Master in Pharmaceutical Plant Design and Management
Classes are mainly held in italian and delivered online.
Prof. Sandri and Prof. Giberti
Introduction to pharmaceutical process engineering
- Engineering principles applied to the pharmaceutical industry
- Unit operations (mixing, granulation, drying, filtration, crystallization)
- Extraction and purification (distillation, chromatography, ultrafiltration)
- Production of sterile APIs (including HPAPIs) and finished sterile medicines
Advanced technologies for drug manufacturing
- Bioreactors and technologies for biologics and biosimilars
- Vaccine and cell therapy manufacturing in controlled environments
- Single-Use Systems (SUS) for pharmaceutical manufacturing
Aseptic manufacturing
- Introduction to microbiology
- Annex 1: EU GMP guidelines for sterile medicinal products
- Aseptic techniques and contamination prevention
- Cleanrooms (ISO 14644-1) and HVAC systems
- Sterilization/biodecontamination: filtration, autoclave, VHP
- Qualification/validation: Media Fill Test, Smoke Studies
- Isolators and RABS
Design and engineering of pharmaceutical plants
- Concept/basic/detailed design, regulatory references, trends (ISPE and others)
- Design and layout (HPAPI, biological agents, BSL 1–4)
- Space optimization (pressure differentials, laminar flows, HVAC)
- Water systems (WFI, Purified Water, Pure Steam)
- Continuous vs Batch Manufacturing
- Sizing, energy efficiency, and sustainability
- Project management, commissioning, FAT/SAT
Aseptic techniques and validation of aseptic processes
- Sterility testing and contamination control
- Environmental sampling and microbiological monitoring
- Endotoxin and particulate testing
- Isolator decontamination/validation
- Terminal sterilization and aseptic filling validation
Control systems and quality in pharmaceutical manufacturing
- Validation and qualification (IQ, OQ, PQ)
- Real-time monitoring and PAT
- Risk analysis and safety engineering
- Chemical (HPAPI) and microbiological (viral) contamination management
Automation and digitalization in the pharmaceutical industry
- Industry 4.0/5.0 and digital transformation
- Automation and robotics for sterile products
- SCADA and MES
- Machine Learning and AI for process optimization
- Data integrity and document management
Logistics, supply chain, and industrial regulation
- Traceability and serialization
- Supply chain and production flow optimization