Testing and release for pharma and life sciences
Environmental monitoring
We provide cGMP-compliant environmental monitoring for cleanrooms and controlled areas in pharmaceutical and medical device manufacturing. Our services include viable and non-viable particle monitoring, surface and air testing, and compliance with ISO 14644, USP, and EU GMP guidelines. Whether performed on-site by our trained technicians or through self-sampling kits, our monitoring programs help ensure contamination control and regulatory compliance.
Why Choose Synergy Health Utrecht?
GMP-compliant & ISO 13485-certified laboratory
On-site and remote monitoring options
Aligned with USP, EP, ISO 14644 and EU GMP
Experienced microbiologists and cleanroom experts
Quick turnaround, clear reporting and audit-ready documentation
What is Environmental Monitoring?
Environmental monitoring is designed to verify that cleanrooms and other controlled environments are operating within defined cleanliness standards. It includes two main elements:
Viable monitoring: Detection and enumeration of bacteria, yeast, and mold in air, on surfaces, and on personnel (e.g. gloves, gowns).
Non-viable monitoring: Measurement of airborne particles using laser particle counters, to assess air cleanliness.
Together, these measures confirm the aseptic conditions of production environments and help identify contamination risks before they affect product quality.
Our monitoring programs can be tailored to your facility and include:
Personnel: gloves, gowns, hands
Air: viable and non-viable counts, temperature, humidity, HEPA filter integrity
Surfaces: floors, walls, equipment, workstations
Utilities: compressed air (viable and non-viable), water systems (chemical and microbiological)
Cleanroom performance: differential pressure, lighting levels, airflow visualization (smoke tests)
Disinfectant qualification: verification of cleaning agent efficacy
Service Options: Flexible and Scalable
Synergy Health Utrecht offers two service models to suit your operational needs:
1. On-site Monitoring by Our Experts
Our qualified technicians perform sampling at scheduled intervals, using validated methods and calibrated equipment.
2. Self-Monitoring Kits
We provide sampling kits (contact plates, air samplers, swabs) and loan testing instruments, allowing your team to perform monitoring internally. Full training and guidance included.
Both options start with a site assessment, where we help define sample points, frequencies, and cleanroom classification requirements.
Cleanroom Classification & Certification
Cleanroom class or grade depends on the criticality of the operation performed. Our environmental monitoring services support classification based on:
ISO 14644-1 particle counts
EU GMP Annex 1 viable counts
USP <1116> guidance
We help classify and certify cleanrooms for industries such as:
Pharmaceutical manufacturing
Medical device production
Raw materials handling
Packaging manufacturing
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