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Pharmaceutical & Medical Packaging News, May/June 2015

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Page 27 of 43 • Pharmaceutical & Medical Packaging News May/June 2015 28 Filling Mounted Vertical Wall Advances Filling Customers have been demanding this line for compliance, effciency, and optimization. By Matthew Sanderson Associate Editor M archesini Group's Stery- Capsy is a compact filling, stoppering, and closing system designed to ease product decontamination and provide safety to operators. Devel- oped to be installed vertically along a wall, the system can be integrated with bufers, loaders, loading and unloading units for freeze-dried products, capping units, and, in the case of the line to be exhibited at ACHEMA 2015, a rotary table and double tray loader. Per its news release, Marchesini states the Stery-Capsy ofers "perfect accessibil- ity" to all critical zones, pre-arrangement to fit closed restricted access barrier sys- tems (cRABS) or isolator containment systems, plus simplified management of spare parts and maintenance. The Stery-Capsy has a balcony design aimed to keep areas where product is exposed separate from where mechani- cal components are installed. With this, Marchesini says it guarantees a "perfectly sterile process," in addition to cutting washing, drying, and decontamination times by 50 percent compared with con- ventional machines. "As usual, a new concept can require some years to be understood," Antonio Leggieri, spokesman for Marchesini, tells PMP News. "The wall installation can be difcult in an existing filling depart- ment. However, in the last five years, most of our customers have been asking for this type of line in order to comply with the strictest cGMP requirements, be more efcient, and optimize their classi- fied spaces." He said the Stery and Capsy are designed to be installed under the isolator to manufacture potent drugs, which must be washed out from the machine at the end of the batch. "The vertical wall mounting design offers very efficient washing, draining, and drying of inner surfaces. There are no horizontal surfaces to wash [and] no points of retention," Leggieri said. As a result, Leggieri said it is easy to decontaminate the isolated machine with spray balls and automatic drying. "The time required to prepare the machine for the next batch is shortened and the cost for washing media is mini- malized (the high purified water is very expensive)," he said. The Stery-LC was created by Mar- chesini's partner, Corima, in designing packaging machines for sterile products. The balcony structure allows for in-line vial filling, and movements within the machine's critical zone are completed by rotary drives. Marchesini claims the structure allows the efficiency of the laminar flow to reach the "highest pos- sible level" to protect the area where the product is exposed, as well as "perfectly" Once flled, vials are sent to the capper on the Capsy-LC.

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