Facility Monitoring and Support

Eurofins BioPharma Product Testing network of laboratories offers a comprehensive range of microbiology and chemistry capabilities in support of your facility monitoring and process validation projects—all performed in strict adherence to cGMP requirements. We have completed more than 200 facility validation projects for pharmaceutical manufacturers, biopharmaceutical companies, pilot plants, API manufacturers and tissue processors. Our experts are well versed in fulfilling validation needs with the flexibility to handle the unique specifications of any project.

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 multi- and large-volume projects while consistently meeting your needs for rapid turnaround time and results.
We offer outstanding service and flexible options in sample collection with daily sample courier service in the U.S. and pickup and analysis of samples on weekends (with advance arrangements by the client).
We can provide sample collection containers for your Process Water Testing and Environmental Monitoring.

Testing Available

Process Water Testing (EP/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

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

Instrumentation

Applied Biosystems Genetic Analyzer
MALDI-TOF (Bruker)
9,000-square-foot, limited-access-controlled microbiology laboratories include HEPA filtration and validated cleaning, disinfection & monitoring programs
SMA Portable Viable Air Samplers
Met One Laser Non-viable Air Samplers
HPLC, GC, TOC, ICP-OES, NVR for testing swab & rinse samples for residual product, raw material or cleaning agents

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