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Biologics, a class of pharmaceutical products derived from living organisms, have revolutionized the field of medicine by offering targeted and highly effective treatments for various diseases. Biologics, including vaccines, monoclonal antibodies, and gene therapies, being highly sensitive and complex products, require meticulous handling and storage.

As the demand for these innovative therapies continues to rise, the importance of robust biologics packaging becomes paramount. In this blog post, we will delve into the significance of biologics packaging inspection, specifically container closure integrity, and explore how helium leak detection plays a crucial role in ensuring the quality and safety of these life-changing medications.

Biologics are inherently vulnerable. Their intricate structures and potent nature necessitate a delicate balance between protection and functionality. Packaging plays a pivotal role in this, acting as a shield against environmental threats like moisture, oxygen, and microbial contamination.

Failing to meet stringent packaging requirements can have dire consequences. Leaky packages could lead to microbial contamination, compromising patient safety. Uncontrolled temperature exposure can render the drug ineffective. Even minor packaging flaws can impact dosage accuracy, potentially jeopardizing treatment efficacy. Therefore, thorough and reliable packaging inspection is not just a quality control measure; it's a critical safeguard for patient well-being. This is where helium leak detection emerges as a powerful tool.

Helium leak detection (HLD) is a precise and reliable technique designed to identify even the smallest leaks in sealed systems. This method utilizes helium as a tracer gas, leveraging its inert, non-condensable, non-flammable, and safe properties. The small atomic size of helium allows it to easily penetrate leaks, facilitating the detection of minute imperfections. The variation in helium concentration is measured and expressed as a leakage rate.

The benefits of using helium include its lower weight compared to other inert gases like neon, its cost-effectiveness, and its availability in various cylinder sizes and pure forms. Unlike hydrogen, which is smaller than helium but not inert, helium provides a dependable and efficient solution for leak detection in diverse applications.

The functionality of a helium leak detector is based on the principles of a field mass spectrometer. An electric beam emitted from the filament ionizes the leaked helium gas, and the resulting ions are accelerated by increased voltage. These ions escape through a split and enter the magnetic field of the analyzer. Due to the mass-dependent circular paths of the ions, only helium ions reach the collector. A specialized detector converts the ion current into an electrical current, which is then amplified by leak detection devices and displayed on a screen. The measured current corresponds to the helium concentration, indicating the presence and magnitude of a leak.

Compared to conventional vacuum bubble and dye penetration test methods, packages can be quantitatively tested using helium as the tracer gas that ensures higher levels of accuracy. Such an approach allows a comparison between multiple packaging materials and forms production line settings and stability storage conditions, supporting the entire lifecycle.

• Helium is a highly sensitive leak test technology, equipped with the detection of extremely small leaks which is not possible with other leak testing methods.
• Using a high vacuum technique, the leak test thresholds to be set down as low as 1×10-12l.sec-1, a sensitivity level allowing unique comparisons between package components, for example.

In today's health-conscious world, the popularity of nutraceuticals – those magical molecules promising a healthier you – is exploding. From vitamin gummies to herbal concoctions, these nutritional powerhouses line our shelves, offering a convenient path to wellness. But what about the very container that holds these life-changing potions? Nutraceutical packaging comes with unique challenges and navigating them requires innovative solutions and cutting-edge testing methods.

While nutraceuticals offer a plethora of health benefits, their packaging comes with inherent risks that can compromise product quality and safety. The nutraceutical industry faces unique challenges related to packaging, including ingredient stability, contamination, and regulatory compliance. Exposure to light, moisture, and oxygen can degrade the potency of bioactive compounds, rendering the product less effective. Contamination during the manufacturing and packaging process poses a risk to consumer safety. Additionally, regulatory bodies impose stringent standards to ensure the quality and authenticity of nutraceutical products.

Methods to Ensure Integrity of Nutraceutical Packaging

To address these challenges, manufacturers are turning to advanced testing methods for package integrity. Package integrity testing involves assessing the strength and robustness of the packaging to prevent leaks, breakages, or other vulnerabilities.

1. VeriPac Series

The VeriPac series by PTI offers cutting-edge inspection systems designed for leak detection and package integrity testing. These systems employ a non-destructive and non-invasive approach, contributing to waste reduction while delivering real-time and quantitative results. The technology is based on the ASTM-approved Vacuum Decay leak test method F2338, a methodology recognized by the FDA for its reliability and accuracy.

The VeriPac testers seamlessly connect to specially designed test chambers, creating a controlled environment for the inspection process. During testing, a vacuum is applied to the package, and absolute transducer technology is employed to monitor changes in vacuum levels over a predefined test duration. This meticulous monitoring allows the system to swiftly identify leaks and defects within the package.

One of the key advantages of the VeriPac series lies in its efficiency and objectivity. The entire process is quick, eliminating the need for subjective assessments and ensuring a non-destructive testing approach. This makes the VeriPac series suitable for various testing scenarios, ranging from laboratory offline testing to the rigorous demands of 100% inline testing in production environments.

Given the adherence to the ASTM-approved Vacuum Decay leak test method F2338, these inspection systems not only meet industry standards but also comply with FDA regulations. This recognition further underscores the reliability and precision of the VeriPac series in ensuring the integrity of packages.

2.Seal-Sensor PQX Technology

The Seal-Sensor PQX is an advanced automated pouch seal quality inspection system designed for seamless integration into production lines. Leveraging Seal-SensorTM Airborne Ultrasonic technology, this cutting-edge system conducts swift online scans of final pouch seals, aligning with ASTM Test Method F3004 and FDA consensus standards. Its deterministic and quantitative approach enables the rapid identification of defects, including incomplete seals, weak areas, and concealed issues that could compromise product quality.

The system operates with remarkable efficiency, delivering pass/fail results and generating traceable data in less than a second, even at speeds of up to 350 mm/sec. This ensures a quick and reliable assessment of seal quality, contributing to enhanced overall production efficiency.

The Seal-Sensor PQX is characterized by its user-friendly design and plug-and-play functionality, making it easy to integrate into existing manufacturing setups. Its modest footprint ensures that it can be seamlessly incorporated into various production environments without occupying excessive space. In the event of a defective pouch seal, the system features a built-in reject chute that promptly removes defective pouches from the production line. This not only prevents substandard products from progressing further in the manufacturing process but also helps maintain the integrity of the overall production flow.

As the nutraceutical boom continues, innovative packaging and rigorous testing methods like VeriPac and Seal-Sensor PQX are crucial to ensure the safety, efficacy, and trust in these life-changing supplements. By prioritizing package integrity, we unlock the true potential of these wellness wonders.

Class III medical devices are the highest risk medical devices, as they support or sustain life, are implanted, or present potential unreasonable risk of illness or injury. Examples of Class III medical devices include:

• Pacemakers
• Defibrillators
• High-frequency ventilators
• Cochlear implants
• Fetal blood sampling monitors
• Implanted prosthetics

Because of the high risk associated with Class III medical devices, it is essential to ensure that their packaging is intact and that the devices are sterile. Class III medical devices are the most strictly regulated medical devices by the US Food and Drug Administration (FDA).

There are several challenges associated with Class III medical device package integrity testing . One challenge is that the devices themselves are often complex and delicate, making them difficult to test without damaging them. Another challenge is that the packaging for Class III medical devices must be very effective in protecting the devices, maintain the sterile barrier and protect from contamination and damage during product lifecycle until point of use. To ensure the integrity of Class III medical devices, it is important to implement a comprehensive quality control program that includes the following measures:

• Design and testing: Medical device manufacturers must design and test their devices to ensure that they meet all applicable safety and performance standards.
• Manufacturing and assembly: Medical device manufacturers must implement strict quality control measures during the manufacturing and assembly process to ensure that devices are produced consistently and to a high standard of quality.
• Packaging: Medical device manufacturers must design and test their packaging to ensure that it can protect the devices from contamination and damage during shipping and handling.
• Testing: Medical device manufacturers must test a sample of each batch of devices to ensure that they meet all applicable safety and performance standards.

Package integrity testing and seal integrity testing are crucial for medical device packages to ensure the protection of the enclosed products from external contaminants and environmental factors. Maintaining package integrity is essential to prevent the compromise of sterile barriers, safeguarding the sterility of medical devices and ensuring their efficacy in clinical applications. Additionally, these tests help meet regulatory requirements, promoting patient safety and ensuring the reliability of medical devices throughout their lifecycle

1. Vacuum Decay technology

PTI's VeriPac Vacuum Decay technology is a non-destructive, online inspection system that can be used to test the integrity of Class III medical device packaging. The VeriPac system uses a vacuum chamber to create a differential pressure between the inside and outside of the packaging. This differential pressure is then used to detect any leaks in the packaging. PTI's VeriPac system is particularly well-suited for testing Class III medical device packaging because it is able to test a wide variety of packaging materials and designs. Additionally, the VeriPac system is able to test the integrity of the packaging without damaging the packaging or the product inside.

2. Airborne Ultrasound technology

PTI's Airborne Ultrasound technology is another non-destructive, online inspection system that can be used to test the integrity of Class III medical device packaging. The Airborne Ultrasound system uses ultrasonic waves to inspect the packaging for any defects. The Airborne Ultrasound system is particularly well-suited for testing Class III medical device packaging because it is able to detect a wide variety of defects, including small holes, tears, and wrinkles. Additionally, the Airborne Ultrasound system is able to test the integrity of the packaging without damaging the packaging or the product inside.

Package integrity testing is an essential part of the quality control process for Class III medical devices. By implementing CCI testing, medical device manufacturers can help to ensure the safety and efficacy of their devices.

In today's fast-paced world, where technology is advancing at an unprecedented rate, automation has become a crucial tool for various industries seeking to streamline processes and enhance efficiency. One sector that stands to significantly benefit from automated inspection is seafood packaging. With its stringent quality control requirements and the necessity to maintain consumer trust, seafood companies are increasingly turning to automated systems to revolutionize their packaging processes. This transformative shift in the industry is enabling higher quality, improved safety, and increased customer satisfaction.

Automated pouch seal inspection systems are being implemented throughout the food packaging. This blog will focus on one particular market segment, seafood processing, from the initial sorting and grading of the seafood to the final packaging stages. These systems employ a range of technologies, such as computer vision, machine learning, and robotics, to carry out tasks that were previously done manually.

To protect shelf life and require product quality freshness, seafood packaging in pouches and flexible package formats requires adequate and thorough testing of the seals to detect any defects or breaches in the seal that would affect the product. Introducing the Seal-Sensor PQX , an advanced and fully automated handling system combined with a cutting-edge pouch seal inspection solution. This innovative technology incorporates PTI's Seal-Sensor Airborne ultrasound, enabling seamless online scanning of the final pouch seal at remarkable speeds. The Seal-Sensor PQX complies with ASTM Test Method F3004 and is recognized by the FDA as a consensus standard for inspecting seal quality.

With its integrated conveyor, the Seal-Sensor PQX effortlessly integrates into your production line, streamlining the inspection process. The system conducts a rapid linear scan of the pouch seal, providing immediate inline verification of seal quality even at high production outputs. In a matter of seconds, the test result data is generated, allowing for swift decision-making.

Despite its powerful capabilities, the system boasts a compact footprint, ensuring minimal space requirements. The user-friendly full-screen HMI (Human-Machine Interface) conveniently displays the test result data as each pouch is scanned. The inspection rates can reach impressive speeds of up to 350 mm/sec.

To maintain a seamless production flow, the Seal-Sensor PQX features a built-in reject chute that swiftly removes any defective pouches from the line. Additionally, the system incorporates a stack light, which provides clear visual cues to easily identify pass or fail results.

Automated inspection is revolutionizing seafood packaging by improving accuracy, efficiency, and safety while ensuring compliance with regulations. By harnessing the power of machine vision and AI, seafood companies can enhance quality control, maintain consumer trust, and reduce operational costs. As the industry continues to embrace automation, the future of seafood packaging looks promising, with increased efficiency, sustainable practices, and safer products. By investing in automated inspection systems, seafood companies can thrive in a competitive market, secure customer loyalty, and contribute to a more sustainable and technologically advanced future.

Airborne ultrasound technology is revolutionizing various industries and applications, thanks to its remarkable versatility and benefits. This groundbreaking innovation utilizes sound waves to detect, measure, and analyze different elements present in the air. Its potential spans across industrial sectors, healthcare, and various other areas, making it an invaluable tool with boundless opportunities.

The ability to identify concealed defects, achieve precise medical diagnoses, and enhance our daily lives through non-invasive means becomes a reality with airborne ultrasound technology. By tapping into sound waves beyond the limits of human hearing, it unveils a realm of possibilities that were once confined to our imaginations.

In this blog, we will delve into the fundamentals of airborne ultrasound technology and shed light on the advantages it brings to various sectors.

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 can tell 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 (100% online testing). 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 in-depth seal quality analysis and 100% inline testing on the production line.

• 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.

Seal quality inspection is a critical step in the packaging process, as it ensures that the package is properly sealed and will protect its contents from contamination or damage during shipping and storage. This is especially important for packages that are used in industries such as pharmaceuticals, medical devices, and food packaging.

Two common types of packaging materials used in these industries are Tyvek® and porous packaging. Tyvek® is a synthetic material made of high-density polyethylene fibers that are spun together to form a tough, lightweight material that is resistant to tears, punctures, and moisture. Porous packaging, on the other hand, is typically made of materials like paper, cardboard, or fabric that allow air and moisture to pass through. Both Tyvek® and porous packaging require careful attention to seal quality inspection to ensure that the package is properly sealed and that its contents are protected. This may involve using specialized testing equipment to measure the strength of the seal for any signs of defects.

In industries where the contents of the package are particularly sensitive, such as pharmaceuticals, seal quality inspection is often regulated by government agencies like the Food and Drug Administration (FDA) to ensure that products meet strict quality standards.

Seal-Scan® is an Airborne Ultrasonic Technology (ABUS) for offline non-destructive and seal integrity testing analysis of pouch seals. It is a deterministic, quantitative, high-resolution method for inspecting pouch seal defects and seal integrity for consistency. The test is non-destructive, non-invasive and requires no sample preparation. Seal-Scan® offers advanced process control digital imaging software tools that enable detailed analysis of seal quality. The Seal-Scan system uses ASTM test method F3004-13. This test procedure approval was developed using PTI's ABUS technology.

Unlike Seal-Scan® technology, Seal-Sensor™ technology offers 100% online inspection of final pouch seals. It is a deterministic, quantitative, rapid and reliable method of inspecting pouch seals for defects. The Seal-Sensor identifies a number of imperfect seals, partial or weak areas of seals, and seals that appear visually acceptable but have defects that affect product quality, value, and durability.

• 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.

Seafood packaging plays a crucial role in preserving the freshness and quality of seafood products from the time of catch or processing to the point of sale. It ensures that seafood reaches consumers in a safe and desirable condition, maintaining its taste, freshness and nutritional value. When it comes to the seafood industry, quality control and food safety are paramount. A critical aspect of preserving the freshness and integrity of seafood products lies in the effectiveness of the package closure or seal. In a flexible package format such a pouch, a faulty seal can lead to spoilage and contamination. Among the various aspects of seafood packaging, the inspection of seals is necessary to verify that the seal is intact and reliable to protect the package from physical damage and contamination, providing consumers with an assurance of quality.

In the past, manual inspection processes were employed to detect potential seal defects, but they often proved time-consuming, labor-intensive, and prone to human error. With the advent of new technologies and automation platforms, seafood producers can now ensure the quality of their package seals with greater speed, precision, and reliability.

The Seal-Sensor PQX is a fully automated handling system and pouch seal inspection solution. It incorporates a built-in conveyor that can be seamlessly integrated into a production line. Utilizing PTI's Seal-Sensor airborne ultrasound technology, it scans the final pouch seal online at high speed. This technology is compliant with ASTM Test Method F3004 and is recognized as an FDA consensus standard for seal quality inspection.

The Seal-Sensor PQX performs a rapid linear scan of the pouch seal, offering immediate seal check and verification of seal quality at high production outputs. The test results are generated within seconds, allowing for swift data driven decision-making and process control.

This plug and play system is designed for inline pouch seal integrity testing and can be easily installed due to its small footprint. The system features a user-friendly full-screen HMI that displays the test result data as the pouches are scanned. Inspection rates can reach up to 350 mm/sec, ensuring efficient throughput.

In addition, the Seal-Sensor PQX incorporates a built-in reject chute that promptly removes any defective pouches from the production line. Furthermore, a built-in stack light provides easy identification of pass/fail results, enabling quick intervention and minimizing the potential for defective products to enter the market.

• 100% pouch seal inspection
• Easy integration into production lines
• Adjustable for different size pouches
• Manual load or robotic pick & place
• Built-in reject chute

In conclusion, the seal quality inspection in seafood packaging is a critical step in ensuring the freshness, quality and safety of the product. By preserving freshness, preventing contamination, building consumer trust, and complying with regulations, seal inspection plays an indispensable role in the seafood industry. Manufacturers, distributors, and retailers must prioritize seal inspection as an integral part of their quality control processes to safeguard the reputation of their brands and the well-being of their customers.

Pouch seal inspection refers to the process of evaluating the quality of the seals on a pouch or bag. This can be done visually or through mechanical testing to ensure the seals are strong enough to maintain the integrity of the contents within the pouch. This is an important step in the packaging process to guarantee the integrity of the contents and to prevent product contamination or spoilage. The purpose of pouch seal inspection is to ensure that the seals will not break or leak, thereby preserving the quality and safety of the product.

Traditional seal integrity testing methods are unreliable because they miss unseen defects and mistakenly qualify pouches that have visual flaws. One of the most efficient techniques for non-destructive testing of flexible pouch packaging seals is Airborne Ultrasound technology. Seal-Sensor PQX is a non-contact Airborne Ultrasound technology technology to test package seals 100% online.

The Seal-Sensor PQX is a fully automated pouch seal inspection and handling technology. It comes with an integrated conveyor that can be readily connected into a production line. PTI's Seal-Sensor Airborne Ultrasonic technology is used to automatically scan the final pouch seal online at high speed. Seal-Sensor technology is an ASTM Test Method F3004 and an FDA consensus standard for inspecting seal quality.

Seal-SensorTM is an Airborne Ultrasonic Technology that inspects the final pouch seal 100% online and non-destructively. Seal-Sensor is a deterministic, quantitative, quick, and dependable approach for inspecting pouch seals for defects. Seal-Sensor detects incomplete seals, partial or weak areas in seals, and a variety of frequent defects in seals that appear visually acceptable but contain problems that impact product quality, value, and shelf-life. In less than one second, a single linear scan (L-Scan) of the pouch seal delivers a pass/fail result as well as quantitative, traceable data. At high outputs, a quick linear scan of the pouch seal allows immediate seal check/verification of seal quality. Data from tests is generated in seconds.

The Seal-Sensor PQX is a plug-and-play system for checking the quality of pouch seals inline. This simple-to-install system has a modest footprint and a full-screen HMI for displaying test result data as pouches are scanned. Inspection speeds can reach 350 mm/sec. A built-in reject chute swiftly removes flaws from the line, and a built-in stack light makes determining pass/rail outcomes simple.

• 100% pouch seal inspection
• Easy integration into production lines
• Adjustable for different size pouches
• Manual load or robotic pick & place
• Built-in reject chute

Seal integrity of pouches is examined to ensure that the packaging provides the necessary product protection. Seal integrity tests are commonly used to evaluate user-friendly sustainable packaging choices. With an increased interest in sustainable packaging, novel structures such as monolayer recyclable flexible packaging are being developed, making it vital to guarantee that the seals for these structures stay strong. Poorly sealed pouches can cause significant issues for pharmaceutical manufacturers. Incorrect seals may cause contamination or product spoilage in addition to product waste. Pouch seal integrity testing is also used to lower the possibility of product recalls. Product recalls can draw the attention of drug safety regulators, leading to fines and penalties. As a result, seal integrity testing is critical to ensuring that such scenarios do not occur. Thus, PTI have developed two effective testing methods for evaluating the integrity of pouch seals.

Automated Pouch Seal Inspection Techniques Offered by PTI:

1. VerPac LPX Technology

The VeriPac LPX series is PTI’s line of fully automated package quality inspection systems for 100% inline testing. VeriPac LPX systems utilize PTI's Vacuum Decay technology, an ASTM Test Method F2338, developed using the VeriPac platform. The Food and Drud Administration (FDA) recognizes the test technique as a consensus standard for package integrity testing, and it is listed in ISO 11607 and USP Chapter 1207> guidelines. The LPX provides a practical and dependable solution to the concerns associated with infrequent testing, allowing process-related quality issues to be identified and remedied sooner rather than later. The VeriPac LPX for flexible packaging allows for continuous testing of pouches, stick packs, sachets, and other flexible packaging types.

The VeriPac LPX has a dynamic robotic design tailored to fit your production requirements. The LPX series are scalable, modular systems designed to satisfy the needs of manufacturing lines.

VeriPac LPX Benefits

• Automated testing enables the highest level of container quality assurance.
• Deterministic, quantitative test method.
• ASTM Test Method F2338 and FDA standard, ISO 11607.
• Distinct PASS/FAIL results.
• Highly accurate test results - low false positives and false negatives.
• High Signal Noise Ratio (SNR) for peak sensitivity and reliability.
• Non-destructive, non-subjective, no sample preparation.
• Pick-and-Place option back into the production line.
• Auto reject option of defects removed from the production line.
• USP <1207> compliant.

2. Seal-Sensor Technology

Seal-Sensor is an Airborne Ultrasonic technology that inspects the final pouch seal 100% online and non-destructively. Seal-Sensor is a deterministic, quantitative, quick, and dependable approach for inspecting pouch seals for defects. Seal-Sensor detects incomplete seals, partial or weak areas in seals, and a variety of frequent defects in seals that appear visually acceptable but contain problems that impact product quality, value, and shelf-life. A single linear scan (L-Scan) of the pouch seal delivers a pass/fail result as well as quantitative, traceable data in less than one second.

Seal-sensor Benefits

• Deterministic inspection method producing quantitative results.
• Non-destructive, non-invasive, no sample preparation.
• Works for any material and combinations, regardless of color, transparency, print, surface finish and porosity.
• Can be integrated for 100% online defect detection of the final pouch seal.
• Repeatable and reliable results.
• Eliminates subjective, manual vision inspection methods.
• Economical, cost-effective solution for seal integrity testing the final pouch seal.

The integrity of the package is critical to maintaining the sterile barrier and preventing microorganism penetration throughout the distribution process. Microorganisms can enter a packaging system if it has defects, compromising product safety. Flexible pouches are frequently used as primary packaging, or packaging that comes into contact with the product, in the Lifescience (pharmaceutical, medical device) and food industries. Any breach of the sterile condition is regarded as a serious risk and frequently results in the destruction of valuable products. As a result, seal integrity testing of flexible packages is critical.

Seal Integrity Testing using Airborne Ultrasound Technology

PTI’s Airborne Ultrasound technology is an ASTM Test Method F3004 and FDA recognized standard for seal integrity testing method capable of conducting advanced seal quality inspection of pouches and flexible packaging. It is a non-destructive, non-invasive technique capable of accommodating multiple packaging materials such as Tyvek, paper, foil, film, aluminum, plastic and poly and is also proven to provide deterministic, reliable and accurate test results.

This method works by sending ultrasound waves through the package seal as they move along the sensor head, causing sound wave reflections. When there is a leak, the seal strength is reduced or eliminated. Variations in signal strength are closely monitored in order to detect seal defects. Airborne Ultrasound technology's ability to detect various types of seal defects, including visible and invisible, leaking and non-leaking, process-related and random, makes it a viable option for seal quality inspection of flexible packages. “Ultrasound is one of the only technologies that are telling us what the quality of that physical bonded nature of the seal materials are,” says Oliver Stauffer, CEO of PTI. PTI offers two configurations of Airborne Ultrasound testing technology; Seal-Scan® and Seal-Sensor.

Seal-Sensor™ is an Airborne Ultrasonic technology that inspects the final pouch seal online and non-destructively. Seal-Sensor is a deterministic, quantitative, quick, and dependable method for inspecting pouch seals. Seal-Sensor detects incomplete seals, partial or weak areas in seals, and a variety of common defects in seals that appear visually acceptable but contain defects that impact product quality, value, and shelf-life. In less than one second, a single linear scan (L-Scan) of the pouch seal produces a pass/fail result as well as quantitative, traceable data.

Benefits of Seal - Sensor Technology

• Deterministic inspection method producing quantitative results
• Non-destructive, non-invasive, no sample preparation
• Works for any material and combinations, regardless of color, transparency, print, surface finish and porosity
• Can be integrated for 100% online defect detection of the final pouch seal
• Repeatable and reliable results
• Eliminates subjective, manual vision inspection methods
• Economical, cost-effective solution for seal integrity testing the final pouch seal

Medical devices being extremely sensitive to moisture and oxygen ingress, ensuring their sterility is of paramount importance. Such sterile products are often packaged, transported and distributed to different locations that can expose the package to various humidity levels throughout the distribution cycle. Porous packaging materials are often used by medical device manufacturers for packaging sterile devices. Therefore, maintaining the microbial barrier of porous packages is very crucial.

Read on to know more about the technologies offered by PTI for evaluating the integrity of porous packages, thereby maintaining sterility and microbial barrier.

Porous Package Integrity Techniques:

1. VeriPac Series

Vacuum decay is a test method that has been proven over decades and improved with new technology innovations. PTI has developed Vacuum Decay technology using VeriPac instruments that are recognized by the FDA as a consensus standard for container closure integrity testing (CCIT) and are listed in ISO 11607 and USP Chapter 1207.

VeriPac test systems can be used to inspect a wide range of packaging formats flexible, rigid and semi-rigid packaging. Since this technology is non-destructive, non-subjective and requires no sample preparation, it significantly reduces costs and product waste. VeriPac inspection systems use cutting-edge innovation to provide repeatable, more sensitive, and more robust detection of defects. Apart from container closure integrity testing, VeriPac test systems can be used for stability studies, clinical trials, quality assurance testing and statistical process control (SPC).

Technology Overview

The test begins by connecting VeriPac leak testers to specially designed test chambers. The packages to be tested are placed inside the test chamber and a vacuum is applied. 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 presence of a leak is indicated by a change in an absolute and differential vacuum. VeriPac test systems can be designed for manual or automatic operation.

Benefits of VeriPac Series

• Deterministic, quantitative test method
• Defect detection down to 0.034 cc/min
• Highest level of repeatability and accuracy
• Cost effective with rapid return on investment
• Simplifies the inspection and validation process
• Results proven superior to dye ingress
• ASTM test method and FDA standard
• USP <1207> Compliant

2. Airborne Ultrasound Technology

Airborne Ultrasound technology has established itself as a highly practical solution for non-destructive testing of porous packages. This technology can be applied for 100% defect detection of package seals along with seal quality testing and analysis.

Airborne Ultrasound technology makes use of ultrasound waves to identify defects in package seals. When high-frequency sound waves are passed through the package seal, it causes reflections of sound waves. Variations in signal strength are monitored closely to detect defects. Airborne Ultrasound technology's wide range of applications including Tyvek, paper, foil, film, aluminum, plastic and poly make it a practical option for seal integrity testing across different industries.

PTI has redefined seal integrity testing with its latest improvements in the form of Seal Scan (Offline) and Seal-Sensor (automated online seal inspection). 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.

Advantages of PTI’s Seal Scan and Seal Sensor Method:

• 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.
• ASTM Test Method F3004 and FDA recognized standard for seal quality inspection

Testing the integrity of newly developed packaging is a critical step in ensuring that it serves its requirements in every situation. Packaging needs to ensure that it sustains physical and mechanical stress and keeps the contents fresh until they reach the end user. In order to understand how packaging behaves under different circumstances, flexible packaging testing is quite important. Procedures for testing flexible packs are quite different from rigid packaging. Compared to rigid packaging, flexible packaging can present unique challenges in how to test both the integrity of the package and the seal quality. Some of the solutions offered for flexible package testing by PTI.

Flexible package integrity testing techniques

1. VeriPac Flex System

PTI's VeriPac FLEX systems are versatile non-destructive CCIT methods, designed specifically for pouches and other flexible packaging with dry-filled products. The technology utilizes an ASTM method for vacuum decay leak testing (F2338) listed in ISO 11607 and recognized by the FDA as a consensus standard for package integrity testing. PTI's VeriPac FLEX Systems are available in several configurators that can accommodate various package specifications and test sensitivity requirements. Such configurators for both the leak test instrument and the test chamber capacity enable evaluation of small format sachets and stick packs, up to large bulk size pouches and bags. A unique feature of this technology is that it requires no changeover of settings or tooling and is proven to provide high levels of sensitivity, reliability and practicality in testing a complete range of flexible packaging formats and sizes.

Technology Overview

The test begins by connecting the VeriPac tester to the appropriate FLEX chamber based on the size range of the package. The two VeriPac systems paired with the FLEX chamber provide different leak detection capabilities depending on the application. While the integrated flexible test chamber (IFC) is intended for sachets or stick packs with low headspace, the Drawer Style test chamber (D-Series) is ideal for package formats and bulk products. The unique difference with VeriPac FLEX systems is how the package is tested. PTI utilizes its flexible membrane that conforms to the package shape and size, eliminating any stress and damage to the film materials. Multiple packages can be tested in a single test cycle.

Benefits of VeriPac Flex System

• Non-destructive, non-subjective, no sample preparation.
• Deterministic, quantitative test method.
• Test multiple packages in a single test cycle.
• Cost effective with rapid return on investment.
• Supports sustainable packaging and zero waste initiatives.
• Simplifies the inspection and validation process.
• Accurate and repeatable results.
• ASTM test method and FDA standard.
• USP < 1207> compliant

2. Airborne Ultrasound Technology

PTI's Airborne Ultrasound technology is a non-destructive and non-invasive seal quality inspection method. The test is conducted by allowing ultrasound waves to pass through the package seal causing the reflection of sound waves. To identify the defects, variations in the reflected signals’ strength are analyzed. PTI offers two configurations of Airborne Ultrasound testing technology; Seal-Scan® and Seal-Sensor.

Seal-Sensor™ is a deterministic, quantitative method that inspects the final pouch seal non-destructively 100% online. Seal-Sensor detects incomplete seals, partial or weak areas in seals, and many common defects in seals that appear visually acceptable yet possess defects that affect product quality, value and shelf-life.

Seal-Scan® is an Airborne Ultrasonic Technology (ABUS) that inspects and analyzes pouch seals non-destructively offline for in-depth seal quality evaluation and analysis. Seal-Scan® is a semi-automatic inspection system with x-y drive, used for the detection of seal defects, seal characterization and material analysis.

Advantages of PTI’s Seal Scan and Seal Sensor Method:

• 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.

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.

Medical device industry is crucial to health care system as they play a vital role in the delivery of many health care services. Over the past few decades, tremendous developments in medical technologies have challenged the medical device packaging industry to ensure quality and reliability in packaging. Although testing package quality of all medical devices is critical, in case of Class III medical devices it amplifies several folds. Class III medical devices are understood as devices that sustain or support life, are implanted, or present potential unreasonable risk of illness or injury. Examples include pacemakers, breast implants, and respiratory ventilators. Since these devices are directly placed into human bodies, proper packaging is required to ensure the quality of the product until it reaches the patient. Any breach in the packaging can cause contaminants to enter the device, thereby making it more of a threat to the patient than a treatment. Hence appropriate CCI technologies are needed to ensure standardized packaging quality.

Container Closure Integrity Testing(CCIT) is a leak detection test conducted using a non-destructive package inspection system to ensure sterility and product quality throughout its shelf life. Earlier, probabilistic test methods such as bubble test, dye ingress and manual visual inspection were used to test package quality of medical devices. However, these traditional methods lacked accuracy and provided uncertain and subjective results. In order to overcome the shortcomings of probabilistic methods, industries are now moving towards deterministic methods that assures a higher level of accuracy with quantitative results. According to Oliver Stauffer, Chief Executive Officer at PTI - Packaging Technologies & Inspection “ There is a huge shift in the industry toward deterministic and quantitative test method. 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.”

Packaging Technologies & Inspection-PTI’s VeriPac Vacuum Decay Technology and Airborne Ultrasound Technology have revolutionized automated CCI Technologies.

Vacuum Decay Technology is a CCI testing method that detects leaks in nonporous, rigid or flexible packages. Such tests are conducted by placing a sample in an evacuation test chamber, drawing vacuum and monitoring vacuum level for any decay, indicating a leak. Such tests are known to provide reliable and quick results. PTI’s VeriPac Vacuum Decay Technology is a non-destructive package inspection system based on the ASTM vacuum decay leak test method (F2338-09) and accredited by the FDA for package integrity testing. Its applications include empty and pre-filled syringes, liquid-filled and lyophilized vials and other flexible and rigid liquid-filled packaging. PTI’s PERMA- VAC technology, known to provide consistent and reliable results is the latest development in the VeriPac line of test systems. The VeriPac Universal Blister Verification (UBV) system designed for non-destructive blister package leak detection uses a volumetric imaging technology to measure the motion of a blister package under vacuum to detect leaks.

PTI’s Airborne Ultrasound Technology is a non-destructive Seal Integrity Test used to examine seal quality for defects. “Ultrasound is one of the only technologies that are telling us what the quality of that physical bonded nature of the seal materials are,” says Oliver Stauffer, CEO of PTI. Under this method, high-frequency sound waves are passed through the pouch seal area, causing the reflection of sound waves. Variations of the reflected signal strength are used to reflect defects if any. PTI’s Airborne Ultrasound Technology for 100% Inline inspection of pouch seals has been extremely helpful in verifying final pouch seal quality. Any defect in the pouch seal including voids and delamination, foreign materials and inclusions, incomplete seals and misaligned seals can be detected using a Seal-Sensor scan and are automatically rejected from the production line.

Vacuum Decay Method (VDM) is used by manufacturers of packages for the food, beverage, industrial and pharmaceutical industries in order to detect leaks in rigid or flexible packages.

Both methods are established ASTM test methods: Vacuum Decay ASTM F2338 and Airborne Ultrasound ASTM F3004.These technologies are non-destructive methods and can be chosen depending on the characteristics of the product to be tested.

Seal integrity is the key to ensuring quality of packaging goods. Testing the integrity of package seals helps ensure that packaging provides sufficient product protection. Seal quality test analyses the mechanical strength of the seal thereby securing appropriate material bonding to maintain package quality throughout the product’s shelf life. Any defect in the seal can initiate a leak and will contaminate the product while directly harming its shelf life. With the increasing trend towards flexible packaging, the demand for seal testing has readily grown. Since flexible packaging involves using materials that are sustainable, environment friendly and lower in cost it is essential to ensure that the seals of such package remain intact from the point of manufacture throughout its distribution and use. Seal integrity testing is widely used in different industries including Pharmaceutical, Medical Device, Food & Beverage, Nutrition, Bottles & Containers.

Destructive Vs. Non-Destructive Test Methods

Destructive methods are identified as methods that may damage the product during the assessment and even though the seal passes the test the product becomes useless. Since these tests were incapable of finding non-leaking seal defects, demand for such tests has steadily declined. Traditional test methods like peel strength burst or fish tank bubble come under this category.

Unlike destructive methods, non-destructive test methods are those that do not harm the product and they can be returned to the mark after testing. Reduction in wastage coupled with material cost advantage gives non-destructive methods an edge over destructive methods. According to Oliver Stauffer, Chief Executive Officer at PTI - Packaging Technologies & Inspection “There is a huge shift in the industry toward deterministic and quantitative test methods”. Non-destructive test method can be of the following types:

• 1. Vacuum decay test
• 2. Ultrasonic seal test

Vacuum Decay Method (VDM) is used by manufacturers of packages for the food, beverage, industrial and pharmaceutical industries in order to detect leaks in rigid or flexible packages.

Ultrasonic seal test is an innovative non-destructive Seal Integrity Test used to examine seal quality for defects. The ultrasonic seal test has wide application and is primarily used to detect any defects in the seal area. PTI uses Airborne Ultrasound technology which is a non-destructive and non-invasive seal quality inspection method. “Ultrasound is one of the only technologies that are telling us what the quality of that physical bonded nature of the seal materials are,” says Oliver Stauffer, CEO of PTI. This method is applicable for many materials types such as Tyvek®, paper, foil, film, aluminum, plastic & poly. The test is conducted by allowing ultrasound waves to pass through the package seal causing the reflection of sound waves. To identify the defects, variations in the reflected signals strengths are analyzed

PTI offers two variants of Airborne Ultrasound testing technology; Seal-Scan® and Seal-Sensor. The Airborne Ultrasound testing technology creates a quick analysis of the seal area without tampering with the packaging to identify defects such as incomplete or missing seals, wrinkles, channel defects, and so on. The technology is in high demand due to its applicability across different industries.

• 1. Provides quantitative results using non-destructive seal quality inspection
• 2. Accurate and reliable outcome
• 3. Cost-effective
• 4. Can be used on materials like Tyvek®, paper, foil, film, aluminum, plastic & poly