Engel system streamlines validation for medical parts

Validation Assistant Developed in collaboration with Hack Formenbau GmbH, Kirchheim unter Teck, Germany, this system for medical parts molders combines Engel’s iQ assistance systems — including iQ clamp control, iQ hold control, iQ weight control, iQ flow control, and the iQ process observer — with Hack’s Moldlife Sense technology and structured software modules. It merges machine-side assistance functions, tool-integrated sensor technology and structured software modules. Together with Engel’s other iQ systems, the technology supports process window determination and automatically monitors and controls critical process variables within a validated production environment, to maintain compliance with standards such as those set by Good Manufacturing Practices (GMP) or the U.S. Food and Drug Administration (FDA). The assistant supports all phases of validation: Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) and Process Validation (PV). The assistant also provides structured documentation elements such as checklists for virtual design-of-experiments (DoEs). It is suitable for both small and large production lots. 

What’s new? The Validation Assistant, which Engel demonstrated on an E-motion 280 Combi MW injection molding machine at the K show.  

Benefits Speed and convenience, and reduced process risks. The Validation Assistant reduces the burden of validating processes, reducing time and staffing requirements; it also simplifies transfer of validated processes to additional machines or sites. This means products can come to market much faster. 

Engel Machinery Inc., York, Pa., 717-764-6818, www.engelglobal.com