This webinar discusses some of the history and drivers that began the movement from compliance-based approaches to the science-based, risk-based and statistics-based approaches to cleaning validation introduced in the American Society for Testing and Materials (ASTM) E3106 “Standard Guide for Science Based and Risk Based Cleaning Process Development and Validation” and the ASTM E3219 “Standard Guide for Derivation of Health Based Exposure Limits (HBELs)” and provides an overview of both Standards as well as other ASTM standards in development.
Part 1 – Background on Science, Risk and Statistics-Based Cleaning Process Development and Validation
- Historical drivers
- Proposed 1996 Revisions to the GMPs
- Risk-MaPP and origin of ASTM E3106
Part II – Introduction to ASTM E3106
- Cleaning risk (hazard) identification
- Setting HBEL derived cleaning limits
- Cleaning process development
- Risk-based selection of analytical Methods
- Cleaning Process Capability
- Cleaning control strategy using visual inspection
- Risk review and new product introduction
Part III – Introduction to E3219
- What is a Health Based Exposure Limit (HBEL)?
- How are HBELs derived?
- Adjustment factors
- “Qualified expert”
Top Ten Reasons to Attend:
- What is risk and how can you measure it?
- What is an HBEL?
- Who is qualified to determine an HBEL?
- What is the “toxicity scale”?
- What is the CEF and “cleanability scale”?
- What are the “detectability scales” ?
- What is the “Cpu-based process capability scale”?
- What is the Shirokizawa Matrix?
- How to qualify visual inspection
- New product introduction