Contamination risk management
Pseudomonas, Burkholderia, and other targeted organism detection.
Facility and process validation services
Reliable testing services to ensure your facility stays compliant
When it comes to facility and process validation, there is no room for error. Whether supporting the construction of a new facility or maintaining compliance in an operational one, the challenges are real: tight timelines, shifting schedules, pressure of passing regulatory inspections.
Within the Eurofins BioPharma Product Testing network of laboratories, we understand the complexity of even the most routine activities, so our Facility and Process Validation Support services go far beyond ticking boxes. We deliver tailored, comprehensive solutions that ensure your new builds (green field, brown field), expansions, or operational environments meet the highest regulatory standards. Our dedicated project managers maintain communication with general contractors, construction project management and/or client quality and regulatory managers.
With a full range of microbiology and chemistry testing capabilities, our global network supports everything from routine environmental monitoring to critical process validation projects. Our regional teams are equipped to coordinate on tight timelines, initiate testing within 24 hours of sample collection when required, and adapt flexibly to project shifts—providing the technical expertise you need, exactly when you need it.
Whether you are launching a new facility or maintaining GMP compliance in routine operations, Eurofins BPT offers strategic, reliable, regional support to reduce risks in your validation activities. Our services help you stay on schedule, stay compliant, and stay ahead of unexpected issues.
Facility and process validation support services
Viable and non-viable air sampling, compressed gas sampling, surface and personnel 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
On-site sample collection
Seamless integration with your facility teams to ensure rapid and compliant sampling.
Endotoxin indicator preparation & testing
Disinfectant efficacy testing
Biological indicator incubation & enumeration
Cleaning validation & consulting studies designed to quantify the elimination of bacteria and virus during the cleaning procedures utilized at your manufacturing facility
Establishment of site specific isolates for use in facility and cleaning validation, along with disinfectant efficacy studies
Using a risk-based approach, Eurofins BPT 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)
Total aerobic microbial count, endotoxin testing, total organic carbon, conductivity, nitrate, and heavy metals testing.
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/faecal coliform testing (source water)
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
