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What is the goal of a package validation?

Package validations are carried out to ensure that the packaging of a product meets the necessary requirements.

This includes, among other things:

  1. Conformity with regulatory requirements: For certain products, there are legal regulations and standards regarding packaging. A package validation ensures that the packaging meets these requirements.
  2. Sterilization: Packaging that is defined as a sterile barrier must enable sterilization and maintain it until the time of use. A sterile barrier system must enable aseptic provision.
  3. Product protection: The packaging should ensure that the product is protected from contamination, damage, moisture, light or other environmental influences during transportation and storage.
  4. Logistics and handling: The packaging must be safe to handle, transport and store. Package validation ensures that the packaging meets the logistical requirements.

By carrying out package validations, potential problems can be identified and rectified before the product is launched on the market. This helps to reduce costs due to product losses, complaints and recalls and to ensure customer satisfaction. Package validation is part of the technical documentation of a medical product and can provide evidence of coverage of parts of the essential safety and performance requirements of Regulation (EU) 2017/745.

What happens during a package validation?

A validation is carried out according to a validation plan in which the number of specimens, test methods and acceptance criteria are defined.

The requirements vary depending on the area of application, product and package type as well as regulatory specifications. The results are documented in a validation report to make clear whether the packaging meets the requirements.

We offer individual solutions for the re-validation of the packaging process.

In accordance with DIN EN ISO 11607-1, we carry out complete validations of the packaging process, shelf-life and transportation for sterile barrier systems and help to determine worst-case scenarios.

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In which areas are packaging validation used?

Package validations are required in many industries where packaging must meet certain legal and specific requirements. At PAConsult, we particularly test the packaging of sterile but also of non-sterile medical products.

According to the Medical Device Regulation (MDR), medical products must be packaged in such a way that their characteristics are not impaired during transportation and storage, e.g. by fluctuations in temperature or humidity. Package validations can provide proof of this. Any risks can be better assessed and controlled with the results of a package validation.

Standards: DIN EN ISO 11607-1 und Methoden aus Anhang B, DIN EN ISO 11607-2, ASTM F1980, ASTM D4169, ISTA series 

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