Pharmaceutical Container Decommissioning System
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Solution Overview
Problem
The pharmaceutical industry faces challenges in ensuring the secure disposal of spent packaging materials to prevent counterfeiting, as bulk pharmaceutical containers are often discarded and can be reused to introduce counterfeit products back into the supply chain, highlighting the need for effective tracking and destruction of identification information.
Innovation Solution
A system comprising a portal, interrogation zone, controlled access receptacle, and destruction device that reads and records serialized and non-serialized information from data carriers, ensuring the secure tracking and destruction of items, including pharmaceutical product containers, to prevent reuse and ensure compliance with regulations like Title 21 CFR Part 11.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If bulk pharmaceutical containers are discarded without tracking, then disposal cost and time are reduced, but the risk of counterfeiting increases as containers can be reused to introduce counterfeit products
Solution Approach 1:
The system performs preliminary actions by reading and recording identification information from data carriers on pharmaceutical containers before destruction. This ensures that even if containers are discarded, their unique identifiers are captured and tracked, preventing future misuse while maintaining efficient disposal processes.
Solution Approach 2:
The system establishes feedback loops where destruction events are recorded and tracked through databases. This creates an audit trail that provides continuous monitoring and verification that destroyed containers cannot be reintroduced into the supply chain, thereby reducing counterfeiting risk while maintaining disposal efficiency.
2Object-affected harmful factors
If identification information is destroyed along with containers, then counterfeiting risk is reduced, but tracking and verification capability is lost
Solution Approach 1:
The system extracts identification information from data carriers on containers before destruction. By separating the capture of identification data from the destruction process, the system preserves tracking capability while still eliminating the physical containers that could be misused for counterfeiting.
Solution Approach 2:
The system creates copies of identification information from data carriers and stores them in databases before destroying the original containers. This copying process ensures that tracking and verification capabilities are maintained through recorded data while the physical containers are securely destroyed to prevent counterfeiting.
3Device complexity
If manual tracking processes are used, then system complexity is reduced, but labor cost and time consumption increase
Solution Approach 1:
The system replaces manual mechanical tracking processes with automated electronic reading devices that capture identification information from data carriers. This substitution eliminates manual labor while maintaining relatively simple system architecture, significantly reducing time consumption without excessive complexity.
4Productivity
If automated destruction systems are implemented, then destruction efficiency is improved, but system complexity and initial cost increase
Solution Approach 1:
The system merges the reading, tracking, and destruction functions into an integrated automated process. By combining these operations into a single coordinated system, the patent achieves high destruction efficiency while managing overall system complexity through functional integration rather than separate complex subsystems.
Data Source
AI summary
Systems and processes for tracking the status of an item are disclosed. Systems and processes for decommissioning identifying information from pharmaceutical product containers are disclosed.