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Pharmaceutical & Medical Packaging News, May/June 2015

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29 May/June 2015 Pharmaceutical & Medical Packaging News • pmpnews.com separate the work area from the mechan- ical component area at the back of the machine. The machine is designed to be easily installed against walls and to guaran- tee safe use for operators, as well as the possibility to equip with loaders, bufers, lyo loaders, tray loaders, and cappers. The vertical balcony allows for isolating technology or RABS installations where WIP, drying, and SIP do not interfere with the depth of the machine. In addition, the air discharged can be directed or recov- ered from the bottom area, Marchesini claims, to ensure airflow without dead zones or turbulence. Leggieri noted there is "complete sepa- ration" between the technical part and the process part, which cannot be ofered by the traditional machine. "Due to this design, the machine is not deep and all operative stations have an easy access because of the gloves," he said. The vials are transported on the Stery- LC by a linear motion belt with a slower maximum production speed than the laminar flow velocity, in order to avoid turbulence, the company says. Incoming vials sent from the loader are arranged in a single row by an infeed scroll before being transferred into the pucks. The pucks are inserted in the belt with a straightforward "T" coupling, which can be installed using sterile gloves and trans- ferred into the filler through any type of door or bag. The compactness of both the pucks and the scroll, along with the capping head, means size parts can be installed in full compliance with good manufacturing practices, the company claims. The infeed scroll is driven by an independent brushless motor separate from the main motor so that the flow of vials can be stopped to allow the convey- ance belt to unload downstream or to create empty spaces in the pucks, which is required by the Association for Con- necting Electronics Industries. The vials never come into contact with the guides or any other mechanical part while being filled, and they are filled by a peristaltic pump or a volumetric pump, both of which can be installed simultane- ously on the same machine, according to Marchesini. This allows for continu- ous motion by means of a walking beam driven by another programmable brush- less motor, meaning accelerations, decelerations, and the speeds can be programmed according to the product, to the vials, and to other factors that may afect the filling process. The line can be totally customizable, Marchesini concludes. The walking beams moves with just rotary movements below the vial conveyor belt and can work with single fill or fractional fill movements, if requested. Following the filling phase, vials are sent directly from the linear conveyor belt to the rotary cap-placing tower. Product protection solutions, such as booths or isolators for cRABS, can be quoted sepa- rately on request and can be easily added to the machine. The balcony design of the Capsy- LC ensures "excellent exposure to the laminar flow," Marchesini says, and "perfect segregation of the contami- nation-controlled area from where the mechanical components are installed." It also means that air discharged can be "directed" efficiently or recovered at the bottom. The combined high tech and made in Italy design yields a machine that not only meets all regula- tory provisions for injectables, but also halves washing, drying, and decontami- nation times when compared with con- ventional machines. Once filled, vials are sent to the Capsy, ready for capping. Its cap feeder allow the operator to fill the hopper directly from sterile sacks without any other steps in between, the company claims. At ACHEMA, Marchesini will fea- ture the Capsy's new alu-capping head, aimed to improve the finish and the cap- ping quality for flip-of caps. The smaller capping head, made of stainless steel, uses a hardening treatment to sanitize it without compromising stainless fea- tures or durability. In addition to the scroll, the conveyance star wheels and the plates mean that the size part can be installed in full compliance with good manufacturing practices. In the capping phase, both the compression force on the cap from a proportional regulator, and the rolling speed of the cap against the blade from a brushless motor are controlled so the process is repeatable, according to Marchesini. "Marchesini has already sold its technology to important multinational pharma companies and also to as many national private industries," Leggieri said. "The challenge is to sell more and more to the pharma companies of the merging countries." Leggieri said the company thinks that safety and quality in injectable drugs manufacturing cannot be optional for any pharma company independently from their country and budget. For more company information, visit http://www.marchesini.com. 0 The Stery-LC has a balcony design.

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