Syringe Seal Defect Detection via Optical Imaging
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Solution Overview
Problem
Current methods for inspecting syringes lack effective means to detect seal defects in both dry and wet, non-lubricated syringes, which can lead to reduced shelf life and contamination risks due to inadequate sealing between the stopper and syringe barrel.
Innovation Solution
The method involves optically imaging the contact area between the stopper and syringe barrel to form a contact image, analyzing for discontinuities in the seal line, and determining if the syringe exceeds a defect criteria, using a system that includes a line scan camera and image processing to identify defects in both dry and wet non-lubricated syringes.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If silicone oil is applied to the stopper to improve sealing and reduce friction, then the ease of operation and sealing effectiveness are improved, but the reliability deteriorates due to potential degradation of medicine and protein aggregation
Solution Approach 1:
The patent removes silicone oil from the system entirely, using a dry, non-lubricated stopper instead. This extraction of the harmful substance eliminates the risk of medicine degradation and protein aggregation while maintaining sealing effectiveness through optimized stopper-barrel contact geometry and material properties.
Solution Approach 2:
The patent employs a disposable, sterile, non-lubricated stopper designed for single use. The stopper is engineered to provide adequate sealing and sliding performance without requiring lubrication, and is discarded after one use to eliminate any risk of contamination or degradation associated with lubricants.
2Measurement precision
If optical inspection methods are developed to detect seal defects in non-lubricated syringes, then the measurement precision of seal quality is improved, but the device complexity increases
Solution Approach 1:
The patent utilizes color changes or visual contrast differences in the contact area between the stopper and syringe barrel to indicate seal quality. The optical inspection system detects variations in color, reflectivity, or visual appearance of the contact line to identify defects such as gaps, improper contact, or sealing issues, providing a simple yet effective non-contact detection method.
Solution Approach 2:
The patent replaces complex mechanical inspection methods with optical inspection technology. Instead of using mechanical probes, gauges, or contact-based measurement devices, the system uses light-based detection to assess seal quality, thereby reducing mechanical complexity while improving measurement precision and enabling non-contact inspection.
3Reliability
If the stopper is made non-lubricated to eliminate silicone oil concerns, then the reliability of medicine stability is improved, but the sealing effectiveness may deteriorate due to increased friction
Solution Approach 1:
The patent applies local quality optimization by designing the stopper with specific surface characteristics, material composition, and contact geometry tailored for dry sealing. The stopper material and surface treatment are engineered to provide adequate friction and sealing performance without lubrication, creating localized optimal conditions for seal formation at the stopper-barrel interface.
Solution Approach 2:
The patent changes key parameters of the stopper system, including material properties, surface roughness, contact pressure distribution, and geometric configuration, to achieve effective sealing in a non-lubricated state. These parameter adjustments ensure that the stopper maintains reliable contact with the barrel while eliminating dependence on silicone oil for sealing performance.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
This approach allows for accurate detection of seal defects in syringes, enhancing the reliability of the sealing process and reducing contamination risks by visually inspecting the contact images for discontinuities and color changes indicative of defects.
Implementation Method 1
optically imaging a contact area between a stopper positioned in a syringe barrel of a dry, non-lubricated syringe to form a contact image
Data Source
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AI summary
Systems and methods for detecting syringe seal defects are described, including associated syringe stopper designs having seal areas and indicating areas, as well as associated inspection systems and methods for optical imaging and analysis for syringe seal defects in dry and wet syringes.