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:

  1. Siting of a pharmaceutical facility - the civil engineering/chemical engineering relationship.
  2. Quality assurance, GMP and validation.
  3. Containment.
  4. Economic principles in manufacturing.
  5. Hygiene, cleaning in place (CIP) and sterilisation in place (SIP).
  6. Water in pharmaceutical manufacturing.
  7. Pharmaceutical manufacturing facility features, layout and design.
  8. 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.