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Sterile & Non-Sterile QC

Microbiology Testing Services

State-of-the-art cleanrooms (Class 100 / ISO 5) providing rapid pathogen detection, sterility clearance, bioburden evaluation, and water quality testing.

Microbiology Testing Portfolio & Study Details

Click on any study card below to expand and view comprehensive testing methodology, pharmacopoeias, and sample specifications.

USP <71> / IP

Sterility Testing

Direct inoculation & membrane filtration sterility clearance in Class 100 / ISO 5 cleanroom isolators.

USP <61>/<62>

Microbial Limit Testing (MLT)

TAMC, TYMC, and specific pathogen clearance for non-sterile raw materials and finished oral/topical products.

USP <85>

Bacterial Endotoxin Test (BET)

Kinetic chromogenic, turbidimetric, and gel-clot LAL assays for pyrogen quantification.

ISO 11737-1

Bioburden Testing

Quantitative microbial load estimation prior to sterilization of devices and drug substances.

ISO 14644

Environmental Monitoring

Active air sampling, settle plates, contact surface swabs, and personnel glove prints for cleanrooms.

USP <1231>

Water Testing (PW / WFI)

Microbiological testing for Purified Water (PW) and Water for Injection (WFI).

USP <51>

Antimicrobial Effectiveness (AET)

Evaluating preservative efficacy in multi-dose pharmaceutical preparations.

cGMP / PIC/S

Media Fill Validation

Aseptic process simulations using sterile nutrient media for sterile manufacturing lines.

ISO 11930

Preservative Efficacy Testing

Assessing preservation system robustness in cosmetics, topicals, and oral suspensions.

AOAC / EN 13727

Disinfectant Efficacy Studies

Quantitative suspension and surface tests to validate the antimicrobial performance of disinfectants, sanitizers, and sporicidal agents.

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