HVAC
HVAC for Biopharma
Recently delivered for AbbVie, and for participants from the Singapore and US pharmaceutical industries.
For engineers, managers and technicians in biopharma plants, design firms, contractors and C&Q companies, and for anyone new to pharma HVAC.
Module 1 · Pharma HVAC design
- Key considerations: protecting product, people and environment
- Starting point: user requirements
- Cleanroom classifications (A, B, C, D, CNC)
- Air changes, filtration and air distribution
- Room differential pressures
- Temperature and relative humidity
- Alarms, set points and pressure recovery
- AHU configurations: primary and secondary AHUs, terminal cooling and reheating coils
- Design examples: tableting and sterile facilities
- Reviewing HVAC design
Module 2 · GMP regulations and compliance
- FDA, EU GMP, WHO GMP and PIC/S guidelines
- HVAC qualification process and practices:
- Design qualification (DQ)
- Installation qualification (IQ)
- Operational qualification (OQ)
- Performance qualification (PQ)
How it runs: interactive, with questions, discussions, exercises and experience-sharing. Each module opens with clear learning goals and closes with a short quiz.