Aims and Objectives
This advanced subject is designed to give an advanced understanding of good aseptic practices, relevant to cleanroom and aseptic managers and supervisors. The subject is designed to teach participants to identify risk situations that may impact sterility assurance. In order to do this the subject is case study orientated and students are encouraged to investigate industry situations.
On completion of this subject students will be able to:
- State the requirements of cGMP Annex 1
- Identify critical cGMP areas such as personnel, critical equipment, water systems and "sterile" water, cleanroom monitoring and control, bioburden controls and principles of sterility assurance.
- State the limitations of sterility testing, the concept of sterility assurance and theory of sterilisation.
- State the purpose and requirements for media fills.
Content
#1 GMP Principles -Sterile Manufacturing
This module introduces the participants to the requirements of the cGMP Annex 1 (Manufacture of Sterile Medicinal Products).
- State the special cGMP requirements for the manufacture of sterile products.
- Define the difference between aseptic processing and terminal sterilisation of products.
- Find information in the EU/PICs/TGA cGMP Annex #1 for Sterile Products.
- List the key principles of sterile manufacture to minimise risk.
- State the importance of bioburden control.
#2 Sterility Assurance and Sterilisation
This module discusses the limitations of sterility testing, the concept of sterility assurance and theory of sterilisation.
- State the difference between sterility assurance and the sterility test.
- List factors that affect sterility assurance levels (SAL).
- State conditions for successful sterilisation.
- Define the importance of media fills to Sterility Assurance.
#3 Operating and Managing a Cleanroom
This module discusses the work practices needed to maintain sterility of aseptically manufactured products.
- Describe the design requirements for cleanrooms.
- Describe operational requirements
- List Dos and Don'ts of Cleanroom Behaviour.
- List environmental standards for Cleanrooms.
- Describe various requirements for operator qualification.
#4 Validation of Autoclaves and Depyrogenation
This module covers the requirements for sterilization and depyrogenation of equipment and finished products
- Understand the manufacturing controls used for aseptically filled and terminal products.
- Define the terms z, D & F and be able to use them to calculate cycle parameters for sterilisation processes.
- State conditions for successful sterilisation.
- List the IQ, OQ and PQ requirements for moist heat sterilisation, dry heat sterilisation and radiation sterilisation.
#5 Aseptic Processing
This module provides an introduction to the concept of sterility assurance and its importance to aseptic processing.
- State the special conditions for aseptic processing including operator qualification
- Bioburden and Aseptic Processing - sources and controls.
- List the validation requirements and acceptance criteria for aseptic media fills
- Define the importance of media fills to sterility assurance.
- Review of the latest FDA guidance for aseptic processing
#6 Sterile Manufacture of Biotech Products
This module provides important concepts for the manufacture and sterility assurance over biotechnology products:
- List the major process steps for biotechnology products.
- Describe the difference between open and closed processing.
- Describe conditions for bioburden control.
- Describe conditions for pyroburden control.
