Cleaning Validation of Pharmaceutical Equipments

The Cleaning validation is performed to demonstrate the effectiveness of procedures for Cleaning to remove residue of previous product. After the process, equipments used for manufacturing of the product, shall be cleaned as mentioned in respective SOPs for cleaning. All procedures of cleaning of process equipments used to manufacture more than one product shall be validated. If the product contains more than one active substance, the active substance least soluble in water and/or highly potent is tested, unless otherwise specified in the individual specification. Before initiating any cleaning validation, a product specific specification shall be prepared. The specification shall mention the acceptance criteria for the existing products, however if acceptance criteria becomes stringent or maximum rinse volume is changed after addition of new products, the acceptance criteria and maximum rinse volume is communicated to concerned department. The stringent acceptance criteria is added in the specifications during the scheduled periodic review of the specifications. Maximum Allowable CarryOver ( MACO) Different criteria are used for calculation of MACO 1. For the calculation by considering 0.1 % Safety factor

Daily therapeutic dose of product A in mg

Min. Batch Size of Product B (in mg)

Limit (mg) = ----------------------------------- x -----------------------------------------------1000 Max. daily therapeutic dose of product B in (mg) Where, Product A – Product manufactured before cleaning Product B – Next Product after cleaning 2. For Considering 10 ppm as acceptance criteria.

1000 – Multiplication factor to convert value in mcg from mg. V – Volume of solvent used to dispense swab. C – Cumulative surface area of the equipments used (in cm2).x ----------C V Where. . D – Swabbed Surface Area in cm 2 . Calculation of acceptance criteria for swab samples Active Ingredient Residue (For Non-dedicated equipments): Acceptance criteria based on the following rationale for swab samples : 1000 D Limit (PPM) = MACO x ---------.The quantity equivalent to 10 mg/L of the batch size is considered as the acceptance criteria for the acceptance criteria as 10 ppm.

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