Ensuring the highest standards in the medical industry is crucial, especially when it comes to medical devices and pharmaceuticals.

Microbiological leak test of sterile packaging for air permeability and moisture (initial and repeat test)

The microbiological leak test of packaging for medical devices to be sterilized in accordance with DIN 58953-6 covers an important aspect of the basic safety requirements for packaging. This test proves that the packaging is able to protect the product from contamination even in the presence of moisture and air.

During this test, the packaging is tested for its integrity and impermeability to microorganisms. Special test procedures are used to ensure that the products are not contaminated during transportation or storage. This is particularly important to ensure the safety and efficacy of medical products.

By complying with DIN 58953-6 and carrying out the microbiological leak test, manufacturers can ensure that their sterile packaging meets the quality standards and that the packaging is suitable for the intended use. This test is therefore an important part of the design and manufacturing process for medical devices.

If you require further information on microbiological leak testing of sterile packaging in accordance with DIN 58953-6 or would like support in implementing this standard in your company, please do not hesitate to contact us at verpackungspruefung@gfps.de


  • DIN 58953-9

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