Design criteria and containment evaluation for pharmaceutical containment systems in aseptic dosage form manufacturing facilities

Design criteria and containment evaluation for pharmaceutical containment systems in aseptic dosage form manufacturing facilities
Takeda, Morihiko
5/1/2003
Pharmaceutical Technology
This article describes the design criteria required to contain active pharmaceutical ingredients and the containment evaluations of barrier isolation systems used in aseptic dosage form manufacturing facilities. The isolation systems include closed and open systems, which are designed to allow manipulations at levels of containment 1 [micro]g/[m.sup.3] and are categorized in the performance-based exposure control limit of 4. To evaluate the containment performances of not only the equipment itself but also of the facilities as a whole, this study focused on describing the ...
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