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20.04.2005 - INTERPHEX 2005 |
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Jacob K. Javits Convention Centre - New York City - April 26th 28th 2005 |
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 The Isolator API The API is the first isolated mini-batch production line for hospital pharmacies and manufacturing laboratories. The API is equipped with an internal small size filling/capping unit, conceived for aseptic manufacturing of syringes and vials (from 0.5 ml to 100 ml). The filling system is disposable and presterilized: no cleaning, no aseptic assembly of the parts required, since the disposable filling system, including the filter, is supplied pre-assembled in sterile package. The API isolator is bio-decontaminated with vaporized hydrogen peroxide (106 spores log reductions) through a Steris VHP system and is fully equipped with control and recording probes (temperature, relative humidity, pressure & air speed), particle counting and microbiological monitoring devices.  Filled and Capped vials - Biosafe® a-ß transfer port The inside of the working chambers is made of stainless steel AISI 316L, mirror polished. A laminar flow maintains the GMP class A/100 conditions and a positive pressure (> 60 Pa) protects the internal environment from potential external contaminations. An integrated air cooling system maintains the correct work temperature inside the cabinet. The egress of the finished product from the working cabinet is performed using the Biosafe ® air tight disposable a-ß flange system, without compromising the sterility of the isolator. Easy to use, maintenance free, 30 minutes set-up. Complete validation protocols for cGMP compliance are available. The filling/capping unit has been developed in conjunction with M.A.R., the Italian filling machine specialist. This special unit is able to handle up to 40 vials or syringes per minute.  Syringes loading No change-over operations are requested, but only simple adjustment. This machine is supplied with a disposable presterilized dosing system (Acerta by Millipore) that offers complete product containment. Thanks to the integration of Isolator and filling/capping unit, a single Siemens PLC controls all the functions of the system. |
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ESRA GENOVA September 2008 |
Symposium XII |
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SINTETICA SA Pharmaceuticals Address: Via Penate, 5 - 6850 Mendrisio (CH)
Phone: +41(0)91 640 42 50 Fax: +41(0)91 646 85 61 - C.p. 1764 - e-mail: info@sintetica.com
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