We have a state-of-the-art, purpose-built sterility test isolator incorporating a vaporised hydrogen peroxide (VHP) generator, minimising the potential of false positives associated with other types of sterility testing environments.
We use two methods to perform sterility testing:
- Inoculation in two types of media for detection of aerobic and anaerobic microorganisms
- Inoculation period of 14 days with intermittent observations
- Performed in a Grade A Isolator (with optional VHP) to reduce risk of naturally occurring bacteria and fungi contamination delivering false positives and out-of-specification results
Membrane filtration sterility testing
- Enclosed sterile units allowing two samples of equal volume to filtered simultaneously through two membrane filters
- Incubated in two types of media to facilitate detection of aerobic and anaerobic microorganisms
We test bulk and final drug products as well as raw materials. We also perform bacteriostasis/fungistasis tests to assess if microorganism growth is inhibited.
Our test methods comply with USP <71> and Ph. Eur. 2.6.1