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In the pharmaceutical industry, ensuring the safety and integrity of drug products is of paramount importance. Contamination or compromise in the packaging of vials can lead to significant risks for both patients and manufacturers. Hence, meticulous quality assurance measures are implemented to guarantee that every vial meets the highest standards of quality.

One crucial aspect of quality control in vial production is Container Closure Integrity testing (CCIT). CCI inspection is a vital step to verify the hermetic sealing of vials, ensuring that no leaks or defects compromise the product's sterility or stability. Over the years, various technologies have emerged to improve CCI inspection processes, and one of the most advanced and sensitive methods available today is helium leak detection.

Testing Integrity of Vials using Helium Leak Detection Technology

Helium leak detection technology has revolutionized container closure integrity testing by providing highly sensitive and precise detection of leaks in vials. Helium leak detection can be understood as the process of identifying leaks in any closed or sealed system with the help of helium gas and measuring its concentration as it escapes due to leakage. Common applications of helium leak testing include pre-filled syringes, cold form blister packs, foil pouches and many other package formats. This technology can precisely determine integrity between specific primary container closure system components, making it an ideal choice for testing the integrity of pharmaceutical products.

This method utilizes helium gas, which has exceptional properties that make it an ideal tracer for leak detection purposes. By harnessing the unique characteristics of helium, manufacturers can perform comprehensive testing to identify even the smallest leaks, enhancing the overall integrity of vial packaging.

Why is Helium used as a Tracer Gas?

• Helium is used as a tracer gas because of certain unique qualities that make it ideal for leak testing.
• Non-toxic, non-condensable, non-flammable.
• Helium gas is inert, which means it does not interact with the components being tested.
• Since the atomic size of helium is very small, it can easily breach through pathways reliably and easily.
• Compared to other tracer gases, helium is less expensive and readily available.
• Its presence in the atmosphere is not more than ppm.

Technology Overview

The test process starts by introducing helium into the package, which is then subjected to a vacuum. The quantity of helium that escapes from the package is then measured using a helium leak detector, providing a quantitative measure known as the leak rate. In addition to leak testing, helium leak detection technology has proven to be effective for tasks such as package design, failure analysis, tooling qualification, packaging line setup and validation, and monitoring product quality. The use of helium leak detection in accordance with ASTM F2391 is a widely accepted and extensively utilized method in the pharmaceutical industry.

Overall, the adoption of helium leak detection revolutionizes CCI quality assurance, upholding high standards, and supports production quality monitoring at a higher more reliable level.

Airborne ultrasound technology is revolutionizing various industries and applications, thanks to its remarkable versatility and benefits. This groundbreaking innovation utilizes sound waves to detect, measure, and analyze different elements present in the air. Its potential spans across industrial sectors, healthcare, and various other areas, making it an invaluable tool with boundless opportunities.

The ability to identify concealed defects, achieve precise medical diagnoses, and enhance our daily lives through non-invasive means becomes a reality with airborne ultrasound technology. By tapping into sound waves beyond the limits of human hearing, it unveils a realm of possibilities that were once confined to our imaginations.

In this blog, we will delve into the fundamentals of airborne ultrasound technology and shed light on the advantages it brings to various sectors.

PTI’s Airborne Ultrasound technology is a seal quality inspection test method, capable of non-destructively examining seal quality for defects. It is an ASTM Test Method F3004 and FDA Recognized Standard for seal quality testing. Such tests are mainly conducted to provide enhanced seal quality inspection of pouches, flexible packages and tray seals. Airborne Ultrasound technology ensures in-depth seal quality analyses and is applicable for multiple packaging materials Tyvek, paper, foil, film, aluminium, plastic and poly. According to Oliver Stauffer, CEO of PTI-Packaging Technologies & Inspection, “Ultrasound is one of the only technologies that can tell us what the quality of that physical bonded nature of the seal materials are.

Under this technology, ultrasound waves are passed through the package seal which causes reflections of sound waves. The signal strength is reduced or eliminated in the presence of a leak/defect. Such variations are closely observed to identify the leak. Inability to detect non-leak defects is a common challenge faced by most leak test methods. However, with Airborne Ultrasound technology, users are able to identify various types of seal defects; visible and invisible, leaking and non-leaking, process-related and random.

PTI has redefined seal integrity testing with its latest improvements in the form of Seal Scan (Offline) and Seal-Sensor (100% online testing). Both these technologies utilize non-contact airborne ultrasonic testing technology. With the advancements in form of Seal Scan and Seal-Sensor, Airborne Ultrasound technology has been proven to be the most effective method for non-destructive seal integrity testing, in both offline laboratory testing for in-depth seal quality analysis and 100% inline testing on the production line.

• Deterministic seal quality inspection technique that assures quantitative and reliable results
• Applicable for multiple material types and combinations regardless of color, transparency, print, surface finish or porosity.
• Eliminates subjective manual inspection methods.
• Non-destructive, non-subjective, no sample preparation
• Technology can be integrated for 100% online defect detection of the final pouch seal.