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PharmTech
March 2019
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In This Issue

Build your pharma development and manufacturing knowledge base with the latest whitepapers, application notes, posters, and other educational resources from bio/pharma industry suppliers.

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FEATURED WHITEPAPER

Leveraging Predictive Analytics for Pharmaceutical Innovation

Jeff West; XiltriX North America

Interested in pharmaceutical industry innovation? Find out how predictive analytics is changing the ways in which pharmaceutical companies address laboratory operations, facility and equipment conditions, and quality and compliance.

Manufacturing

Continuous Twin Screw Granulation

Thermo Fisher Scientific

Twin-screw granulation (TSG) offers a significant advantage over traditional granulation methods—the possibility of continuous manufacturing. Due to the recognized advantages of continuous manufacturing, TSG has drawn increased attention in recent years.

This whitepaper summarizes the most important process parameters and their influence on product quality as well as crucial parameters for scale-up based on a recent study. The results show that it is possible to tailor particle size distribution of the granules, which enables scientists in pharmaceutical technology to influence final product quality right from the start. This whitepaper also provides a summary of useful recommendations to address typical errors in designing, developing, and scaling-up TSG. Consequently, TSG leads to faster process development and reliable scale-up from lab to production scale.

Analysis Using Counter-Rotating Twin Screw Extruder

Brian Machado, Abbe Haser, Feng Haight, Charlie Martin, and Augie Zhang; Leistritz Extrusion

Various extrusion operating conditions and formulations were used to enhance the solubility and recovery of meloxicam (MLX) in copovidone to near 100% on a counter-rotating twin screw extruder (TSE).

Quality

Cleaning Validation for Pharmaceutical Manufacturing

Alconox, Inc.

This paper outlines the basics of cleaning validation and discusses the support services you should seek from your critical cleaning products supplier to optimize your cleaning validation process.

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