Medical Device
Seal Integrity Testing and Seal Quality Analysis
Medical Device Packaging Seal Inspection
Overview
Complementing the high cost of medical device manufacturing, there is a high value placed on the sterility and quality of the final product which are the main reasons for successful integration of Seal-Scan® airborne ultrasound seal inspection for medical device packaging.
Seal-Scan® inspection systems characterize seals that appear visually acceptable yet possess defects that affect product quality and shelf-life. The Seal-Scan® 525 is an offline inspection system used for the detection of seal defects, seal characterization and material analysis. Seal-Scan® 525 is an excellent tool to analyze the sealing process that is ultimately the key to a good quality seal.
The Seal-Scan® 525 provides advanced digital imaging software tools for process control which offers in-depth seal quality analysis. Seal-Scan® 540 is the online configuration for automated inline scanning of pouch seals that will find defects 100% online.
Benefits
- Characterizes overall quality and uniformity of the seal
- Non-destructive solution for process control/quality control/process optimization
- Analyzes seal quality
- Provides statistical sealing trend analysis
- Produces high resolution Opto-Acoustic image of seal
- Replaces visual and/or destructive inspection methods
- Supports sustainable packaging and zero waste initiatives
Seal-Scan® Technology vs. Manual Vision Inspection
Medical device manufacturing is a labor intensive process and unit costs are typically high for a variety of reasons, including design, regulatory compliance, specialized labor and unique equipment involved in the manufacturing process.
Manual visual inspection of medical device packaging is typically used to evaluate the quality of the final package seal, but too often a defect or quality deviation goes undetected. Operators are capable of detecting only 80% of defects at best, with diminishing detection capability as inspection time increases.1 Even with added visual inspectors, defects will go undetected due to the physical aspects of seal defects. The physical nature of a seal defect is often independent of visual characteristics, making them undetectable to the human eye.
Also, defect detection often occurs further downstream in the manufacturing process from where the actual defect was created, which results in producing an increasing number of units before the problem is identified and corrected. Visual inspection of medical device packaging will continue to be a point of contention due to the lack of efficient detection.
Defects can be both random and process related, requiring diligent inspection of all package seals. The ideal solution is a
non-destructive method for inspecting the physical properties of the seal and a non-subjective analysis to determine the seal
quality. Seal-Scan® inspection systems utilize airborne ultrasound technology which uses a transmission of high frequency sound waves through the pouch seal area, providing a pass or fail result of seal quality. A linear scan analysis of the seal area will detect channel defects, misaligned seals, incomplete and missing seals immediately after the package has been sealed. Process related defects can be addressed and corrected immediately, which significantly reduces the quantity of defective packages produced. Seal-Scan inspection systems are non-destructive, non-invasive and require no sample preparation.
Seal-Scan® Specification Overview
Seal-Scan® 525 Pouch Seal Samples L-Scan and C-Scan Results
Pouch Analysis Examples
Folding a Tyvek® seal can lead to the separation of Tyvek fibers. Seal-Scan® technology is sensitive to the separation of Tyvek fibers and is capable of detecting the folded areas. These areas could be potential defects, putting the package contents at risk.
Accurate, Effective Local Defect Detection
