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.

At 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:

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Contamination Risk Management

Pseudomonas, Burkholderia, and other targeted organism detection.

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Environmental Monitoring

Viable and non-viable air sampling, compressed gas sampling, surface and personnel monitoring.

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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

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On-site Sample Collection

Seamless integration with your facility teams to ensure rapid and compliant sampling.

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Process Validation and Facility Validation

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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 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.

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Process Water Testing (Ph. Eur./USP/JP/BP)

Total aerobic microbial count, endotoxin testing, total organic carbon, conductivity, nitrate, and heavy metals testing.

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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)

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Instrumentation

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  • 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