Annex 5 Supplementary guidelines on good manufacturing ...

as other factors such as gowning requirements. GMP and clean area standards should be used in conjunction with each other to defi ne and classify the different manufacturing environments. 220 cross-contamination Contamination of a starting material, intermediate product or fi nished

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Cleanroom Basics - CERHB

©UF What is a cleanroom? ISO 14644-1: • 'A room in which the concentration of airborne particles is controlled, and which is constructed and used in a manner to minimise the introduction, generation, and retention of particles & microbes inside the room and in which other relevant parameters, e.g. temperature, humidity, and pressure, are