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

This 2-day intensive course covers critical pharmaceutical utility systems that are important for proper functionality, compliance and efficiency of manufacturing facilities.

What You’ll Learn:
Participants will gain practical insights into key systems such as:
– Water: Potable Water, Purified Water, Water for Injection (WFI)
– Steam: Plant Steam, Industrial Steam, Pure Steam/Clean Steam
– Gases: Compressed Air, Nitrogen, Process Gases 

• Industry best practices for commissioning and qualification of pharmaceutical water and steam systems

• Effective sampling techniques for water, steam, and process gases

• Control strategies for maintaining system integrity and preventing contamination

• Application of HVAC systems in both sterile and non-sterile environments

• Key considerations for:

  • Oral solid dosage manufacturing

  • Sterile product manufacturing facilities

Guidelines & References
This course is aligned with globally recognized regulatory guidelines and references including:
– ISPE Baseline Guide – Water and steam systems
– PIC/S Guideline,
– WHO Guidelines and Technical Reports
– ISO 14644,
– BP and Phar. Eur.
– USP
– PDA Technical Reports & ISO 22519

-EMA/INS/GMP/443117/2020 (revised): Q&A on production of water for injections by non-distillation methods – reverse osmosis and biofilms and control strategies
EMA/CHMP/CVMP/QWP496873/2018 (revised): Guideline on the quality of water for pharmaceutical use
– EU GMP Annex 1 (revised): Safety and quality in sterile product manufacturing

What You’ll Walk Away With
This training equips your team with the knowledge to prevent contamination risks, ensure regulatory readiness, and maintain consistent product quality.