Annex 5 Supplementary guidelines on good …

215 World Health OrganizationWHO Technical Report Series, No. 961, 2011 Annex 5 Supplementary guidelines on good manufacturing practices for heating , ventilation and air- conditioning systems for non-sterile pharmaceutical dosage forms1. Introduction2. Scope of document3. Glossary4. Products and personnel Air fi ltration Unidirectional airfl ow Infi ltration Cross-contamination Displacement concept (low pressure differential, high airfl ow) Pressure differential concept (high pressure differential, low airfl ow) Physical barrier concept Temperature and relative humidity5. Dust control6. Protection of the General Dust in exhaust air Vapour and fume removal7. Design of HVAC systems and General Air distribution Recirculation system Full fresh-air systems Additional system components8.

216 1. Introduction Heating, ventilation and air-conditioning (HVAC) play an important role in ensuring the manufacture of qual ity pharmaceut ical products .

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  Guidelines, Good, Supplementary guidelines on good, Supplementary, Ventilation, Conditioning, Heating, Ventilation and air conditioning

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