Upgraded Ultrasonic Welder Supports FDA 21CFR Part 11

Featuring recent upgrades that enable the collection and transmission of weld data in support of the Food and Drug Administration’s (FDA) 21 Code of Federal Regulations (CFR) Part 11 data-integrity standards, key ergonomic improvements, and a unique patent-pending Dynamic weld-mode, the Branson GSX-E1 2.0 is the newest and most advanced ultrasonic welding solution for small or delicate plastic parts from Emerson, Brookfield, Conn.

The first of two key software upgrades is reportedly enables Branson GSX-E1 2.0 welders to support FDA 21 CFR Part 11 standards for data integrity. Users can implement compliance measures to validate user signatures, authorize multilevel user access and system security, create audit trails, and securely retain and duplicate data or records associated with medical manufacturing.

The second upgrade equips GSX-E1 2.0 welders with market-leading encryption technology and secure data transfer capabilities using Emerson-engineered Web Services. This upgrade is said to ensure total integrity for weld-data transfers from the manufacturing floor to local or remote enterprise quality management systems.

The GSX-E1 2.0 welder also offers a new, patent-pending Dynamic weld-mode, which is a first-in-the-market adaptive welding mode that enables the welder to recalculate and adjust key parameters during the weld cycle to optimize individual part quality. This unique feature can dramatically improve the consistency of insertion, staking and other welding operations for parts with complex structures and variable material characteristics. Numerous ergonomic improvements also simplify installation, save working space, and make the welder’s graphical interface even easier to use.

First launched at NPE2018, the upgraded GSX-E1 2.0 welder would of been one of three new assembly equipment highlights from Emerson at NPE2021.