Microbiology Divison

Multifaceted Technical Expertise

Our Microbiology Division provides unique capabilities, showcasing expertise across Pharmaceuticals, OTC, Consumer Healthcare, Cosmetic/Personal care, Specialty Chemical and Medical Device Industries. Whether our clients are interested in routine compendial testing or specialized or unique product development, our staff provides technical knowledge associated with the FDA, EPA and International and Client Custom programs. In addition to these trusted programs, our team also offers consultation services for Microbiology issues that may arise.

Our Capabilities

  • Microbial Limits / Test Method Suitability
  • • USP <61>/<62> , EP 2.6.12/EP 2.6.13 and BP, JP, AOAC, ASTM & Client Methods
  • • USP <51>, PCPC(CTFA), EP 5.1.3, JP, & Client Methods
  • • ISO 11930
  • Environmental Monitoring (Validations and Routine Monitoring)
  • Microbial Identifications (Genotypic)
  • Bioburden (AAMI)
  • • USP <71> and AAMI Methodologies
  • Disinfectant and Antiseptic Efficacy USP <1072>
  • Ames Mutagenicity Testing (OECD 471, ISO)
  • FDA BAM Chapter 23 – Cosmetic Testing / Import Detentions
  • Custom Research Projects/Client Specific Protocols
  • Regulatory Consulting
  • Specialty Programs
  • • Antiseptic Efficacy Studies
  • Informational References
  • • USP General Chapter <61>—Microbial Examination of Nonsterile Products: Microbial Enumeration Tests
  • • USP General Chapter <62>—Microbial Examination of Nonsterile Products: Test for Specified Organisms
  • • USP General Chapter <51>—Antimicrobial Effectiveness Test
  • • ISO 11930 Cosmetics — Microbiology — Evaluation of the antimicrobial protection of a cosmetic product

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