Pharmaceutical Technology - July 2020 - Buyers' Guide

PharmTech - Buyers Guide - July 2020

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126 Pharmaceutical Technology BUYERS' GUIDE 2020 P h a r mTe c h . c o m INNOVATION OUTLOOK THOUGHT LEADER SLONME - STOCK.ADOBE.COM S P O N S O R E D C O N T E N T Bill Turner Technical Service Manager of Tooling and Tablets Natoli Engineering Company USING ENGINEERED TABLET PRODUCTION TOOLING TO MITIGATE QUALITY ISSUES By using science and engineering in your tablet formulation process and tablet compression tooling design, potential tablet defects can be identified and addressed before production. When engineering tablet production tooling, the industry generally references the Tableting Specification Manual, or similar standards, for punch-to-die clearances. If the clearance meets these standards, then the set should be correct, right? But not every formulation is the same, so one set of clearances and tolerances will not always be correct for all products. Too often a product makes it to production with issues related to tablet compression affecting efficiency of the overall process, such as powder sifting, tool binding, and product scorching due to improper clearance related to the formulation. Too tight a clearance creates binding issues, too great yields sifting due to fine particle size and lack of uniformity. It takes an enormous investment to get a powder from research to production. The granulation is not a viable product made available to the consumer until it has undergone tablet compression. In the tablet press, the lower punch is positioned within the die bore, where it acts as a plug retaining the powder for compression. As the lower punch cycles through the various stages of compression, the movement causes friction, resulting in heat. The finest powder (fines) can bypass the punch tip and die bore, which can cause tool binding resulting in discolored or scorched material as well as premature wear on the punch tip and head. Excessive friction can cause quality issues such as dark specks, scorched belly band, and more. These resulting tablet defects will hinder production, causing unnecessary delays and additional costs. Although there are published standards related to tip and die clearance, these standard clearances sometimes may not be conducive for an efficient process. An engineered customized solution is prescribed for the characteristics of the formulation. At the onset of product development, the tooling supplier needs to work closely with the tablet manufacturer to better understand the formulation characteristics. By sharing critical data regarding particle size and melting point, your tooling supplier will be better informed to provide customized tool clearances. Natoli Scientific based in Telford, Pennsylvania offers comprehensive customized services to solve tableting difficulties and improve the process, including formulation evaluation. Customized designs for punch-to-die clearance considering thermal expansion and formulation characteristics, your tooling supplier can recommend appropriate punch-to-die clearances resulting in a more efficient tablet compression process. ABOUT BILL TURNER, TECHNICAL SERVICE MANAGER Mr. Turner has more than 40 years of engineering tablet production tooling experience at Natoli. He also educates and trains sales/service staff and conducts industry training seminars. ABOUT NATOLI ENGINEERING COMPANY, INC. Natoli is a global leader in tablet compression tooling manufacturing. Nearly 50 years of innovation and excellence earned them international acclaim for quality and reliability. NATOLI ENGINEERING COMPANY Company Name : Natoli Engineering Company, Inc. Phone : 636.926.8900 Email : info@natoli.com Website : www.natoli.com

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