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Microbiology testing

Assure your safety and effectiveness with GMP microbiology testing services that deliver accurate data, responsive support, and dependable results across development and commercial programs.

Microbiology testing

Microbiology testing services you can trust

Microbiological control is critical to ensuring product safety, protecting patients, and maintaining regulatory compliance. Our microbiology testing laboratory provides reliable, GMP-compliant data to support your programs at every stage.

Backed by experienced microbiologists and robust quality systems, we perform testing aligned with United States Pharmacopeia/National Formulary (USP/NF), European Pharmacopoeia (EP), Japanese Pharmacopoeia (JP), and client-supplied methodologies. Whether executing compendial tests or developing custom protocols, our teams work closely with you to address unique product challenges, mitigate risk, and deliver timely, defensible results that support confident decision-making.

Our microbiology testing services include:

Microbial limits and bioburden testing: Assessment of microbial levels and absence of specified organisms to support quality and regulatory compliance.
Sterility testing: Flexible development and commercial-stage sterility testing supported by rigorous quality systems and on-time delivery.
Bacterial endotoxin testing (BET): Detection and control of endotoxins in parenterals, APIs, and excipients.
Antimicrobial effectiveness testing (AET): USP <51> testing to evaluate preservative system robustness in non-sterile aqueous products.
Microbial identification: Testing for accurate identification to support investigations, prevent recalls, and protect patient safety.
Environmental and cleanroom monitoring: Viable and non-viable air particulates, surface sampling, compressed gases, and water testing.
Biological indicator and sterilization testing: Verification of sterilization process effectiveness, supported by expert guidance.
Custom protocols and on-site sampling: Client collected or on-site sampling options with tailored protocols to meet specific GMP needs.

Secure Data Accessibility

PacePort is our secure client data access portal; a web-based data delivery system that allows you to access to methods, specifications, reports, and other information at any time, from any location. The materials available via PacePort are of sufficient quality to be used during audits.

Portal access

Specialized microbiology services

Our teams apply deep technical expertise and practical GMP experience to address complex microbiological challenges, providing both routine testing and advanced support when programs demand it.

Bioburden Testing

Bioburden and microbial limits testing evaluate resident microbial levels and confirm the absence of specified pathogens. Recovery method suitability assessments validate testing within your product matrix, supporting regulatory compliance, quality assurance, and product safety.

Test method references include:

USP <60> Microbiological Examination of Nonsterile Products—Tests for Burkholderia Cepacia Complex (BCC)
USP <61> Microbiological Examination of Nonsterile Products: Microbial
Enumeration Tests
USP <62> Microbiological Examination of Nonsterile Products: Tests for Specified
Microorganisms
USP <2021> Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests for Nutritional and Dietary Supplements
USP <2022> Microbiological Procedures for the Absence of Specified Microorganisms in Nutritional and Dietary Supplements
EP 2.6.12 Microbiological Examination of Non-Sterile Products: Microbial Enumeration
Tests
EP 2.6.13 Microbiological Examination of Non-Sterile Products: Test for Specified Microorganisms
ISO 11737-1 Sterilization of health care products — Microbiological methods Part 1: Determination of a population of microorganisms on products

Antimicrobial Effectiveness Testing (AET)

We evaluate preservative systems in non-sterile, aqueous formulations using USP <51> antimicrobial effectiveness testing, helping ensure product stability and patient safety throughout shelf life.

Test method references include:

USP <51> Antimicrobial Effectiveness Testing
EP 5.1.3 Efficacy of Antimicrobial Preservation

Sterility Testing

Comprehensive sterility testing services tailored to development and commercial needs. Our flexible approach, supported by robust quality systems, ensures data integrity while meeting demanding timelines and production schedules.

Test method references include:

USP <71> Sterility Test
ISO 11737-2 Sterilization of health care products — Microbiological Methods Part 2: Tests of Sterility Performed in the Definition, Validation and Maintenance of a Sterilization Process

Endotoxin Testing

Bacterial endotoxin testing is essential for parenteral drugs, medical devices, raw materials, excipients, APIs, and water systems. Our experts deliver sensitive, reliable testing to uphold product safety and regulatory expectations.

Test method references include:

USP <1085> Guidelines on the Endotoxins Test
USP <85> Bacterial Endotoxins
<161> Medical Devices
EP 2.6.14 Bacterial Endotoxins

Particulate Matter Testing

Visible and sub-visible particulate testing for injectable products, drug delivery systems, and medical devices extracts to ensure compliance and patient safety.

Test method references include:

USP <787> Subvisible Particulate Matter in Therapeutic Protein Injections
USP <788> Particulate Contamination
USP <789> Particulate Matter in Ophthalmic Solutions
EP 2.9.19 Particulate Contamination: Sub-visible Particles

Biological Indicator Testing

Expert evaluation of sterilization process effectiveness, even for complex product designs or sterilization methods, with meticulous execution to minimize false positives. We offer biological indicator testing services for in the validation, performance verification, and with-use verification of cleaning and sterilization processes, such as steam sterilization, ethylene oxide sterilization, and gamma irradiation.

Test method references include:

USP <55> Biological Indicators – Resistance Performance Tests
ISO 11138 Sterilization of Health Care Products – Biological Indicators

Microbial Identification Testing

Accurate microbial identification to support investigations, prevent recalls and protect patients, executed with precision, speed, and scientific rigor.

Test methods include:

Genotypic
Proteotypic
Phenotypic

Analytical testing to help you move forward and stay ahead

Raw Materials

ICH Stability Storage Services

ICH Stability Storage Services

Packaging and Distribution

Packaging and Distribution

Extractables and Leachables Testing

Extractables and Leachables Testing

Impurities Testing

Impurities Testing

Reference Standards

Reference Standards

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Whether you’re shaping early plans or preparing to scale, our teams are here to help you move forward with clarity and confidence. Start the conversation and we’ll get back to you quickly.

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