Nitto Avecia Pharma Services
Microbiological Testing

Microbiological Testing

With 28 years experience in supporting all compendial microbiological testing, Avecia Pharma has the in-depth experience, established quality systems, and know-how to best support your product life cycle at any stage.

Partner with Avecia Pharma's Microbiology Team

As the demand for precision and timeliness microbiological data rises, trust Avecia Pharma to deliver. We offer extensive testing services via our highly qualified microbiology team. Our depth of expertise combined with our novel approach to dedicated project management and high quality reporting ensure the timeliness your projects demand.

Avecia Pharma offers a broad range of cGMP, high quality microbiological services. Tests are performed according to official compendial methods such as USP, EP, BP, JP, AAMI, ISO standards and client specific protocols. A validated Class 100 Sterility Isolatior provides the highest quality sterility testing for finished product release.

At Avecia Pharma, our mission is to provide our clients with outsourcing solutions that make their drug development priorities possible.

We perform the tests you need at all stages

  • Raw material
  • In-process
  • Final product

Experienced Compendial Support

  • Microbial limits testing based on USP, EP, JP
  • LAL endotoxin quantification (gel-clot, kinetic chromogenic, and turbidimetric methods)
  • Bioburden testing
  • Sterility testing
  • Antimicrobial effectiveness testing
  • Container/Closure Integrity testing (microbial ingression and dye immersion)
  • Water quality testing
  • Environmental monitoring
  • Specialized microbiology testing

Product Validation/Release Testing Expertise

  • Sterility test validation (bacteriostasis/fungistasis)
  • LAL validation (inhibition/enhancement)
  • Disinfectant efficacy testing
  • Closure integrity testing (microbial ingression and dye immersion)
  • Sterilization validations (steam, EO, gamma radiation, chemical)
  • Bioburden recovery
  • Method development and validation
  • Environmental monitoring

Microbiology Testing Systems

  • Walker Barrier AMP 2000 Six Glove Sterility Test Isolator with VHP generator
  • Millipore Steritest™ system
  • Metone non-viable particulate counter

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