Pharmaceutical Cleanroom Classification using ISO 14644-1 and the EU GGMP Annex 1 Part 1: Testing rationale
Cleanroom classification is an essential part of the qualification activities in pharmaceutical cleanrooms that confirm the effectiveness of the cleanroom’s airborne contamination control system. A review of the classification requirements and principles associated with ISO 14644-1:2015 and the 2008 version of Annex 1 of the EU GGMP is contained in this first article, and a suitable classification test method derived for aseptic manufacturing. A second article will consider the application of the method by means of practical examples. Key words: Cleanroom classification, ISO 14644-1, EU GGMP Annex 1
Multi-layer controller with state-constraint: Vehicle lateral stability control based on fuzzy logic
2021 ◽
pp. 095440702110142
1995 ◽
Vol 5
(1)
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pp. 354-362
2019 ◽
Vol 8
(1)
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pp. 39-44