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Validation of Clean rooms

If you have clean rooms, you need MPQ to ensure that they are truly clean — and that they stay that way.

MPQ’s environmental sciences team helps you maintain control of your controlled environment. It’s a proven resource for clean room testing needs arising from manufacturing of medical devices or pharmaceuticals, as well as sterile compounding in hospital pharmacies.

Count on MPQ to provide these and other clean room validation advantages;

  • Ensured regulatory compliance
  • Low or no process disruption
  • Less downtime
  • Greater productivity

MPQ investigates, identifies, locates, assess, and resolves contamination problems throughout your controlled spaces. Our work meets or exceeds applicable clean room testing requirements for regulatory regimes including the International Organization for Standardization (ISO).

Our staffs comprise highly trained microbiologists with long experience applying modern clean room validation technologies in all varieties of controlled environments. And our expertise and capabilities continue to grow. In recent years, MPQ has tripled its professional staff and doubled the size of its facilities in laboratories, people, and technology. Result: more resources for your specific clean room testing needs.

Clean Room Validation and Testing Services

When a clean room has just been built it must be tested to ensure that it is working correctly. The quantity and quality of air supplied, the air movement between and within clean rooms and the particle (and where necessary microbiological) counts in the clean room should be shown to be correct. These requirements are laid down in ISO 14644-1 and the documents listed below.

  • BS EN ISO 14644-1: Classification of Air Cleanliness
  • BS EN ISO 14644-2: Specification for Testing and Monitoring to Prove Continued Compliance with ISO 1466-1
  • BS EN ISO 14644-3: Test Methods
  • EU GGMP: Guide to Good Manufacturing Practice for Medicinal Products
  • PD 6609-2000: Environmental Cleanliness in Enclosed Spaces - Guide to Test Methods
  • HTM 2025: Validation and Verification of Ventilation in Healthcare Premises
  • Quality Assurance of Asceptic Preparation Services 4th Edition

During its lifetime, a clean room must be checked to ensure it continues to comply with the initial design standard. Testing is therefore undertaken at regular intervals to ensure that the room and clean air supply remains fit for purpose throughout its working life. This also applies to clean air devices such as isolators, laminar air flow cabinets and uni-directional air flow systems. The team at Quality Control West Midlands includes a dedicated certified clean room specialist who can carry this work out for you.

Recommended frequencies

  • QA of Aseptic Preparation Services 4th Edition (A M Beaney)
  • Particle Count and Air Velocities (Critical Devices) every three months
  • HEPA filter integrity every year
  • ISO14644-2 = <Class 5 every six months or > Class 5 annual

Services we offer

Clean room testing services provided by MPQ includes;

  • Filter integrity testing (DOP testing)
  • Measurement of air velocities in clean rooms and clean air devices
  • Measurement of room air change rates
  • Measurement of pressure differentials (clean rooms, isolators etc)
  • Sampling for airborne particles
  • Sampling for airborne microbial contamination
  • Surface sampling for microbial contamination
  • Lockout times of isolator transfer hatches
  • Isolator pressure decay tests

Example scope of application

  • Pharmaceutical manufacturing/Compounding Facilities
  • Hospital theatres
  • Sterile supply departments
  • Any area where clean air supply is critical