Requalification and Monitoring of cleanrooms

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

We offer:

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Elaboration of risk-based monitoring plans

in accordance with corresponding standards and guidelines

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Execution of requalifications

by skilled and well trained employees

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Complete GMP-compliant documentations

We has pleasure in supporting 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. In recurring cycles documented evidences are provided 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 always should be determined risk-based and system related.

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

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 ("at rest" or "in operation"), documented in preapproved test plans and evaluated by specific reports.
Documentations are made as per DIN EN ISO 14644, VDI 2083 or EC GMP-Guidelines.

Do you have questions about requalification and monitoring of cleanrooms?

Please contact us.​​​​​​​