Pharmaceutical Technology - May 2018

Pharmaceutical Technology eBook - Biologics and Sterile Drug Manufacturing

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Page 47 of 61

48 Pharmaceutical Technology BIOLOGICS AND STERILE DRUG MANUFACTURING 2018 P h a r mTe c h . c o m Fill/Finish F ill/finish processing is one of the most crucial operations in bio- pharmaceutical manufacturing. Considering how much is at stake once a product reaches the fill/finish manufacturing stage, it is important to seek the most up-to-date technologies for this process. The following recently introduced equipment, products, and sys- tems are designed to streamline the fill/finish operations. Single-use filling assemblies AdvantaPure's sterile-molded filling assemblies are suited for single- use vial and syringe filling (1). The products are made from AdvantaSil silicone tubing and molded components, or weldable and sealable AdvantaFlex biopharmaceutical tubing and components. The assemblies are supplied sterilized, feature molded junctions for continuous flow, and are designed to reduce leak and entrapment issues associated with barbed fittings. The multiport tri-clamp design helps reduce potential leak points and minimizes holdup volume, according to the company. Tabletop peristaltic liquid-filling machine The Flexicon PF7 peristaltic tabletop aseptic liquid-filling machine from Watson-Marlow Fluid Technology Group is suitable for GMP- regulated biotechnology and pharmaceutical operations (2). The machine is designed for precision dispensing by weight or by volume using the company's Accusil platinum-cured silicon tubing; the sys- tem can work with aseptic single-use f luid paths, reducing the risk of cross contamination. According to the company, changing the f luid path can be achieved in less than 60 seconds. The device is programmed with recommended filling parameters and users can adapt filling parameters to their application needs; up to 200 user programmable formulas can be stored and password pro- New Technologies Streamline Fill/Finish Manufacturing Amber Lowry Recent technological advances help streamline the fill/finish manufacturing process. DMITRY K ALINOVSKY/SHUTTERSTOCK.COM

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