Procedure how to prepare Cold Chain (2-8°C) shipment of clinical samples in tropical settings.
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
Reviewed by: hdeboeck
Create Date: 20090902
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.
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Procedure how to prepare Cold Chain (2-8°C) shipment of clinical samples in tropical settings.
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.
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Procedure how to prepare Cold Chain (2-8°C) shipment of clinical samples in tropical settings.
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.
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Procedure how to prepare Cold Chain (2-8°C) shipment of clinical samples in tropical settings.
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
7.
Figure 3: Apply the cold storage
label on one side of the triple
package. It is not important on
which side.
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.
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Procedure how to prepare Cold Chain (2-8°C) shipment of clinical samples in tropical settings.
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
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Procedure how to prepare Cold Chain (2-8°C) shipment of clinical samples in tropical settings.
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.
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Procedure how to prepare Cold Chain (2-8°C) shipment of clinical samples in tropical settings.
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.
Figure 5: Check if the
StopWatch Freeze-Tag 3M
device consists of a
MonitorMark and a Freeze Tag.
MONITORMARK
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.
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Procedure how to prepare Cold Chain (2-8°C) shipment of clinical samples in tropical settings.
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.
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Procedure how to prepare Cold Chain (2-8°C) shipment of clinical samples in tropical settings.
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).
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Procedure how to prepare Cold Chain (2-8°C) shipment of clinical samples in tropical settings.
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
Triple Packaging
PP containers
Secondary Packaging
Cardboard inner separation
10L/40
Water packs
StopWatch Freeze-tag 3M
Thermometers MIN/MAX 50/+70°C
-
NUMÉRO D’ARTICLE
PUR BIOS 001040
10L
310 x 310 x 320 mm
ACSS000001
screw system 1250 ml
ACIS000001
FOURNISSEUR
Exam Packaging
PRIX /pp
€27,39
Exam Packaging
€5,23
Exam Packaging
€1,68
vide, 0,6L
PCOLCONT2R
620-0919
MSF supply
MSF supply
VWR
€2,75
€ 9,11
€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: [email protected]
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Procedure how to prepare Cold Chain (2-8°C) shipment of clinical samples in tropical settings.
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: [email protected]
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: [email protected]
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
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Procedure how to prepare Cold Chain (2-8°C) shipment of clinical samples in tropical settings.
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Procedure how to prepare Cold Chain (2-8°C) shipment of clinical samples in tropical settings.
8. LABELS
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