TechniKrom

TechniKrom, Inc., a supplier of pharmaceutical equipment and solutions, continues to enhance its “Adaptive PAT” technologies for creating stable and accurate liquid blending processes.

Adaptive PAT is a patented, PLC-controlled approach to real-time adaptive control of a blending process. It essentially programs a system such that the blend is not released to the process until it meets tight, preset specifications. It also promises to eliminate the need for tank farms and excessive quality-control testing. (See Pharmaceutical Manufacturing, July/August 2004, p. 39.) The success of chromatography, for instance, is often compromised by excessive variability in key process input variables (KPIVs). By increasing mobile phase blend accuracy, product resolution (purity) and reproducibility are enhanced.

One of TechniKrom’s new applications for Adaptive PAT is in reagent/buffer preparation and dilution systems. The portable, stand-alone units dilute buffer concentrates on demand, thus reducing dramatically the number, and the Buffer quality is simultaneously enhanced as any batch-to-batch variability of the concentrated feedstocks from any source is adaptively adjusted for. The units can also be customized to adjust the pH of product streams.

The importance of the upgrade systems is that they allow manufacturers to adapt and upgrade their current pharmaceutical systems and transition to more PAT-able processes. “It’s really a graceful migration rather than a throwing-away-the-baby-with-the-bathwater approach,” says John Walker, TechniKrom’s vice president of engineering. “We took our front-end, accurate blending platform and made it a separate module with a PLC associated with it, able to hook into the back end of anyone else’s equipment. A second benefit customers enjoy is that they simultaneously upgrade their software to full compliance with 21 CFR Part 11.”

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