Drug Package Validation Using Tiered Scrutiny Thresholds

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Solution Overview

Problem

Existing drug product packaging systems lack the ability to effectively validate the contents of packages based on tiered evaluation factors, particularly for enhanced scrutiny scenarios, which can lead to potential harmful interactions or errors in medication dispensing.

Innovation Solution

Implementing a drug product package validation system that uses tiered evaluation factors, including enhanced scrutiny factors, to assign validation scores and determine if manual validation is required, utilizing artificial intelligence for image processing and detection, and adjusting validation thresholds based on factors like patient age, gender, pharmacogenomic profiles, and drug interactions.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If automated validation is used for all drug packages, then productivity is improved, but reliability deteriorates due to inability to detect enhanced scrutiny cases

Engineering Contradiction:

Improvevalidation throughputVSAvoidvalidation accuracy

Core Design Contradiction:

ProductivityVSReliability

Solution Approach 1:

The validation process is segmented into automated validation for standard cases and manual validation for enhanced scrutiny cases. The system divides packages into two groups: those requiring only automated validation and those requiring manual review, allowing high-throughput processing of routine packages while ensuring reliable detection of problematic cases through human expertise.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The enhanced scrutiny factor acts as an intermediary mechanism that bridges automated and manual validation processes. It identifies packages that need transition from automated to manual validation based on specific risk indicators, ensuring that packages requiring human judgment are appropriately flagged without compromising overall system productivity.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Reliability

If manual validation is used for enhanced scrutiny cases, then reliability is improved, but productivity deteriorates due to increased processing time

Engineering Contradiction:

Improvevalidation accuracyVSAvoidvalidation throughput

Core Design Contradiction:

ReliabilityVSProductivity

Solution Approach 1:

Manual validation resources are applied locally and selectively only to packages with enhanced scrutiny factors rather than universally. This ensures high reliability for problematic cases while maintaining overall system productivity by limiting manual intervention to where it is most needed based on specific risk indicators.

Inventive Principle:

Principle #3Local quality

Solution Approach 2:

The system applies partial manual validation only to the extent necessary for enhanced scrutiny cases. Rather than implementing full manual review for all packages, it applies manual validation partially and selectively to specific high-risk packages, optimizing the balance between reliability and productivity.

Inventive Principle:

Principle #16Partial or excessive action

3Ease of operation

If validation thresholds are fixed, then ease of operation is improved, but adaptability deteriorates for patient-specific risks

Engineering Contradiction:

Improvevalidation process simplicityVSAvoidpatient-specific validation flexibility

Core Design Contradiction:

Ease of operationVSAdaptability or versatility

Solution Approach 1:

Validation thresholds are made dynamic rather than fixed. The system automatically adjusts validation requirements based on patient-specific factors such as age, gender, and pharmacogenomic profiles. This allows the validation process to adapt to individual patient risks while maintaining ease of operation through automated threshold adjustment without requiring manual configuration for each case.

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The system changes validation parameters dynamically based on patient characteristics and drug properties. By modifying validation thresholds and scrutiny levels according to specific patient-risk profiles and drug interaction potentials, the system achieves both adaptability to patient-specific needs and operational simplicity through automated parameter adjustment.

Inventive Principle:

Principle #35Parameter changes

Data Source

PatentUS12561781B2Methods, systems, and computer program product for validating drug product package content using tiered evaluation factors

Publication Date: 2026.02.24 PARATA SYSTEMS LLC

AI summary

A method includes receiving a drug product package containing one or more drug products therein; evaluating the one or more drug products contained in the drug product package based on a plurality of drug product evaluation factors, the plurality of drug product evaluation factors including an enhanced scrutiny factor; assigning a validation score to the drug product package based on evaluating the one or more drug products contained in the drug product package, a magnitude of the validation score being greater with decreasing patient risk; and validating the drug product package. Validating the drug product package comprises: validating the drug product package based on a first comparison of the magnitude of the validation score with a first threshold responsive to a presence of the enhanced scrutiny factor and a second comparison of the magnitude of the validation score with a second threshold responsive to an absence of the enhanced scrutiny factor, the first threshold being greater than the second threshold; or identifying the drug product package as requiring manual validation responsive to the presence of the enhanced scrutiny factor.