Microbiology Testing

We evaluate the effectiveness of antimicrobial preservatives in multi-dose pharmaceutical products, following pharmacopoeial methods (e.g., Ph. Eur., USP).

Microbiological analysis of pharmaceutical-grade water, including purified water and water for injection (WFI), to comply with regulatory standards.

Accurate species-level identification of bacteria, fungi, and yeasts using biochemical and molecular methods (e.g., MALDI-TOF ).

Verification of media performance to support microbial recovery in microbiological assays, as required by GMP guidelines.

Quantitative testing to assess the bioburden of non-sterile drug products and raw materials.

Sensitive detection of bacterial endotoxins using the Limulus Amebocyte Lysate (LAL) assay to ensure injectable product safety.

Testing under aseptic conditions to confirm the absence of viable microorganisms in sterile pharmaceutical products.

Routine and campaign-based monitoring of cleanroom environments — including air, surfaces, and personnel — to ensure GMP compliance.

Microbial testing for GMP batch release, supporting timely product release to market.

Microbiological stability under ICH storage conditions to determine shelf-life and product robustness.

Tailored development and ICH-compliant validation of microbiological methods to meet your specific formulation and regulatory needs.

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