To provide a framework for the design of an aseptic manufacturing facility in the production of pharmaceuticals.

 

Module Content

• Overview of the biopharmaceutical industry, aseptic manufacturing production facilities design
• Overview & design philosophy, sterilisation and disinfection (thermal and non-thermal), lyophilisation, facility architecture and layout, air classification, ventilation, air conditioning & HEPA filtration, water, surface finishes, pressure, barrier isolation technology, personnel, clothing, design considerations in the rest of the facility, regulatory framework and issues.