Common Pitfalls in Aseptic Processing and Cleaning Validation

I. Introduction to Root Cause Analysis

• Methods used during deviation investigations
• Structured thought process tools
• Real Life examples of the “tools in action”
• Tying it all together to get at the root cause

II. Learning from Our Mistakes

• Common errors and deviations
• Corrective action analysis — What can be done to prevent repeats!
• Control monitoring — How to ensure your “fixes stick”
III. Interactive Exercise
Using a real life example, participants perform an investigation into a cleaning validation failure utilizing structured
thought process tools and develop recommendations for corrective actions.
IV. Bonus Material
• Six Sigma tool templates
• Relevant articles

Common Pitfalls in Cleaning Validation

I. Finalize the Cleaning Method and Manage Change

 Issues that must be addressed to avoid inspectional findings
 Case studies of flaws in the cleaning methods that have resulted in rejection of the entire cleaning validation effort
 Define dirty and clean hold time
 Serial batch production
 Amount of water and water pressure
 Flow rate for final rinse, etc.
 What happens when new operators are engaged?
 What happens when the supplier of your detergent kills off the product line?

II. Sampling and Testing challenges

 Sampling tools, containers and techniques
 Analytical methods from the perspective of mistakes learned through hands-on experience
 Save time, aggravation and reduce inspectional citations
 Twenty years of case studies with practical tips for designing and implementing a program that really works.

III. Interactive Exercise

Using case studies developed by the presenter, participants review and identify potential pitfalls in the cleaning
validation efforts presented for review. The group then presents and discusses findings and prevention methods to
ensure a cleaning validation protocol, report and ongoing management of the cleaning program that passes
regulatory scrutiny during inspections.
IV. Bonus Material
 List of cleaning validation references
 FDA guide to cleaning validation