Giving you confidence

from construction through to compliance

Building a new facility, or upgrading an existing one, means balancing engineering timelines, ever-evolving designs, and a maze of regulatory requirements to work through. For validation engineers and build teams, the pressure to launch on time while navigating change orders, resourcing issues, and requalification risks is constant.

The Eurofins BioPharma Product Testing network of laboratories brings clarity and control to that complexity. Our facility monitoring and validation services are designed specifically for new builds and retrofits and provide strategic, scalable support that will flex with changes in your schedule and safeguard compliance.

We understand just how critical your validation window is. That’s why we offer rapid mobilisation, expert consultation, and seamless integration into your project planning. Whether we’re supporting EMPQ, executing GMP-compliant testing, or managing retesting due to construction delays, our expert team will ensure you stay on track.

Our technicians, engineers, and microbiologists collaborate closely with your internal teams and contractors to avoid costly missteps and ensure readiness for inspection. We pride ourselves on delivering results with the accuracy and documentation regulators expect, whether you're preparing for PQ, PPQ, or full operational readiness.

Whether your facility is a greenfield development, retrofit, or expansion, in us you will discover a partner that understands the stakes, the science, and the schedule. 

Our Offering

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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, we provide 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)

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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