Automation Prescribed For Drug Makers

Although there was no “hard” news

concerning the U.S. Food and Drug Administration’s (FDA,www.fda.gov) much discussed Process Analytical Technology (PAT) initiative, every automation supplier wanted to talk about what PAT will mean for both the pharmaceutical industry and for automation suppliers.

According to the FDA, “the goal of PAT is to understand and control the manufacturing process, which is consistent with our current drug quality system: quality cannot be tested into products; it should be built in or should be by design.” PAT is defined by the FDA as a system for designing, analyzing and controlling manufacturing through timely measurements of critical quality and performance attributes of raw and in-process materials and processes, with the goal of ensuring final product quality.

If that sounds like traditional process control, it should, according to spokespeople for each of the automation suppliers in attendance. The suppliers included ABB, Emerson Process Management, Foxboro/Invensys, GE, Honeywell, Rockwell Automation, and Siemens. Although the initiative anticipates development of new analytical instruments that may measure such product criteria as molecular structure, current thinking in the industry is that it also will allow for continuous process improvement. Other industries take that concept for granted, but the regulatory process, especially the requirement for an extensive validation process after any changes, has been seen as inhibiting process improvements and therefore greater manufacturing efficiencies.

Milwaukee-based Rockwell Automation (www.rockwell.com) had several industry-related announcements. One was that Rockwell engineers will be available as a service to help original equipment manufacturers (OEMs) in the industry meet regulatory compliance issues. They will “assess project risks, review application requirements, establish protocols and procedures and assist with regulatory standards implementation. OEMs also receive customer-tailored training programs for ongoing compliance assurance, vendor audit preparation and program management and guidance on maintaining computer system compliance and validation.”

Not to be outdone on the services front, Emerson Process Management (www.emersonprocess.com), Austin, Texas, announced a service initiative of its own dubbed OpEx Advantage. Emerson has built much expertise in the industry and will now make it available to customers as a service. The company says that it can help customers achieve operational excellence (OpEx) in various areas through services ranging from analyzing processes to helping implement solutions.

Meanwhile, GE Fanuc (www.gefanuc.com), Charlottesville, Va., announced the release of an upgrade to its Proficy Historian Version 3.0. New features include new OPC (an open connectivity standard) alarm and events collection and storage capabilities, uptime improvements through redundancy and high availability functionality, co-existence and integration with OSI Software PI systems through two-way data sharing, and expanded national language support.

Gary Mintchell