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13. VALIDATION: Set Acceptance Criteria for Cleaning Validation

I. Overview of Methods to Establish Residue Limits

  • When it is appropriate to use calculation-based limits?
  • Laboratory studies that can be used to support setting limits
  • When it is appropriate to set data derived limits?
  • Understand the differences in setting limits based on single product versus multi-product equipment


II. Understand and Calculate Maximum Allowable Carryover (MAC) and 10ppm Limits

  • Review the MAC equation and 10ppm equation
  • Walk-though an example of how to calculate limits using these equations
     

III. Learn How to Go from the Calculation to a Cleaning Validation Limit

  • Calculate the limit in the swab desorption sample
  • Calculate the limit in the analytical rinse sample


IV. Setting Acceptance Criteria for Non-Product Specific Tests (e.g., Bioburden, LAL)

  • Typical industry rationale used for setting these limits
  • Risk-based approach to setting justifiable limits
     

V. Interactive Exercise
Attendees determine rinse and swab cleaning validation limits based on performing MAC calculations.

 

Dawn Tavalsky
Director of Validation
Genzyme (a Sanofi Company)