Microbiology Testing
60+ Years of Microbiology Testing Excellence
Global Microbiology testing for pharmaceuticals and medical devices is a crucial component of ensuring product safety and effectiveness. This testing utilises specialised techniques to identify and assess the presence of microorganisms.
Our GMP and GLP compliant laboratories boast decades of experience in microbiology, sterility and environmental monitoring. We are consistently audited by the Medicines and Healthcare products Regulatory Agency (MHRA) and the US Food and Drug Administration (FDA), ensuring our ongoing compliance with GMP and GLP standards.
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
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.
