Blogs

16
Mar 2021

Why Seal Integrity Testing is Critical in Medical Device Industry

Why Seal Integrity Testing is Critical in Medical Device Industry

In the medical device industry, appropriate packaging is meant to ensure product protection and integrity throughout the entire supply chain. Medical device packaging requirements are very strict and should adhere to health and safety regulations across borders, signifying the relevance of packaging validation standards. Faulty packaging can cause various problems for medical device companies as well as patients. A package containing a sterile medical device should not only reach the doctor or medical facility damage free, but it should also be able to maintain its quality and sterility until used. Hence seal integrity testing of medical device packages is critical.

Seal integrity testing is a crucial element to ensure quality of packaged sterile products. A compromised seal can initiate a leak, destroying the protective atmosphere of products and reducing its shelf life. It can also lead to massive product recalls, causing huge monetary loss and tarnished brand reputation. Hence, applying the right seal integrity testing system is vital to ensure that the packages are properly sealed to avoid potential contamination and breach in sterility.

Although there are multiple methods to conduct a seal integrity test, it can be broadly classified into destructive testing methods and non-destructive testing methods. Under destructive testing method, the package may get destroyed and cannot be returned to the market after testing. On the other hand, non-destructive test methods do not cause any harm to the packages resulting in material cost advantage and reduced waste. “There is a huge shift in the industry towards deterministic and quantitative test methods,” comments Oliver Stauffer, Chief Executive Officer at PTI - Packaging Technologies & Inspection. “This includes Vacuum Decay and Airborne Ultrasound for medical device applications. The industry is currently moving away from dye ingress and manual visual inspection because there are so many blind spots in applying them and there’s a huge false sense of assurance.”

Seal integrity testing using Airborne Ultrasound technology

PTI’s Airborne Ultrasound technology is an ASTM Test Method F3004 and FDA recognized standard for seal quality integrity testing. It is a non-destructive seal quality inspection method for effective seal quality testing and analysis. With the capability of non-destructive and non-invasive seal quality inspection, Airborne Ultrasound technology is a optimal choice for testing integrity of pouches, flexible packages and tray seals.

This method operates by propagating ultrasound waves through the package seal as they move along the sensor head, causing reflections of sound waves. In the presence of a leak, the seal strength is either reduced or eliminated. Signal strength variations are closely monitored to detect defects. The ability of Airborne Ultrasound technology to identify several types of seal defects; visible and invisible, leaking, and non-leaking, process-related and random makes it a practical choice for seal quality inspection in the medical device industry.

Benefits of Airborne Ultrasound technology

  • Non-destructive seal quality inspection technique with quantitative test results.
  • Eliminates subjective manual inspection methods.
  • Cost effective
  • Non-destructive, non-subjective, no sample preparation
  • Supports multiple packaging materials including Tyvek®, paper, foil, film, aluminum, plastic & poly
  • ASTM Test Method F3004, FDA Recognized Standard and referenced in USP 1207 Guidelines.
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seal integrity testing, seal quality inspection, medical device package inspection, medical device packaging, airborne ultrasound technology, benefits of airborne ultrasound technology
137
20
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.
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Airborne ultrasound technology, seal quality inspection, seal quality testing, Seal Scan, Container Closure Integrity testing, CCIT
150
11
Dec 2020

What are the Different Seal Quality Inspection Techniques Offered by PTI?

What are the different seal quality inspection techniques offered by PTI

Seal integrity plays a vital role in ensuring the quality of packaging products. Even a minute defect in the seal can initiate a leak, which can compromise the quality of the product and directly affect its shelf life. It can also result in huge financial losses to the manufacturer. That being said, manufacturers give considerable importance to conducting appropriate seal integrity tests to ensure package integrity at every stage of its lifecycle.

Seal integrity testing methods can be classified into two- Destructive testing methods and Non-Destructive testing methods. Since under Destructive methods, the packages may get destroyed, its popularity has steadily declined over the past few decades due to this waste and high cost. “There is a huge shift in the industry towards deterministic and quantitative test methods,” says Oliver Stauffer, Chief Executive Officer at PTI - Packaging Technologies & Inspection. “This includes vacuum decay and airborne ultrasound for medical device applications. The industry is currently moving away from dye ingress and manual visual inspection because there are so many blind spots in applying them and there’s a huge false sense of assurance.”

Seal quality inspection techniques offered by PTI:

Vacuum Decay technology is a non-destructive Container Closure Integrity test method, used for seal quality inspection in nonporous, rigid or flexible packages. With the ability to detect leaks down to the sub-micron level, , Vacuum Decay technology is identified as one of the most practical vacuum-based leak detection methods. Its ability to provide quantitative, reliable and repetitive test results make it ideal solution for seal quality inspection in Pharmaceutical, Medical Device and Food and Nutrition industries.

Under this method, the sample packages are first placed in a close fitting evacuation test chamber that contains an external vacuum source. The vacuum levels and changes in vacuum over a pre-determined time are closely monitored. The single or dual vacuum transducer technology is used to monitor the test chamber for both the level of vacuum as well as the change in vacuum over a predetermined test time. The changes in the absolute and differential vacuum indicate the presence of leaks and defects within the package.Over the past few years, Vacuum Decay technology has seen great advancements in the form of PTI’s PERMA-VAC technology and VeriPac FLEX Series.

The next generation PERMA-VAC technology is a single or dual vacuum transducer technology that has made the VeriPac line of test systems the most sensitive vacuum-based leak tests available in the market. It has higher test sensitivity for providing accurate and reliable results and can be applied to rigid and semi-flexible packages alike. PTI’s PERMA-VAC technology ensures the most stable test measurement ever achieved through vacuum decay.

VeriPac FLEX series is an ideal package inspection solution for dry filled pouches and flexible packaging. To accommodate different package formats and test sensitivity requirements, VeriPac FLEX series is available in several configurations with multiple test chamber sizes.

 

2.Airborne Ultrasound technology:

Airborne Ultrasound technology is yet another seal quality inspection technique, which is capable of non-destructively conducting advanced seal quality inspection of pouches and flexible packaging. It is capable of accommodating multiple packaging materials like Tyvek, paper, foil, film, aluminum, plastic and poly and is also proven to provide deterministic, reliable and accurate test results.

As the name suggests, this method utilizes ultrasound waves to detect defects in package seals. Ultrasound waves are passed through the material as the package seal moves along the sensor head. This causes reflections of sound waves. Such signal strength variations are closely monitored to identify defects if any. Its ability to evaluate seal quality even under conditions where the defect may not result in a leak, makes Airborne Ultrasound technology a practical choice for seal quality inspection across different industries.

PTI’s Seal-Scan (Offline) and Seal-Sensor (Online) are the latest advancements to the ultrasound test series. Both these technologies make use of non-contact airborne ultrasonic testing technology and have been established as one of the most effective methods for inspection of flexible package seals. Airborne ultrasound is also an ASTM Test Method F3004 for seal quality inspection.

 

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seal quality inspection, airborne ultrasound technology, vacuum decay technology, container closure integrity testing, ccit, container closure integrity
189

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