Temperature control tools and supply chain management
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1 Temperature control tools and supply chain management Umit Kartoglu - WHO T. Prusik, Ph.D. 1
2 Why bother about temperature monitoring B. Schreiber Technet Thailand
3 Temperature sensihvity of vaccines Principles and considerahons for adding a vaccine to a nahonal immunizahon programme FROM DECISION TO IMPLEMENTATION AND MONITORING hvp://apps.who.int/iris/bitstream/10665/111548/1/ _eng.pdf?ua=1 3
4 Currently heat excursions are easier to detect than freezing if VVM is applied B. Schreiber Technet Thailand
5 Live avenuated influenza vaccine lacks effechveness due to high temperature exposure in US distribuhon No VVM used in US Ineffec1ve influenza vaccine administered to children Conclusions: This study showed that the lack of vaccine effec/veness observed with LAIV in the US against H1N1pdm09 viruses was associated with exposure of some LAIV lots to temperatures above recommended storage condi/ons during US distribu/on, and is likely explained by the increased suscep9bility of the A/California/7/2009 (H1N1pdm09) LAIV strain to thermal degrada9on. Vaccine Sep 30;34(42): doi: /j.vaccine Epub 2016 Sep 6 5
6 Examples and main use of WHO recommended temperature monitoring devices for storage and transporta1on of vaccines Device Int. transport Primary store In-country transport Intermediate store In-country transport Service level Electronic temperature monitor with LCD screen Vaccine cold chain monitor Vaccine vial monitor Freeze indicator Multi-channel computerized temperature recording sys. Electronic refrigerator temperature logger Downloadable electronic temperature data logger Dr. Umit Kartoglu - WHO
7 Vaccine vial monitors (VVMs) Only temperature monitoring devices that rouhnely accompany vaccines through the enhre supply chain Applied by vaccine manufacturers VVMs record cumulahve heat exposure through a gradual color change If the color of the inner square is the same or darker than the outer circle, the vaccine should be discarded VVMs do not record exposure to freezing temperatures hvp://apps.who.int/iris/bitstream/10665/183583/1/who_ivb_15.04_eng.pdf?ua=1 7
8 Cold chain monitor (CCM) cards Only used for internahonal shipment of OPV packed with dry ice CumulaHve exposure to temperatures up to +34 C is indicated by blue staining along the length of the white indicator strip marked A, B, C. Exposure to a single event above +34 C is indicated by blue staining of the white dot in sechon D of the indicator Shipping details s are recorded on the card itself by the manufacturer at the point of dispatch and by the receiving store at the point of arrival hvp://apps.who.int/iris/bitstream/10665/183583/1/who_ivb_15.04_eng.pdf?ua=1 8
9 Electronic shipping indicators Record the temperature at Hme intervals of 10 minutes or less for up to 20 days They have digital displays and pre-set alarm thresholds to reflect the heat and/or freeze sensihvity of the vaccine being shipped Some brands are able to download the temperature data to a computer. 9
10 Programmable electronic temperature and event logger systems best op1on for primary and subna1onal stores Temperature sensors should be placed in every cold room, freezer room, vaccine refrigerator or vaccine freezer in the store and directly linked to a central computer-based monitoring point via wired or wireless connechons Central data storage allows temperature records to be analyzed electronically, and the system can be configured to produce periodic reports Systems can also be configured with sensors which monitor door openings as well as other performance characterishcs such as relahve humidity and voltage fluctuahons Can also be equipped with local audible alarms and/or alarm strobes and configured to send alerts to responsible staff via auto-dialer, and SMS Internet or intranet connechvity ophons are also available; these allow for remote monitoring and alarm reporhng from mulhple sites on a nahonal basis. hvp://apps.who.int/iris/bitstream/10665/183583/1/who_ivb_15.04_eng.pdf?ua=1 10
11 Remote temperature monitoring devices hvp://apps.who.int/immunizahon_standards/vaccine_quality/pqs_catalogue/ 11
12 Stores typically have one or more vaccine refrigerators and maybe a vaccine freezer Health facilihes are onen with a single vaccine refrigerator The table below sets out the ophons in order of preference hvp://apps.who.int/iris/bitstream/10665/183583/1/who_ivb_15.04_eng.pdf?ua=1 12
13 30-day electronic temperature recorders (30 DTRs): These stand-alone devices are placed with the vaccine load in a vaccine refrigerator They log the refrigerator temperature at 10-minute intervals or less for 30 consecuhve days on a rolling basis They also record and display a 30-day history of any heat and freeze alarm violahons that have occurred Alarms are triggered if the temperature in the refrigerator drops to -0.5 C or below for 60 minutes or if it exceeds +8 C for a conhnuous period of 10 hours As long as the temperature has remained within the recommended range, the device displays OK or a Hck symbol On newer models, data can also be downloaded to a computer via a USB (universal serial bus) interface. 30 DTRs are not designed to be used in vaccine freezers hvp://apps.who.int/iris/bitstream/10665/183583/1/who_ivb_15.04_eng.pdf?ua=1 13
14 Electronic freeze indicators These are small digital devices that are placed with freeze-sensihve vaccines during transport or storage The devices have a visual indicator that shows whether the vaccine has been exposed to freezing temperatures Once the alarm indicator is triggered, the device is no longer usable and should be discarded. Otherwise the device can be used unhl the built-in bavery expires. These stand-alone devices are placed with the vaccine load in a vaccine refrigerator hvp://apps.who.int/iris/bitstream/10665/183583/1/who_ivb_15.04_eng.pdf?ua=1 14
15 Cold boxes and vaccine carriers hvp://apps.who.int/iris/bitstream/10665/183583/1/who_ivb_15.04_eng.pdf?ua=1 15
16 Transport by refrigerated vehicles hvp://apps.who.int/iris/bitstream/10665/183583/1/who_ivb_15.04_eng.pdf?ua=1 16
17 User programmable temperature loggers The principal tool for conduchng cold chain temperature monitoring studies, for transport route profiling and for temperature mapping in cold rooms, freezer rooms and refrigerated vehicles Currently prequalified models are affordable and user-friendly and can be used several Hmes The user can define alarm thresholds, set the frequency of temperature recordings and programme start and stop Hmes At the end of the study, data can be downloaded to a computer for analysis Most models have built-in baveries (when the bavery expires the device is discarded); others have replaceable baveries and can be reused hvp://apps.who.int/iris/bitstream/10665/183583/1/who_ivb_15.04_eng.pdf?ua=1 17
18 Many resources available hvp:// hvp:// hvp://apps.who.int/iris/bitstream/10665/183584/1/who_ivb_15.03_eng.pdf hvp:// hvp://epela.net/epela_web/evvm.html hvp://epela.net/epela_web/introduchon.html hvp://apps.who.int/immunizahon_standards/vaccine_quality/pqs_catalogue/ 18
19 B. Schreiber Technet Thailand
20 Challenges in the immunizahon supply chain B. Schreiber Technet Thailand
21 Challenges in the immunizahon supply chain B. Schreiber Technet Thailand
22 Challenges in the immunizahon supply chain B. Schreiber Technet Thailand
23 Challenges in the immunizahon supply chain B. Schreiber Technet Thailand
24 Growing concerns AcceleraHng pace of vaccine introduchons R. Steinglass Technet Thailand
25 Concern More storage space required for new vaccines R. Steinglass Technet Thailand
26 Concern Availability of exishng vaccines R. Steinglass Technet Thailand
27 Concern Basic vaccine management R. Steinglass Technet Thailand
28 Growing concerns New realihes for today and the future R. Steinglass Technet Thailand
29 ImmunizaHon supply chain and logishcs A Call to AcHon hvp:// R. Steinglass Technet Thailand
30 ImmunizaHon supply chain and logishcs A Call to AcHon R. Steinglass Technet Thailand
31 Case study - Turkey 31
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34 Parcel Applied 2D barcodes - Examples Package Box Primary Package Each vials are in single dose presentahons 34
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37 Integrated Health Informa1on System Stock Control Temperature Control Vaccine Information System (Aşı-net) Management Family Medicine Information System (AHBS) Decision Support System (KDS) Hospital Information System (HBS) Technet
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48 UNICEF elearning course 48
49 THANK YOU!! 49
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