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Pharmaceutical Manufacturing and Packing Sourcer

Taking the Lab to the Sample

Swagelok Company’s Dave Simko discusses PAT implemented with miniature modular technology

Pharmaceutical manufacturers have relied on laboratory testing to resolve process, product and quality issues for the last century. Analysis is performed off-line; that is, a sample is extracted from the process and transported to the laboratory for analysis.

However, taking the laboratory to the sample can change the way the analyses are conducted. Off-line analyses can be replaced with at-line, on-line, in-line and non-invasive analyses. The FDA Guidance for Industry (PAT – A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance) promulgated in final form in September 2004, encourages the use of available process analytical tools to support innovation and efficiency in pharmaceutical processing.

Miniature modular platform technology provides the means to build and install compact sampling systems, sensor arrays, and complete miniature process analyser systems. Such systems have been installed in chemical processing plants and refineries. Combining process analytical technology (PAT) with miniature modular platform technology allows the analyses to be made at the process line and the results to be made available immediately. This article discusses PAT and analyses that bring the analyser close to the process line; the results of applying miniature modular technology in analyser systems in processing plants; cleanliness issues and solutions; and potential applications of the combined technologies in pharmaceutical processing.

FDA PAT INITIATIVE

The goal of the FDA PAT Initiative is to reduce pharmaceutical development and manufacturing costs by improving quality, reducing rejections, and reducing the time to market. It encourages the use of up-to-date scientific principles and innovative, readily available analytical tools to monitor and control the processes by operating on the basis of continuous interfacing with a reliable sample of the process fluid being evaluated.

The aim of this guidance is to describe a scientific, risk-based regulatory framework to support innovation and efficiency in pharmaceutical development, manufacturing and quality assurance. The PAT framework is a system for designing, analysing and controlling pharmaceutical manufacturing through timely measurements of critical quality and performance attributes of raw and in-process materials and processes to ensure final product quality. The framework consists of two parts:

  • A set of scientific principles and tools fostering and supporting innovation
  • A strategy for regulatory implementation that will accommodate innovation

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Dave Simko is Manager of Marketing Resources for Swagelok Company. He began his career with Swagelok in valve design engineering and was Chief Engineer. He moved into sales and marketing more than 25 years ago, holding a number of positions, including Director of Sales for valve operations, construction sales manager for the corporation, and his present position. He has worked extensively in North America, Europe, Japan, China and Southeast Asia, and has extensive technical knowledge of all of the company’s core markets and industries served. His recent efforts have been focused on the biopharmaceutical industry. Prior to joining Swagelok, he spent several years in the aircraft gas turbine industry. Dave has a degree in Mechanical Engineering. He holds several patents in the area of valve and fitting design and has published numerous technical articles and papers. He is a member of the American Society of Mechanical Engineers (ASME), the American Institute of Chemical Engineers (AIChE) and the Instrumentation, Systems, and Automation (ISA) Society.
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