Microbiological testing is an important factor in ensuring a product’s safety, efficacy and timely project completion. At AAIPharma Services, we provide clients with more than 30 years of microbiological expertise developed from serving the biotech, pharmaceutical and medical device industries.

Our core strengths include non-sterile product evaluation (microbial limits testing), sterile product testing, preservative effectiveness, antibiotic potency assays, environmental monitoring support and disinfectant qualification studies. We pay strict attention to every detail as we methodically test and/or monitor the conditions of our clients’ GMP manufacturing environment and the quality of products produced.

Our offerings include compendial microbiological testing per the USP, EP / PhEur, JP, BP:

  • Analysis of non-sterile products
    • Microbial limits test
    • Microbial enumeration and validation
    • Tests for specified organisms
    • Microbial identification
    • Water activity testing
  • Sterile product testing
    • Method suitability – bacteriostasis / fungistasis
    • Sterility testing by membrane filtration and direct transfer with barrier isolator technology
    • Antimicrobial effectiveness (preservative efficacy) validation and testing
  • Bacterial endotoxin testing
    • Inhibition / enhancement studies
    • Gel clot Limulus Amebocyte Lysate (LAL) assay
    • Kinetic chromogenic LAL assay
    • Turbidimetric LAL assay
  • Environmental monitoring & facility support
    • Disinfectant efficacy / disinfectant qualification studies
    • Microbial identification
    • Incubation and enumeration of settling plates
    • Pharmaceutical water system validation and routine testing (WFI, purified water, clean steam)
    • Biological indicator total viable spore count, purity and post-exposure testing
  • Container closure integrity testing
    • Container closure integrity by dye ingress
    • Container closure integrity by microbial ingress
  • Microbial identification
    • Microbial identification by MIDI and VITEK II
    • Strain typing by DiversiLab rep-PCR system

 

pdf