For packaging sterile devices in the medical industry, porous packaging materials are widely used. The sterile products are frequently packaged, shipped, and distributed to multiple places, where they may be exposed to a range of humidity conditions during the course of the distribution cycle. The leaks in the porous packaging materials can contaminate medical devices as well as products. These leaks are frequently observed at tiny pinholes or breaches in the seals between packing components. Hence, maintaining the microbial barrier of sterile medical devices is of grave importance. In order to maintain the sterility and microbial barrier, various package integrity test solutions can be used. Airborne Ultrasound technology is one such method.
Airborne Ultrasound Technology Overview
Airborne ultrasound is an inspection method for testing seal quality that is able to evaluate seals for defects without causing any damage. It is an FDA recognized standard and ASTM Test Method F3004 for testing seal quality. Such tests are mostly carried out to provide enhanced tray seals, flexible packages, and pouch seal quality inspection. Tyvek®, paper, foil, film, aluminum, plastic, and poly are just a few of the packaging materials that may be used with Airborne Ultrasound technology to ensure in-depth seal quality analyses.
Integrity Testing of Porous Packages using Airborne Ultrasound Technology
Airborne Ultrasound technology is one of the commonly used methods for testing the seal quality of porous packages. In this technique, sound waves are reflected when ultrasound waves pass through the packaging seal. The signal intensity is reduced or destroyed when there is a leak or defect. These variations are meticulously monitored to identify defects. With airborne ultrasound technology, it’s now possible to identify a variety of seal defects, including visible and invisible, leaking and non-leaking, process-related and random both offline in the lab and in automated production environment.
Airborne Ultrasound technology has been proven in the field with both online (Seal-Sensor) and offline (Seal-Scan) solution options. Both of these technologies make use of non-contact airborne ultrasonic testing. It is known to be among the best techniques for non-destructive testing of flexible packaging seals in both offline laboratory testing for seal quality analysis and 100% inline testing on the production line. According to ASTM F3004-13, this is the standard test procedure for the airborne ultrasound evaluation of seal quality and integrity.
Benefits of Seal-Scan and Seal-Sensor Methods
- Deterministic seal quality inspection method that produces quantitative outcomes.
- Regardless of color, transparency, print, surface polish, or porosity, this method works for all material types and combinations.
- Non-destructive and non-subjective test technique that does not require any sample preparation.
- Technology may be used for 100% online final pouch seal defect detection.
- Seal quality inspection results are repeatable, reproducible and reliable.
- Cost-effective solution for testing seal integrity and seal analysis that characterizes the overall quality and uniformity of the seal.
According to studies, the conventional seal inspection techniques are ineffective because they miss undetectable flaws and wrongly reject pouches that are tightly sealed. Airborne Ultrasound is a deterministic seal quality testing method. The technology has established itself as a highly practical solution for non-destructive testing of porous packages. The integrity of porous packages can be tested efficiently using Airborne Ultrasound technology.
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