D – Swabbed Surface Area in cm
Calculation of acceptance criteria for Rinse samples
Active Ingredient Residue (For Non-dedicated equipments): Acceptance criteria based on thefollowing rationale for rinse samples:
Calculation [Applicable to all items of common equipment in product train].
Limit (PPM) = MACO X -------------- x ------
C – Cumulative surface area of the equipments used (in cm
V – Volume of solvent used for rinse of the same in mL per cm
1000 – Multiplication factor to convert value in mcg from mg.
Calculation of recovery factor :
% Recovery shall be not less than 75% unless otherwise specified and justified in individualprotocol of analytical method validation. Recovery factor shall be calculated as follows:
Recovery factor shall be calculated as follows:
Recovery factor = --------------------
Microbiological Quality:a) A Total count limit, is Not more than 10 cfu/100 ml
by rinse method.
b) Not more than 5 cfu / 25 cm
Cleaning validation shall be performed on all the products. The matrix for acceptance criteriashall be prepared when the same set of equipment is used for different products.
After addition of new product the acceptance criteria and maximum rinse volume shall berecalculated in matrix. If the acceptance criteria is stringent than as specified in theRevalidation of cleaning procedure:
Revalidation of cleaning procedure is required if any of the following occur and revalidationof cleaning procedure shall be performed on a minimum of three cleaning cycles.
Modification of cleaning procedure / Surface area of product contact parts of the equipmentor any modification to the equipment which has got direct bearing on product contact parts.
Change in cleaning procedure.