Microbiology & Sterility Testing

Microbiology & Sterility Testing

Neopharm offers complete microbiology and sterility testing to help ensure the safety of various products and ingredients including pharmaceuticals, cosmetics, personal care products, vitamins, water, veterinary products, natural health products, etc. All analyses are performed in compliance with cGMP requirements using methods from relevant compendia and pharmacopoeia. Our experienced microbiology team can perform a wide range of compendial assays, including: USP/NF, AAMI, BP/Ph. Eur, AOAC, AWWA, FDA-BAM and Client supplied methods.

ANALYTICAL SERVICES PROVIDED

The following analyzes are performed in compliance with current GMP requirements:

  • Antibiotic-microbial assays
  • Antimicrobial effectiveness testing (AET)
  • Microbial limit tests
  • Pathogen detection
  • Bioburden analysis; TAMC, TYMC
  • Disinfectant efficiency testing
  • Optical microscopy
  • Water testing
  • Vitamins
  • Bacterial endotoxin test
  • Methods development and validation
  • Particle size analysis
  • Microbial identification (aerobic & anaerobic bacterias, yeasts, molds)
  • Crystallinity
  • Sterility testing
  • Sieve analysis

FACILITY & EQUIPMENTS

  • LEVEL 2 laboratory facilities
  • Microbiological ID systems
  • Omnilog (aerobic bacteria)
  • Microlog (anaerobic bacteria, yeasts, molds)
  • Inhibition zone reader
  • HIAC/Royco particle counter
  • Sterility Room (Class 100, Class 10 000; ISO Class 5, ISO Class 7)