Blogs CCIT

Sep 2022

Package Integrity Testing Systems for Porous Packaging

Package Integrity Testing Systems for Porous Packaging

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.

package integrity test solutions, seal quality testing, airborne ultrasound, container closure integrity, cci technologies
Sep 2022

All About Airborne Ultrasound Technology

All About Airborne Ultrasound Technology

The integrity of container closure systems can be interpreted as their capacity to maintain a sterile barrier against potential contaminants that could compromise the quality of the end product. The sterile barrier can be damaged by even the smallest leak, which might affect the product's healing properties. Over the years, dye ingress and microbial ingress are common leak testing methods. It has been proven that they provide inaccurate and subjective results. As a result, regulatory organizations have mandated a shift towards more deterministic test procedures that can be controlled, calibrated, and provide a definite determination of CCI. Airborne Ultrasound technology is a deterministic test method mentioned in the revised USP< 1207> Chapter Guidance for seal quality testing.

Explain Airborne Ultrasound Technology

Airborne Ultrasound Technology is a technique for testing the seal quality. It is an ASTM test method F3004 and the Food and Drug Administration (FDA) approved standard for seal quality testing. Such inspections are mainly done to provide improved seal quality inspection of pouches, flexible packages and tray seals. Airborne Ultrasound technology ensures in-depth seal quality analysis and is applicable to multiple packaging materials such as Tyvek, paper, foil, film, aluminum, plastic and poly.

In this technique, sound waves are reflected when ultrasound waves travel through the packaging seal. In the presence of a leak or fault, the signal intensity is diminished or removed. To find the leak, these fluctuations are carefully monitored. More sound is reflected, and less sound is transferred through the seal as the acoustic difference between the medium increases (most evident at the transition from a gas to solid state). The inability to detect non-leak defects is a common challenge faced by most leak test methods. However, users may recognize a variety of seal defects, including visible and invisible, leaky and non-leaking, process-related and random, using airborne ultrasound technology.

Seal-Scan and Seal-Sensor

Under this technique, VeriPac leak testers are connected to a test chamber specially designed to hold the sample package. The package that has been put inside the test chamber is subjected to vacuum. A single or dual vacuum transducer technology is used to monitor the vacuum level as well as how the vacuum changes during a predefined test period. The existence of leaks and other defects within the package is determined by monitoring variations in an absolute and differential Seal-Scan® and Seal-Sensor™ are the two configurations of Airborne Ultrasound technology. Seal-Scan® technology inspects and analyzes pouch seals non-destructively offline. This deterministic, quantitative, high resolution method inspects pouch seals for defects and seal integrity for consistency. Testing does not involve sample preparation, and is non-invasive as well. The technique includes advanced digital imaging software tools for process control that allow in-depth seal quality analysis. Utilizing Airborne Ultrasound technology, Seal-Scan® systems evaluate seal quality and integrity in accordance with ASTM Test Method F3004-13. Seal-Scan® is a semi-automatic inspection system with an x-y drive for the detection of seal defects, seal characterization, and material analysis.

Seal-Sensor™ is an Airborne Ultrasonic technology that inspects the final pouch seal 100% online in a non-destructive manner. Seal-Sensor™ is a deterministic, quantitative, fast, and reliable way to test for defects in pouch seals. The Seal-Sensor™ technology detects defective seals, seals with partial or weak areas, and several other typical seal defects that may not be physically visible but have an impact on the quality, and life span of the product. A pass/fail result and quantitative, traceable data are generated by a single linear scan (L-Scan) of the pouch seal in less than one second.

Why Use Airborne Ultrasound Technology?

  • Deterministic inspection technique yielding quantifiable results.
  • Non-destructive, non-subjective, and does not need sample preparation.
  • Independent of color, transparency, print, surface polish, or porosity, it is applicable to all materials and combinations.
  • Can be integrated completely online to identify defects in the final pouch seal.
  • Consistent and dependable results.
  • Referenced in USP Chapter 1207.Inexpensive method for evaluating the seal integrity of the final pouch seal.
  • Describes the overall quality and uniformity of the seal.

Both Seal-Scan® and Seal-Sensor™ technologies utilize non-contact airborne ultrasonic testing technology. With the innovation of Seal Scan and Seal-Sensor, Airborne Ultrasound technology has emerged as the most reliable technique for non-destructive seal integrity testing, both in offline laboratory testing for seal quality analysis and 100% inline testing on the production line.

airborne ultrasound, seal quality testing, seal integrity testing, container closure integrity, cci technologies
Feb 2022

Automation of Class III Medical Device Packaging

Automation of Class III Medical Device Packaging

Testing Container Closure Integrity (CCI) is crucial for ensuring the quality of Class III medical devices. Class III medical devices are sterile components that are designed to be inserted directly into the human body. These devices often sustain or support life, are implanted or pose an unreasonably high risk of disease or damage. A compromised package can serve as a vehicle for microbial transmission and compromised sterility, leaving patient safety at risk. When bacteria or other impurities enter the container, the device ceases to be a treatment and becomes a danger to the patient. Similarly, a breach of the seal affects the sterility of the device and may present a serious quality concern at a key point of usage.

Testing Challenges in the Medical Device Industry

There are three basic approaches to package integrity testing:

  • 100% in-line testing: All products in a batch are tested on a high-speed production line at an acceptable level of CCI assurance.
  • Small batch testing: Testing a statistically significant batch size for certain quality parameters and extrapolating to match the quality of the manufacturing lot.
  • Testing Offline: Operators test packages individually or in smaller batches.

Dye penetration is a technique for identifying defects in package body and seals that has a variable detection capacity. When carried out correctly, the approach can identify pinholes and channel defects as small as 20 microns. This method is only used to validate the packaging process and offers minimal value to in-process quality monitoring. The method is time-consuming to implement and provides limited information in the effort to ensure the quality of high-risk applications.

For CCI testing, the majority of medical device manufacturers use a 100% in-line manual visual inspection technique. Manual visual inspection has been proved to be one of the least reliable techniques for ensuring quality. The failure of manual visual inspection is caused by a number of factors. According to ASTM test method F1886, a manual visual inspection may detect 75-micron channel defects in a transparent seal 60-100% of the time. Although manual visual inspection can be applied as a 100% test method, performance on the task decreases significantly over time. This method is not applicable if the package format is not transparent or semi-transparent.

How Vacuum Decay and Airborne Ultrasound Technologies are Automated?

Vacuum Decay is a deterministic method proven to offer predictable and reliable results for CCI testing of high-risk package applications. This is an ideal solution for non-porous medical device applications. When the major focus of the inspection is the final seal of a porous package, Airborne Ultrasound is exceptionally efficient and reliable at detecting seal defects that are invisible to the manual visual inspector. Both approaches have shown to be reliable non-destructive testing methodologies, and one or the other can be used for inspection based on the unique features of the product and container.

The automation of each technology looks a little different. Vacuum Decay enables approximately 25 to 50 samples per minute, with low throughput detecting single-digit micron leak sizes. Airborne Ultrasound is a rapid-fire sensor that transmits 1000 pulses per second of sound through the seal. The final seal of Tyvek® pouches and other flexible packaging systems may be scanned at a rate of 20 inches per second (~40 cm/sec), with the capacity to detect the most frequent seal faults and seal quality concerns. Both methods enable a production line to ensure quality while reducing production throughput.

The Airborne Ultrasound technology offered by PTI can be automated in many ways. Basically, the technology can measure the quality of a quantitative seal in any way that the pouch seal can pass through the ultrasound inspection head. Ultrasound can be applied to the production flow, which captures seal quality when exiting a band-sealer or transferring pouches through a production line. Robotic handling may also be used to do a full 360-degree seal inspection on all pouch seals. Airborne Ultrasound has the flexibility to be deployed in a variety of production lines and has high reliability in detecting critical defects.

Vacuum decay is often utilized for both Tyvek® trays and non-porous container types. While a vacuum takes longer to do a test (about 5 seconds on a Tyvek tray), the sensitivity and stability of this technology make it perfect for low output applications with high sensitivity requirements. Robotic handling solutions can serve many test stations at the same time, allowing for increased product throughput without losing sensitivity.

Medical devices are packaged and delivered in a variety of ways, ranging from porous flexible packaging to non-porous rigid containers. The range of product types and packaging options create unique inspection challenges that must be overcome in order to assure seal strength, sterility, and quality. Airborne Ultrasound and Vacuum Decay offer 100% testing capabilities as well as an accurate inspection that includes quantitative test results and a pass/fail result. These new automated technologies, with more sensitive leak detection capabilities, inspect containers at a higher rate.

airborne ultrasound, vacuum decay leak testing, container closure integrity testing, container closure integrity, cci testing
Feb 2022

Understanding CCIT's Seal-Scan Technology

Understanding CCIT's Seal-Scan Technology

Package integrity leak test methods offered by CCIT such as Seal-Scan utilize non-contact Airborne Ultrasonic technology for seal integrity testing and seal quality analysis of pouches and flexible packaging. The method is applicable to pharmaceutical as well as medical device packaging.

Seal Quality Testing and Seal Analysis using Seal-Scan Technology

Seal-Scan® is a non-destructive offline inspection and analysis technique for pouch seals using Airborne Ultrasonic technology (ABUS). Seal-Scan® offers advanced digital imaging software tools for process control, including in-depth seal quality inspection. Seal-Scan system uses the non-destructive ASTM Test Method F3004-13 for "Evaluation of Seal Quality and Integrity Using Airborne Ultrasound Technology." This test method was approved using PTI's ABUS technology. Seal-Scan® is a deterministic, quantitative, high-resolution technology for inspecting pouch seals for defects and ensuring seal integrity.

Seal-Scan has two scanning modes:

  • Linear Scan (L-Scan) to simulate online defect identification (line graph)
  • C-Scan for detailed seal analysis, resulting in pixel-by-pixel seal evaluation (Opto-Acoustic image)

Technology Overview

The pouch seal or packaging material is scanned between two focused ultrasonic sensors. Ultrasonic waves travel through single or several layers of bonded materials. The reflection of sound waves caused by ultrasonic transmission via different materials reduces/eliminates signal intensity. The signal level that passes through the seal is a function of the seal's quality. Defects of various forms, such as leaking and non-leaking, process-related and random, can be detected. Seal-Scan® can provide Opto-Acoustic images as well as thorough statistical analysis using one of two scan modes (L-Scan and C-Scan).

An L-Scan is a single linear scan along the seal's X-axis that generates a line graph of seal integrity and replicates real-time inspection. C-Scan generates a series of scans (along the X and Y-axis of the seal region), that offers a high-resolution ultrasonic image of the seal structure. This technology, via the Seal-Sensor, can be integrated into a pouch production process for 100% online seal defect detection.

Benefits of Seal-Scan Technology

  • Deterministic inspection approach yielding quantitative results.
  • Works with any material and combination, independent of color, transparency, print, surface polish, or porosity.
  • Produces a high-resolution Opto-Acoustic seal image.
  • Characterizes the overall quality and consistency of the seal.

Seal-Scan® is a semi-automatic inspection system with an x-y drive that is used to identify seal defects, characterize seals, and analyze materials. This approach is non-invasive, non-destructive, and does not need any sample preparation. The ability of PTI to adapt this technology to diverse production restrictions and conditions makes it an effective solution for flexible packaging systems.

seal quality inspection, airborne ultrasound, container closure integrity, cci technologies, package integrity test solutions
Aug 2021

Airborne Ultrasound Technology - A Unique Method to Reduce Food and Nutrition Packaging Risk

Airborne Ultrasound Technology - A Unique Method to Reduce Food and Nutrition Packaging Risk

Airborne Ultrasound is a deterministic test method for seal quality inspection and analysis of material types such as aluminum, foil, paper, plastic, poly, film & Tyvek. In accordance with ASTM F3004-13, airborne ultrasound is a standard test technique for evaluating seal quality and integrity. It has been proven to be one of the most successful non-destructive testing methods for flexible package seals. As per research the standard seal inspection methods are inaccurate because they fail to detect invisible defects and mistakenly reject well sealed pouches. Airborne Ultrasound technology, on the other hand, has been proven in the field of both online and offline solution options

How does Airborne Ultrasound Technology mitigate the risk of food and nutrition packaging?

Packaging has been an integral part of food and nutrition preservation in recent decades. Food is packaged with the intention of being transported and stored. Quality, brand, safety, and value of a product are all affected by packaging. To ensure the safety of their products, food producers pack their products in a way that ensures they are correctly constructed, tamper-proof, defect-free, and complete.

In Airborne Ultrasound technology, sound waves are reflected when ultrasound waves are allowed to travel through the packaging seal. Change in the intensity of the reflected signal is used to identify defects. The seal is positioned in a straight line between a pair of transducers, then moves them along the seal. Transmission and reflection of the ultrasound occur at the transition from one medium to another. When the difference in acoustic properties between two materials is greater, only less sound is transmitted, and more sound is reflected. Thickness variations have a minor impact. It is possible to identify a wide range of defects, including those that are visible and invisible, leaking and non-leaking, process-related and random.

As one of the most successful methods for non-destructive testing of flexible packaging, Airborne Ultrasound technology was awarded the ASTM Test Method F3004-13 in 2013. The flow of gas or liquid through the seal is an example of seal defect. Inability to discover non-leak defects is a basic problem with leak testing methods. However, Airborne Ultrasound technology gives a complete way to evaluating seal quality, even when a seal has a defect but may not leak.

Key benefits of Airborne Ultrasound Technology

  • Deterministic inspection technique resulting in quantitative results
  • Non-destructive, non-subjective, zero sample preparations
  • Detects defects in the final pouch seal in real time
  • This method works with any material and combination, regardless of color, porosity, surface finish, transparency, and print
  • The subjective manual vision inspection procedures are no longer necessary
  • Results are repeatable and reliable
  • Testing the final pouch seal integrity at a low cost
  • Characterizes the seal's overall quality and consistency
seal quality inspection, airborne ultrasound, nutritional packaging inspection solutions, seal integrity, container closure integrity testing

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