Pharmaceutical Technology - May 2018

Pharmaceutical Technology eBook - Biologics and Sterile Drug Manufacturing

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46 Pharmaceutical Technology BIOLOGICS AND STERILE DRUG MANUFACTURING 2018 P h a r mTe c h . c o m W i t h t h e u s e o f RT U c o m p o n e nt s , t h e re l at ion s h ip b e t we en d r u g m a nu f a c t u re r s a nd component suppl iers is cha ng i ng—t he component suppliers a re now ta k ing on t he responsibility of optimizing and validating all component prepa ration processes as wel l as providing certificates of analysis as assurance of conformity to all specifications. Conclusion Drug product and parenteral packaging com- ponent manufacturers are continuously evolv- ing in a lig nment w it h t he adva ncements in technolog y and increasing regulatory require- ments to better ensure the quality and safety of i njec t able d r u g produc t s for pat ient s . T he incorporation of barrier technology and f lexible f illers and the use of RTU packaging compo- nents are rapidly gaining adoption as safe and effective solutions for fill/finish processes and container closure systems, respectively. With the use of RTU components, the drug manu- facturers can eliminate the need for component preparation, streamline t heir processes, and increase their focus on drug product develop- ment and manufacturing. PT Fill/Finish For parenteral packaging lines, new syringe f iller s meet the rising demand for pref illed syringes. Compac t and f lexible, the FSP 05 f illing and stoppering machine from Marchesini Group for nested syringes accurately f ills up to 12,000 syringes/h. Available with various dosing options, the system of fers precise and gentle centering and handling, which minimize the chance of breakage (1). The Injec ta syringe f iller f rom IMA Life Nor th America relies on advanced robotics to smoothly process tubs and components and limit operator access to the working area. Glass-to - glass contac t is minimized, and in-line process control makes it possible to reject a single non-conforming syringe. Other features include complete accessibilit y and fully automatic component feeding and handling (2). For low-volume needs and small spaces, Cozzoli Machine o f f e r s t h e FS V50 M i n i M o n o b l o c k m ac h i n e f o r v ials ranging from 1–100 mL. Designed for use in a cleanroom environment with hood isolation and laminar f low, the machine f ills liquids or powders and applies a stopper or cap at speeds up to 50 vials/min (3). For quality control, Antares Vision is launching an enhanced Lyo-Check inspec tion machine for lyophilized (freeze-dried) produc ts. Dedicated sof t ware and optical layout suppor t the system's vision architec ture. "We believe the machine will have a signif icant impac t on the lyophilized produc t sec tor in terms of prolonged storage possibilities, higher produc t qualit y due to improved inspec tion, and lower process costs compared to manual inspec tion," said Davide Sacchet ti, business development manager for Inspec tion Machines at Antares Vision, in a press release (4). References 1. Marchesini, "INTERPHEX 2018, the Marchesini Group Focuses on Aseptic Packaging and Cosmetic Packaging Markets," Press Release, Feb. 26, 2018. 2. IMA Group, "The IMA Group at INTERPHEX 2018, Discover IMA's Innovation!," Press Release, Feb. 26, 2018. 3. Cozzoli Machine Co., "Cozzoli Machine Company to Exhibit at INTERPHEX 2018," Press Release, Mar. 5, 2018. 4. Antares Vision, "At INTERPHEX NYC, Antares Vision to Debut Enhanced Lyo-Check Machine for Lyophilized Products, and Showcase ATS Four Serialization Software," Press Release, Mar. 12, 2018. —Hallie Forcinio is Pharmaceutical Technology's packaging editor. INNOVATIONS IN FILLING AND INSPECTION MACHINES

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