Microbiological Testing

Keystone Labs offers a broad range of critical microbiological testing services. Our microbiology laboratory is equipped with current technologies to analyze raw materials, active pharmaceutical ingredients, and finished products in accordance with current United States Pharmacopoeial (USP) methodologies / NF and other compendial methods.  Our experienced staff are capable to develop, validate and utilize client specific procedures.

In addition, our extensive and comprehensive microbiology services we specialize can isolate and identify microorganisms from diverse sources with particular expertise in the environmental and pharmaceutical applications.

We offer a wide range of microbiological testing, including:

  • Microbial Limit Test (Enumeration Test) – USP<61>
    • Total Yeast and Mold Count (TYMC)
    • Total Aerobic Microbial Count (TAMC)
  • Test for Specified Microorganisms USP<62>
    • Identification of Microorganisms
    • Presence/Absence of Objectionable Microorganisms
  • Sterility Testing:
    • Membrane Filtration (MF)
    • Direct Transfer
  • Bacterial Endotoxin Testing
  • Antimicrobial Effectiveness Testing
  • Alflatoxin Testing
  • Allergen Testing
  • Disinfectant Testing
  • USP validation
  • Cell Banking:
    • Preparation of cell banks
    • Purity and viability testing