Cleanroom Validation

Filter Integrity Testing

We offer a full range of cleanroom validation services for start up and existing facilities, all our lead engineers are professionally accredited for cleanroom testing (Irish Cleanroom Society:CTCB-I) & we have vast experience working with compliance & validation departments with regard to doc prep, FDA, IMB audit preparation. We have previously worked in all sectors of the industry dealing with Pharma, Biopharma, Bulk, sterile & API facilities giving us a strong knowledge of all design requirements & standards within the industry.

We provide a very high standard of documentation for cleanroom testing & can develop in house documentation for annual compliance testing as required.

Our Main Services Include

  • Clean room validation (in compliance with ISO 14644 parts 1-4, IEST-RP-CCOO 6.3 IEST-RP-CC 34.2,ISPE baseline guides, EU cGMP guidelines (orange guide & annex 1), World Health organization (WHO))
  • Biological Safety Cabinet testing (BSCs, class 1,2&3) in compliance with EN 12469 & National Sanitization Foundation (NSF) standard 49
  • Fume cupboard testing to BS EN 14175
  • Down flow booths, weigh booths, unidirectional flow hoods units (ISO, IEST-RP-CC002.2 & PD 6609)
  • Isolators, glove boxes
  • Dust collectors
  • Process filtration
  • Audit preparation
  • Documentation preparation & execution of client protocols

Specific Tests Include

  • HEPA filter integrity testing
  • Room pressurization setup & verification
  • Particle counts
  • Air Chances Per Hour (ACPH)
  • Air volumes
  • Filter face velocities
  • Filter differential pressures
  • Temperature verification & mapping
  • Humidity verification & mapping
  • Airflow visualisation
  • Room recovery rates
  • Building Management System (BMS) verification
  • Fume Cupboard testing (velocities, KI discus)
  • BSC testing
  • Isolators
  • Continuous monitoring
  • Indoor air quality

Our Services