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Cleanroom Testing and Validation

Cleanroom Testing and Validation Services

Vanguard Life Sciences, in collaboration with Enbloc, delivers comprehensive cleanroom testing and validation services for regulated life sciences environments across the UK.

Our experienced validation engineers support cleanrooms, containment suites, microbiological safety cabinets, laminar flow cabinets and associated equipment, including fridges and freezers. All testing is carried out in accordance with BS EN ISO 14644 and EU cGMP requirements, ensuring your facility meets the highest standards of compliance and performance.

Complete validation for regulated environments

Testing and validation are critical to maintaining product integrity, ensuring patient safety and achieving regulatory compliance. Our structured approach provides clear, auditable evidence that your facility is operating within defined parameters.

Through our collaboration with Enbloc, we combine design, build and validation expertise to deliver a seamless, end-to-end service with minimal disruption to your operations.

Validation protocol development and execution

We support the full validation lifecycle, including the development and execution of key protocols:

  • User Requirement Specifications (URS)
  • Factory Acceptance Testing (FAT)
  • Site Acceptance Testing (SAT)
  • Design Qualification (DQ)
  • Installation Qualification (IQ)
  • Performance Qualification (PQ)

This ensures your validation master plan is followed and fully documented from initial design through to operational performance.

Cleanroom testing capabilities

Our cleanroom testing and validation services include:

  • HEPA filter integrity testing (DOP testing)
  • Particle counting to ISO 14644 and EU cGMP standards
  • Volumetric airflow and air change rate measurement
  • Pressure differential testing
  • Clean-up and recovery rate testing
  • Airflow visualisation studies

All testing is performed by CTCB-trained engineers with extensive on-site experience in life sciences and healthcare environments.

Temperature and humidity mapping

We provide on-site temperature and humidity mapping for cleanrooms and associated services of any scale, from small storage units to large facilities exceeding 2,000m².

Using specialist mapping software and calibrated data loggers, we deliver accurate and reliable environmental data. We also support periodic re-validation to ensure your facility continues to perform in line with design specifications.

Microbiological safety cabinet and laminar flow validation

Microbiological safety cabinets and laminar flow cabinets are critical components of many cleanroom processes.

Our engineers are fully trained to carry out testing, commissioning and ongoing compliance for Class I, II and III cabinets, as well as laminar flow systems. By integrating this service with cleanroom validation, we reduce downtime and eliminate the need for multiple contractors.

Environmental monitoring

Environmental monitoring is a key requirement under cGMP Annex 1.

We provide:

  • Settle plate testing
  • Contact plate testing
  • Active air sampling

Through our laboratory partners, we ensure rapid turnaround of results and clear reporting to support your quality and compliance processes.

Vanguard Life Sciences
Unità 1144 Regent Court, The Square, Gloucester Business Park, Gloucester, GL3 4AD

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