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
  • 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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