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m-MiniCH_48-62_MINICH 12/30/13 2:09 PM Page 60 60 January 2014 Corporate Capabilities Tablets & Capsules Mini Case History Automated Testing: A Critical Component of High-Throughput Tablet Production Soft Gel Technologies, Inc.® (SGTI) is a full-service contract manufacturer, specializing in providing marketers with premium quality dietary supplements in a soft gelatin capsule delivery system. SGTI is dedicated to the production and marketing of branded products and turnkey custom formulations exclusively to the nutraceutical industry. We have the capacity to meet high volume demands as well as accommodate smaller jobs in a reliable manner. SGTI obtained GMP certification through the NPA and NSF, including NSF's Athletic Banned Substances program, known as GMP for Sport™. The company has an extensive analytical laboratory on site, which assures product integrity and quality. Global sourcing of ingredients and the ability to provide a full range of product development and marketing services allows SGTI to give its business partners a distinct advantage. SGTI is committed to giving its customers the highest levels of service and support. At Soft Gel Technologies, Inc., we provide our customers with branded and scientifically-researched ingredients, patent and trademark protection, exclusive soft gelatin products, and the latest, state-of-the-art technology and machinery for soft gelatin encapsulation. We offer the customer the fullspectrum package of manufacturing—from formulation to bottling. We can take a customer's concept and deliver a product ready for sale. By having Soft Gel Technologies, Inc. do the work, the customer can focus on branding and marketing the new product. The advantages of automation are shown by a case study comparing a fully automated tablet test system with a manual tablet testing protocol. Contract manufacturing is very competitive, and the ability to offer unsurpassed quality, reduce direct manufacturing costs and provide clients with concise, easy-to-understand test reports can be paramount in maintaining a competitive edge. A contract manufacturer with 17 press bays outputting as many as 15 different products a day – ranging from dietary supplements to OTC products – used five manual tablet testers shared by all the press operators. The quality control lab used the same model tester as production. After reviewing internal IPC and QC processes, the contract manufacturer decided to replace the manual testers with four fully automated testers (in this case, AutoTest 4 Tablet Testing Systems from Dr. Schleuniger Pharmatron) – three in production and one in the QC lab. The automatic tester in the QC lab and one of the production units had a so-called '12-magazine feeder' to allow the set-up of as many as 12 tests at the same time – making it possible to quickly and easily test multiple samples from a wide variety of products and batches. Whereas one tester could be shared among a group of press bays in production, it proved to be equally useful to use a 12-magazine feeder in QC to streamline processes and minimize investment costs. The two remaining automated testers were installed directly in the compression room in combination with portable tablet diverters and an air transport system (see instrument pictured above). One of the main advantages of realizing the press integration with a standalone testing system was that no modification of the existing presses was required. Stack lights were programmed to signal whether a T limit had been exceeded, alerting the press operator. The benefits and increased efficiencies were immediately apparent. Test reports by batch including plausibility, T1 and T2 limits were generated with each tablet sampling in real time. Soft Gel Technologies, Inc. (SGTI) 6982 Bandini Blvd. Los Angeles, CA 90040 Ph: (323) 726-0700 Toll-Free: (800) 360-7484 (SGTI) Fax: (323) 726-7065 Website: www.soft-gel.com E-mail: sales@soft-gel.com Confusing data became a thing of the past and batch release authorizations took place in synergy with production schedules. Customers were pleased to receive test data by email within hours of their products being completed. Delivery times were reduced, as were direct labor costs. Dr. Schleuniger® Pharmatron is a brand of the Sotax Group SOTAX Corporation 2400 Computer Drive Westborough, MA 01581 www.sotax.com