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08:24 Jan 12, 2018 |
English to Russian translations [PRO] Medical - Medical: Pharmaceuticals / Помещения при производстве стерильных ЛП | |||||||
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| Selected response from: Maksym Nevzorov Ukraine Local time: 06:59 | ||||||
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Summary of answers provided | ||||
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4 +2 | вспомогательные чистые помещения |
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supporting clean areas вспомогательные чистые помещения Explanation: -------------------------------------------------- Note added at 8 mins (2018-01-12 08:33:38 GMT) -------------------------------------------------- Из контекста вполне очевидно, что речь идет о двух видах "чистых помещений" - один из них - это некая критическая зона, а второй - вспомогательные чистые помещения, связанные с ней. https://gmpnews.ru/terminologiya/chistye-pomeshheniya/ - вспомогательные чистые помещения (гардеробные, моечные, стерилизационные, коридоры и т. п.). https://www.hygiena.com/doc_download/42-fda-sterile-drug-pro... 217 B. Supporting Clean Areas 218 219 Supporting clean areas can have various classifications and functions. Many support areas 220 function as zones in which nonsterile components, formulated products, in-process materials, 221 equipment, and container/closures are prepared, held, or transferred. These environments should 222 be designed to minimize the level of particle contaminants in the final product and cont rol the 223 microbiological content (bioburden) of articles and components that are subsequently sterilized. |
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