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Sterility Testing

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

Pharmaceutical Testing Laboratory

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