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Qualification, validation: when the packaging units are subjected to severe testing!

25 November 2013

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.

Qualification and validation of the cold chain packaging provide an absolute guarantee of performance and safety for temperature-sensitive products.

Qualification: 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:

  • Design Qualification (DQ) involves compilation of the specification by the User.
  • Qualification 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.

Qualification ensures 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.

Validation: a test of the packaging unit under actual transport conditions

Validation is 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 conditions.

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