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Since many years ago, manufacturers have tested the quality of container closures, and their perceived value has constantly grown. Companies that once relied on probabilistic techniques like the blue dye test are now aiming to use a more reliable and predictable procedure for integrity testing of various package formats. The pharmaceutical industry is getting ready to adapt to the deterministic testing world in order to enhance quality, increase efficiency, and comply with changing regulatory standards.

Overview of Airborne Ultrasound Technology

Airborne ultrasound technology is a seal quality inspection technique. It is an ASTM test method F3004, the FDA approved standard for seal quality testing. Such tests are mainly performed to provide enhanced seal quality testing of pouches, flexible packages and tray seals. Airborne ultrasound technology ensures in-depth seal quality analysis and applies to multiple packaging materials including Tyvek, paper, foil, film, aluminum, plastic and poly.

In this technique, sound waves are reflected when ultrasound waves pass through the package seal. Signal strength is reduced or eliminated in the presence of leakage / fault. Such deviations are closely monitored to detect leakage. The 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, leaky and non-leaky, process-related and random.

Seal-Scan and Seal-Sensor Technology

Seal-Scan and Seal-Sensor are the two variants of Airborne ultrasound technology that utilizes non-contact airborne ultrasonic testing technology. With advancements in the form of seal-scans and seal-sensors, Airborne ultrasound technology has 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.

Seal-Scan® is a non-destructive offline technology that is highly effective in inspecting and analyzing pouch seal defects. It is a deterministic, quantitative, high-resolution package integrity testing method for identifying defects and sealing integrity for consistency. What makes this technique unique is that it is a non-invasive technique and requires no sample preparation. Seal-Scan® provides advanced digital imaging software tools for process control, offering in-depth seal quality analysis. This technology is capable of producing opto-acoustic images and detailed statistical analysis using L-scan and C-scan modes. An L-scan is a single linear scan along the x-axis of the seal that provides a line graph of seal integrity and simulates an online inspection. A C-scan produces multiple scans (in the X and Y-axis of the seal area) that provide a high-resolution ultrasonic image of the seal structure.

Seal-Sensor™ is an Airborne ultrasonic technology (ABUS) that non-destructively inspects the final pouch seal 100% online. The seal sensor detects incomplete seals, partial or weak areas of the seal, and many other common defects in a seal that are visually acceptable, but have that affect product quality, value, and shelf life. A pass/fail result and quantitative, traceable data are produced in less than a second by a single linear scan (L-scan) of the pouch seal. The Seal-Sensor is a definitive, quantitative, rapid and reliable approach to inspecting pouch seals for defects.

Benefits of Airborne Ultrasound Technology

• Non-destructive, non-subjective, no sample preparation.
• Accurate and reliable results.
• Can accommodate a number of packaging formats and materials.
• Eliminates subjective manual inspection methods.
• Deterministic inspection method producing quantitative results.
• ASTM Test Method F3004 and FDA Standard for seal quality inspection.

Today, package integrity test solutions continue to evolve, driven by industry demands, regulatory requirements, and advancements in technology. The focus remains on improving sensitivity, accuracy, and efficiency to ensure the integrity and safety of packaged products.

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.

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.

Packaging has a significant impact on the quality of the products and influences customer purchase decisions. Both of these factors provide significant issues for product design, particularly in the case of food packaging. No other product incorporates as many innovative and improved packaging advancements as food. Due to the increased need for convenience, packaging should be easy to handle, easy to open, resealable, or must be able to be heated directly in a microwave. Furthermore, food packaging must be properly sealed to protect product quality and shelf life. Ensuring safe food packaging through testing and analysis is key to safeguarding human health and protecting the food product.

Food Package Integrity Testing Using VeriPac 310

The VeriPac 310 is a non-destructive, non-invasive leak detection and container closure integrity testing method for the food industry. VeriPac systems eliminate waste and provide operators with a comprehensive view of package quality. The VeriPac 310 test cycle generates real-time results from accurate quantitative measurements, identifying packaging defects before important process concerns develop. Tests can be run in any order and even on the same sample several times. Good packages can be returned to the packing line intact. Testing is more dependable, sensitive, and efficient than destructive procedures like the water bath or burst test. The ASTM-approved patented vacuum decay leak test technique F2338-09, acknowledged by the FDA as a consensus standard for package integrity testing, is used in the VeriPac 310.

Technology Overview

The test method begins by connecting the VeriPac leak testers to a test chamber that is specifically designed to accommodate the package to be evaluated. The package is placed into the vacuum-sealed test chamber. The absolute transducer technology is used to monitor the vacuum level as well as the change in vacuum throughout a predetermined test period in the test chamber. The presence of leaks within the package is indicated by the changes in an absolute and differential vacuum. Test systems can be configured to operate manually or automatically. This inspection method is appropriate for offline laboratory testing as well as production applications for QA/QC statistical process control. The test cycle is non-invasive and non-destructive to both the product and the package, taking only a few seconds.

VeriPac 310 Benefits

• Non-invasive inspection system for leak detection
• Deterministic, quantitative test method
• Non-destructive, non-subjective, no sample preparation
• ASTM test method and FDA recognized standard
• Cost-effective and economical
• Supports zero waste initiatives
• Measures integrity of the entire package

Every packaged food product has a seal that keeps the food item safe inside the packaging. Therefore, food package seal quality testing is performed to ensure that the food packaging used is safe for both customers and the environment. PTI offers a diverse range of testing methods that are applicable to food product packages.

Package integrity testing of medical devices is important to ensure safety and security of the product throughout its shelf life. Medical device packaging aims to protect the product from physical damage, biological contamination, or any other external disturbance. Technological advancements have offered a wide range of sustainable as well as economical packaging materials and formats to the medical device industry. However, irrespective of whether the devices are packed in rigid thermoformed trays with Tyvek or film lids, or in pouches of porous or non-porous materials or sealed bottles or even blister packs, pharmaceutical package testing is critical to verify that their sterile barrier characteristics are not compromised. Today, the market offers a complete range of technologies that can non-destructively inspect medical device packages for container closure integrity.

Package Integrity Solutions for Sterile Medical Device

1. Airborne ultrasound Technology

Airborne Ultrasound technology is a seal quality testing method, 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.

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.

2.Vacuum Decay Technology

Vacuum Decay is a non-destructive Container Closure Integrity test method focused on package integrity and detection of leak paths. Compared to manual inspection and other non-deterministic test methods, Vacuum Decay offers quantitative, deterministic and reliable test results to ensure package integrity. Vacuum decay technology is capable of accommodating a wide variety of packaging formats including filled and sealed rigid, semi-rigid and flexible packaging made of non-porous or porous materials. This test operates by placing packages in a well fitted evacuation test chamber, which has an external vacuum source. The vacuum levels are continuously monitored to identify any variations from a pre-determined targeted vacuum level. A defect in the package will cause air to escape from the package into the test chamber. On the other hand, packages without any defect hold in the air, maintaining constant chamber vacuum level. Vacuum Decay technology has been proven over years to be one of the most practical and sensitive vacuum-based leak detection solutions.

Benefits of Vacuum Decay technology:

• Non-destructive, non-subjective, no sample preparation.
• Capable of detecting defects down to 0.05 cm.
• Accurate, reliable, repeatable results.
• Supports sustainable packaging and zero waste initiatives.
• FDA recognized standard for package integrity testing.
• ASTM test method F2338.

Did you know that majority of defects in high-risk pharmaceuticals including pre-filled syringes are caused by seal defects, attributed to both process and personnel error? While micro leaks pose a risk, the primary causes of defects are larger seal related quality deviations.

As the pharmaceutical industry is constantly seeking opportunities to develop convenient drug delivery methods, pre-filled syringes have come up as practical and reliable source for unit dose medication. The demand for glass syringes faded as the industry moved towards plastic and disposable syringes. Pre-filled syringes are applied across a wide range of medical sector including vaccines, blood stimulants, and therapeutic proteins.

Convenience in use and reduced dosage errors are the primary benefits associated with pre-filled syringes. They make injections easier and safer for both doctors and patients. In addition, pharmaceutical companies are able to minimize drug waste and increase product life span- which are important factors, particularly with costly biopharmaceuticals. However, considering the fact that pre-filled syringes are complicated combination products, manufacturers face a number of challenges in terms of quality control and stability concerns. Therefore, pharmaceutical package testing demands sound knowledge of various CCI testing methods. In this blog, we will understand how Microcurrent HVLD technology offers reliable seal quality testing of pre-filled syringes.

MicroCurrent HVLD Technology for CCI testing of pre-filled syringes.

High voltage leak detection (HVLD) has been a common technology in the market for decades. The latest evolution of HVLD, MicroCurrent technology, aims to achieve a high level of CCI assurance across the entire range of parenteral products. High voltage leak detection is a method included in USP 1207 as a deterministic test methodology and is an established and reliable solution for all liquid filled parenteral products.

HVLD operates on the simple property of electrical current. The package barrier must be non-conductive and would resist voltage from passing through, while the package contents should generally be able to carry voltage. Liquid products with a conductivity of 5 microsiemens and greater meet the requirement for PTI’s MicroCurrent HVLD

The E-Scan 655 is a Microcurrent HVLD technology-based leak test instrument used to inspect vials, syringes, and other liquid filled parenteral products. It is completely non-destructive to the container and product; exposing the package and product to lower voltage than other conductivity-based solutions. The technology uses a non-contact and non-invasive test method that requires no sample preparation. E-Scan 655 can be used with a wide range of liquid-based products including low conductivity sterile water for injection (WFI) and proteinaceous products with suspensions.

Benefits of MicroCurrent HVLD technology

• Non-destructive, non-invasive, no sample preparation.
• High level of repeatability and accuracy.
• Effective across all parenteral products, including extremely low conductivity liquids (WFI).
• Lower voltage exposure produces no ozone, eliminating risk to the product and environment.
• Listed in USP Chapter as recommended method for parenteral liquid package inspection.
• Robust method and approximate 3x Signal-Noise-Ratio for a wide range of product classes and package formats.
• Simplifies the inspection and validation process.