Calculation of maximum allowable carryover in cleaning validation.
[Application Note] Calculation Method for Maximum Allowable Carryover (MAC) in Cleaning Validation
- Establishing the Cleaning Validation Process Each process of cleaning validation is unique, and factors such as raw materials, process flow diagrams, work procedures, and minimum batch size (MBS) influence the cleaning process. The cleaning validation process is divided into three stages: design, qualification, and verification, and these should be continuously confirmed and updated throughout the duration of the process. It is necessary to set a Maximum Allowable Carryover (MAC) when switching products in production equipment. The MAC is the amount of the previous product that can be present in the next product without posing a risk to the patient. Here, we will introduce the method for calculating the Maximum Allowable Carryover (MAC) in cleaning validation.
- Company：セントラル科学
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