Residual limit determination for a cleaning agent corresponding to a validation of an equipment cleaning process
Inventors
Singh, Sumel • Muthusamy, Sivakumar
Assignees
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Publication Number
US-12174617-B1
Publication Date
2024-12-24
Expiration Date
Abstract
Residual limit determination for a cleaning agent corresponding to a validation of an equipment cleaning process is presented herein. A system determines a cleaning agent for cleaning a group of equipment to be used to manufacture a product; and determines a sum of surface areas of respective surfaces of respective groups of parts of the group of the equipment that have been determined to be contacted by the product and the cleaning agent. Based on the sum of surface areas of the respective surfaces that have been determined to be contacted by the product and the cleaning agent, the system determines a cleaning agent residue limit representing a threshold maximum allowable residue of the cleaning agent to be present after the cleaning process has been performed on the group of equipment, and facilitates a cleaning validation of the cleaning process according to the cleaning agent residue limit.
Core Innovation
A cleaning validation system determines a cleaning agent residue limit representing a threshold allowable residue of the cleaning agent to be present after a cleaning process has been performed on equipment. The residue limit determination is based on calculating a sum of shared surface areas that are contacted by both the product to be manufactured and the cleaning agent. The system determines a cleaning agent to be used for cleaning via a cleaning process based on cleaning-process parameters, product, and equipment surface type and surface area together with respective cleaning modes.
The system identifies shared surface areas for respective defined parts of the equipment in response to a determined contacting of the surfaces by the product and the cleaning agent. It then determines the sum of shared surface areas and determines the cleaning agent residue limit based on that sum. After the cleaning process is performed, the system performs cleaning validation according to the cleaning agent residue limit.
Cleaning validation includes identifying portions that have been determined to be difficult to clean using respective risk assessments representing respective degrees of difficulty in cleaning of respective portions. The system uses respective digitized images representing two-dimensional or three-dimensional models of the equipment to identify locations of the difficult-to-clean portions as respective sample locations for performance of the cleaning validation according to the cleaning agent residue limit.
Claims Coverage
The independent claims cover a system, a method, and a non-transitory machine-readable medium for determining a cleaning agent residue limit using surface-area contact sharing between product and cleaning agent, and for performing cleaning validation using risk assessments and digitized 2D/3D models to select sample locations.
Shared surface area-based cleaning agent residue limit determination
Determining a product to be manufactured via equipment, a group of defined parts of the equipment, respective defined cleaning modes of the group of defined parts, and respective surface areas of respective surfaces of the group of defined parts; determining a cleaning agent to be used for cleaning, via a cleaning process, the surface of the defined part; in response to the surface area of the surface of the defined part being determined to be contacted by the product and the cleaning agent, identifying the surface area as a shared surface area for the defined part; determining a sum of shared surface areas of the respective surface areas of the defined parts; and based on the sum of shared surface areas, determining a cleaning agent residue limit representing a threshold allowable residue of the cleaning agent to be present after the cleaning process has been performed on the equipment.
Risk-assessment difficulty identification with digitized 2D/3D model sample location selection
Performing a cleaning validation of the cleaning process according to the cleaning agent residue limit, wherein the performing of the cleaning validation comprises based on respective risk assessments representing respective degrees of difficulty in cleaning of respective portions of the defined parts of the equipment, identifying, via respective digitized images representing two-dimensional or three-dimensional models of the equipment, locations of the respective portions of the defined parts of the equipment that have been determined to be difficult to clean as respective sample locations for performance of the cleaning validation.
Surface area summation for cleaning agent residue limit in cleaning validation
Determining, by the system, a sum of surface areas of respective surfaces of respective groups of parts of the group of the equipment that have been determined to be contacted by the product and the cleaning agent; based on the sum of surface areas, determining a cleaning agent residue limit representing a threshold maximum allowable residue of the cleaning agent to be present after the cleaning process has been performed on the group of equipment; and in response to the cleaning process being performed on the group of equipment, performing, via the system, a cleaning validation of the cleaning process according to the cleaning agent residue limit.
Difficulty determination and sample location identification using risk assessments and digitized 2D/3D images
Performing the cleaning validation, wherein the performing of the cleaning validation comprises in response to determining respective risk assessments representing respective degrees of difficulty in cleaning of respective portions of the respective groups of parts of the group of equipment, determining, by the system based on the respective risk assessments, that the respective portions of the respective groups of parts of the group of equipment are difficult to clean; and identifying, by the system via respective digitized images representing two-dimensional or three-dimensional models of the group of equipment, locations of the respective portions of the respective groups of parts of the group of equipment that have been determined to be difficult to clean as respective sample locations for performance of the cleaning validation.
Machine-readable medium for residue limit computation and risk-based digitized model sampling
Determining a sum of surface areas of respective surfaces of respective parts of a group of equipment, wherein the respective surfaces have been determined to be contacted by a product and a cleaning agent, wherein the product has been determined to be manufactured via the group of equipment, and wherein the cleaning agent has been determined, based on a group of defined parameters corresponding to a cleaning process for cleaning the group of equipment, to be used to clean the equipment; based on the sum of surface areas, determining a cleaning agent residue limit representing a threshold allowable residue of the cleaning agent to be present after the cleaning process has been performed on the group of equipment; and in response to the cleaning process being performed on the group of equipment, performing a cleaning validation of the cleaning process according to the cleaning agent residue limit, wherein the performing of the cleaning validation further comprises based on respective risk assessments representing respective degrees of difficulty according to a difficulty criterion with respect to cleaning of respective portions of the respective parts of the group of equipment, identifying, via respective digitized images representing two-dimensional or three-dimensional models of the group of equipment, locations of the respective portions of the respective parts of the group of equipment that have been determined to be difficult to clean as respective sample locations.
Across the independent claims, the core inventive coverage is the determination of a cleaning agent residue limit using surface-area contact information between product and cleaning agent, followed by cleaning validation that uses risk assessments and digitized two-dimensional or three-dimensional equipment models to identify difficult-to-clean portions as validation sample locations.
Stated Advantages
Avoids conventional MACO overestimation by determining the cleaning agent residue limit based on shared equipment surface area contacted by both product and cleaning agent.
Documented Applications
Cleaning validation for an equipment cleaning process used to manufacture a product, including identifying difficult-to-clean equipment portions and selecting sample locations for validation.
Worst-case assessment triggers for new products or new equipment that modify the cleaning process and require revalidation using an updated cleaning agent residue limit.
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