From refrigerated containers to insulated pouches, every
Sofrigam packaging unit is tested in a metrology laboratory (in collaboration
with the Ater Métrologie laboratory). This is to ensure that the
required temperature remains constant inside the packing unit throughout the
specified period. The tests culminate in qualification of the packaging unit,
followed by its validation.
a guarantee of the performance characteristics of the packaging unit
In order to
evaluate the performance characteristics of an insulated shipping system, the qualification
procedure incorporates 4 requirements:
Qualification (DQ) involves compilation of the specification by the
of the installation (QI) is intended to
demonstrate the conformity of the solution, based on the physical criteria and
the quality requirements defined in the specification.
- Operational qualification
(OQ) consists of describing, conducting and documenting
the tests in order to define, verify and finalise the insulation solution
(procedure, ranges of application for each configuration, calibration
certificates, etc.). As part of the OQ, the
thermal properties of the refrigerated packaging unit are checked by simulating
the temperature profiles in climatic or thermostatic chambers. The QI and OQ
test reports are compiled and approved by the Supplier and the Client.
- The purpose of the Performance qualification (PQ) is to
verify the results of the OQ test under actual operating conditions. This
report is compiled and approved by the User.
compliance with the requirements of health authorities, with the submission of
a test report or a qualification dossier (whichever is required). In addition,
the results can be reproduced and used in evidence in the event of a dispute.
a test of the packaging unit under actual transport conditions
the next stage after the qualification requirement of the performance
characteristics of the packaging. It relates to all the parameters associated
with the transport process. The User
tests the solution under actual conditions of use in order to confirm that it
is fit for purpose. To this end he chooses the modes of transport and the
representative and relevant destinations.
Qualification and validation of the cold chain packaging provide
an absolute guarantee of performance and safety for temperature-sensitive
products. While qualification demonstrates the performance characteristics of
the insulated packaging,
validation signifies approval of the solution for use under actual transport