Department of Clinical Sciences/ Unit of Tropical Laboratory Medicine Département des Sciences Cliniques / Unité de Laboratoire de Médecine Tropicale SOP: Prepare Cold Chain (2-8 C) shipment of clinical samples in tropical settings. Type: Standard Operating Procedure (SOP) Status: draft Written by: vhermans Create Date: 20090902 Reviewed by: hdeboeck Save Date: 20091026 1. OBJECTIF Prepare shipment of clinical samples of Category B UN3373 in a triple packaging with a 10L capacity. Maintain temperatures inside packaging between 2 and 8 C for at least 3 days (72h). 2. PRINCIPE Eliminate the danger of freezing during transport by providing clear guidelines on how to pack and transport clinical samples between restricted temperatures of 2 and 8 C in tropical settings. Proper packaging of clinical samples and environmental test samples of category B (UN3373) includes four basic requirements: 1. Watertight Primary Receptacles 2. Watertight Secondary Receptacles 3. Absorbent Material 4. Sturdy Outer Packaging Maintaining the temperature by using other packaging materials and other volumes than described in this procedure should be tested first before making the shipment. - 1 -
3. MATERIALS - Polyurethane triple packaging: 10L, outer dim 310 x 310 x 320 mm - Polypropylene container (1250ml) - Cardboard inner separation 10L/40 - Absorbent paper - 4 water packs: 0,6L - Freezer with temperature at -20 C - Thermometer inside de freezer - StopWatch Freeze-tag 3M - Detailed list of package content in plastic map - Label UN3373 - Label to show the package must be stored in a cold room (around 5 C) - Tape - Scissors - Marker 4. QUALITY CONTROL To verify that the content of the package was not exposed to temperatures extreme temperatures (below 0 C and above 10 C) a StopWatch Freeze-tag 3M is placed inside the polypropylene container, next to the clinical samples. A cross will appear on the freeze tag when the samples are exposed to temperatures below 0 C for longer than 60 minutes. The color of the monitor mark will change when the samples are exposed to high temperatures. - 2 -
5. PROCEDURE 1. Fill 4 water packs with tap water and close tightly Do not fill them to the top or they will burst in the freezer (until the line indicated on the picture). Figure 1: Fill the water packs with tap water up til the red line indicated on the picture. 2. Check if the water packs are not leaking by holding them upside down and squeezing them. 3. Put the 4 water packs in a freezer of -20 C for at least 24h. If possible, choose a freezer in a cooling room (5 C). 4. Monitor the temperature of the freezer with a thermometer. 5. Apply the label UN3373 on the outside of the package. If the label is not available: Print the template which is added in the annex below OR Draw the label UN3373 BIOLOGICAL SUBSTANCE CATEGORY B with a marker on the triple packaging. Figure 2: Apply the UN3373 label on one side of the triple package. It is of no importance on which side. - 3 -
6. Apply the label that indicates to store the package in a cold room on the outside of the package. If the label is not available you can print the label which is added below this SOP or write STORE BETWEEN 2-8 C on the outside of the package. STORE BETWEEN 2-8 C Figure 3: Apply the cold storage label on one side of the triple package. It is not important on which side. 7. Apply the shipper s and consignee s address on the outside of the triple packaging. The label must contain: name, address and telephone/fax number of both shipper and consignee (receiver). The information can be printed and pasted on the packaging or can be written with a marker. Figure 4: Apply the shipper s and consignee s address on the outside of the triple packaging.it is of no importance on which side. 8. Store the triple packaging in a cold room (5 C), while waiting for the transport. 9. After 24h: take out the water packs and check if they are completely frozen. 10. If you can still hear water inside the water pack while shaking, go back to step 3. If the water packs are completely frozen, you can proceed to the next step. - 4 -
11. If possible, continue the packing of the triple packaging in the cooling room. 12. Check if the triple packaging is clean and dry. If the packaging is wet and dirty, take another triple packaging. 13. Place the cardboard inner separation inside the triple packaging. CARDBOARD INNER SEPARATION 14. Take 2 water packs out of the freezer and keep the 2 other water packs in the freezer. 15. Hold the 2 water packs you took out of the freezer under running tap water for 2-3 minutes. 16. Shake the water pack. If you can hear water running, proceed to next step. If the water pack is still frozen, go back to step 15. Ref fig: WHO 1999, Vaccination pratique La chaîne du froid - 5 -
17. Dry the water packs with a tissue. 18. Take the triple packaging and place the 4 water packs inside. Place a conditioned water pack next to a frozen water pack. FROZEN WATER PACK CONDITIONED WATER PACK 19. Take a close look at the samples/tubes: make sure all the bottles are sealed properly. 20. Avoid direct contact between the samples/tubes. Take the samples/tubes and wrap them inside the absorbent paper. 21. Put the wrapped samples/tubes inside the propylene container and fill the container up using absorbent paper to limit movement. - 6 -
22. Take a close look at the StopWatch Freeze-Tag 3M device. Make sure the MonitorMark and the Freeze-Tag are well attached on the paper. If this is not the case, throw the device away and take another one. MONITORMARK Figure 5: Check if the StopWatch Freeze-Tag 3M device consists of a MonitorMark and a Freeze Tag. FREEZE-TAG 23. Check if the strip to activate the MonitorMark is not yet removed. If the strip is already removed, throw the StopWatch Freeze-Tag 3M away and take another one. Figure 6: Check if the strip to activate the MonitorMark is not yet removed. Strip to activate the MonitorMark 24. Check if the Freeze-tag on the StopWatch Freeze-tag 3M device is in the OK status. This means that the display gives a V sign and not a cross on the display. If the V sign is displayed, proceed to the next step. If the cross is displayed, throw the StopWatch Freeze-tag 3M away and take another one. Figure 7: Freeze Tag: If the V sign is displayed, the Freeze tag is ready to use. If the cross is displayed, you can throw away the device, it is no longer useable. - 7 -
25. Put the StopWatch Freeze-tag 3M inside the propylene container together with the samples and close the container tightly. 26. Place the container inside the triple packaging between the water packs. 27. Close the packaging by placing the cover of the box on top. 28. Place the detailed content list in a plastic map between the cover and the outer flaps. - 8 -
29. Close the triple packaging with tape. 6. MATERIAL INFORMATION Definitions Category A An infectious substance which is transported in a form that, when exposure to it occurs, is capable of causing permanent disability, life-threatening or fatal disease in otherwise healthy humans or animals. UN 2814: Infectious substance, affecting humans UN 2900: Infectious substances, affecting animals only Ex: Ebola virus, Hepatitis B virus (cultures only) Category B These are substances that do not meet the criteria for Category A. Infectious substances in Category B must be assigned to UN 3373. Ex: blood culture, AFB culture Freeze Tag An irreversible temperature indicator that shows if a product has been exposed to freezing temperatures. It consists of an electronic temperature measuring circuit with associated LCD-display. If the indicator is exposed to a temperature below -0.5 C ±0.5 C for more then 60min ± 3min the display will change from the "good" status into the "alarm" status. A small blinking dot in the right hand corner of the LED display indicates that the device is functioning. (Operating T -20 C - +50 C). - 9 -
MonitorMark A heat sensitive indicator in the form of a strip with four windows (A, B, C and D). The indicator operates above 10 C and 34 C. The higher the temperature above the CCM threshold, the more rapidly the colour changes to blue, which is irreversible even when exposed to lower temperatures again. Conditioned ice pack The ice packs are warmed to 0 C by holding them under running tap water or placing them in a bucket of water. References Material PRODUIT NUMÉRO D ARTICLE FOURNISSEUR PRIX /pp Triple Packaging PUR BIOS 001040 Exam Packaging 27,39 10L 310 x 310 x 320 mm PP containers ACSS000001 Exam Packaging 5,23 Secondary Packaging screw system 1250 ml Cardboard inner separation ACIS000001 Exam Packaging 1,68 10L/40 Water packs vide, 0,6L MSF supply 2,75 StopWatch Freeze-tag 3M PCOLCONT2R MSF supply 9,11 Thermometers MIN/MAX - 50/+70 C 620-0919 VWR 13,79 - You can find all the information concerning triple packagings, secondary packagins and cardboard inner separations at Exam Packaging at: http://www.exampackaging.be/ EXAM Packaging SPRL/BVBA Romeinsesteenweg 558 1853 Strombeek-Bever Belgium Email: info@exampackaging.be - 10 -
Phone: + 32 (0)24607755 Fax.: + 32 (0)2 460.60.45 - You can purchase the Min/Max thermometers at VWR: VWR International BVBA Researchpark Haasrode 2020 Geldenaaksebaan 464 3001 Leuven Belgium Email: customerservice@be.vwr.com Phone: + 32 (0)16 385 - You can purchase the empty water packs and StopWatch Freeze-tag 3M at doctors without borders (but you need to have a login at MSF supply): http://extranet.msfsupply.be/ Médecins Sans Frontières Rue Dupré 94 1090 Bruxelles Belgium Email: info@azg.be Phone: 02/474.74.74 7. REFERENCES - Bass A.G., 1993. Vaccines in the national immunization programme. PNG Med J 36, 141-157. - Blanchet O., Support Chaîne du froid, MSF - CDC, Vaccine management - Elliot M.A., 2005. Maintaining the cold chain shipping environment for Phase I clinical trial distribution. Int J of Pharmaceutics 299, 49-54 - Guthridge S.L., 1996. Cold chain in a hot climate. Austr and NZ J of Public Health vol. 20, no 6, 657-660 - Mihomme, 1993. Cold chain study : Danger of freezing vaccines. CCDR, vol 19-5, 33-40 - PATH, 2004. Approaches to Eliminating Freezing in Vaccine Carriers, testing report summary. - WHO 1997, Guidelines for the Safe Transport of Infectious Substances and Diagnostic Specimens. - WHO 1999, Vaccination pratique Module 3 : La chaîne du froid - http://images.fedex.com/downloads/shared/packagingtips/pointers.pdf - 11 -
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8. LABELS - 13 -