Microbial Enumeration Testing for Non-sterile Products
Accurate control of microbial load in non-sterile products is essential for patient safety, product quality and market approval. Cormica provides microbial enumeration testing for nonsterile pharmaceuticals, medical devices and combination products, with methods aligned to USP <61> Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests, Ph. Eur. 2.6.12 and other harmonised global pharmacopoeias.
Our mission is to improve patients’ lives by providing comprehensive testing services that help you launch and release products safely and rapidly across the world. Microbial enumeration is a key part of that promise.
What USP <61> Microbial Enumeration Covers
USP <61> describes quantitative methods for determining the number of viable aerobic microorganisms in non-sterile products, typically reported as:
- Total aerobic microbial count (TAMC)
- Total yeast and mould count (TYMC)
USP <61> describes several approaches for microbial enumeration, including pour plate, spread plate, membrane filtration and most probable number (MPN) techniques. Our microbiology team will help you select the most appropriate technique for your product, and we will always confirm that the method is suitable using inoculated product preparations.
- Confirm that products meet defined microbial limits before release
- Monitor trends in bioburden over time
- Support robust contamination control strategies and investigations
Because USP <61> is harmonised with Ph. Eur. 2.6.12 and equivalent chapters in other pharmacopoeias, a well designed method can support multi-region registrations from a single testing approach.
Typical products tested
We routinely perform TAMC / TYMC testing on a wide range of non-sterile products, including:
- Oral solid dosage forms, such as tablets, capsules and powders
- Oral liquids and suspensions
- Topical and transdermal products, such as creams, gels and lotions
- Inhalation and nasal products, where nonsterile limits apply
- Ophthalmic, ear and rectal preparations, where appropriate
- Raw materials, excipients and in-process samples
- Much more
If you have a complex or novel formulation, our microbiologists can advise on the most suitable test design and sample preparation strategy.
Working With Cormica for Microbial Enumeration
When you choose Cormica for USP <61> and related microbial enumeration testing, you can expect:
- Consultation on the most appropriate method and compendia for your target markets
- Clear guidance on sample requirements and handling
- Transparent timelines for incubation and reporting
- Structured, audit-ready reports that support regulatory submissions and inspections
Whether you need a one-off study or a long-term QC partner, our team is ready to help.
Laboratories near you, supporting global product success
With accredited laboratories in the UK, EU and US, we support pharmaceutical, medical device and combination product manufacturers worldwide. Local support combined with global quality, delivered by teams who understand your regulatory requirements.
Cormica's Microbiology Testing Services
Non-Sterile Product Quality Control Testing
- Bioburden Testing, Recovery & Validation
- Tests for Specified Microorganisms
- Microbial Enumeration Testing (TAMC/TYMC)
- Preservative Efficacy / Antimicrobial Effectiveness Testing (AET/PET)
- Microbial Limits Testing
- Water Testing (Potable, WFI, Purified)
- Growth Promotion Testing of Media
- Method Suitability / Validation for QC Testing
Endotoxin & Pyrogen Testing
- Bacterial Endotoxins Test (BET) – Limulus Amebocyte Lysate (LAL)
- Kinetic Turbidimetric & chromogenic
- Gel-Clot Method
- Monocyte Activation Test (MAT)
- Recombinant Testing
Other Microbiology Testing Services
- Method Validation & Batch Release Testing
- Disinfectant Efficacy Testing
- Microbial Identification
- (MALDI-ToF, MicroSEQ & VITEK)
- Antibiotic Microbial Assay
- Biological Indicator Enumeration
- Reprocessing Validation
- Cytotoxicity Testing
- R&D Support, Bespoke & Client Specific Testing Protocols
Sterility Testing
- Rapid Sterility Testing
- Celsis Bioluminesence
- Celsis Advance for nonfilterable therapies
Celsis Adapt for Cellular therapies
- Celsis Advance for nonfilterable therapies
- Scan RDI Chemiluminesence
- Celsis Bioluminesence
- Millipore Steritest™
- Particulate Testing
- Container Closure Integrity Testing (CCIT)
- Media Fill Incubation and Analysis
Environmental Monitoring
- Cleanroom Environmental Monitoring Support
- EMPQ and Risk Assessment
- Sampling/Incubation/Enumeration
- Reporting and Trending
- Culture Preservation
- Cleaning Validation Support
- Total Organic Carbon (TOC) Analysis
- Trending, Culture Preservation & Microbial ID
Microbiology Testing Conducted to International Standards Including:
- USP: <51>, <60>, <61>, <62>, <63>, <71>, <85>, <87>, <643>, <645>, <788>, <789>, <1072>, <1116>, <1911>, <643>
- Ph. Eur.: 2.2.44, 2.6.1, 2.6.12, 2.6.13, 2.6.14, 5.1.3, 5.1.6, 5.1.11
- ISO: 10993-4, 10993-5, 11137-2, 11737-1>3,
- ICH / GMP: ICH Q7, EU GMP Annex 15
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