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Microbiology Testing Services
Water Systems, Raw Materials & Finished Products per USP <60/61/62>
Capzer Pharmaceuticals provides comprehensive cGMP microbiology testing for purified water systems, raw materials, APIs, excipients, and finished products across tablets, capsules, liquids, creams, and suspensions. Our FDA/DEA-registered laboratory ensures microbial safety through limits testing, bioburden, and pathogen absence confirmation.
Testing follows USP <61> (microbial enumeration), <62> (specified microorganisms), <60> (Burkholderia cepacia), and water methods (TOC, conductivity). Expert microbiologists validate recovery for dosage forms, perform bioburden per ISO 11737-1, and identify isolates supporting facility validation and release.
Partners receive compliant CoAs for Gabapentin capsules and Empagliflozin stability programs from our ISO 17025-accredited facility. This supports ANDA submissions while maintaining microbiological control across manufacturing and supply chains.
Our expert team is here to support you with reliable pharmaceutical testing, analytical solutions, and regulatory guidance. Whether you have a query or need a customized service, we’re ready to assist you at every step.