The packaging inspection is not only a proof of quality, but also a contribution to patient safety. Our processes are based on standards and regulations to ensure that your medical devices meet the highest quality standards.

Testing for packaging integrity

The packaging of medical devices plays a central role, as it must not only protect the contents, but also ensure patient safety by complying with strict legal requirements.

We have specialized in the packaging inspection of medical products. Packaging inspection is an essential step in ensuring the quality and safety of medical devices in accordance with the guidelines.
The bubble test procedure in accordance with ASTM F2096 enables a holistic view of packaging integrity The bubble test is a very valuable test method for checking the integrity of packaging. Leaks are detected by detecting air bubbles escaping from the packaging. To perform the test, the entire test sample is submerged under water and pressurized from the inside with compressed air up to the test pressure. If no air bubbles emerge within the test time, the test sample has passed. If air bubbles escape, this indicates that the packaging is leaking. The test method can be used for both porous and non-porous packaging materials.

By using tried-and-tested test methods and high-quality equipment, GfPS mbH is able to reliably and efficiently test medical device packaging for leaks.

GfPS mbH works in partnership with medical device manufacturers to meet their specific needs and strict regulatory requirements.

Packaging testing using the bubble test at GfPS mbH offers the following advantages:

  • Careful inspection of the packaging ensures that medical products are protected from contamination and meet the highest safety standards.
  • The GfPS tests ensure that the packaging complies with the strict legal regulations and standards for medical products.
  • Patient safety is ensured by checking the integrity of the packaging.

If you would like more information about the bubble test or other packaging tests at GfPS mbH, please contact us at verpackungspruefung@gfps.de.

Guidelines

  • ASTM F2096
  • ASTM F1886/F1886M
  • DIN EN ISO 11607-1

Our packaging inspections and microbiological tests enable us to offer you everything from a single source.

We will be happy to assist you with your questions at
verpackungspruefung@gfps.de

To the overview "Physical examinations"