Alcami offers decades of expertise in providing advanced methodologies for developing biologic and biopharmaceutical products

Microbiological testing ensures product safety, efficacy, and timely project completion. At Alcami, we combine decades of microbiological expertise, developed from serving the biotech, pharmaceutical, and medical device industries, to provide the most current and effective methodologies for developing our customers’ biologic and biopharmaceutical products. We are specialized in non-sterile product evaluation, sterile product testing, tests for specified organisms, rapid sterility, microbial enumeration tests, preservative effectiveness, antibiotic potency assays, environmental monitoring support, and disinfectant efficacy/qualification studies.


  • Analysis of non-sterile products

  • Antimicrobial effectiveness (preservative efficacy) validation and testing

  • Biological indicator total viable spore count, purity, and post-exposure testing

  • Container closure integrity testing (microbial ingress and dye immersion)

  • Disinfectant efficacy/disinfectant qualification studies

  • Endotoxin indicator testing for depyrogenation studies

  • Environmental monitoring and facility support

  • Gel clot limulus amebocyte lysate (LAL) assay

  • Incubation and enumeration of environmental monitoring plates

  • Inhibition/enhancement studies

  • In-use admixture studies

  • Kinetic chromogenic LAL assay | Kinetic turbidimetric LAL assay

  • Method suitability

  • Microbial assay

  • Microbial enumeration and validation

  • Microbial identification (genotypic)

  • Microbial limits test

  • Pharmaceutical water system validation and routine testing (WFI, purified water, clean steam)

  • Protocol-generated studies in support of regulatory filings

  • Rapid sterility

  • Sterile product testing

  • Sterility testing by membrane filtration and direct transfer with barrier isolator technology

  • Tests for specified organisms


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