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25 April 2017
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:
| 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.
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:
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!
