e Repeat Steps G.2.1b to G.2.1d, including all of their sub-steps, for each sensor used in mapping temperature of a specific storage room or equipment, including the sensor for measuring and recording ambient temperature. For example, if there were 20 sensors inside the storage room/equipment and one sensor for recoding ambient temperatures, you must repeat steps G.2.1b to G.2.1d 20 more times. Step G.2.2. Downloading recorded data from Q-tag® sensors Download and save the recorded temperature data from Q-tag® sensors. The steps described below are specific only for Q-tag® sensors. How to Temperature Map Cold Chain Equipment and Storage Areas 43 Step G.2.2a Hold the <START/STOP> button (see Figure 48) until the word “OFF” appears in the corner of the screen of the Q-tag® sensor. This stops it from recording temperature readings. Note: If you do not stop the recording, the computer cannot retrieve the data from the device. Figure 48. Stopping the Q-tag® sensor from recording temperatures Step G.2.2b y Connect the Q-tag® sensor to the computer’s USB port. If the device is connected properly to the computer, a check symbol () and the letters “USB” will appear on the card’s display as shown in Figure 49. Figure 49. Check mark appears on Q-tag® sensor when successfully connected to a computer How to Temperature Map Cold Chain Equipment and Storage Areas 44 A virtual drive will be created automatically in the computer. The drive’s name is <CLM DOC>. Step G.2.2c Go to the computer’s main drive <Computer> and choose the virtual drive <CLM DOC>. Open the drive, which will access a list of files. One of the files has a text extension (.txt). See example in Figure 50. Figure 50. Sample of an automatically created file with a “.txt” extension <BDAE00266_10_201509060817.txt> (example) The following describes the necessary actions to save the recorded temperature data from the sensor to the computer. For this exercise, we use “sensor 1”, which contains temperature data taken in “cold room 1”, as an example. a. First, select and copy the text file created in the <CLM DOC> virtual drive. Example: “BDAE00266_10_201509060817.txt”. b. Copy this text file to the sensor folder with a name corresponding to the sensor number. c. Locate the sensor 1 folder by opening the following folders in a sequential manner: <Documents>, <Temperature Mapping>, <.TM Cold-room 1>, <Device Outputs> and <sensor 1>. d. Then, paste the text file (e.g. “BDAE00266_10_201509060817.txt” in “sensor 1” folder. This saves the data from sensor 1 to the computer. Step G.2.2d Remove the device from the computer. There is no need to push the <START/STOP> button as the device has already been deactivated in Step G.2.2a. Step G.2.2e Repeat Steps G.2.2a to G.2.2d for all other Q-tag® sensors. Step G.2.3. Downloading recorded data from Libero® sensors Download and save the recorded temperature data from Libero® sensors. If you use the Libero® model Ti1-L sensor, you will have already downloaded the software “elproVIEWER”. This software usually is in the folder “Program Files”. Install the software and a shortcut icon will appear on the computer’s desktop. The steps described below are specific only for Libero® sensors. Step G.2.3a Press the <STOP Arrived> button on the Libero® sensor. Step G.2.3b Click on <elproVIEWER> desktop shortcut to run the application. Note: You’ll need to type in a serial number code the first time you run this software. Use this generic code: <N865C- EBBJG-2GRMQ-U7GMG-AJCCS-9>. Step G.2.3.c Connect the Libero® sensor device to the computer’s USB port as shown in Figure 51. A virtual drive – labelled “Libero” – will be created automatically. How to Temperature Map Cold Chain Equipment and Storage Areas 45 Figure 51. Connecting the Libero® sensor to the computer Step G.2.3d Go to the computer’s main drive and click on <Computer>, then select the <Libero> virtual drive as indicated in Figure 52. Figure 52. Selecting the “Libero” virtual drive in the computer Open the drive and you will see a file in a portable document format (PDF), represented with a “.pdf” extension. See sample shown in Figure 53. Figure 53. Sample of a file in “.pdf” format generated by “Libero”, which contains recorded temperature data PDF Libero PDF report 201509064804 15019552.pdf (example) How to Temperature Map Cold Chain Equipment and Storage Areas 46 The following describes the necessary actions to save the recorded temperature data from the sensor to the computer. For this exercise, we use “sensor 1”, which contains temperature data taken in “cold room 1” as an example. a. Select and copy the text file created in the <Libero> virtual drive. Example: “Libero PDF report 201509064804 15019552. pdf”. b. Copy this text file to the sensor folder with a name corresponding to the sensor number. c. Locate the sensor 1 folder by opening the following folders in a sequential manner: <Documents>, <Temperature Mapping>, <.TM Cold-room 1>, <Device Outputs> and < sensor 1>. d. Paste the text file (e.g. “BDAE00266_10_201509060817.txt” in “sensor 1” folder. This saves the data from sensor 1 to the computer. Step G.2.3e Create a text file in the sensor folder by performing the following actions (see Figure 54). a. Right click the white part of the screen and a menu will open. b. Select <NEW>. c. Select <Text file>. d. Give the new text file an easily recognizable name. Example: “Libero 1.txt”. Figure 54. Creating a new text file within the sensor folder Step G.2.3f Open the sensor data file using the “ElproViewer” application by performing the following actions. a. Go to <ElproViewer> software. b. Click on <Add File(s)> from the top menu (see Figure 55). c. Browse to find the relevant sensor folder in which the “.pdf” file was copied in Step G.2.3d. d. Select the file and then click open. In this example, the path is <Documents/Temperature Mapping/.TM Cold- room 1/Device Outputs/Sensor1>. e. When the “.pdf” file opens, click on the <Table> tab at the bottom of the window (see Figure 56). f. Then, click the box in the upper left corner of the table. How to Temperature Map Cold Chain Equipment and Storage Areas 47 g. Right click on the same point (e.g. the box in the upper left corner of the table) and a new box <Copy selected rows to clipboard> will open. h. Click on the newly opened box <Copy selected rows to clipboard> and wait until data retrieval is completed. Figure 55. Location of “add file(s)” in the ElproViewer application Figure 56. Window showing retrieved temperature data from the data table Step G.2.3g a. Go back to the relevant sensor folder. In the example used, the path is <Documents/Temperature Mapping/.TM Cold-room 1/Device Outputs/Sensor1>. b. Open the text file created in this folder in Step G.2.3e. In this example, the text file was named <Libero 1.txt>. c. Copy the data in this text (its name has a “.txt” extension) file. This action will allow all data rows to be pasted into this text file. d. Click <Save> and close the text file. How to Temperature Map Cold Chain Equipment and Storage Areas 48 Step G.2.3h Close “elproVIEWER” software. Step G.2.3i Repeat Steps G.2.3a to G.2.3h for all the Libero® sensors. Note: Do NOT change the name of the <Device Outputs> folder! From this point forward, the steps shown apply to all three types of devices. Step G.3. Importing the temperature data to the main Temperature Mapping tool Open the equipment-specific Temperature Mapping tool. For this exercise, we use “Cold Room 1” as an example. a. Open the Excel® file <Cold-room 1.xlsm> located in the “.TM Cold-room 1” sub-folder of the Temperature Mapping main folder (see Figures 5 and 6). b. Click on the <Logged Data> tab as shown in Figure 57. This will take you to the “Data” worksheet of the tool. c. Click on <Import Data> as shown in Figure 58. Figure 57. Location of the “logged data” worksheet for importing temperature data in the equipment-specific Temperature Mapping tool How to Temperature Map Cold Chain Equipment and Storage Areas 49 Figure 58. Importing recorded temperature data to the equipment-specific Temperature Mapping tool The table in the “Data” worksheet will automatically be filled with the required information from recorded temperatures. All the information is automatically extracted from all sensor files in the “Device Outputs” folder. DO NOT CHANGE this folder’s name. If any of the cells in the “Data” sheet table are empty, it means there might have been some errors in downloading recorded temperature data from the sensors. The table in the “Data” worksheet should be cleared first before repeating the previous steps to determine what might have gone wrong. Once the prerequisite steps are performed again without any issues, repeat Step G.3. All rows in this table should be filled with some digits and/or text. If any row is blank, you should identify and solve the problem. The information in the table within the “Data” worksheet is very important since this will be imported to the “Report” worksheet, which will become the basis for decision-making. Important! Anytime you change the “start date and time” and/or “end dates and time” on the main page, the data should be re-imported. How to Temperature Map Cold Chain Equipment and Storage Areas 50 Figure 59. Sample of data table auto-filled with temperature-recording information imported from the sensors The variables for plotting sensor-recorded temperature data, shown in Figure 59, are further described in Table 8. Table 8. Description of the variables in the “Data” table of Temperature Mapping tool Column no. Column title Descriptions (1) Sensors The numbers are those assigned to the sensors as per the instructions in Step E.1 of Section E. (2) Mean Kinetic Temperatures (C) Mean kinetic temperature (MKT) is the calculated average temperature for each sensor from approximately 216 temperature readings recorded during the test’s duration (48 hours). (3) Min (C) The lowest temperature recorded for each sensor based on approximately 216 temperature readings. (4) Max (C) The highest temperature recorded for each sensor based on approximately 216 temperature readings (5) Mean (C) This is the absolute average temperature, being the sum of all temperatures recorded in all sensors from the beginning to the end of the temperature readings divided by the total number of readings. The mean temperature may not be the same as the recorded mean kinetic temperature. (6) Standard Deviation Standard deviation (SD), represented by the Greek letter σ (sigma), is the quantitative measurement of the amount of variation across a set of data values. A small SD means that most of the readings are similar, while a large SD indicates a large variation across the sensor readings. When SD is equal to zero, it means that all temperature readings are exactly the same. How to Temperature Map Cold Chain Equipment and Storage Areas 51 Column no. Column title Descriptions (7) Safe range Also called “non-alert temperatures range”. The safe temperature range is chosen as per the instructions found in step D1.1 in Section D. For example, safe temperature ranges for: y cold rooms and refrigerators: +2° to +8°C y freezer rooms and freezers: -5° to -15°C y dry stores: +5° to +35°C. (8) Accumulated time below lower alert Accumulated total time in which each sensor’s temperature reading was below the safe temperature range (9) Accumulated time above upper alert Accumulated total time in which each sensor temperature reading was above the safe temperature range (10) Total Freezing Time Number of times each sensor was continuously exposed to temperature equal to or less than 0°C for 60 minutes. This criterion is based on the performance of a FreezeTag® device, which is used to monitor freeze- sensitive vaccines during storage and transportation time. (11) Not enough data for the duration of the test! There might be a cross in red (X) in one or more rows. This means that this particular sensor either did not work at all and did not record temperature data or at a certain time during the test period stopped recording. (12) Not enough data for the “hold- over time” test! There might be a cross in red (X) in one or more rows. This means that this particular sensor either: i) did not work at all and did not record temperature data or, at a certain time during the test period, it ii) stopped recording after the temperature mapping test was completed and the hold-over time test started. This function works only when you activate the hold-over time in cell D20 of the “Test” worksheet (see Figure 27). Step G.4 Once you are satisfied with the data imported into the table, open the <Sketch> worksheet as shown in Figure 60. This worksheet provides a graphical representation of the temperature mapped cold room, including its dimensions, evaporators, shelves and sensors locations, and the status of the recorded MKT. It also has a color-coded legend for temperature alert levels. How to Temperature Map Cold Chain Equipment and Storage Areas 52 Figure 60. Sample of a “Sketch” worksheet showing sensor detecting fluctuations in temperature reading within a cold room As shown in the above example, if any of the sensors recorded MKTs above the higher defined limit, the colour will turn to red. If any of the sensors recorded MKTs below the lower defined limit, the colour will turn to blue. Green means the temperatures stayed within the defined limit. How to Temperature Map Cold Chain Equipment and Storage Areas 53 Section H. Obtaining the Temperature Mapping Report You are almost done. It is now time to review the Temperature Mapping Report. All information about the cold chain equipment or dry store is summarized in the “Report” worksheet of the Temperature Mapping tool. This worksheet is write-protected since all information has been extracted from the data generated by the previous steps. Step H.1 Open the <Report> worksheet as shown in Figure 61. Carefully review the information provided, such as graphs, pictures and tables to make sure everything is in order. Note: It is important to examine all the information in this worksheet and take note of any problematic findings before printing/sharing the report. Figure 61. Sample of the “Report” worksheet in the Temperature Mapping tool How to Temperature Map Cold Chain Equipment and Storage Areas 54 Section I. Making decisions and taking action It is now time to make decisions about how to use the gathered data to improve the store room and equipment that were temperature mapped. You should determine whether the store room or equipment is: 1. Fully suitable. Can items be stored safely throughout the area or in the equipment? 2. Partially suitable. Are there some areas inside the equipment or storage area not suitable for storing the items? 3. Not at all suitable. Is the equipment or storage area mapped not at all suitable for storing the items? In the case of conditions 2 and 3, recommendations should be made as to how to improve the temperature stability of the cold chain equipment or storage area. The date for the next scheduled or ad hoc temperature mapping should be determined and recorded. Use the decision-tree matrix provided in Step I.2 to guide you in making decisions on appropriate action points. Step I.1 Review the MKT recorded for each sensor. Specifically, this information is found in cells C39 onwards in the summary table of the “Report” worksheet. Pay close attention to the temperature data highlighted in red, as these are the areas that require problem-solving. Step I.2 Based on the calculated MKT presented in the summary report table of the “Report” worksheet (sample provided in Figure 61), determine the recommended action points by following the matrix in Figure 62. How to Temperature Map Cold Chain Equipment and Storage Areas 55 Figure 62. Flow chart to guide decision-making and actions Ch ec k al l M KT O f a ll se ns or s Ye s Ye s N um be r o f s en so rs ou ts id e th e de fin ed ra ng e Ch ec k m in a nd m ax te m pe ra tu re Ye s Ye s N o Ye s N o Ye s N o N o N o (s ee M in C & M ax C c ol um ns ) (s ee M in C & M ax C c ol um ns ) N o N o Ar e th e M KT w ith in ac ce pt ab le te m pe ra tu re ra ng e Ch ec k m in a nd m ax te m pe ra tu re Th e te st in di ca te s th at eq ui pm en t i s no t su ita bl e fo r t he in te nd ed it em s On ly fe w o f t he se ns or s ar e ou ts id e th e ra ng e M aj or ity o f t he se ns or s ar e ou ts id e th e ra ng e Al l s en so rs a re ou ts id e th e ra ng e Is a ny s en so r sh ow in g re la tiv el y hi gh er o r l ow er th an de fin ed ra ng e ? Ch ec k ov er al l di ff er en ce b et w ee n th e lo w es t m in a nd hi gh es t m ax te m pe ra tu re s Is th e di ff er en ce ve ry h ig h? Id en tif y a nd a ss es s th e ar ea a ro un d th e se ns or s w ith m ea n te m pe ra tu re s ou ts id e th e ra ng e Ca n th e pr ob le m b e re so lv ed ? M ar k th es e ar ea s w it h “D o no t s to re he at s en si ti ve it em s he re !” D o no t s to re a ny it em s in th is eq ui pm en t! Sp ec if y th e ne xt sc he du le d te m pe ra tu re m ap pi ng . Th e te st in di ca te s th at th e eq ui pm en t i s su it ab le fo r t he in te nd ed it em s Sp ec if y th e ne xt sc he du le d te m pe ra tu re m ap pi ng . Th e te st in di ca te s th at th e eq ui pm en t i s su it ab le fo r t he in te nd ed it em s Is a ny s en so r s ho w in g re la tiv el y hi gh er o r lo w er th an d efi ne d Ch ec k ov er al l d iff er en ce be tw ee n th e lo w es t m in an d hi gh es t m ax te m pe ra tu re s Id en tif y a nd a ss es s th e ar ea a ro un d th e se ns or s w ith m ea n te m pe ra tu re s ou ts id e th e ra ng e Is th e di ff er en ce ve ry h ig h? Ca n th e pr ob le m b e re so lv ed ? Im pl em en t in te rv en tio n Ye s Im pl em en t in te rv en tio n N o Ca n th e pr ob le m b e re so lv ed ? M ar k th es e ar ea s w it h “D o no t s to re he at s en si ti ve it em s he re !” Ye s Im pl em en t in te rv en tio n Im pl em en t in te rv en tio n Ye s N o D o no t s to re a ny it em s in th is eq ui pm en t! Ca n th e pr ob le m b e re so lv ed ? Te st in di ca te s th at eq ui pm en t m ay n ot b e su ita bl e fo r t he in te nd ed it em s Im pl em en t in te rv en tio n Check Min and Max (columns 3 and 4). Is any sensor showing any relatively higher or lower than accepted range? Check the overall difference between the lowest min and the highest max temperatures. Is this indicator not very high (in cell F59, page 2)? Check Min and Max (columns 3 and 4). Is any sensor showing any relatively high below and high above the range particularly for those sensors with mean temperatures outside the range? Are many of them showing high below and high above the range? The test indicates that equipment is NOT suitable for the intended items. Try to find a way to improve the situation. Do not store any items in this equipment! The test indicates that equipment may not be suitable for the intended items. Try to find a way to improve the situation. Do not store any items in this equipment! Check the overall difference between the lowest min and the highest max temperatures. Is this indicator not very high (in cell F59, page 2)? The test indicates that the equipment is suitable for the intended items. Specify the next scheduled temperature mapping. Identify area around the sensors with mean temperatures outside the range and mark them for not storing the sensitive items there! Try to find a solution to improve the situation Are mean kinetic temperatures of all sensors within the acceptable range? Only a few of the sensors are outside the range The majority of the sensors are outside the range All of the sensors are outside the range Yes YesNo No No No Yes YesYes Yes How to Temperature Map Cold Chain Equipment and Storage Areas 56 Step I.3 Open the <Actions> worksheet of the equipment-specific Temperature Mapping tool and fill in the table by following the instructions below. For this exercise, we will use cold room 1 with a defined temperature of +2°C to +8°C. Note: y For Tables A, B and C, all cells in the “Acceptable” column have a yellow background. This means that indicating either “yes” or “no” using the dropdown menu is mandatory. y If “No” is selected, the color of the adjacent cell in the column “Actions to be taken” will change to yellow. This means that you should indicate the appropriate action to address the situation. Step I.3.1 Complete Section A. Actions should be based on sensors’ detailed recorded information, as shown in the example given in Figure 63. Figure 63. Sample of filled in Table A: actions should be based on detailed recorded information Step I.3.2 Complete Section B. Actions should be based on sensors’ detailed recorded information for three horizontal layers, as shown in the example given in Figure 64. How to Temperature Map Cold Chain Equipment and Storage Areas 57 Figure 64. Sample of filled in Table B: actions should be based on detailed recorded information for three horizontal layers. Step I.3.3 Complete Section C. Actions should be based on sensors detailed recorded information in four vertical corners, as shown in the example given in Figure 65. Figure 65. Sample of filled in Table C: actions should be based on detailed recorded information for 4 vertical corners. How to Temperature Map Cold Chain Equipment and Storage Areas 58 Step I.3.4 Complete Section D by indicating your recommendation for the use of the particular cold chain equipment or dry store. Options for recommendation(s) are specified using the dropdown menu. The list of options, presented in Table 9, is dependent on the type of equipment or storage unit temperature mapped. Then, complete Section E of the “Action” worksheet with your general comments elaborating the rationale for your recommendation and other relevant remarks. This part is free typing and you can use alphanumeric characters and symbols. Figure 66 presents an example of a completed Section D and the “comments” box in Section E of the “Action” worksheet. Note: The options in the dropdown menu change based on the type of equipment being temperature mapped. Table 9. List of options for recommended actions on use of the mapped equipment or dry store. List for cold rooms and refrigerators All solid vaccines All vaccines except in areas marked above Only solid vaccines Only solid vaccines except in areas marked above Only liquid vaccines Only liquid vaccines except in areas marked above Only pharmaceutical items and no vaccines Only pharmaceutical items (no vaccines) except in areas marked above All items except pharmaceuticals and vaccines Others (specify in Section E) List for freezer rooms and freezers All solid vaccines All solid vaccines except areas marked above No vaccines No pharmaceutical item All items except pharmaceuticals and vaccines Others (specify in Section E) List for ambient temperatures (dry stores) All pharmaceutical items (no vaccine) All pharmaceutical items (no vaccine) except areas marked above No pharmaceutical item All items except pharmaceuticals and vaccines Others (specify in Section E) How to Temperature Map Cold Chain Equipment and Storage Areas 59 Figure 66. Sample of Sections D and E, indicating recommendations and comments based on the results of the temperature mapping Step I.3.4 Specify the date for the next temperature mapping of the same equipment in cell H95 of the “Action” worksheet (see Figure 67). The next schedule should be based on the actions recorded in the preceding steps. The conditions for setting the next temperature mapping date include the following. a. If the equipment is suitable for the intended items to be stored, then the next temperature mapping should be done two years after, and the succeeding schedules will be every two years henceforth. b. If some major repairs and modifications are recommended, the next temperature mapping should be done immediately after the repairs/modifications are conducted and the initial functionality tests are performed. Figure 67. The date of next temperature mapping: indicated in “cell H95” Step I.4 Printing of the temperature mapping report a. Go back to the <Report> worksheet. b. Click on <Print> tab in in cell K4. c. Make sure the report is duly signed by the responsible staff. d. Keep and file the hard copy of the report in a safe place. How to Temperature Map Cold Chain Equipment and Storage Areas 60 Section J. Managing logos The Temperature Mapping logo (filename: TM_Logo.jpg) can be found in the sub-folder “Source”, which is shown in Figure 3. To access the logo, click on the <logo Images> folder within the “Source” folder. You can also import your agency’s logo or any other logos to this folder. Figure 68 shows an image of the Temperature Mapping logo which can be used in your report or PowerPoint presentations. Figure 68. Temperature Mapping logo An error message might appear if the above-mentioned folder is not in the correct place. Usually Error 1004 relates to this issue. See Annex 4 for the list of possible error messages. Note: You should NOT move, open or use files out of their designated folders. This is very important! How to Temperature Map Cold Chain Equipment and Storage Areas 61 Section K. Repeating temperature mapping for the same equipment or identical equipment This section provides instructions for subsequent temperature mapping of the same or identical equipment. You do not need to repeat all the instructions in this guideline. There are some possible shortcuts when temperature mapping identical equipment. Step K.1. Repeating temperature mapping of the same storage units Once the initial temperature mapping has been completed, all the steps in this guideline do not have to be followed for subsequent temperature mappings. Only these short steps need to be implemented. They are based on the assumption that the same type and number of sensors will be used, and that they will be positioned in the same places as before. Step K.1.1 Copy the Temperature Mapping file from the initial mapping, and assign it a different filename. Step K.1.2 Repeat step E.2.1f of Section E and specify the current date and time. Step K.1.3 Perform all the steps in Sections F, G, H and I. Step K.1.4 Compare the results with those of previous temperature mapping reports and perform necessary actions to resolve any issues. Step K.2. Repeating temperature mapping for identical equipment This step describes the shortcuts to temperature mapping identical equipment. These shorter steps are based on the assumption that the additional equipment is exactly identical in terms of: dimension, position and size of the door(s); number and position of evaporators; and the number, shape, size and position of shelves, and all other specifications. The other assumption is that the same type and number of sensors are used, and placed in the same positions as before. Step K.2.1 Copy the Temperature Mapping file from the initial mapping, and assign it a different filename. Step K.2.2 Repeat step E.2.1f of Section E and specify the current date and time. Step K.2.3 Perform all the steps in Sections F, G, H and I. How to Temperature Map Cold Chain Equipment and Storage Areas 62 Section L. Estimating hold-over time of the storage unit The Temperature Mapping tool allows you to specify whether or not you would like to estimate the “hold-over time”. If you decide to collect the information on “hold-over time” of a specific cold chain equipment, you should follow these steps. Step L.1 Open the “Test” worksheet and select <Yes> from the dropdown menu in cell D20. This means you will be testing the “hold-over time” of the equipment to be mapped. Then, perform the temperature mapping exercise as usual. Step L.2 Switch off or disconnect the cooling units from their power supply after completing temperature mapping per required duration (e.g. minimum of 48 hours – or any duration from 48 up to 72 hours). Step L.3 Leave the sensors inside the storage unit for an additional 10 hours, without opening the door/s. Step L.4 At the end of the 10-hour period, remove the sensors from the storage unit and follow all the steps in Sections G, H and I. The temperature-mapping application will provide you with a report of the temperatures of all sensors inside the storage unit from the time the cooling units are turned off until the first sensor reaches 10°C. This will be the hold-over time of the storage unit at the recorded mean outside ambient temperature. If none of the sensors reach 10°C in 10 hours’ time, this means the hold-over time of this storage unit is equal to or greater than 10 hours after being exposed to the particular ambient temperature. How to Temperature Map Cold Chain Equipment and Storage Areas 63 Annex 1: When to conduct temperature mapping after modifications or major repairs This list is not exhaustive and any additional repairs not listed must be discussed between Departmental Manager, QA Manager and Engineers/Technicians to deduce the risk and to decide on whether mapping is required or not. y Full refurbishment of walk-in fridge / freezer y Change of Compressor on walk-in fridge freezer, upright fridge, freezer or incubator. y Re-gassing of Compressor – may be a top-up of gas or full re-gas. Implications must be discussed with engineer and decision taken locally on whether to re-map or not y Change of Fan Motor or fan motor bearings for evaporator or condenser y Change driving and non-driving end bearings followed by lubrication with correct grade of motor bearing lubricant y Circulation fan motor changed y Door catches, locks and hinge changed (external doors) y Door seal replaced due to significant irreparable damage or Door seal to be replaced before significant damage y Pipework and pipe insulation replacement or repair y Replacement of any badly worn fixed and moving contacts y Replacement or adjustment of thermostat y Total freezer defrosts and maintenance (for walk in freezer only). Defrost only may not require remapping but will need to be discussed with engineer to consider risks y Replacement of system valves y Shut down of control panel where associated plant items will also be shut down. In many cases there will be separate plant to run the cold rooms but in cases of only one system then this will require remapping y Check each stage and function of multi stage relay (step controller) in accordance with its associated controller output and ensure correct operation y For cold stores using DX Air Conditioning Units to maintain temperature: x Check condensate pump replace if necessary. Examples of minor repair / maintenance which should not routinely result in a requirement to remapping a facility x Replacement of electrical wiring mains lead; mains plug and plug wiring x Adjustment of door catches locks and hinge operation x System valves checked x Fans checked for alignment and adjustment as required x Operational test of condenser unit x Inspection of drives pulleys and impellers for wear and adjustment as necessary x Checking of chassis and drain tray for condensate leaks and drain tube for free flow x Cleaning of air-cooled refrigeration condenser filter and condenser x Checking of all pipe connections for leaks x Check set cut out points for general calibration and wear x Check control thermostats for correct temperature sets and operation x Removal of build-up of ice on doors and seals x Capillary defrost system x Forced defrost timer / system check x Verification of defrost heater function x Checking of freezer centre temperature with digital thermometer and record instrument delay x Lubrication of driving and non-driving end bearings with correct grade of motor bearing lubricant x Carry out insulation test of motor and record motor running current x Check fixed and moving contacts for wear and replace any badly worn contacts x Electric motors - check that the commutations of open type machines is satisfactory i.e. slip rings or commutators appear to be satisfactory and brushes do not require renewal. Check slip rings or commutator enclosure for carbon or metal deposits and that slip rings are not worn or grooved x Check operation of condensate pump x Sterilize clean and flush if necessary x Ensure cable terminals to be checked x Pipework and seals to be checked x Check on correct condensate discharge into drain How to Temperature Map Cold Chain Equipment and Storage Areas 64 Annex 2: LogTag® temperature data logger System requirements The following minimum specifications are required: y a computer capable of running Windows® XP SP2 or later, or Windows® 2003 Server or later y 60MB free disk space y Internet Explorer 5.0 or later y 1 available serial port and/or 1 available USB port, depending on purchased interface y 1024 x 768, or higher, screen resolution. y 256 screen colours The recommended specifications are: y Processor equivalent to Pentium IV or later y 512MB of available RAM y Internet Explorer 6.0 or later y 65535 (16bit), or more, screen colours. Using the LogTag® with the Interface LogTag® uses the standard interface cradle, wherein it is inserted into the slot from the top to enable communication. The contact pins inside the slot should connect with the matching contact pads on the LogTag® LogTag® Analyzer will automatically download and display any readings or statistics stored inside the LogTag®. How to Temperature Map Cold Chain Equipment and Storage Areas 65 Getting a LogTag® ready for use Once a LogTag® has been re- configured for its next use, any readings previously recorded will no longer be available for retrieval. Click the “Configure...” menu item located in the LogTag® menu. The values initially presented are the configuration parameters that were used when this recorder was last configured. When the details have been entered and the settings adjusted as desired, click on the “Next” button to send the configuration information to the LogTag® (s). Enter the number of sensor in “User ID” box. Choose period of 20 minutes for “Record a reading every” option. Enable alert for cold rooms between 2° to 8°C. Enable alert for freezer rooms between -20° to -10°C. Enable alert for dry store between 0° to 35°C. Configure it to alert should one continuous reading be out of range. How to Temperature Map Cold Chain Equipment and Storage Areas 66 Another way is to load the pre-saved configuration profile Getting results from LogTag® Click Download... from the LogTag® menu. How to Temperature Map Cold Chain Equipment and Storage Areas 67 Annex 3: Sample door sign for temperature mapping Temperature Mapping in Progress Do not open door! Do not touch thermostat! Do not turn off the machine! Start date and time: 01 January 2019, time: 08:00:00 Expected end date and time: 02 January 2019, time: 10:00:00 How to Temperature Map Cold Chain Equipment and Storage Areas 68 Annex 4: Error messages Error # 1004 This error message may appear when you open the source file. This error message indicates that one of the required files for this application is missing in the Temperature Mapping folder. There are two folders that may be missing and cause this error message: 1. Logo Images 2. Device Output This message may appear three times as there are two separate files in Logo Images and the application is searching for these files twice and as well for the Device Output file. If you click on OK, the application may open but: 1. You may not have logos in your reports 2. You will have problems with transferring data from the temperature readings recorded by the sensors. Therefore, it is better to resolve the problem beforehand, making sure that all related and required folders and files are present and in the correct order. Error # 91 This message will appear when you try to transfer recorded temperatures from the <Device Outputs> and the folder is not in the correct location. This usually appears when you click on cell J6 in the Data sheet. Click on OK and then make sure the related and the correct <Device Outputs> folder is in the Temperature Mapping folder. Error # 5 This error message may appear in the Data sheet when you click on cell J6. This means that the Device Outputs folder is present in the correct place but the data recorded in one or more sensors do not correspond to the Start date and/or the End date in cells C36 and C37 on the Main Page. If you click on OK, the first sensor file with a problem will open. In this case, either correct the dates in cells C36 and C37 in the Main Page or replace the sensor data file in the “Device Outputs” folder. These error messages and others will appear if the instructions in this Guideline are not followed step- by-step and if the files and their order are changed. How to Temperature Map Cold Chain Equipment and Storage Areas 69 References 1. Choundhary A. SOP for Temperature Mapping Study. Pharmaceutical guidelines. [blog]. (not dated) (https://www.pharmaguideline.com/2008/02/sop- for-procedure-for-temperature.html, accessed 26 Nov 2019). 2. Debreceni A. Planning a Successful Warehouse Mapping Study. Masy Bioservices. 2019. 3. Drucker B (2013). Proper storage and shipping of pharmaceuticals with the aid of temperature mapping. Ezine @articles. [blog]. 2013 (http://ezinearticles. com/?Proper-Storage-And-Shipping-Of- Pharmaceuticals-With-The-Aid-Of-Temperature- Mapping&id=7941976, accessed 26 Nov 2019). 4. Eight Steps to Validating/ Mapping a Chamber  : Application Note. Vaisala. Helsinki, Finland. 2011 (https://www.vaisala.com/sites/default/files/ documents/LSH-8-Steps-to-Mapping-Validation- Project.pdf, accessed 26 Nov 2019). 5. Ellab Validation Solutions. Temperature Mapping: Facts and Considerations. [Ellab White Paper]. 2019 (https://www.ellab.com/Files/Files/White- Papers/White-Paper-Temperature-Mapping- Facts-and-Considerations-ellab.pdf, accessed 26 Nov 2019). 6. Gibson AC. Warehouse temperature mapping explained. Ezine @rticles. [Blog]. 2011 (http:// ezinearticles.com/?Warehouse-Temperature- Mapping-Explained&id=6192578, accessed: 26 Nov 2019). 7. Jacob D. Temperature Mapping in Pharmaceuticals. Pharma Treasures. [Blog]. 2011 (https://pharmatreasures. blogspot.ca/2011/10/temperature-mapping-in- pharmaceuticals.html, accessed: 26 Nov 2019). 8. Powell S., Molinolo A., Masmila E., Kaushal S. Real- Time Temperature Mapping in Ultra-Low Freezers as a Standard Quality Assessment. Biopreservation and Biobanking Vol. 17, No. 2, 2019. 9. Silverman K. “Temperature mapping study of United States distribution systems” (thesis). Rochester Institute of Technology. Scholar Works, 2012 (http://scholarworks.rit.edu/cgi/viewcontent. cgi?article=8357&context=theses, accessed 26 Nov 2019). 10. Taylor J. Recommendations on the Control and Monitoring of Storage and Transportation Temperatures of Medicinal Products. 2012 (https:// temptrust.mesalabs.com/wp-content/uploads/ sites/47/2012/05/MHRAcon007569.pdf, accessed: 26 Nov 2019). 11. Temperature Mapping. Validation-Online. Net. 2005 (https://www.validation-online.net/ temperature-mapping.html, last accessed 26 Nov 2019). 12. Vacker LLC. Detailed Procedure and Guidelines on Temperature Mapping Study and Qualification of Cold Rooms, Warehouses, Vans, Trucks, Reefers, Refrigerators and Boxes for Pharmaceutical Industry. Vacker LLC. Ver 3. Dubai, UAE. 2016 (http:// www.vackerglobal.com/pdf/temperature-mapping- study-and-qualification.pdf, accessed 26 Nov 2019). 13. Weddle, GB, Benton, RL. Temperature Mapping and Monitoring: Quality-Control Tools for Pharmaceutical and Medical Device Warehousing. Johnson Controls, Inc : Milwaukee, USA. 2004. 14. WHO. Temperature Mapping of Storage Areas. Supplement 8 to WHO Technical Report Series, No. 961, 2011. WHO HQ, Geneva, May 2015. How to Temperature Map Cold Chain Equipment and Storage Areas 70

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