Qualification / requalification of cleanrooms and clean zones

in accordance with DIN EN ISO14644 1-4 und GMP-Annex 1

Procedure and documentation

For conducting a qualification or a requalification, we have defined the following procedure:

1.) Preliminary discussion: 
Recording of all target parameters from the planning phase (resulting in the drawing- up of the qualification, (work) schedule and work instruction plans – SOP)
2.) Presentation of drawn-up documentation:
Approval to conduct the qualification in accordance with generated documentation by the client’s QMS
3.) Qualification, requalification:
Performing qualification / requalification according to the schedule and SOP
4.) Handover of the draft qualification documents:
Release of draft documentation by the QMS of the client
5.) Final meeting and hand over of documentation

Air technical measurements (technical and physical examination)

  • room air temperature and room humidity
  • air velocity / volume flow for calculating the air exchange rate
  • differential pressures at the terminal particulate air filters in order to determine the degree of contamination for subsequent measurements
  • pressure level verification (proof of flow direction by means of a smoke test)
  • pressure cascades (detection of positive or negative pressure into the respective adjoining cleanroom areas; measurement with subsequent adjustment of the pressure monitoring system)
  • pressure sound level measurement
  • flow visualization

Particulate and microbiological examination

  • filter integrity test according to DIN EN ISO 14644 Part 3 or filter scan test according to 1946-4 (in older systems, in case a filter integrity test is not possible structurally)
  • microbiological examination (in older systems until 2008, the terminal particulate air filters are subject to a measurement of the number of airborne microbes) room class determination by means of an examination of the number of particles and microbes in the air
  • recovery test according to DIN EN ISO 14644-3

The test report contains a detailed listing of all measured values and their evaluation in accordance with mandatory legal requirements and regulations.