Package validation

What is the goal of a package validation?

Packaging validations are carried out to ensure that a product's packaging, especially in the medical field, meets the required specifications.

This includes, among other things:

Conformity with regulatory requirements:There are legal regulations and standards regarding packaging for certain products. Packaging validation ensures that the packaging meets these requirements.
Sterilization:A packaging system defined as a sterile barrier must allow for sterilization and maintain it until the point of use. A sterile barrier system must allow for aseptic presentation.
Product Protection:The packaging shall ensure that the product is protected from contamination, damage, moisture, light, or other environmental influences during transport and storage.
Logistics and Handling:The packaging must be safe to handle, transport, and store. Packaging validation ensures that the packaging meets logistical requirements.

By performing packaging validations, potential problems can be identified and resolved before the product is launched. This helps reduce costs from product loss, complaints, and recalls, and ensures customer satisfaction. Packaging validation is part of a medical device's technical documentation 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?

Validation is performed according to a validation plan, which specifies the number of test samples, methods.

The requirements vary depending on the application area, product and packaging type, and regulatory specifications. The results are documented in a validation report to make it traceable whether the packaging meets the requirements.

We offer customized 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 define worst-case scenarios.

In which areas are packaging validation used?

Packaging validations are required in many industries where packaging must meet specific legal and particular requirements. At PAConsult, we specifically test the packaging of sterile, as well as non-sterile, medical devices.

According to the Medical Device Regulation (MDR), medical devices must be packaged in such a way that their characteristics are not compromised during transport and storage, for example due to temperature or humidity fluctuations. Packaging validations can provide evidence for this. Any risks can be better assessed and controlled with the results of a packaging validation.

Standards: DIN EN ISO 11607-1 and methods from Annex B, DIN EN ISO 11607-2, ASTM F1980, ASTM D4169, ISTA series