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AFNOR NF S99-700 Qualified Packaging

15 May 2013

Sofrigam insulated packaging are qualified according to NF S99-700 homologated French standard, published in October 2007 by AFNOR. It provides a thermal performance qualification method of temperature-controlled shipping solutions for health products.

Abbes Kacimi, Cold Chain Expertise Manager, tell you more about this standard:

Two qualification protocols and common criteria

NF S99-700 standard propose two qualification protocols. The standard qualification strictly follows a standard protocol for shipping packaging in France and in Europe, for 96 hours or less. The specific qualification allows adaptations to particular specifications.

Afnor nf s99-700 insulated shipping system

To perform tests, the standard requires common criteria for both types of qualification. They ensure equipment and measurement reliability:

  • The thermostatic chambers used to simulate the temperature profiles must be qualified and verified according to NF X 15-140 standard. They should ensure the stability and the homogeneity, as well as the ability to reproduce profiles segments with the required accuracy.

  • The measuring system must be calibrated and connected to national standards. It should allow the measurement of temperatures with an expanded measurement uncertainty less than 1. Data recording shall be permanent and without impact on the tightness of the packaging.

  • For the operating procedure, packaging and its components must be identified before testing. All items must be thermally stabilised and temperature sensors must be fixed on the primary packaging of the test load unit before thermal preconditioning. The minimum number of sensors is required according to the net volume of the packaging (payload). Rules are given for the locations of the sensors on the hottest points and coldest points in the packaging. Rules are also fixed for the arrangement of the containers in the thermostatic chamber air flow circulation.

  • For the interpretation of the results, the test conditions must conform to the protocol. For each temperature profile, three tests must be performed for each loading rate rate. All temperature measurements must be within the specified limits, taking into account the measurement uncertainties.

nf s99-700 qualificationDepending on the chosen protocol (standard or specific), the qualification parameters are imposed (required), selected or specified.

We will specify these parameters in a future article!

Sofrigam cold chain packaging, qualified according to NF S99-700

From large volume containers to the Nomad range for patients through VIP refrigerated boxes for very long time, all Sofrigam isothermal containers are qualified according to NF S99-700 standard. They comply with this standard according to the standard protocol or the specific protocol.

The Metrology laboratory « Ater Métrologie » certifies that Sofrigam insulated packaging meet the required criteria. « Ater Métrologie » laboratory has skills and technical means to test small and large containers up to 3000 litres, and perform more than 2000 tests per year. It is certified ISTA, ISO 9001 : 2008 and ISO 14001 : 2004.

AFNOR NF S99-700 qualification can prove the thermal performance of a temperature-controlled packaging, in the conditions described in the applied protocol.

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