Pharmaceutical Microbiology

  • Microbial Identification – bacteria, yeasts, and filamentous fungi
           • MALDI-TOF Mass Spectrometry (Bruker MALDI Biotyper®)
     Biochemical Identification (VITEK®)
  • Antimicrobial/Preservative Effectiveness
    • USP <51>
    • ISO 11930:2012
    • Personal Care Products Council (PCPC) Methods – M-3, M-6, and M-7
  • LAL Endotoxin Analysis, USP <85> (Kinetic Chromogenic Assay and Gel-clot Method)
  • Antibiotics Assays, USP <81>
  • USP <61> Microbial Enumeration Tests
  • USP <62> Tests for Specified Organisms
    • Clostridia
    • Gram Negative
    • Salmonella
    • Escherichia coli
    • Pseudomonas aeruginosa
    • Staphylococcus aureus
    • Candida albicans
  • USP Suitability Assay
  • USP <1227> Validation of Microbial Recovery
  • USP <2021> & <2022> Microbiology for Dietary Supplements
  • FDA-Bacteriological Analytical Manual (BAM) – Chapter 23 – Microbiological Methods for Cosmetics
  • Minimum Inhibitory Concentration (MIC) Evaluations
  • Minimum Bactericidal Concentration (MBC) Evaluations
  • Time-Kill Studies

Environmental Monitoring – Click for more information

  • Plant Sanitation Audits
  • RODAC Plating
  • Air Density Analysis
  • Swab / Sponge Testing
  • Total Plate Count
  • Water Quality Monitoring
  • Yeast and Mold Count and Identification