Isolators – perfect security
 
Peak filling quality can be achieved with an isolator. An isolator uses partition walls, glove ports, sterile transfer technology and overpressure to separate its aseptic interior from the operator environment, thus enabling a pathogen- free, 3- shift filling operation to be carried out even over lengthy periods of time. Recently, progress has been made with regard to the few disadvantages of the isolator technique those being the high initial investment cost and the time-consuming costly approval process. Since the publication of the FDA guideline “Sterile Drug Products Produced by Aseptic Processing” in September 2004, in which the isolator was shown to have significant advantages over traditional processing, the approval barriers can now be more easily calculated. The process technology for bio-decontamination has also become more robust and reliable. The Bosch bio-decontamination system, SafeVAP, initially launched in 2003, has set standards in efficiency and reliability and was approved by the FDA in 2006...

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For more information please contact:

Johannes Rauschnabel
Phone: +49 79 51 402 452
johannes.rauschnabel@de.bosch.com