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Medical Device Manufacturing Environments - A Commentary

机译：医疗器械制造环境-评论

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For those concerned with developing requirements for aseptic processing or semiconductor wafer fab environmental specifications, the choices are easy: there essentially are none! For critical environments regulated by the U.S. Food and Drug Administration (FDA), the compliance limits are widely published and understood. One could argue about how appropriate the guidelines really are, especially since environmental specifications are not product specifications and in light of the current focus on sustainability, the FDA guidelines may be deemed too conservative. However, the fact remains that the guidelines are clear and product safety is No. 1. Likewise, we can readily discern what the killer particle size is for die production based on linewidth, and go from there.
机译：对于那些关注无菌工艺或半导体晶圆厂环境规范发展要求的人来说，选择很容易：根本没有选择！对于受美国食品药品监督管理局（FDA）监管的关键环境，合规性限制已得到广泛发布和理解。人们可能会争论该指南的真正适用性，尤其是由于环境规范不是产品规范，并且鉴于当前对可持续性的关注，FDA指南可能被认为过于保守。但是，事实仍然是准则很明确，产品安全性排名第一。同样，我们可以很容易地根据线宽辨别模具生产的杀手级粒径，然后从那里确定。

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