Clean Room Systems

 

The business sector Cleanroom Systems is focussed on automation projects ruled by GAMP conditions and additional requirements. Typically, they are operated in cleanroom of classes 5 and 6 with laminar flow and fulfill contamination control and sterilization requirements. Systems engineering is governed by the GAMP-specific processes Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ). Software validation (CSV) is of clearly outstanding importance.

Applications include the handling and packaging of tubs and vials for the pharmaceutical industry as well as the coating of implants by bioactive media.

 

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