Medical device quality control inspection is considered to be highly significant in ensuring safe delivery of medical devices from their place of origin to the market. However, tremendous development in medical technologies have challenged the medical device packaging industry to ensure quality and reliability in packaging
Adding to that, drug contamination is a serious concern in any medical industry- specifically for Class III medical devices. Class III medical devices are understood as devices that sustain or support life and are implanted, or present potential unreasonable risk of illness or injury. Since these devices are directly placed into human bodies, proper packaging is required to ensure quality of the product until it reaches the patient. Any breach in the packaging can cause contaminants to enter the device, causing major health risks. Hence, appropriate package integrity testing and seal quality inspection of Class III medical devices are required so as to ensure seal quality and sterile barrier integrity are maintained.
Initially, manufacturers heavily relied on visual inspection or other probabilistic test methods to inspect seal quality and integrity. However, such methods lacked accuracy and reliability in terms of test results. Hence, manufacturers are now shifting towards non-destructive method for evaluating seal quality and inspecting physical properties of a seal. One such technique that is increasingly becoming popular among medical device manufacturers is Airborne Ultrasound technology. It is an ASTM test method F3004 and FDA recognized standard for seal quality integrity testing. These tests are primarily conducted to provide advanced seal quality inspection of pouches, flexible packages and tray seals. The test is conducted by transmitting 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 also be addressed and corrected immediately, which significantly reduces the quantity of defective packages produced
Airborne Ultrasound technology variants, namely Seal-Scan® and Seal-Sensor provide both, offline and online inspection of packages and accommodate various package specifications, test sensitivity and package handling requirements. Seal-Scan® offline systems offer in-depth seal quality analysis and seal characterization. Seal-Sensor online inspection systems for automated 100% inline scanning of pouch seals can be integrated into pouch production or pouch handling line. They provide a quick analysis of the seal area without tampering with the packaging to identify defects, such as incomplete or missing seals, wrinkles, channel defects and so on.
Advantages of Seal Scan and Seal Sensor method
- Deterministic seal quality inspection method that produces quantitative results.
- This method works for any material type and combinations regardless of color, transparency, print, surface finish or porosity.
- Non-destructive and non-subjective test method that requires no sample preparation.
- Technology can be integrated for 100% online defect detection of the final pouch seal.
- Repeatable, reproducible and reliable results for seal quality inspection.
- Cost-effective solution for seal integrity testing and seal analysis that characterizes overall quality and uniformity of the seal.
package integrity testing, seal quality inspection, container closure integrity, medical device package inspection