Sterility Testing

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:

Direct inoculation

  • 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

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Resources

  • White paper

    Additive Manufacturing - A Metallurgical Perspective

    pdf 4 MB

  • Newsletter

    Pharmaceutical Newsletter

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