Cleaning Validation Acceptance Criteria for Rinse Samples

GOOD VALIDATION PRACTICE (cGVP) CLEANING VALIDATION
1

For cleaning validation of liquid preparation tank (M/s. Airpac 2500/2000 ltr gross/working capacity); I planed to take rinse samples only since swabs will be difficult because of tank size.
What will be the acceptance criteria in this case?
I calculated the MACO (µg), then divided it by total contact area (µg/cm2), but after that I have to multiply it by the sample area, and here I could not decide what the sample area will be in case of rinse sample.

Is there another way of calculating the acceptance criteria in this case?

Thanks and regards

2

1.Please look PDA TECHNICAL REPORT NO .49
Points to consider Biotechnology Cleaning Validation.( this is a latest release just 2 months old)

  1. LeBlanc, D. A. 1998. Establishing scientifically justified acceptance criteria for cleaning validation of finished
    drug products. Pharmaceutical Technology 22 (1 0): 136-148.