Sterility testing is an important step in microbiological quality control in accordance with GMP (Good Manufacturing Practices) requirements.

Sterility tests

Sterility tests are used to ensure that sterile products do not contain viable microorganisms before they are released and administered to patients.

It is recommended and required by the relevant standards to validate newly launched products by a method suitability test, especially if the product contains antimicrobial ingredients. This test is based on the selection of test samples that are considered the worst-case scenario in relation to the product being tested. After a five-day incubation to assess microbial growth, all microorganisms are considered detectable and validation is considered successful

Our sterility tests are carried out in specially certified clean rooms that are certified in accordance with ISO standard 6.

In the event of microbial growth during incubation, the microorganisms are differentiated directly to ensure that the sterility test can be evaluated.

Guidelines:

  • according to Ph. Eur. 2.6.1
  • MST according to Ph.Eur. 2.6.1
  • according to USP <71>
  • MST according to USP <71
  • according to DIN EN ISO 11737-2
  • MST according to DIN EN ISO 11373-2
  • MST according to DIN EN ISO 11737-2

We will be happy to support you with your questions about sterility tests at
freigabe@gfps.de
.