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Medical device packaging plays a fundamental role in safeguarding the product and retaining its quality throughout its shelf life. A package containing medical devices should not only reach the hospital defect free, but it also must withstand sitting on a shelf, possibly for years, without breaking down. Therefore, medical device packaging should be in line with international regulations and quality standards. In order to ensure quality of medical device packages, manufacturers reply on package integrity and seal quality test methods. Although the market offers a complete range of inspection techniques, it is important for manufacturers to choose the appropriate one based on packaging material used and sensitivity levels required.

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. PTI’s Airborne Ultrasound technology (ASTM Test Method F3004-13) uses a transmission of high frequency sound waves through the pouch seal area, providing a simple 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. If the system detects a package defect, the product can immediately be removed from the packaging and reworked. Process related defects can be addressed and corrected immediately, which significantly reduces the quantity of defective packages produced.

Package inspection using Seal-Scan technology

PTI's Seal-Scan® is a non-destructive Airborne Ultrasonic technology (ABUS) that inspects and analyzes pouch seals offline. Seal-Scan® is a semi-automatic inspection system with x-y drive, used for the detection of seal defects, seal characterization and material analysis. This technology utilizes the ASTM Test Method F3004 for seal quality and integrity evaluation. .Seal-Scan® is a deterministic, quantitative, high-resolution method that inspects pouch seals for defects and seal integrity for consistency. Testing using a Seal-Scan® is non-destructive, non-invasive, and requires no sample preparation. Seal-Scan® provides advanced digital imaging software tools for process control which offers in-depth seal quality analysis. PTI has designed several configurations of SEAL-SCAN® for both offline inspections to accommodate various package specifications, test sensitivity and package handling requirements.

Technology overview

Under this method, the pouch seal or package material is scanned between two focused ultrasonic sensors. Ultrasonic waves pass through single or multiple layers of bonded materials. Ultrasonic propagation through different mediums causes reflection of sound waves and reduces/eliminates signal strength. Seal Scan technology can detect different types of defects including leaking and non-leaking, process-related and random are detectable. This technology can produce Opto-Acoustic images as well as detailed statistical analysis by either of two scan modes (L-Scan and C-Scan). An L-Scan is a single linear scan along the X-axis of the seal that provides a line graph of seal integrity and simulates online inspection. C-Scan produces multiple scans (along X and Y-axis of seal area) that provide a high-resolution ultrasonic image of the seal structure. This technology can be integrated into a pouch production line via the Seal-Sensor for 100% on-line seal defect detection.

Benefits of Seal Scan Technology

• Deterministic inspection method producing quantitative results
• Works for any material and combinations, regardless of color transparency, print, surface finish and porosity
• Produces high resolution Opto-Acoustic image of seal
• Characterizes overall quality and uniformity of the seal