Validation & Measurement

Note: From 1/4–2024, the Validation & Measurement service is not included in Brookhaven’s product portfolio. We have chosen to focus on our core business within Monitoring Systems and Instruments for controlled environments as well as associated service and calibration. For inquiries regarding services for validation and measurement of clean rooms, we therefore ask you to contact Pharma Hospital Consulting PHC AB (johan@pharmahospital.se or daniel@pharmahospital.se) for further consultation.

We perform various types of clean room test and validation services like filter test, particle counting, microbial air sampling, air flow measurements and VHP sterilization.

Validation/Projects

  • Validation plan
  • DQ / IQ / OQ / PQ Validation document for clean rooms
  • Validation/Function control of operation theatres and CSSD
  • Risk analysis
  • Traceability matrix
  • Development of URS
  • Preliminary studies
  • Requests for clean rooms, clean air equipment as well as protective ventilation
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Measurement

  • Filter Test / Leak Test of HEPA filter in ceiling diffuser / filter boxes
  • LAF benches / safety benches, Operational ceiling
  • Particle measurement / Clean room classification
  • Recovery test
  • Airflow measurement
  • Air turnover measurements
  • Air velocity measurements
  • Press / Air direction controls
  • Visualization of air movements
  • Control / Calibration of differential pressure
  • Function control of LAF units, fume cupboards, biosafety cabinets and other protective device
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Microbial sampling

  • Active air sampling
  • Fallout plates
  • Surface sampling
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Sterilization

6-log sterilization with hydrogen peroxide in gaseous form of:

  • Clean room
  • Material transfer hatches
  • Isolators
  • Operating theatres
  • Isolation rooms
  • Biosafety labs
  • Filter cabinets
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Other services

  • Replace HEPA filter and prefilter
  • HVAC adjustment of differential pressure
  • Development of methods and procedures
  • Inspections
  • Advice on clean rooms and operating theatres
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