Pharmaceutical Plant Design & Engineering
Overview
Pharmaceutical plants require stringent control of cleanliness, sterility, and regulatory compliance to ensure the safety and efficacy of drugs. The focus is on Active Pharmaceutical Ingredients (API) production, formulations, injectables, and aseptic processing
Key Industries
- API Manufacturing – Bulk drug substances.
- Formulations – Tablets, capsules, syrups, ointments, and creams.
- Sterile & Injectable Facilities – Vaccines, IV fluids, biologics.
- High-Potency Drug Facilities – Handling HPAPIs (oncology drugs, hormones).
Key Aspects of Pharmaceutical Plant Design
- Classified as per ISO 14644-1 (ISO 5, ISO 7, ISO 8).
- Pressure differentials to prevent contamination.
- Water for Injection (WFI), clean steam, compressed air systems.
- Reverse Osmosis (RO), Ultrafiltration (UF), and distillation.
- Isolators, Restricted-Access Barrier Systems (RABS).
- Unidirectional material & personnel movement.
- cGMP, FDA, EMA, WHO GMP, USFDA, 21 CFR Part 11.
- IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification).
- Use of SCADA, PLC, and MES systems.
- IoT-enabled condition monitoring for predictive maintenance.