Acceptance & periodic examination of clean rooms

Technical and pharmaceutical clean rooms of all cleanliness levels

Clean rooms are the heart of any production facility. With their years of experience, the experts at Gesa Hygiene-Gruppe will help you from creation, acceptance and requalification to periodic cleaning.

Our services:

Specialist clean room planning advice

  • Support for developers, planners and builders with the planning and creation of clean rooms

Clean room qualification

  • Acceptance testing of technical and pharmaceutical clean rooms (including pharmacies) in accordance with DIN EN ISO 14644 and EU-GMP
  • Support for developers, planners and builders with the planning and creation of clean rooms

Clean room qualification

  • Regular monitoring of clean rooms and clean zones (LF systems)
  • Reviewing the clean room class using particle concentration
  • Filter integrity test and filter leak test
  • Air velocity measurement on HEPA filter outlets and checking the ventilation rate
  • Measurement of the filter differential pressure and test groove method leak test
  • Recovery test
  • Flow visualisation
  • Climate-related measurements (temperature, humidity, degree of turbulence)
  • Examination of the air pressure cascade
  • Closure leak test Microbiological monitoring in accordance with EU-GMP Annex 1

Testing of workbenches, LAF systems and laboratory hoods

  • EN 12469-compliant microbiological safety workbenches
  • DIN 12980-compliant cytostatics safety workbenches
  • Product protection workbenches
  • LAF systems
  • Clean boxes / clean benches, air flow cabinets
  • EN 14175-compliant laboratory hoods / fume hoods
  • Checking displacement air velocity, exhaust air and intake air
  • Filter fit and leak testing (filter integrity test)
  • Product protection and retention capacity inspection by means of flow visualisation or Ki discus test
  • Checking of clean room class for the work area using particle concentration
  • Alarm function testing

Disinfection

  • Complete disinfection of clean rooms
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