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The integrity of the package is critical to maintaining the sterile barrier and preventing microorganism penetration throughout the distribution process. Microorganisms can enter a packaging system if it has defects, compromising product safety. Flexible pouches are frequently used as primary packaging, or packaging that comes into contact with the product, in the Lifescience (pharmaceutical, medical device) and food industries. Any breach of the sterile condition is regarded as a serious risk and frequently results in the destruction of valuable products. As a result, seal integrity testing of flexible packages is critical.

Seal Integrity Testing using Airborne Ultrasound Technology

PTI’s Airborne Ultrasound technology is an ASTM Test Method F3004 and FDA recognized standard for seal integrity testing method capable of conducting advanced seal quality inspection of pouches and flexible packaging. It is a non-destructive, non-invasive technique capable of accommodating multiple packaging materials such as Tyvek, paper, foil, film, aluminum, plastic and poly and is also proven to provide deterministic, reliable and accurate test results.

This method works by sending ultrasound waves through the package seal as they move along the sensor head, causing sound wave reflections. When there is a leak, the seal strength is reduced or eliminated. Variations in signal strength are closely monitored in order to detect seal defects. Airborne Ultrasound technology's ability to detect various types of seal defects, including visible and invisible, leaking and non-leaking, process-related and random, makes it a viable option for seal quality inspection of flexible packages. “Ultrasound is one of the only technologies that are telling us what the quality of that physical bonded nature of the seal materials are,” says Oliver Stauffer, CEO of PTI. PTI offers two configurations of Airborne Ultrasound testing technology; Seal-Scan® and Seal-Sensor.

Seal-Sensor™ is an Airborne Ultrasonic technology that inspects the final pouch seal online and non-destructively. Seal-Sensor is a deterministic, quantitative, quick, and dependable method for inspecting pouch seals. Seal-Sensor detects incomplete seals, partial or weak areas in seals, and a variety of common defects in seals that appear visually acceptable but contain defects that impact product quality, value, and shelf-life. In less than one second, a single linear scan (L-Scan) of the pouch seal produces a pass/fail result as well as quantitative, traceable data.

Benefits of Seal - Sensor Technology

• Deterministic inspection method producing quantitative results
• Non-destructive, non-invasive, no sample preparation
• Works for any material and combinations, regardless of color, transparency, print, surface finish and porosity
• Can be integrated for 100% online defect detection of the final pouch seal
• Repeatable and reliable results
• Eliminates subjective, manual vision inspection methods
• Economical, cost-effective solution for seal integrity testing the final pouch seal

There are certain aspects that need to be maintained regardless of whether you operate in the food packaging sector or the pharmaceutical products manufacturing industry to ensure that a quality product will be provided to the clients. Package integrity testing is required for items that must be packaged so that they can be sterilized and maintained sterile for a defined amount of time, throughout the product lifecycle.

Package Integrity Testing Using VeriPac 455

The VeriPac 455 is a non-destructive, non-invasive, and highly sensitive Container Closure Integrity Testing (CCIT) method that may be implemented into protocols at any stage of the handling process. Stability research, clinical trial investigations, quality assurance testing, and production statistical process control are examples of applications for this technology (SPC). Leak rates as low as 0.05 cc/min can be found with the VeriPac 455. Results have consistently outperformed and outperformed the dye ingress test in terms of accuracy.

The VeriPac 455 core technology is based on the ASTM vacuum decay leak test method (F2338-09) recognized by the FDA as a consensus standard for package integrity testing. This test method was developed using VeriPac leak test instruments. The VeriPac 455 is equipped with the patented PERMA-Vac dual vacuum transducer technology, which increases test sensitivity and yields reproducible, dependable results.

Additionally, the VeriPac 455 contains major improvements in networking and internet access that enable remote operation, system monitoring, and MES integration. Test systems can be built to operate automatically or manually. This inspection method is appropriate for QA/QC statistical process control and laboratory offline testing. The test cycle only lasts a few seconds, the results are objective, and the testing is non-destructive to the product and the package.

Inspection Criteria

• Measures seal integrity of entire container or package
• Measures and verifies container closure system integrity
• Tests for gas leaks for dry products (lyophilized vials, powder filled)
• Tests for liquid leaks (liquid filled vials, pre-filled syringes)

Benefits

• Non-destructive, non-subjective, no sample preparation
• Defect detection down to 0.01 cc/min
• Highest level of sensitivity, repeatability and accuracy
• Results proven superior to dye ingress
• Deterministic, quantitative test method
• Supports sustainable packaging and zero waste initiatives
• ASTM test method F2338 and FDA standard for package integrity testing
• Vacuum Decay technology referenced in USP 1207 guidelines