Who We Are

Microbiology Analytical was founded by industry professionals with deep experience supporting pharmaceutical, biotechnology, and medical device manufacturers, built specifically to handle the programs that don’t fit a standard testing model.

Our team has supported hundreds of testing programs across regulated industries, including outsourced programs with tight timelines, difficult matrices, and direct regulatory scrutiny. Clients come to us for investigations, deviation support, and method troubleshooting, not just routine testing. When something isn’t working, we’re built to diagnose it.

We operate as part of the CS Analytical laboratory network, giving clients access to integrated testing capabilities across microbiology, gas testing, materials testing, packaging, biocompatibility, and container closure integrity, without managing multiple vendors.

We work with teams across:

Pharmaceutical · Biotechnology · Medical Device · Combination Products · Packaging & Components · CMOs

The Importance of Microbiology Testing

Microbial contamination is one of the most consequential risks in pharmaceutical and medical device manufacturing. It can compromise product safety, trigger regulatory action, and (at its most serious) cause direct patient harm. Microbiology testing is the primary tool for detecting, controlling, and investigating that risk.

But the testing only works if the methods do. Inhibitory products, poor recovery, incomplete neutralization, and small sample volumes aren’t edge cases in regulated manufacturing; they’re the norm. Methods that work on paper often fail in practice, and when that happens, results become indefensible.

Most testing programs are designed for ideal conditions. Ours aren’t.

We focus on making methods work under real conditions: optimizing recovery, solving neutralization challenges, and generating data that’s clear, complete, and audit-ready, not just technically compliant. This is a technical, problem-solving approach to outsourced testing. Not high-volume throughput.

Standards we work to:

USP · EP · ISO · FDA cGMP

Our Capabilities

We support testing programs across the full scope of pharmaceutical and medical device microbiology, with particular depth in method development, suitability, and programs requiring customized approaches.
Service
Scope
Enumeration & Specified Organisms
USP <61> / <62> / <60>: TAMC, TYMC, Burkholderia cepacia complex
Endotoxin Testing
USP <85> / ISO 8871-4 / USP <161>: device extractions, fluid path, raw materials, packaging
Sterility Testing
USP <71>: validation, stability, and routine release programs
Biocompatibility
USP <87> / <88> / <1031>, ISO 10993: cytotoxicity and biological reactivity
Antimicrobial Effectiveness
USP <51> / <1072>: preservative systems, disinfectants, admixture testing
Elastomer & Packaging Microbiology
USP <381> / <382> / <665> / <661.1> / <661.2> / ISO 8871-3
Particulate Analysis
USP <787> / <788> / <789> / <790>: subvisible and visible, raw materials and drug products
Environmental & Utility Microbiology
USP <1231> / <1116>: cleanroom monitoring, water systems, bioburden investigations
Through our laboratory network under CS Analytical, we connect clients to integrated testing across microbiology, gas testing, materials testing, packaging and biocompatibility, container closure integrity, and package integrity, without managing multiple vendors.

Our Services

Microbiology Testing

Specialized microbiological testing for pharmaceutical, biotechnology, and medical device manufacturers — designed for programs where standard approaches fall short. → Learn More

Biocompatibility Testing

Strategic USP <87>, <88>, and ISO 10993 programs for medical devices, elastomers, and packaging materials, designed to satisfy regulatory expectations while minimizing unnecessary in vivo testing. →  Contact Us

Endotoxin Testing

USP <85> programs designed around interference, extraction geometry, and regulatory expectations: for drug products, medical devices, packaging systems, and raw materials. → Get Started

Microbial Enumeration

USP <61>, <62>, and <60> programs built around your product matrix, including inhibitory formulations, complex recoveries, and Burkholderia cepacia complex detection.→ Contact Us

MB Analytical Showcase

Microbiology Testing

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USP <87> In Vitro Cytotoxicity testing

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Pharmaceutical & Medical Gas Testing Experts

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