Microbiology Testing
GMP & GLP Microbiology Testing
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.
Our Pharmaceutical and Medical Device Microbiology Testing Services
Bioburden and Microbial Enumeration Testing
- Absence of Specified Organisms
- Process Validation for Bioburden Recovery
- Water Testing (Potable, WFI, Purified)
- Quality Control & Non-Sterile Product Microbial Enumeration
Advanced Microbiology Testing Services
- Antimicrobial & Preservative Efficacy Testing
- Disinfectant Efficacy Testing
- Microbial Identification
- (MALDI-ToF, MicroSEQ & VITEK) & Sequencing
- Antibiotic Microbial Assay
- Biological Indicator Enumeration
- Reprocessing Validation
- R&D Support / Bespoke Testing Protocols
Sterility Testing
- Sterility Testing (Including Millipore Steritest™)
- Microbiological Sterilisation of Medical Devices
- Rapid Sterility Testing
- Bioluminescence
- Celsis Bioluminesence
- Scan RDI Chemiluminesence
- Particulate Testing
Endotoxin & Pyrogen Testing
- Bacterial Endotoxins Test (BET) – Limulus Amebocyte Lysate (LAL)
- Recombinant Testing
- Monocyte Activation Test (MAT)
- Cytotoxicity Testing
Environmental Monitoring
- Cleanroom Environmental Monitoring
- Cleaning Validation Support
- Sampling & Testing
- Total Organic Carbon (TOC) Analysis
- Trending and Culture Preservation
Microbiology Testing Conducted to International Standards for Pharmaceuticals and Medical Devices:
- USP: <51>, <60>, <61>, <62>, <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
