Bio/pharmaceutical GMP sterility testing must be performed on any product intended to be sterile, such as large or small-volume parenterals, ophthalmic, non-injectable preparations, antibiotics, oils, emulsions, medical devices and more. SGS provides pharmaceutical sterility testing in accordance with the European Pharmacopeia 2.6.1 and USP <71> for pharmaceuticals and CFR 610.12 for biologics.
Why choose sterility testing from SGS?
- Sterility testing under aseptic conditions in a certified ISO 6 clean room within an ISO 5 laminar airflow hood
- Tests for sterility using an isolator environment – an enclosed environment, sealed from the outside environment and sanitized by hydrogen peroxide vapor creating a “germ-free” environment
- Working conditions monitored regularly by sampling of the working area of each test and carrying out appropriate controls
- Membrane filtration testing for filterable products.
- Direct inoculation testing for items that cannot be filtered
A world-leading provider of sterility testing
As a world leader in sterility testing, we offer you unrivaled experience of generating protocols and performing method suitability tests (bacteriostasis/fungistasis) to validate the testing process, based on your product’s specific formulation, batch size and fill volume. We will determine the appropriate method for your product, whether it contains preservatives or bacteriostatic or fungistatic compounds.
For membrane filtration and direct inoculation test methods, the samples are incubated for 14 days in the test media. Fluid thioglycollate medium (FTM) is primarily intended for the culture of aerobic and anaerobic bacteria, and will be incubated in a 30-35C incubator. Soy-bean casein digest medium (SCDM) is suitable for the culture of both fungi/yeast and aerobic bacteria, and will be incubated in a 20-25C incubator.
To discuss your sterility testing requirements, contact us today.