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AFNOR NF S99-700 Standard: the qualification criteria

10 June 2013

In a recent article we saw that the NF S99-700 standard offered two qualification protocols, and we mentioned the required criteria common to both protocols. Abbes Kacimi, the Expertise Director for the cold chain will now talk about the criteria to select or specify to carry out the qualification tests.

qualification nf s99-700Depending on the selected protocol (standard or specific), the qualification parameters are imposed, selected or specified. For standard qualification all the parameters below are imposed without any changes. If at least one parameter is modified the qualification is considered to be specific. In this case the parameters corresponding to the need are selected and the others are adapted by specification in the specifications document.

The parameters to select or specify to qualify an insulated shipping system under standard S 99-700

1- Test load

The test product is an empty bottle (glass or plastic) of 2 to 5 ml placed on a cardboard or plastic support, placed in a compact cardboard sheath.

2- Temperature profiles

The standard proposes 21 standard temperature profiles from 1 hour to 96 hours, thus making it possible to cover various distribution circuits and different seasons for shipping in France and Europe. These standard profiles represent different situations:

  • Short transport cycles by the patient: 4 profiles of 1 or 2 hours
  • Local distribution: 5 profiles of 6 or 16 hours
  • National and European distribution: 12 profiles of 24 hours, 48 hours or 96 hours

3- Number and location of the sensors

The minimum number of sensors is fixed depending on the working volume of the box. The rules given by the standard for the positioning of the sensors must be followed.

4- Loading rate

The tests must be carried out with minimum and maximum loading rates.

5- Thermal pre-packing

Depending on the temperature range, each element of the configuration (product, gel pack, packaging) must be stabilised at the required temperature for the required duration.

6- Constitution of the configuration to be qualified

The preparation of the configuration to be qualified (load) is carried out at (23+3) °C. The time to constitute the configuration must be the shortest possible.

7- Compliance

In the standard qualification, compliance is declared for a referenced packaging, a temperature profile and a preservation temperature interval. In the specific qualification, compliance is declared for a referenced packaging and a referenced specifications document.

Our insulated shipping systems are pre-qualified under the AFNOR NF S99-700 standard: a guarantee of performance and reliability to optimise your control of the cold chain!

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