[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.
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- Method for calculating MAC Method to derive MAC from TDD (daily intake): MAC is calculated using a safety factor based on risk assessment (typically 1000) using information from the current product and the next product. Method to derive MAC from LD₅₀ (lethal dose for 50% of the population): The LD₅₀ of product A is used to calculate the no observable effect level (NOEL), from which MAC is derived. - Setting product reference values Once MAC is determined, it is necessary to calculate the actual product reference values. Common sampling methods include swab samples and rinse samples. - TOC reference values TOC reference values are calculated by multiplying the product reference values by the carbon content ratio. - Summary A lifecycle approach based on the latest FDA guidance is considered best practice for the cleaning validation process. Non-specific analytical methods such as TOC are recommended. For more details, please refer to the application note.
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Cleaning validation
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