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    CDMOHUB

    Connecting biotech and pharma teams with verified manufacturing partners worldwide.

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    © 2026 CDMOHUB. All rights reserved.

    CDMO Hub, Inc. Registered in Delaware, USA

    CDMOHUBCDMOHUB
    Find ExpertsBriefingsPricing
    CDMOHUB

    Connecting biotech and pharma teams with verified manufacturing partners worldwide.

    Platform

    • Find CDMOs
    • Find Experts
    • CDMO Matchmaking
    • Expert Matchmaking
    • Modality Guides
    • Supplier Maps
    • Join as Partner

    Company

    • About Us
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    © 2026 CDMOHUB. All rights reserved.

    CDMO Hub, Inc. Registered in Delaware, USA

    CDMOHUBCDMOHUB
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    1. Home
    2. /CDMOs
    3. /Microbiology Testing CDMOs
    Capability

    Microbiology Testing CDMOs

    Compare CDMOs with GMP microbiology laboratory capabilities for sterility testing, endotoxin analysis, bioburden, and environmental monitoring.

    About Microbiology Testing

    Microbiology testing ensures pharmaceutical products are free from harmful microorganisms and endotoxins. For sterile products (injectables, ophthalmic), sterility testing and endotoxin analysis are critical release tests. For non-sterile products (oral, topical), bioburden limits and specified organism absence testing protect patient safety.

    Environmental monitoring is the ongoing surveillance component of microbiology. CDMOs must continuously monitor manufacturing areas for viable and non-viable particulates, surface contamination, and personnel contamination. Trending environmental monitoring data provides early warning of contamination control issues before they affect product quality.

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    Frequently Asked Questions

    What are the core microbiology tests for pharmaceutical products?+
    Core tests include: sterility testing (USP <71> or equivalent), bacterial endotoxin testing (LAL or rFC, USP <85>), bioburden testing (USP <61>/<62>), antimicrobial effectiveness testing (USP <51>), environmental monitoring (air, surface, and personnel sampling), water system monitoring (TOC, conductivity, microbial limits), and growth promotion testing for culture media.
    What is the difference between LAL and rFC endotoxin testing?+
    LAL (Limulus Amebocyte Lysate) is the traditional endotoxin test using horseshoe crab blood extract. rFC (recombinant Factor C) is the synthetic alternative that does not require animal-sourced reagents. Both are accepted by FDA and EMA, though rFC is gaining adoption for ethical and supply chain sustainability reasons. CDMOs offering both methods provide flexibility for sponsors with different preferences.

    Related Categories

    Analytical Services CDMOsSterile Injectable CDMOsAseptic Processing CDMOsFill-Finish CDMOsDrug Product CDMOs

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    CDMOHUB

    Connecting biotech and pharma teams with verified manufacturing partners worldwide.

    Platform

    • Find CDMOs
    • Find Experts
    • CDMO Matchmaking
    • Expert Matchmaking
    • Modality Guides
    • Supplier Maps
    • Join as Partner

    Company

    • About Us
    • Contact

    Legal

    • Terms of Service
    • Privacy Policy

    © 2026 CDMOHUB. All rights reserved.

    CDMO Hub, Inc. Registered in Delaware, USA