Qualification Insulated Shipping System

Pharmaceutical companies are responsible for a safe transport of their medication. From factory to end user. The temperature control of the medication is an important factor. Because this differs per transport and medication, qualification tests are always conducted.

A qualification test can be used to determine with a high level of certainty that the packaging and especially the product within will be able to perform on the basis of established criteria.

Topa Institute conducts qualification tests in accordance with ASTM and ISTA standards. 

Thermal packaging

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A Thermal packaging consists of multiple components: the outer box, insulating materials, and refrigerants. In order to know exactly how the thermal packaging must be built, this is developed in a customized way.

Specialized packaging engineers are involved in this process from beginning to end.

Protocol

Prior to the qualification of the thermal packaging, a protocol is established in which the test procedure and all boundary conditions of the project are described. After approval by the client, the temperature tests are conducted.

The temperature tests are generally conducted in triplicate in order to prove the reproducibility. Calibrated thermocouples are used when performing qualification tests. After the completion of a qualification project, an extensive report is written. 

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