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
  • Antimicrobial Preservative Effectiveness
    • USP <51>, PCPC(CTFA), EP 5.1.3, JP, & Client Methods
    • ISO 11930
  • Water Activity Testing (based on USP <1112>)
  • Water Testing (Qualification and Routine Testing)
  • Environmental Monitoring (Validations and Routine Monitoring)
  • Microbial Identifications (Genotypic)
  • Bioburden (AAMI)
  • Sterility Validation and Testing (Class 1000 Clean Room)
    • USP <71> and AAMI Methodologies
  • LAL/Endotoxin Testing, USP <85>
  • Antibiotic Potency Assays, USP <81> – Routine Testing and Method Verification
  • Stability Testing Programs – ICH Guidelines
  • Disinfectant and Antiseptic Efficacy USP <1072>
  • Antimicrobial Studies (In-Vitro and In-Vivo)
  • 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
    • US Food and Drug Administration (FDA)
      • Microbiological Safety and Cosmetics
      • FDA Pharmaceutical Microbiology Manual
    • United States Pharmacopeia (USP)
      • 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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