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
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
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
- 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.
Depending on the chosen
protocol (standard or specific), the qualification parameters are imposed
(required), selected or specified.
We will specify these parameters in a future
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.