- Regulatory Background - FDA,HPRA approach
- Best Industry Approach to Cleaning Studies: Cleaning Strategies, Sampling Methods, Acceptance Criteria
- Calculation of carry over limits
- Cleaning Methods: Manual, Clean in Place (CIP), Steam in Place (SIP), Clean out of Place (COP)
- Methods for evaluating level of cleaning: Visual, Based on Toxicity of substances, Swab Limits, Rinse Limits
- Development of Bracketing procedures
- Development of Worst case rating Procedure
- Dirty Equipment Hold Time (DEHT)
- Clean Equipment Hold Time (CEHT)
- Identification of Hard to Clean Places
- Layout of a Cleaning Validation Protocol
Programme overview
This course is designed to provide detailed understanding of cleaning validation for regulated industries, with particular focus on medical device and pharmaceutical cleaning activities.
Who is the course for
Validation Engineers
Quality Engineers
Personnel designing cleaning methods
Learning outcomes
- Understand regulatory requirements
- Understand key elements that should be in cleaning procedure – TACT
- Understand various cleaning methods
- Layout of cleaning validation protocol
- Understand about ADE (Acceptable Daily Exposure) and PDE (Permitted Daily Exposure) limits
- Understand dedicated cleaning equipment approach