Pharmaceutical Testing

Microbiology Testing — Bioburden, Sterility, Endotoxin

Pharmaceutical microbiology testing for non-sterile and sterile drug products, raw materials, packaging and environmental monitoring samples. Methods aligned to USP <61>, <62>, <71>, <85> and the Ph. Eur. equivalents, supported by media fertility checks, growth-promotion testing and method suitability.

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What It Covers

Scope of Work

Microbial enumeration / bioburden (TAMC, TYMC)

Tests for specified microorganisms (E. coli, Salmonella, S. aureus, P. aeruginosa, others)

Sterility testing — membrane filtration and direct inoculation

Bacterial endotoxin testing (LAL — gel-clot, kinetic chromogenic)

Antimicrobial preservative-efficacy testing (PET / challenge test)

Method suitability / bacteriostasis-fungistasis verification

Environmental monitoring — surface, air and personnel

Identification of recovered isolates (16S / MALDI on referral)

How We Do It

Methods & Instrumentation

Membrane Filtration

Sterility testing of filterable products and large-volume parenterals.

Direct Inoculation

Sterility for products that interfere with filtration.

Pour Plate / Spread Plate

TAMC and TYMC enumeration to USP <61>, Ph. Eur. 2.6.12.

Selective Media Recovery

Specified-organism testing per USP <62>, Ph. Eur. 2.6.13.

LAL — Kinetic Chromogenic

Quantitative endotoxin to USP <85>, Ph. Eur. 2.6.14.

LAL — Gel-Clot

Limit-test endotoxin where chromogenic interference is a risk.

Preservative Challenge

USP <51>, Ph. Eur. 5.1.3 efficacy of antimicrobial preservation.

Regulatory Framework

Standards This Work Maps Onto

Methods, documentation and acceptance criteria are designed to align with the standards below. This describes design intent — formal accreditations are listed on the About page.

USP <61> — Microbial Enumeration

USP <62> — Specified Microorganisms

USP <71> — Sterility

USP <85> — Bacterial Endotoxins

USP <51> — Preservative Efficacy

Ph. Eur. 2.6.12 / 2.6.13 / 2.6.14 / 5.1.3

EU GMP Annex 1 — Manufacture of Sterile Medicinal Products

What You Receive

Typical Deliverables

Microbial CoA per batch

Method suitability / validation report

Sterility test report with positive / negative controls

Endotoxin report (CSE certificate, lysate sensitivity, recovery)

PET study report with log-reduction kinetics

Trended environmental-monitoring data with action / alert flags

Who It's For

Sectors We Support

Sterile and non-sterile drug-product manufacturers

CMOs supporting clinical-trial supply

API manufacturers needing microbial limits

Medical-device manufacturers (basic micro)

Cosmetic and consumer-healthcare brands needing PET

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