The sterility test is required as release specification in parenteral dosage forms and several medical devices.
The sterility test is used in order to verify the absence of microbiological contamination (bacterial, yeasts and moulds) in samples of materials or products sterilized or manufactured aseptically.
What is needed for these studies?
The sterility test is performed under aseptical conditions. For this test is required an isolation equipment or sterile rooms and a suitable monitoring program of the working conditions. In addition, the growth promotion test must be carried out in the selected media.
The sterility test must be carried out according to the Chapter 2.6.1. Sterility of European Pharmacopoeia, as well as the GMP certification.
What Netpharmalab offers to you…
At Netpharmalab, we may perform not only the sterility test but also the growth promotion test in the selected media in accordance to European Pharmacopoeia.
GMP
