Titlebook: Containment Technology; Progress in the Phar Hans-Jürgen Bässler,Frank Lehmann Book 2013 Springer-Verlag Berlin Heidelberg 2013 Electron Be

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Decontamination of Aseptically Operated Isolators,. Here is the method of choice the heat sterilization with steam (SIP). All plant parts or accessories which do not withstand the temperatures to be achieved for successful steam sterilisation, must be fumigated with a decontamination procedure, which makes the surfaces in the work area free of livi

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Monitoring of the Process Environment, of the aseptic manufacturing environment. Over a longer period of time, (trends) a consistent monitoring program allows to detect changes in the status “free of germs” of the isolator. The monitoring of the isolator helps to identify possible routes of contamination quickly and allows taking approp

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Technological Outlook,y, which is also reflected in the dimensions and capacity of the isolator units required for fill-finish production steps. These products usually react very sensitive to external influences and cannot be terminally sterilized, therefore an aseptic preparation method with controlled environment is re

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https://doi.org/10.1007/978-3-662-36298-3ed hazardous for operators. Full protective suits have the disadvantage that they are expensive in purchase and reconditioning, and time-consuming changes for the operator are necessary. Furthermore, the environment cannot be effectively protected from the release of problematic chemicals. The prote

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https://doi.org/10.1007/978-3-662-36298-3 also the process like testing pharmaceutical samples for sterility or aseptic filling of vials and syringes can be protected from microbial and particular contamination. There are several methods with different levels of protection, starting from simple laminar flow units with PVC curtains up to op

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Rhizomorpha (Dematophora) necatrix n. sp,o filter the exhaust air for the aeration of containments. The design and the efficiency of the filter system depends highly on the targets, which are defined by the OEL level (Operators Exposure Level) of the material, the amount of dust created in the process and the SAL (Sterility Assurance Level