Cleaning Validation of Pharmaceutical Equipments
Know what is cleaning validation, maximum allowable carryover ( MACO), acceptance criteria and recovery factor in cleaning validation. The Cleaning validation is performed to demonstrate the effectiveness of procedures for cleaning to remove the residue of the previous product. After the process, the equipment used for manufacturing of the product shall be cleaned as mentioned in respective SOPs for cleaning. All procedures for cleaning of process equipment 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 forthe existing products, however, if acceptance criteria become stringent or maximum rinse volume is changed after addition of ...

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