Jan 2021

Why is Airborne Ultrasound Technology Gaining Popularity in Medical Device Package Testing?

Why is Airborne Ultrasound Technology Gaining Popularity in Medical Device Package Testing

The World Health Organization (WHO) has stated that healthcare associated infections pose the highest risk in the delivery of healthcare services globally. This causes a serious threat to millions of patients worldwide every year. Therefore, ensuring sterility of medical devices is an important way to reduce the risk associated with faulty medical devices in hospitals and other healthcare settings.

Appropriate packaging and packaging materials are crucial to help preserve sterility of medical devices. Conventionally, medical device manufacturers relied on manual visual inspection as a method for assuring quality. However, such methods lacked accuracy and reliability in test results. To overcome the limitations of traditional test methods, manufacturers moved towards deterministic Container Closure Integrity testing methods that ensured quantitative and accurate test results.

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 are telling 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. 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 seal quality analysis and 100% inline testing on the production line.

Benefits of Airborne Ultrasound technology:

  • 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.
Airborne ultrasound technology, seal quality inspection, seal quality testing, Seal Scan, Container Closure Integrity testing, CCIT
Sep 2020

The Importance of Seal Integrity Testing in the Food and Nutrition Industry

Importance of Seal integrity testing

Food and nutrition packaging are much more than attractive containers kept on a retail shelf. Packaging executes multiple functions since it conveys information about the product, educates the consumers, ensures product protection, helps market the product and much more. Therefore, manufacturers of food and nutrition products must keep package quality at the forefront.

Innovations in packaging including the use of flexible packages and shift from plastics to more sustainable materials have accelerated packaging challenges. Hence, ensuring package quality is vital for preventing possible contamination and resultant spoilage of goods. Often, customers may or may not be aware of such contamination, which can cause serious health problems. In case of high-risk individuals such as the elderly or children under 5 years, the consequences may be fatal. Such consequences have a direct impact on company/brand image resulting in product recalls and huge financial losses.

This stresses the importance of implementing appropriate packaging integrity testing solutions in the production line. Among many other techniques available in the market, seal integrity testing is a popular choice for most manufacturers. There are multiple methods of conducting a seal integrity test including destructive and non–destructive test methods. A method applicable in one situation may not be so in other. Manufacturers should choose the appropriate technology depending upon package type, product specifications, defect profile, and testing requirements.

Methods of Seal Integrity Testing

Under destructive testing methods, the sample package may get destroyed and become useless even though the seal passes the test. Demand for such tests has steadily declined due to its inability to detect non-leaking defects. Common test methods under this category include water bath/bubble testing and peel strength test.

To overcome the shortcomings of destructive test methods, non-destructive test methods and technology advancements have been developed. Such methods cause no harm to the package or product and they can be returned to market after testing. According to Oliver Stauffer, Chief Executive Officer at PTI - Packaging Technologies & Inspection “There is a huge shift in the industry toward deterministic and quantitative test methods”. PTI’s VeriPac Vacuum Decay Series and Airborne Ultrasound technology are non-destructive test methods having high applicability in the food and nutrition industry.

PTI’s VeriPac Vacuum Decay technology is a non-destructive package inspection technique, applicable for rigid and flexible packages and with a capability of detecting leaks as small as 10 microns. It has the potential to test different size pouches, stick packs or sachets without any changeover in parts or system settings. VeriPac FLEX Systems, a non-destructive package inspection technique specifically for dry-filled flexible packaging (pouches, stick packs and sachets). The VeriPac FLEX Series are available in several configurations taking into account varied package specifications and test sensitivity requirements.

Pouches are the common form of packaging for many food products like juices, snacks, nuts and coffee. Therefore, ensuring package integrity of such pouches are crucial. PTI’s Airborne Ultrasound technology is a non-destructive seal integrity test that serves as an ultimate solution for pouch seal quality testing, specifically to check that final top seal after filling and sealing the pouch contents. When high frequency sound waves are passed through the pouch seal area, reflections of sound waves are created. Defects are identified by analysing variations of reflected signal strength. It ensures 100% defect detection of pouch seals. PTI’s ultrasound technology can be applied to 100% defect detection of pouch seals as well as for in-depth seal quality testing and analysis.

VeriPac Vacuum Decay technology (F2338) and Airborne Ultrasound technology (F3004) are both ASTM test methods and also FDA consensus standards for package integrity and seal quality inspection. According to the specific nature of the product and package, appropriate testing methods can be selected.

seal integrity testing, airborne ultrasound technology, seal quality testing, airborne ultrasound, package integrity testing, vacuum decay technology
Sep 2020

Airborne Ultrasound Technology-The ultimate choice for Seal Integrity Testing

CCIT - A risk mitigation tool for parenteral products

Seal integrity is the key to ensuring quality of packaging goods. Testing the integrity of package seals helps ensure that packaging provides sufficient product protection. Seal quality test analyses the mechanical strength of the seal thereby securing appropriate material bonding to maintain package quality throughout the product’s shelf life. Any defect in the seal can initiate a leak and will contaminate the product while directly harming its shelf life. With the increasing trend towards flexible packaging, the demand for seal testing has readily grown. Since flexible packaging involves using materials that are sustainable, environment friendly and lower in cost it is essential to ensure that the seals of such package remain intact from the point of manufacture throughout its distribution and use. Seal integrity testing is widely used in different industries including Pharmaceutical, Medical Device, Food & Beverage, Nutrition, Bottles & Containers.

Destructive Vs. Non-Destructive Test Methods

Destructive methods are identified as methods that may damage the product during the assessment and even though the seal passes the test the product becomes useless. Since these tests were incapable of finding non-leaking seal defects, demand for such tests has steadily declined. Traditional test methods like peel strength burst or fish tank bubble come under this category.

Unlike destructive methods, non-destructive test methods are those that do not harm the product and they can be returned to the mark after testing. Reduction in wastage coupled with material cost advantage gives non-destructive methods an edge over destructive methods. According to Oliver Stauffer, Chief Executive Officer at PTI - Packaging Technologies & Inspection “There is a huge shift in the industry toward deterministic and quantitative test methods”. Non-destructive test method can be of the following types:

  • 1. Vacuum decay test
  • 2. Ultrasonic seal test

Vacuum Decay Method (VDM) is used by manufacturers of packages for the food, beverage, industrial and pharmaceutical industries in order to detect leaks in rigid or flexible packages.

Ultrasonic seal test is an innovative non-destructive Seal Integrity Test used to examine seal quality for defects. The ultrasonic seal test has wide application and is primarily used to detect any defects in the seal area. PTI uses Airborne Ultrasound technology which is a non-destructive and non-invasive seal quality inspection method. “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. This method is applicable for many materials types such as Tyvek®, paper, foil, film, aluminum, plastic & poly. The test is conducted by allowing ultrasound waves to pass through the package seal causing the reflection of sound waves. To identify the defects, variations in the reflected signals strengths are analyzed

PTI offers two variants of Airborne Ultrasound testing technology; Seal-Scan® and Seal-Sensor. The Airborne Ultrasound testing technology creates 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. The technology is in high demand due to its applicability across different industries.

Reasons to choose PTI’s Seal Scan and Seal Sensor Method:
  • 1. Provides quantitative results using non-destructive seal quality inspection
  • 2. Accurate and reliable outcome
  • 3. Cost-effective
  • 4. Can be used on materials like Tyvek®, paper, foil, film, aluminum, plastic & poly
seal integrity testing, airborne ultrasound technology, seal quality testing, airborne ultrasound, seal scan, flexible packaging

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