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World Health Organization - gmpua.com

World Health Organization Supplementary Guidelines on Good Manufacturing Practices for Heating,Ventilation and Air conditioning (HVAC) Systems for Non-sterile Dosage Forms Praphon Angtrakool Working document (2004) Food and Drug Administration 1. Introduction X HVAC systems assists in ensuring the manufacture of quality products and also result in operator comfort. X HVAC systems design influences architectural layouts, with regard to items such as airlock positions, doorways and lobbies. X The prevention of the contamination and cross-contamination is an essential design consideration of the HVAC system. X The design of the HVAC system should be considered at the concept design stage. 1. 2. Glossary (1). X Cleanroom : A room or area with defined environmental control of particulate and microbial contamination, constructed and used in such a way as to reduce the introduction, generation and retention of contaminants within the area, and in which other relevant parameters ( temperature, humidity and pressure) are controlled as necessary.

World Health Organization Supplementary Guidelines on Good Manufacturing Practices for Heating,Ventilation and Air conditioning (HVAC) Systems for …

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