Good Aseptic Practices and Sterile Products

Aims: 
To provide an advanced understanding of the manufacture of sterile drugs and devices, in particular, to identify risk situations that may reduce sterility assurance, and implement appropriate control strategies

Outline Syllabus: 

• Concept of sterility assurance
• Concept and source of bioburden
• Limitations of sterility testing
• Theory of sterilisation
• Requirements of the EU cGMP Annex 1 and FDA GMPs
• cGMP requirements for personnel, critical equipment, water systems and “sterile” water, cleanroom monitoring and control, bioburden controls and principles of sterility assurance.
• Purpose and requirements for media fills.
• Work practices needed to maintain sterility of aseptically manufactured products.  It provides the
• Monitoring systems.
• Sterilization and depyrogenation of equipment and finished products
• Aseptic processing.

Learning Outcomes:
On successful completion of this module, the student will be able to:

(1) Knowledge and Understanding

• State the special cGMP requirements for the manufacture of sterile products.
• Discuss the difference between aseptic processing and terminal sterilisation of products.
• List the key principles of sterile manufacture to minimise risk.
• State the difference between sterility assurance and the sterility test.
• List factors that affect sterility assurance levels (SAL).
• Define the role of media fills in Sterility Assurance.
• State the special conditions for aseptic processing.
• Describe the difference between open and closed processing.

(2) Discipline skills

• Identify and implement effective strategies for bioburden control.
• Train and qualify operators in cleanroom gowning and behaviour
• Use Z, D & F to calculate cycle parameters for Sterilisation processes
• Review sterilization records
• Prepare qualification protocols for moist heat sterilisation, dry heat sterilisation and sterile filtration
• Prepare SOPs for conducting media fills