Cleanroom Services

Requalification and Monitoring of Cleanrooms

To ensure full functionality, cleanrooms must be regularly requalified and monitored. This applies in particular to plants operated within the GMP environment. We offer complete requalification of your cleanroom according to all common guidelines as well as automatic monitoring systems to monitor the critical parameters.

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It would be our pleasure to support you with planning and realising monitoring systems that are tailor-made regarding specific requirements.

Please contact us.

A requalification ensures that a cleanroom is still in a qualified state even after a certain period of operation or changes. Documented evidences are provided in recurring cycles that plants meet the requirements according to current standards and guidelines. Corresponding standards contain recommendations concerning execution intervals for testing single parameters. However, execution intervals should always be determined in a risk-based and system related manner.

An automatic monitoring system is used to monitor cleanrooms. All critical parameters of the cleanroom system are permanently and completely documented. Audits are possible at any time. The system sends an alarm signal when deviations from the target value occur so that the operator can immediately intervene if necessary.

Using our monitoring systems, the following parameters can be monitored:
  • Particle concentration
  • Room differential pressures
  • Air velocities
  • Temperatures
  • Relative humidity
  • Microbiological routine monitoring
We carry out the following measurements as part of the requalification:
  • Air flow velocity
  • Determination of the air change rate
  • Determination of the air flow volume
  •  Measuring the room differential pressure
  • Filter integrity test
  • Measuring the filter differential pressure
  •  Determination of the purity class
  •  Recovery test
  •  Measuring the temperature and humidity
  •  Microbiological tests and determination of the bacteria count
  • Change of filters

All measurements are executed in a predetermined status, either "at rest" or "in operation". They are documented in pre approved test plans and evaluated by specific reports.
Documentations are made as per DIN EN ISO 14644, VDI 2083 or EC GMP-Guidelines.

Any questions about requalification and monitoring of cleanrooms?

Please contact us.​​​​​​​