Skip to : [Content] [Navigation]
 

TECHNOLOGY NEWS: ASSEMBLY SYSTEMS

Cleanroom-Friendly Ultrasonic Welding Equipment Meets US FDA’s 21 CRF Part 11

Cleanroom-compatible ultrasonic welding systems feature an operator interface that allows observation of the complete welding process and the use of curve progression for finite weld quality optimization.
Constructed with smooth surface, a line of welding systems offers integrating air filtration systems and other cleanroom-ready features. The machines also incorporate an operator interface and tracking mechanism that complies with US FDA’s 21 CFR Part 11, which specifies how electronic records and electronic signatures must be handled. The Medialog machines from Herrmann Ultraschalltechnik GmbH & Co. KG (Karlsbad Ittersbach, Germany; www.herrmannultrasonics.com) are available in two sizes and can achieve up to 5000 W performance with welding frequencies of 20, 30, or 35 kHz.

The FDA System Component (FSC) interface ensures consistent follow-up of all actions performed by authorized users and maintains time-stamped audit trails. Individualized access authorization protects access to critical welding parameters. FSC uses electronic signatures to secure authenticity, completeness, and confidentiality of the data.

Operating on a Windows XP platform, the system enables observation of the complete welding process on a 12-in. display. A curve progression feature allows users to optimize the operating window of the weld. The system also supports a target performance comparison between the reference weld and the actual weld.

To meet cleanroom requirements, Medialog welders have a smooth exterior finish and advanced air filtration systems. Incoming air is filtered to a higher standard than would be necessary in other manufacturing environments, and the exhaust air is collected and can be directed through existing ventilation systems.

Copyright ©2008 European Medical Device Manufacturer