Pharmaceutical Technology - May 2018

Pharmaceutical Technology eBook - Biologics and Sterile Drug Manufacturing

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Pharmaceutical Technology BIOLOGICS AND STERILE DRUG MANUFACTURING 2018 49 tected for future use. According to the company, the machine's validation-friendly operator interface can reduce the risk of filling errors. Large keys and a color display aid operation while working in gloves or behind glass within a restricted-access barrier system or laminar air flow unit. The low shear pumping action of peristaltic fillers ensures product is transferred undamaged and with high precision, the company reports. The machine offers repeatable filling of volumes from 0.2 mL up to 250 mL, with accuracy better than ±0.5%, to prevent overfilling. The unit can connect to a range of balances and printers for calibration and batch reporting to help compliance with GMP and regulatory demands. It also connects to bottle handling systems, including the company's FlexFeed 15, 20, and 30, or other third-party systems, to facilitate integration with automated filling lines. Product set for aseptic filling workcells Ompi EZ-fill vials and Daikyo Seiko's PLASCAP press- fit closures are designed as a product set to work with Vanrx Pharmasystems' Aseptic Filling Workcells (3). Product set combinations are available in Inter- national Organization for Standardization stan- dard 6R, 8R, and 10R vials, and corresponding 20-mm press-fit closures and are certified to work with Vanrx's Microcell Vial Filler and SA25 Asep- tic Filling Workcell. Commercial ready-for-hu- man-use stock and closure integrity performance results are available from the suppliers. The suppliers said that pharmaceutical com- panies using the product set are assured that the combination will function as a high-performance primary packaging system for sterile injectables. Elements of the set have been proven for compat- ibility and machinability with Vanrx aseptic filling systems, the companies report. The ready-to-use product set is commercially avail- able and certified to work with Vanrx's Microcell Vial Filler, a gloveless robotic isolator for vial filling that can be used to make clinical trial supplies and develop new products, and SA25 Aseptic Filling Workcell, a gloveless robotic isolator that performs material han- dling, filling, and closing activities within a closed isolator. Testing for the product set was completed as part of the Matrix Alliance, a collaboration be- tween leading pharmaceutical packaging compa- nies including Vanrx, Ompi, and Daikyo created to provide aligned manufacturing processes and packaging solutions. CMO adds aseptic fill/finish line Ajinomoto Althea announced the installation of an Optima VFVM 7000 aseptic f ill/f inish line t hat supports a range of drug substance APIs compatible with both peristaltic and ro- tary piston pump f illing systems (4). The f ill/ f inish line enables large batch sizes and han- d les a range of f illing volumes (0.2–100 mL) while reducing product loss. According to the compa ny, t he equ ipment a lso of fers i n-pro- cess-cont rol, nit rogen pu rg i ng, a nd severa l additional features to maximize yield. References 1. AdvantaPure, "AdvantaPure Introduces Single-Use Filling Assemblies," Press Release, Dec. 19, 2017. 2. Watson-Marlow Fluid Technology Group, "WMFTG Unveils Flexicon PF7 Tabletop Peristaltic Liquid Filling Machine," Press Release, Jan. 29, 2018. 3. Vanrx, "Vanrx Announces Compatibility Between Ompi EZ-fill vials, Daikyo Seiko PLASCAP press-fit closures, and Aseptic Filling Workcells," Press Release, Feb. 7, 2018. 4. Ajinomoto Althea, "Ajinomoto Althea, Inc. Announces New Aseptic Fill Finish Line," Press Release, Aug. 24, 2017. PT

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