Target limit for Swab samples
for individual equipment:
Based on the MAR, target limit for swab sample to determine based on the following calculation:
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:
Total Volume (L) of final Rinse for train of equipments
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 1000Total Volume (L) of final Rinse for train of equipments
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