Download e-book for iPad: Containment Technology: Progress in the Pharmaceutical and by Hans-Jürgen Bässler, Frank Lehmann

By Hans-Jürgen Bässler, Frank Lehmann

ISBN-10: 3642392911

ISBN-13: 9783642392917

ISBN-10: 364239292X

ISBN-13: 9783642392924

This e-book covers all facets of containment know-how intensive and the newest advancements during this interesting box are brought. This publication is a key ebook to making plans engineers, construction managers and people drawn to getting an image of the various purposes of the isolator expertise. References on literature, legislation, norms and guidance will help the reader to develop into conversant in the containment technology.

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Extra resources for Containment Technology: Progress in the Pharmaceutical and Food Processing Industry

Example text

This lies on the different number of clean room classes that are relevant to the operation. These clean rooms are connected by air locks. In this example, both clean rooms have the same impact area of 12 m2 in the high-purity working range of the highest class A, which is indispensable in the pharmaceutical sector. To keep this area germ- and particle-free, operators of the variant RABS need around three clean room grade levels of Grade B–D. The isolator system needs on the other hand around the high-purity work area in the surrounding environment only a simple clean room class (D).

7(7)). When the freeze drying process is finalized, the stoppers are completely inserted in the objects and they are unloaded to the capping isolator (Fig. 7(8)). 44 3 Product Protection Isolators Fig. 7 Concept of a vial-filling line for four freeze-dryers in isolator technology (Source SKAN AG) The circulating air handling is fitted over the working chamber (Fig. 8(1)). The cabinet and the processing of incoming and outgoing air are usually built into the overlying technical area. The supply air is delivered from the installation room or from building HVAC systems.

7a(2)) or a split butterfly valve to the hopper. During the transfer, it is important to ensure that the hopper is not flowing over. This can be done by a PE liner attached on the RTP (Fig. 7a(3)). The hopper is the area in the isolator, where most of the dust is created by the vibration of the tablets. The second part of the isolator (Fig. 7b(a)) encloses the blister process, the area where the tablets or capsules are transferred into the cavities of the plastic foil. After thermoforming the plastic film, the foil with the formed cavities will pass the mouse hole on the bottom of the second isolator part.

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Containment Technology: Progress in the Pharmaceutical and Food Processing Industry by Hans-Jürgen Bässler, Frank Lehmann


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