Facility Validation & Environmental Monitoring
Eurofins BioPharma Product Testing network of laboratories offers a comprehensive range of microbiology and chemistry capabilities in support of your facility validation, water system validation and monitoring, and environmental monitoring projects— all performed in strict adherence to cGMP requirements. With 250 over facility validation and environmental monitoring projects completed for pharmaceutical manufacturers, biopharma companies, pilot plants, API manufacturers and tissue processors, our experts are well versed in regulatory expectations and are accustomed to handling unique project specifications.
We’ve expanded our on-site collection with courier service for both new facility validation and routine environmental monitoring providing coverage for the U.S. Eastern Seaboard. This dedicated regional team of specialists provides the flexibility required to ensure timely collection, even when your timeline shifts.
Why Choose Eurofins BioPharma Product Testing?
- Our Facility Validation teams are the largest in the industry, and with unmatched laboratory capacity, we are capable of handling multisite and large volume projects while consistently meeting your needs for rapid turnaround time and results.
- Outstanding service and flexible sample collection options with daily sample courier service and pickup, including weekend sample analysis (with advance arrangements.
- We can provide sample collection containers for your Process Water Testing and Environmental Monitoring.
Process Validation and Facility Validation
- Cleaning Validation & Consulting studies designed to quantify the elimination of bacteria and virus during the cleaning procedures utilized at your manufacturing facility
- Disinfectant Efficacy Testing
- Biological Indicator Incubation & Enumeration
- Endotoxin Indicator Preparation & Testing
- Establishment of site specific isolates for use in facility and cleaning validation, along with disinfectant efficacy studies
- Using a risk-based approach, Eurofins provides thorough evaluation and consultation of critical sampling locations throughout a facility, from gowning areas to the manufacturing floor, to ensure the facility is in a state of control prior to initiating manufacturing activity.
Process Water Testing (Ph. Eur./USP/JP/BP)
- On-Site Sample Collection
- Total Aerobic Microbial Count (membrane filtration or pour plate)
- Endotoxin Testing
- Total Organic Carbon Testing
- Conductivity Testing
- Nitrate Testing
- Heavy Metals Testing
- EU Directive Testing on Drinking Water
- Total Coliform/Fecal Coliform Testing (source water)
Environmental Monitoring
- On-site Sample Collection
- Incubation of Samples
- Viable Air Sampling
- Non-viable Air Sampling
- Compressed Gas Sampling
- Process Water Sampling
- Clean Steam Sampling
- Surface Sampling
Instrumentation
- Applied Biosystems Genetic Analyzer
- Bruker MALDI Biotype – Microflex®
- 9,000-square-foot, limited-access-controlled microbiology laboratories include HEPA filtration and validated cleaning, disinfection & monitoring programs
- High Volume SAS 100/180 (Surface Air System)
- Triobas Duo Viable Air Sampler
- Lasair III Non-viable Air Sampler
- Lasair Pro 5100
- Dewpoint Meter
- Drager Aerotest Alpha
- TSI Aerotrak 9310 Particle Counter
- Edgetech Instruments Handheld Thermo/Hygromer
- HPLC, GC, TOC, ICP-OES, NVR for testing swab & rinse samples for residual product, raw material or cleaning agents
