Sterility Testing
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.
The United States Pharmacopoeia (USP) and European Pharmacopoeia (EP) both require specific articles and substances to be sterile. Surfaces are considered sterile if the possibility that it has been contaminated by viable microorganism is equal or less than one in a million. Sterility tests are performed through direct inoculation sterility testing, or through membrane filtration sterility testing.
Medistri SA has accreditation STS 504 for this analysis, both in routine testing and in validation (detection and deactivation of interference and growth inhibitors). Our procedures meet the requirements of appropriate and current versions of European and United States pharmacopeia and ISO standards.
Biocompatibility Testing
Complex Medical Devices need to assess the biocompatibility of their medical device materials and processes by taking a risk-based approach to their biological safety evaluations.Our laboratory takes into consideration the materials, processing, and historical use of the device. This allows to perform a comprehensive assessment of biological responses for each medical device in relation to its safety.
Medistri’s Biocompatibility testing performed according to: ISO 10993
Sterilisation Validation
Prior to beginning routine sterilisation, a product with a sterile claim needs to complete a validation process to ensure the Sterility Assurance Level claimed is met.
Work with Medistri to Mitigate risks. Improve your product's safety. Strengthen your Supply Chain.
Contract Sterilisation Services
Medistri’s sterilisation infrastructure was engineered to allow you to save time and distribute your products on the market faster. We have optimised our sterilisation processes to provide you with the fastest sterilisation services available to date.
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