Plant design and manufacturing principles for (bio)pharmaceutical production
Module Title - Plant design and manufacturing principles for (bio)pharmaceutical production
Number of credits – 10
Topics covered in the module include:
- Siting of a pharmaceutical facility - the civil engineering/chemical engineering relationship.
- Quality assurance, GMP and validation.
- Economic principles in manufacturing.
- Hygiene, cleaning in place (CIP) and sterilisation in place (SIP).
- Water in pharmaceutical manufacturing.
- Pharmaceutical manufacturing facility features, layout and design.
- Control in pharmaceutical manufacturing.
Many of these topics are brought together towards the end of the module through a 1 day workshop focusing on the preparation of a client specification for a DNA manufacturing facility and consideration of a number of room specifications (utilities supply, room finish, room classification, etc..) to ensure their compliance with GMP.