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-12366846-B2
Publication Date
2025-07-22
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
The cleaning-validation system determines a cleaning agent residue limit for a cleaning validation of a cleaning process of a group of equipment by identifying parts that are contacted by a product during manufacture of the product and are contacted by a cleaning agent during the cleaning process. The system calculates a sum of surface areas for the parts, and determines the cleaning agent residue limit based on the sum for the parts rather than using a total equipment surface area approach.
The system performs cleaning validation of the cleaning process using the cleaning agent residue limit at sample locations that are identified as difficult to clean. The identification uses digitized images representing two-dimensional or three-dimensional models of the group of equipment and uses respective risk assessments representing respective degrees of difficulty in cleaning respective portions of the parts of the group of equipment.
The system further supports validation mapping and validation outcomes by identifying sample locations and associating sample locations with a data store and a cleaning validation process. The cleaning validation results determine whether an amount of a cleaning agent residue on a test sample from each location is lower than the cleaning agent residue limit.
Claims Coverage
The independent claims cover at least four inventive-feature groupings: (i) residue-limit determination using a sum of surface areas for shared product- and cleaning-agent-contact parts, (ii) cleaning validation at difficult-to-clean sample locations identified from digitized 2D/3D equipment models and risk assessments, (iii) associating sample locations with validation outcomes and residue-limit comparison, and (iv) worst-case modification triggers based on product and equipment attributes.
Shared surface area-based cleaning-agent residue limit determination
Determining parts of a group of equipment that are contacted by a product during manufacture of the product and that are contacted by a cleaning agent during a cleaning process of the group of equipment; determining a sum of surface areas for the parts; and, based on the sum for the parts, determining a cleaning agent residue limit for a cleaning validation of the cleaning process of the group of equipment.
Digitized 2D/3D models and risk-assessment identification of difficult-to-clean sample locations
Performing the cleaning validation of the cleaning process using the cleaning agent residue limit at sample locations identified using digitized images representing two-dimensional or three-dimensional models of the group of equipment, where the locations are to be difficult to clean based on respective risk assessments representing respective degrees of difficulty in cleaning respective portions of the parts of the group of equipment.
Associating sample locations with validation outcomes and residue-limit comparison
Associating sample locations with a cleaning validation process, where a cleaning validation determines whether an amount of the cleaning agent residue on a test sample from each location is lower than a specified cleaning agent residue limit.
Worst-case modification triggers based on product and equipment attributes
Modifying the cleaning process and performing a second cleaning validation using a second cleaning agent residue limit when a newly added product is determined to be a worst-case product, and/or modifying the cleaning process and performing a second cleaning validation using a second cleaning agent residue limit when newly added equipment is determined to be worst-case, based on defined group of conditions.
Across the independent claims, the method/system/medium determines a cleaning agent residue limit based on a sum of surface areas of equipment parts contacted by both product and cleaning agent, then performs cleaning validation at sample locations judged difficult to clean using digitized 2D/3D models and risk assessments. The claims also cover associating sample locations with validation outcomes using a residue-limit comparison and modifying validation using worst-case triggers for newly added product or equipment based on defined product- and equipment-related conditions.
Stated Advantages
Can reduce overly stringent cleaning-agent residue limits and associated cleaning resource use.
Documented Applications
No documented applications found
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