Reliable sterility testing and the development or validation of product-specific methods are critical steps in the drug development process. Sterility testing is required to ensure viable contaminating microorganisms are not evident in a product. This testing is conducted by direct inoculation or membrane filtration methods and is performed in a cleanroom environment.
Medistri provides Sterility Testing of pharmaceutical products, biotechnology products, medical devices and consumer products. Sterility testing is required during the sterilisation validation process as well as for routine release testing. The three methods of Sterility Testing are
- Membrane filtration
- Direct Transfer (Product Immersion)
- Product Flush.
The preferred method is direct inoculation of culture media for bacteriology. The routine sterility test at Medistri SA is performed in a cleanroom (ISO 7) under laminar flow.
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