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