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

By Hans-Jürgen Bässler, Frank Lehmann

This e-book covers all elements of containment know-how intensive and the most recent advancements during this fascinating box are brought. This e-book is a key ebook to making plans engineers, creation managers and people attracted to getting an image of the several functions of the isolator expertise. References on literature, legislation, norms and guidance will aid the reader to turn into conversant in the containment technology.

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If the bottles are correctly filled, which is verified by check weighing, the bottles are transported to the next compartment, if not, bottles are eliminated from the line through an RTP port 190 into a plastic bag. In this isolator part of the filling line the most dust from the tablets is created. Operating the counter isolator, there are two glove ports in the front screen, which allow access of the operator to all surfaces in the isolator. The glove port locations were determined in a mock up study.

For the production and use of radioactive drugs and the preparation of dosing and filling processes are ‘‘hot cells’’ used with the unidirectional air flow. 32 2 Isolators for Personnel- and Environmental Protection Therefore the fans are moving the air in the recirculation mode. In addition, the necessary negative pressure in the cell is created for working with radioactive substances. With filtered intake air—mostly from the installation room—and filtered exhaust air—often using activated charcoal as an additional filter step—the fixed air exchange rate is ensured by appropriate valve settings.

1 Personal Protection Isolators in the Pharmaceutical Industry 21 Fig. 7a PE liner attached on an RTP Fig. 7b Isolator on a balcony type blister machine (Source SKAN AG) isolator, the area with less dust exposition, while the outlet air filter is located in the loading section. In this way, a constant flow from the blister isolator to the loading section is provided. In the air balance, the two mouse holes should be considered too. Operating the blister machine in the containment, there are two glove ports in the loading isolator and five glove ports in the front screen of the second isolator part, which allow access of the operator to all surfaces in the isolator.

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