Laboratory Services

Microbiology Testing

Laboratory Services
Microbiology Support
Routine and Custom Testing

Advanced Microbiology Testing for Biologic and Biopharmaceutical Products

At Alcami, we leverage decades of expertise in microbiological testing to ensure the safety, efficacy, and quality of biologic and biopharmaceutical products. Our advanced methodologies, honed through years of experience in the biotech, pharmaceutical, and medical device industries, are designed to meet the rigorous demands of product development and regulatory compliance. We offer a comprehensive range of microbiological services that support our clients’ needs throughout the development process.

CORE MICROBIOLOGY TESTING CAPABILITIES

Analysis of Non-Sterile Products

Antimicrobial Effectiveness Testing

Biological Indicator Testing

Container Closure Integrity Testing

Disinfectant Efficacy Studies

Endotoxin Indicator Testing

Environmental Monitoring and Facility Support

Gel Clot LAL Assay

Incubation and Enumeration of Environmental Monitoring Plates

Inhibition/Enhancement Studies

In-Use Admixture Studies

Kinetic Chromogenic and Turbidimetric LAL Assays

Method Suitability Testing

Microbial Assay and Enumeration

Microbial Identification (Genotypic)

Microbial Limits Testing

Pharmaceutical Water System Validation and Testing

Protocol-Generated Studies

Rapid Sterility Testing

Sterile Product Testing

Sterility Testing by Membrane Filtration and Direct Transfer

Tests for Specified Organisms

Microbiology Support

Microbial Identification

Microbial identifications provide insight into the types of recovered organisms — and whether they can negatively impact your product. Alcami’s team utilizes the MicroSeq with a vast library of bacteria, yeast, and fungal genus and species. The identification of organism recoveries assists in the determination of root causes for environmental excursions and product contaminations.

Disinfectant Efficacy Studies

Disinfectant efficacy studies, critical for all cleanroom environments, are also part of Alcami’s portfolio. The cleaning regiments and disinfectants implemented must be sufficient for all surface types. Confidence in your cleaning operations is important when evaluating failures within an environmental monitoring program.

Biological Indicators

Alcami’s laboratory can support you with population verification of biological indicators and post-exposure evaluation through media submersion and incubation followed by growth observation.

Why Choose Alcami for Microbiology Testing and Support?

Alcami’s microbiology testing services are built on a foundation of scientific rigor and industry-leading expertise. Our comprehensive testing solutions are designed to support every phase of product development, ensuring that your biologic and biopharmaceutical products are safe, effective, and compliant with regulatory standards. Whether you need routine testing or specialized studies, Alcami provides the reliable and accurate results you need to advance your projects with confidence.

Related Topics
Microbial Challenge In-Use Studies
Designing a Disinfectant Study for Your Clean Room
Environmental Monitoring & Cleanroom
Compendial Testing
Contact Alcami
Summary

Alcami offers comprehensive microbiology testing services designed to ensure the safety, efficacy, and regulatory compliance of biologic and biopharmaceutical products. With decades of experience, our team provides advanced testing capabilities, including sterility testing, microbial identification, and environmental monitoring. Alcami’s rigorous methodologies support every phase of product development, delivering reliable and accurate results.

Related Topics
Microbial Challenge In-Use Studies
Designing a Disinfectant Study for Your Clean Room
Environmental Monitoring & Cleanroom
Compendial Testing
Contact Alcami
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