Tuesday 24 September 2013

Cleaning Validation Calculation formula for Target limit for swab samples and Rinse Samples

Target limit for Swab samples for individual equipment:
Based on the MAR, target limit for swab sample to determine based on the following calculation:

                                       A x 1000 x B x RF                                                       
Target value for swab (in ppm) = -----------------------------
                                                                   C x D

Where,
A = MAR in mg of “previous” product or “Product to be cleaned”
B = Swab sample area (in 100 cm2)
RF = Recovery factor for Glass, SS or other MOC of equipment
C = Total contact surface area of equipment (in cm2)
D = Dilution volume of swab sample, 1000 = Conversation factor from mg to ppm


Target limit for Rinse sample for individual equipments:
Based on the MAR, target limit for Rinse sample to determine based on the following calculation:

                                                      MAR in mg                                                      
Target Rinse (in ppm) = ------------------------------------------------------------------------ x 1000
                                          Total Volume (L) of final Rinse for train of equipments

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