Ensuring Your Product's Safety, Efficacy, and Timely Project Completion.
Microbiological testing is an important factor in ensuring your product’s 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.
Alcami’s core strengths include non-sterile product evaluation, sterile product testing, tests for specified organisms, microbial enumeration tests, preservative effectiveness, antibiotic potency assays, environmental monitoring support, and disinfectant efficacy/qualification studies.
Your Timeline is Our Timeline.
Alcami strives to set the standard for excellence in the contract development and manufacturing organization (CDMO) space. Our latest initiative for excellence is critical in any phase of the drug development process: timelines.
Alcami offers a full range of compendial, compliant microbiological testing
per the USP, EP/PhEur, JP, BP
- 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
- Sterile product testing
- Sterility testing by membrane filtration and direct transfer with barrier isolator technology
- Tests for specified organisms