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Article | REF: BE7011 V1

Clean Rooms and Energy Savings

Author: Philippe BOURBON

Publication date: October 10, 2024

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2. Regulations and standardization

Depending on their field of activity, users of cleanrooms are subject to regulations requiring them first and foremost to control contamination. The following standards and/or regulations are potentially applicable to them, depending on their activities (non-exhaustive list):

  • pharmaceutical Good Manufacturing Practices (GMP) ;

  • European medical device regulations (MDR 2017/745);

  • good preparation practices ;

  • good hospital pharmacy practice ;

  • the order of June 11, 2013 on the rules of good practice designed to guarantee biological safety and security;

  • the decree of July 16, 2007 setting out the technical preventive measures, in particular containment, to be implemented in research,...

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