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Qualification reference documents for insulated packaging: which should be given priority? (3/3)

25 April 2017

In the previous article, we looked at the qualification protocols for temperature controlled packaging solutions inherent to each reference document. In this latest article, we have listed all of the reference documents which allow thermal qualification of an insulated packaging solution to be achieved. Our cold chain expert engineer Abbes Kacimi has compared, commented on and analysed these reference documents to help you find what you need more easily.


pharmaceutical insulated packaging qualification, thermal qualification reference documents

Which thermal qualification reference documents were selected for the comparison?

Among the different reference documents , we have selected only those which have a thermal efficiency qualification method for insulated boxes , i.e. the following reference documents:

  • French standard NF S99-700
  • American standard ASTM D3103-07
  • German standard DIN 55545-1:2006-03
  • ISTA 5B Guide combined with ISTA Procedure 7D and the ISTA 7E standard
  • WHO Guidelines WHO/IVB/05.23. We have selected this guide because it proposes temperature profiles as well as the number and positioning of sensors.

Comparative table of qualification reference documents for packaging

NF S99-700 (AFNOR) ASTM D3103-07 DIN 55545-1: 2006-03 ISTA 5B, 7D and 7E WHO IVB05-23
Year of Publication 2007 1999
Révised in 2007
2006 2002, 2007 and 2010 2005
Publisher AFNOR ASTM DIN ISTA OMS
Status of reference document Norm Norm Norm Guide procedure and standard Guide
Area of
application
Insulated packaging solutions for healthcare products Insulated packaging solutions in general Insulated packaging solutions in general Insulated packaging solutions in general Insulated packaging solutions for vaccines
Content 1 qualification method and 2 protocols 1 qualification method 1 test 1 test procedure 1 test procedure
Temperature Profiles 21 variable cyclical profiles No 1 constant 72 hour profile
at +30 °C
12 variable
cyclical profiles
2 constant 48 hour profiles at +43 °C and -5°C
Number and positioning of sensors Yes No
(recom-mendations only*)
1 sensor in the centre No 
(recom-mendations only*)
Yes
Standard test product Yes No No No No
Consideration of measurement uncertainties Yes No No No No

* Overall indications on the number and positioning of sensors to guide users of the reference document without giving specifications.

Analysis and conclusion: NF S99-700, the most comprehensive reference document




NF S99-700 standard, cold chain packaging qualification, pharmaceutical packaging


Only the reference documents NF S99-700, ASTM D3103-07 and DIN 55545-1:2006-03 are produced by official standardisation bodies and have the status of norms. Both the NF and ASTM norms allow thermal qualification of temperature controlled packaging to be achieved.

Nevertheless, the NF S99-700 standard is the most comprehensive because it puts forward:

  • two packaging qualification protocols (a standard protocol and a specific protocol),
  • one standard test product,
  • 21 temperature profiles from 1 to 96 hours all year-round,
  • number and positioning of sensors. 

As for the DIN standard it does not permit qualification which guarantees a sufficient level of safety.

With regard to the ISTA 5B guide, the ISTA 7D procedure and the ISTA standard, these reference documents do not have the status of a norm. All of these documents are supplementary: their combination (fusion) in a single protocol or with the ASTM D3103-07 standard allows in effect thermal qualification to be achieved.

Lastly, the tests proposed by the WHO Guidelines (WHO/IVB/05.23) represent stress tests and do not represent the conditions of an actual logistical circuit. It can be supplementary to another reference document but on its own, it does not allow significant thermal qualification to be achieved. Only the (AFNOR) NF S99-700 standard requires measured uncertainties in the declared conformity to be taken into consideration.

With these 3 articles, we have looked at the different thermal qualification reference documents for insulated packaging solutions in order to help you choose a high performance qualified packaging solution adapted to your cold chain needs

If you have any questions, contact us

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