PHARMACEUTICAL UTILITIES (HVAC, WATER, COMPRESSED AIR, NITROGEN, STEAM)

This 3 day course will cover important pharmaceutical utility systems that areimportant for proper functionality of the manufacturing plant, such as:Water (Potable Water, Purified Water and Water for InjectionSteam (Plant, Industrial)Pure Steam/Clean SteamSystem and Process Gases (Compressed air, Nitrogen).

References: ISPE Baseline Guide – Water and steam systemsApproaches to commissioning and qualifications of pharmaceutical waterand steam systems.Sampling for pharmaceutical water, steam and process gases.Good practice guide – Heating, ventilation and air conditioning (HVAC).Oral solid dosage forms.Sterile product manufacturing facilitiesPIC/S Guideline, WHO Guidelines and Technical ReportsISO 14644, BP and Phar. Eur.USP, PDA Letter – ISO 22519, PDA

EMA/INS/GMP/443117/2017:Questions and answers on production of water for injections by non-distillation methods – reverse osmosis and biofilms and control strategiesEMA/CHMP/CVMP/QWP496873/2018:Guideline on the quality of water for pharmaceutical use EU GMP Annex 1 Revision: Manufacture of sterile medicinal products