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Sterility Testing

Sterility testing is performed to assess the absence of viable microorganisms in medical device and pharmaceutical products. 

What We Do

We perform validation testing to ensure that the ability to sustain microbiological growth is not affected by a determined sterility method such as direct transfer or fluid pathway on a medical device or pharmaceutical product. We also ensure the presence or absence of microorganisms from medical devices or pharmaceutical products post sterilization.


  • USP Sterility
  • Low Dose Verification
  • Membrane filtration
  • Direct inoculation 
  • Bacteriostasis and Fungistasis Validation

Why It Matters

  • Determine whether viable microorganisms are detected in tested samples. 
  • Support sterilization process development and validation activities. 
  • Investigate potential contamination concerns
  • Generate microbiological data that supports quality and regulatory objectives.  
  • Meet USP <71>, ANSI/AAMI/ISO 11737-2 and other regulatory requirements. 

Sterility Test Codes

Sterility

Non-USP Sterility

S700

USP Sterility

S702

Bacteriostasis & Fungistasis

Non-USP Bacteriostasis & Fungistasis

S701

USP Bacteriostasis & Fungistasis

S703

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