Blogs CCIT

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
93
29
Jul 2021

Why is Seal Integrity Testing of Medical Device Packaging Important

Why Seal Integrity Testing of Medical Device Packaging is Important

For sterile medical devices, seal integrity testing ensures product efficacy, shelf-life stability, and microbial sterility. Common defects that can threaten the integrity of the seal include voids, wrinkles, dust or other random particles. Hence, inspecting seals after they have been formed is important. Earlier, visual inspection or other destructive testing methods were used for seal quality inspection. However, they lacked accuracy and reliability in test results. But technology is changing. Today, the market offers a range of non-destructive inspection techniques that ensure highly sensitive and reliable seal quality inspection. Even then, the suitability depends on the type of packaging and the size of defect that needs to be inspected.

Relevance of Airborne Ultrasound Technology in Seal Quality Inspection

Airborne Ultrasound technology is a non-destructive container closure integrity testing method, capable of examining seal quality for defects. 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. It is an ASTM Test Method F3004 and FDA recognized standard for seal quality testing. 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 can identify various types of seal defects; visible and invisible, leaking and non-leaking, process-related and random.

Latest improvements in Airborne Ultrasound Technology are in the form of Seal Scan (Offline) and Seal-Sensor. Both these technologies utilize non-contact airborne ultrasonic testing technology. Seal-Scan® technology has been proven in the field by several online and offline units installed. 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.

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.
Readmore...
container closure integrity testing, airborne ultrasound technology, medical device testing, ccit
116
23
Jul 2021

CCIT for Pharmaceutical Package Integrity

CCIT for Pharmaceutical Package Integrity

Over the last two decades, pharmaceutical industry has seen tremendous growth in the form of technological advancements and drug delivery system innovations. However, such innovations have increased quality assurance challenges for drug manufactures. For this reason, drug product manufacturers give at most importance to their quality control procedures as well as package integrity tests. All packaging forms, whether pouches constructed of porous or nonporous material, rigid thermoformed trays with Tyvek or film lids, bottles with induction-welded seals, or blister packs, need verification that their sterile-barrier characteristics are not compromised. Previously, only sterility testing was conducted on pharmaceutical packaging. However, when it was realized that sterility testing alone is not sufficient to hold the integrity of the medical products, the US FDA published Guidance for Industry for Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products. This emphasized the importance of verification of microbial barrier properties of a pharmaceutical product package (i.e., CCI).

Relevance of CCIT in pharmaceutical package testing

Container Closure Integrity Testing is an assay to evaluate whether container closure systems can maintain sterile barriers against potential damage. Even a minute defect in the container can cause external elements to enter the product, thereby reducing its shelf life. Common threats that can pass through a defected container closure system include microorganisms, reactive gases, and other substances. Considering the ability of such threat to deteriorate product quality, undertaking appropriate CCI tests are beyond crucial. However, it should be noted that CCI is not a one-time process, rather an integral and comprehensive approach. It is evaluated throughout the manufacturing lifecycle of a sterile drug product -from primary package development until the products are dispatched.

Container closure systems are made up of primary packaging components and secondary packaging components. Components like vials or syringes that are in direct contact with the product are called primary packaging components. Although there are multiple CCI techniques available in the market today, regulatory guidelines have broadly classified methods into probabilistic and deterministic test methods. Under a probabilistic test method, results are generated through a series of events, each with a respective probability distribution. Thus, the accuracy of the results cannot be assured. In contrast to a probabilistic method, deterministic test methods assure quantitative results with higher level of accuracy and reliability. The United States Pharmacopeia in 2016 issued new guidelines stating that deterministic methods are preferred over probabilistic test methods. Container closure integrity testing can be performed in many different ways. All the testing methods have pros and cons. Given below is a list of non-destructive Container Closure Integrity test methods:

  • Airborne Ultrasound technology
  • Vacuum Decay technology
  • Microcurrent HVLD technology
  • Helium Leak Detection
  • Pressure Decay leak testing
  • Force Decay leak testing
Readmore...
pharmaceutical package testing, container closure integrity testing, Vacuum Decay Technology, Airborne Ultrasound technology
116
15
Jul 2021

Vacuum Decay Technology Raising Standards for Pharmaceutical Package Testing

Vacuum Decay Technology Raising Standards for Pharmaceutical Package Testing

Right from clinical trials to drug packaging, all aspects for pharmaceutical industry are subject to strict quality control regulations. The process of selecting and validating appropriate packaging for pharmaceutical products takes a significant effort. Pharmaceutical package testing is conducted to ensure the suitability of drug packaging for its intended use. It included all components containing the product, even if they are in direct contact with the drug or not. As such, containers should be capable of retaining the healing properties of the drug product throughout its shelf life or until it is administered. Even a minute breach in container closure integrity can compromise the safety and effectiveness of the drug product. This realization has prompted pharmaceutical product manufacturers to conduct appropriate container closure integrity tests to ensure product sterility throughout its lifecycle.

Why use Vacuum Decay technology for pharmaceutical package testing?

PTI’s Vacuum Decay technology is a non-destructive container closure integrity testing method, capable of evaluating both liquid and air-filled containers and detecting defects as small as below 1 micron. Non-destructive testing provides a greater understanding of package quality while also reducing waste. Waste reduction delivers a fast return on investment and brings operations closer to green initiatives. Proven to be the most practical and sensitive vacuum-based leak test method, Vacuum Decay technology is an ASTM test method, FDA consensus standard, eliminating false positives and subjective results associated with manual visual inspection. Vacuum Decay technology can identify leaks in sealed rigid, semi-rigid and flexible packaging made of non-porous or porous materials. It provides reliable, accurate and repeatable test results that ensure deterministic package testing and leak detection.

Vacuum Decay technology operates by placing sample packages in a closely fitting evacuation test chamber, which is equipped with an external vacuum source. 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 absolute and differential vacuum indicate the presence of leaks and defects within the package. Vacuum Decay technology is a practical alternative and significant improvement to destructive test methods and can precisely detect leaks as small as 5 microns, identifying process issues before they become critical, avoiding catastrophic quality deviations.

Benefits of PTI’s Vacuum Decay Test System

  • Better process control - reliable and sensitive leak detection of quality critical defects.
  • The advantage of test results that are both qualitative (pass/fail) and quantitative (Statistical data with each test result).
  • Repeatable test results demonstrate the reliability of the instrument and test data.
  • Cost savings - Eliminates product loss, waste and mess of both packaging and coffee that results from using destructive testing methods
  • Using a non-destructive leak test method allows an increase in the number of products samples tested.
  • Rapid test cycle and minimal training required to operate tester.
  • Rapid ROI due to substantial cost savings and elimination of product loss.
Readmore...
container closure integrity testing, pharmaceutical package testing, vacuum decay technology
118
02
Jun 2021

Evaluating Relevance of Seal Quality Inspection in Medical Device Industry

Evaluating Relevance of Seal Quality Inspection in Medical Device Industry

Talking about medical devices, ensuring seal quality or seal strength of sterile medical device packaging are extremely crucial as well as highly regulated. Medical device package seal contains a flexible barrier which is joined to the rigid container through an advanced adhesive. A defect in the seal such as an incomplete or weak seal can initiate leaks, contaminating the product and reducing its shelf life. Hence, for quality control purposes, seal quality inspection of medical device packages is mandatory.

Historically, manual inspection was the most popular method used to inspect seal defects. Although this is covered by an ASTM method (ASTM F1886), it lacked accuracy and reliability in terms of test results. “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.”

Airborne Ultrasound technology is a non-destructive seal integrity test method capable of advanced seal quality inspection of pouches and flexible packaging. Seal defects can be of two types- leak defects and non- leak defects. While it is easier to detect a leak defect, detecting non-leak defects can be a challenge for manufacturers. However, Airborne Ultrasound technology allows non-destructive Container Closure Integrity testing of multiple seal defects including visible and invisible, leaking and non-leaking, process-related and random- making it a practical solution for medical device seal quality inspection.

Technology overview

Airborne Ultrasound technology 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. In the presence of a leak, the signal strength is either eliminated or reduced. Such variations in signal strength are analyzed to identify the defects. Seal scan testing is a practical solution to recognize defects, such as inconsistent seals or areas of seals that fail to meet minimum width requirement. Seal-Scan® and Seal-Sensor utilize non-contact airborne ultrasonic testing technology for advanced seal quality inspection. Seal-Scan® technology has been proven in the field by several online and offline units installed.

Benefits of Airborne Ultrasound technology

  • Deterministic seal quality inspection method that produces quantitative results.
  • This method works for any material type and combinations regardless of color, transparency, print, surface finish or porosity.  
  • Non-destructive and non-subjective test method that requires no sample preparation.
  • Technology can be integrated for 100% online defect detection of the final pouch seal.
  • Repeatable, reproducible and reliable results for seal quality inspection.
  • Cost-effective solution for seal integrity testing and seal analysis that characterizes overall quality and uniformity of the seal. 
Readmore...
container closure integrity testing, seal integrity testing, seal quality inspection, airborne ultrasound technology
360

Popular Blogs

Tags

Why Microcurrent HVLD is the most preferred CCI technique for Parenteral Product Leak Testing ?

May 24, 2021   |   485

Microcurrent HVLD is one of the most preferred container closure integrity testing method for Biological & Parenteral Product Leak Testing

Evaluating Relevance of Seal Quality Inspection in Medical Device Industry

Jun 02, 2021   |   360

Evaluating quality and integrity of package seal is an important criteria for medical device package inspection. Airborne Ultrasound technology allows non-destructive seal quality inspection of multiple device packages.

Airborne Ultrasound Technology for Efficient Medical Device Package Inspection

May 28, 2021   |   359

Package integrity testing of medical devices is vital to ensure the products maintain quality and sterility throughout its shelf life or until it is administered.

Pharma Package Testing CCI of High-Risk Pharmaceuticals

May 21, 2021   |   339

Pharma package testing now has become an integral part of the pharmaceutical industry when it comes to the package integrity of high-risk pharmaceuticals.

How has VeriPac Systems Raised Standards for Container Closure Integrity Testing

Jul 02, 2021   |   236

The VeriPac test methods are non-destructive, non-invasive inspection system for CCI and package integrity testing.
COPYRIGHT 2020, CCIT, ALL RIGHTS RESERVED PRIVACY AND COOKIES TERMS OF USE
Popup