Ultrasonic welding in a clean room: Secure, clean and FDA compliant welding

To meet the increasing requirements for ultrasonic assembly processes in clean environments, Herrmann Ultrasonics, Inc. introduces the MEDIALOG, which is based on the successful and widely established DIALOG welding systems. The new MEDIALOG welding machines are mostly used by medical device manufacturers and other plastic assembly manufacturers with special requirements. The machines were designed with a new smooth finish and clean room friendly surfaces to meet the lower particle requirements. Incoming air is filtered to a higher standard. In addition the exhaust air is collected and can be directed through the existing ventilation system. The non-contact capacity start buttons ensure a safe two-handed machine operation.

The MEDIALOG machines come in two sizes with welding performances up to 5,000 watt with welding frequencies of 20, 30 or 35 kHz. The Windows® XP based system guarantees a user-friendly operator interface guide and observation of the complete welding process shown in detail. Herrmann Ultrasonics offers a target performance comparison between the reference weld and the actual weld on a 12” color graphic touch display. The operating window of the welding process can be easily optimized by means of the curve progression for finite weld quality optimization.

The MEDIALOG includes the unique operator interface FDA System Component (FSC) that meets the demanding guideline of the Food and Drug Administration (FDA 21 CFR chapter 11). FSC assures a consistent follow-up of all actions performed by authorized users and records time stamped audit trails. The creation of customized individual access authorization ensures predefined, controlled limited access to critical welding parameters. FSC uses electronic signatures in order to secure authenticity, completeness and confidentiality of data.