The production and sterilization of a sterile medical device requires the application of validated microbiological testing. Sterilization Consulting Services has the experience and expertise in medical device microbiology to assist in all of the required testing. We will work with either in-house or a contract laboratory to insure that the testing performed meets and exceeds the AAMI/ISO requirements. In addition, we will provide guidance in the establishment of product families to reduce the overall costs of the testing.
Services provided include the management of:
- Biological indicator / BI testing
- Test of Sterility
- Bacteriostasis/Fungistasis (B/F)
- Bioburden testing
- Bioburden Validation
- Establishment of Bioburden Families
- Manufacturing Environment Test Programs
- Sterile Media production
- Growth Promotion