Microbiological Services

From method validation to finished product testing, our fully cGMP compliant Microbiological Services Laboratory routinely supports a wide range of services. All testing is performed on-site, which facilitates an extremely fast turnaround time. Our experienced staff ensures that all product quality requirements are met.

Some of these capabilities are:

  • Full support of the Manufacturing Services:
    • Purified water
    • WFI system monitoring
    • Environmental monitoring
    • Compressed air monitoring
  • Microbial Limits Preparatory Testing and Microbial Limits Testing conforming to the USP/NF, EP, and JP
  • Antimicrobial (Preservative) Effectiveness Testing
  • Bioburden evaluation of product containers
  • Method validation
  • Bacterial Speciation and Fungal Identifications
  • Environmental monitoring (on-site and off-site):
    • Particulate
    • Viable monitoring
    • Surface monitoring
    • Air monitoring
  • Generation of protocols, reports, SOPs and monographs.
  • Microbiological Services Equipment
  • Incubators
    • 20-25°C
    • 27-29°C
    • 30-35°C
    • 35-37°C
    • 41-43°C
    • 43-45°C
    • 55-60°C
  • Total Organic Carbon Analyzer
  • Milliflex Plus Pump Filtration System
  • DUO SAS Super 360 Air Samplers
  • MetOne Laser Particle Counter
  • Microscopes
  • Biological Safety Cabinet
  • Beta Star Autoclave
  • Balances
  • pH meter
  • Conductivity Meters
Microbiological Services was last modified: February 26th, 2015 by pmrsinc