Sterilisation Critical Control Points
Why are Sterilisation steps often defined as Critical Control Points and what does this mean?
Sterilisation Principles in Practice® has been designed to provide the most comprehensive overview of moist heat and dry heat sterilisation science and is ideal for delegates who are new to the industry as well those experienced people who are looking for a refresher. Our courses have been adapted for the virtual learning environment and continue to receive excellent feedback.
After attendance of the Sterilisation Principles in Practice course delegates will be able to confidently answer this question through an understanding of the regulations and application of fundamental scientific principles of moist heat and dry heat sterilisation.
Regulations and Standards
- Understand the Regulations and Guidelines for Sterilisation processes
- Understand the requirements of EN285 tests and acceptance criteria
- Understand the requirements for biological indicators and how to demonstrate an SAL
- Understand the Overkill approach and BI/ Bioburden approach
- How is sterilisation achieved in practice?
- Cycle design principles of Porous and Fluid load cycles
- Design principles for Dry heat and Depyrogenation processes
- How to select the most appropriate steriliser for the application
Application of Risk Assessment
- Understand why sterilisation steps are critical control points within a contamination control strategy
- Practical examples of the application of risk assessment to control the process
Qualification & Validation
- Practical examples of how to put the Principles in Practice
- Cycle Development and PQ strategies
- Methods to define worst case challenges
Critically assess sterilisation steps and identify potential process improvement opportunities
1st AugustRouge in Pharmaceutical Water Systems
16th NovemberA strong case for HydroGienic®