We has pleasure in supporting you with planning and realising monitoring systems that are tailor-made regarding specific requirements.
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.
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.