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

This three (3) days course will cover important Pharmaceutical Utility Systems such as Water (Potable Water, Purified Water, and Water for Injection), Steam (Plant, Industrial), Pure Steam / Clean Steam, System and Process Gases (Compressed air, Nitrogen). This is important for proper functionality of the manufacturing plant. References: ISPE Baseline Guide: Water and Steam Systems, Approaches to Commissioning and Qualification of Pharmaceutical Water and 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 Facilities. PIC/S Guideline, WHO Guidelines and Technical Reports, ISO 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 strategies, EMA/CHMP/CVMP/QWP/496873/2018: Guideline on the quality of water for pharmaceutical use, EU GMP Annex 1 August 2023.

  • Date : June 26, 2024 - August 1, 2025
  • Time : 00:00 - 00:00 (UTC+0)

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