This 3 day course will cover important pharmaceutical utility systems that are important for proper functionality of the manufacturing plant, 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)
References:
- ISPE Baseline Guide – Water and steam systems
- Approaches 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 facilities
- PIC/S Guideline, WHO Guidelines and Technical Reports
- ISO 14644, BP and Phar. Eur.USP, PDA Letter – ISO 22519, PDA