Blogs CCIT

17
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.

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airborne ultrasound, vacuum decay leak testing, container closure integrity testing, container closure integrity, cci testing
158
08
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.

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seal quality inspection, airborne ultrasound, container closure integrity, cci technologies, package integrity test solutions
148
30
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
Readmore...
seal quality inspection, airborne ultrasound, nutritional packaging inspection solutions, seal integrity, container closure integrity testing
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