[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.
Inquire About This Product
basic information
- 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.
Price range
Delivery Time
Applications/Examples of results
Cleaning validation
catalog（2）
Download All Catalogs
Company information
Since our establishment in 1967, we have been dedicated to the development and dissemination of water quality measurement devices that anyone can use quickly, easily, and with high precision. In today's world, where the effective use of water, a limited resource, is required alongside environmental conservation, we aim to be a total solution provider that responds to all water environments by utilizing our water quality measurement devices, technology, and services. Furthermore, leveraging the latest technology and years of know-how, we are committed to delivering user-friendly and reliable water quality measurement devices more affordably, quickly, and widely.
