Setup reportedly meets ISO Class 7 (Class 10,000) and is said to be fully compliant with FDA and GAMP requirements, as well as DQ, IQ, and OQ documentation. Has since been applied to dust-free molding of automotive trim.

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About 18 months ago, an injection molder in the Czech Republic wanted to enter the medical molding field and wanted to achieve clean-room molding conditions without prohibitive cost. So its press supplier, Sumitomo (SHI) Demag (U.S. headquarters in Strongsville, Ohio) developed a self-contained clean room integrating an IntElect 160-metric-ton, all-electric press, fully integrated six-axis robot, and a bagging system for parts. This clean-room setup reportedly meets ISO Class 7 (Class 10,000) and is said to be fully compliant with FDA and GAMP requirements, as well as DQ, IQ, and OQ documentation.

Available for presses of 100 to 280 m.t., the compact, turnkey “activeCell” system incorporates tight machine guarding to form a sealed manufacturing area, antistatic paint, and laminar-airflow cabinets on top of the mold area to supply HEPA-filtered air to the molding and packaging area. The system is designed for platen mounting of a Motoman jointed-arm robot (see bottom photo) so that the overall width is only 500 mm more than a standard machine.

Since this project, the company has applied this clean-room concept to dust-free molding of automotive decorative trim.