FPC50 Filling, stoppering and capping machine – Peristaltic aseptic filling from 0.1 to 100ml – No cross contamination – Disposable Aseptic Fluid Path simplifies validation (DAFPA) – Universal format parts reduce costs – Quick and easy change-over between batches WorlD leADers iN AsePtic PeristAltic FilliNg FPC50 Filling, stoppering and capping machine Fpc50 is a highly flexible aseptic a wide range of vials, stoppers – Fast and easy change-over filling system with integrated full and caps. thereby, compared to between batches or partial stoppering and crimp other automatic filling systems, capping of vials. future investments in format parts – Disposable aseptic fluid are significantly reduced – or path ensures simple cleaning it provides a ready-to-use and validation easy to validate filling system for more likely not necessary, at all. small batch production for vial change-over between various vials, – High filling accuracy sizes between 2ml and 100ml. stoppers and caps can be done with- Fill volumes range from 0.1ml in minutes by the operator, without – Universal format parts for to 100ml and a filling accuracy any special tools or technical support stoppers and crimp caps of ± 0.5% can be obtained. from staff outside the cleanroom. – Vial format parts are not needed the entire fluid path is designed Fpc50 is designed to be placed for single use making cleaning under a laF or raBs unit and all – No special tools needed for validation extremely simple and materials and surfaces comply format changes permits fast change-over between with gmp standards for aseptic – Compact unit on castors with the various liquids to be filled. filling. the Fpc50 is also available small footprint thus, the peristaltic filling system in a special version, Fpc50iso, on the Fpc50 eliminates time which is designed for integration – Special version for integration into consuming and costly logistic into an isolator. an isolator is available (FPC50ISO) procedures related to having the Fpc50 is the perfect solution product or volume dedicated – IQ/OQ documentation can be for small batches at contract provided pumps in stock. fillers and for a highly flexible the universal format parts supplied production for clinical trials within – Standard machine with many with the Fpc50 can be used for r&d departments. reference customers Watson-Marlow Flexicon Frejasvej 2–6 dK-4100 ringsted denmark tel. +45 5767 1155 Fax +45 5767 0541 www.wmflexicon.dk FPC50 technical speciFications TECHNICAL SPECIFICATIONS a walking beam with central adjust- operator interface is an easy-to- Applications: ment of guide rails transports vials clean touch screen and keypad. – Filling and partial stoppering of lyophilisation stoppers from the rotary table to the different the control panel is integrated into work stations. thus, no format parts a control box, which is attached to – crimp capping are required for the entire vial range the machine cabinet or supplied – Filling, full stoppering of injection between 2ml and 100ml. as a stand-alone unit to be placed stoppers and crimp capping Format parts for stoppers consist at a distance from the machine. Stoppers: Ø13 mm and 20 mm injection and only of the chute, jaws and piston. the touch screen has self-explana- lyophilisation stoppers (samples to be Format parts for crimp caps consist tory menus for control of machine sent to Watson-Marlow Flexicon prior only of the chute and crimping head. parameters. sensors ensure no to final quotation) the vibrator bowl for the stoppers vial/no fill, no vial/no stopper Caps: can be applied for both 13mm and and no vial/no cap. moreover, the Ø13 mm and 20 mm flip-off aluminium number of stoppers and caps in caps and/or plain aluminium caps. 20mm injection and lyophilisation (samples to be sent to Watson-Marlow stoppers. For the crimp caps the the chutes is monitored. errors at Flexicon prior to final quotation) same vibrator bowl can normally the stoppering or capping stations, Infeed and outfeed trays: be applied for both 13mm and as well as at the outfeed, will stop Width/open end min. 200mm/7.9” 20mm caps. the machine automatically. – max. 305mm/12” Fpc50 has integrated support of it is possible to store up to 20 sets Production capacity of parameters as complete Up to 25 units per minute depending nozzles for gas purging before and on fill volume and vial size after filling of liquid. a valve for gas programs. the programs and the various machine functions can be Filling volume: purging is optional. 0.1ml to 100ml password protected. Vials can be loaded into the machine Accuracy: from a removable infeed tray from preparing the Fpc50 for a new vial, ± 0.5% can be obtained on liquids with the front or from the left side of the stopper and cap is an easy task. a viscosity like water and a constant machine. this allows installation of the guide rails for the vial and the suction level the Fpc50 under a laF unit or inside position of the format parts for the Mains: a raBs. collection of vials takes stopper and the cap are adjusted in a 110/230VAc – 50/60Hz place on a removable tray. few minutes by turning four handles. Power consumption: Max. 1200W Air supply / pneumatic connection: Dimensions in mm/inch Min. 5 bar clean and dry air Air consumption: Max. 100 litres per minute Materials: stainless steel and anodised aluminium. Product and stopper contact parts in Aisi316l 1356/53.4 800/31.4 970/38.2 Interface: 2 x rs232 serial communication for balance and printer 1 x 24V output signal for nitrogen 2397/94.8 purge valve 656/25.8 1552/61.1 2 x external error for interface with 79-401-301 issUe 2 0908 · 13608 · bureaulist.dk for example a particle counter communication with rABs (specified by Watson-Marlow Flexicon) 612/24.1 Ingress protection: iP32 for machine base iP54 for control panel Weight: Min. = 200/7.9 272/10.9 Max. = 305/12 400 kg 1198/47 Max. = 305/12 Min. = 200/7.9 Watson-Marlow Flexicon cannot be held responsible for any errors or omissions. Subject to change without notice.