Test for sterile filling (media fill test)

The media fill test is used to check the sterility of filling and manufacturing processes.

The test for sterile filling is carried out by simulating the filling conditions with a liquid complex medium instead of your product. You then send us the filled culture media in your final packaging. The test is carried out by incubating the samples under specified parameters in order to stimulate the growth of any microorganisms present.

After the incubation period, the culture media are examined for the presence of microorganisms. This can be done by visual inspection, microbiological tests or other suitable methods. In addition, a test for unhindered growth of test germs in the presence of the product is recommended to ensure that no bacteriostatic and/or fungistatic activities of the products or product parts influence the test results of the media fill test and that the selected test procedure is therefore suitable. We will provide you with documentation of the assessment of the results for sterility and appropriate growth.

Our investigations help to identify and minimize sources of contamination. Rely on our expertise to achieve the highest quality standards in sterile pharmaceutical production. Our goal is to ensure the effectiveness of aseptic techniques and to identify and minimize sources of contamination in the production process.

Guidelines:

• Pharmacopoeias such as the European Pharmacopoeia (Ph. Eur.) Ph. Eur. 2.6.12
• USP <61>
• GMP (Good Manufacturing Practice) guidelines, including ICH Q7A for pharmaceutical manufacturing
• ISO 13408-1 – Aseptic processing of healthcare products

We will be happy to assist you with your questions about media fill testing at
freigabe@gfps.de
.