We are pleased to give you an insight into the stability studies of packaging for sterile medical devices. Accelerated ageing in accordance with ASTM F1980 and real-time ageing are part of our portfolio of physical tests. These methods make it possible to prove the shelf-life stability and reliability of packaging for medical products by means of subsequent integrity tests.

Accelerated ageing studies

The accelerated ageing of your medical devices and their packaging can be used to carry out stability tests on aged test samples after a shorter period of time. These studies are used to assess the potential effects of long-term storage on the packaging materials and to validate the packaging and the expiration date.

After consultation, we can cover your individual ageing parameters in our climate chambers.

The stability tests/integrity tests can be carried out on sterile barrier systems (SBS) for accelerated ageing in accordance with DIN EN ISO 11607-1 if no real-time ageing data is available; a parallel start of real-time ageing is required.

Accelerated ageing accompanied by real-time ageing makes it possible to reduce the time-to-market.

Guidelines

  • DIN EN ISO 11607
  • FDA
  • ASTM F1980

Real-time aging studies

Real-time ageing ensures a realistic simulation of storage conditions. Packaging integrity tests can be ordered at regular intervals to verify the stability and integrity of your packaging materials.

The ageing studies are required to demonstrate the functionality of the sterile barrier system (SBS) over the shelf life.

Our ageing studies comply with the applicable requirements of DIN EN ISO 11607 “Packaging for medical devices to be sterilized in the final packaging” and the FDA.

This conformity enables us to offer you a precise and reliable assessment of the long-term performance of your medical packaging.

Guidelines

  • DIN EN ISO 11607
  • FDA
  • ASTM F1980

For further information on our packaging inspection portfolio, please do not hesitate to contact us. We look forward to supporting you in ensuring the quality and safety of your medical devices.

Rely on our expertise to ensure that your medical products retain their quality and safety even after years of storage.

For further information, please contact us at
verpackungspruefung@gfps.de

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