HMI system provides compliance support, reduces development time for pharma OEM

A commercial HMI solution is helping a pharmaceutical OEM reduce development time and meet U.S. FDA 21 CFR Part 11 safety regulations for its custom batch sterilizers.

03/10/2005



A commercial HMI solution from Rockwell Automation is helping Stock America reduce development time and meet U.S. FDA 21 CFR Part 11 safety regulations for its products. The company builds custom batch sterilizers, such as this Multi-Mode 1500 and associated equipment for food and pharmaceutical processors.

A commercial HMI solution is helping a pharmaceutical OEM reduce development time and meet U.S. FDA 21 CFR Part 11 safety regulations for its custom batch sterilizers. Using Rockwell Software ’s RSView Supervisory Edition HMI software running on Allen-Bradley VersaView industrial computers, Stock America improved the integrity of its data acquisition and reduced development time 20% to 30%.
The company builds custom batch sterilizers and associated equipment for food and pharmaceutical processors. It works with end-users to design, install, and validate in-container sterilization technology to help ensure products and packaging are contamination-free.

To meet 21 CFR Part 11 compliance regulations, the company’s customers must track users of the sterilizers and control systems, manage action audit trails, and archive electronic records. RSView SE lets Stock America provide compliance support without custom development. The system automatically runs reports at the end of each shift, documenting required authentication and audit data. It also allows code reuse to cut down time needed to create new HMI programs. Previously, a typical custom batch sterilizer involved about 240 hr of engineering time. The same project now takes approximately 200 hr.

—Jeanine Katzel, senior editor, Control Engineering, jkatzel@reedbusiness.com





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