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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

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

Medical devices are available in a variety of forms with complex geometric attributes such as valves, tubes and others that can complicate the medical device testing process. Hence, medical device leak testing equipments are expected to provide high levels of sealing effectiveness and test result sensitivity to narrow down the complexities.

Medical Device Package testing using Seal Scan technology

Seal-Scan® is a deterministic, quantitative, high-resolution method based on is an Airborne Ultrasonic Technology (ABUS). It is highly effective in non-destructively inspecting and analyzing pouch seals for defects and seal integrity for consistency. Seal-Scan systems utilize the ASTM Test Method F3004-13, which is a non-destructive test method for evaluating seal quality and integrity using Airborne Ultrasound technology. The test procedure is simple, quick and requires no sample preparation. Additionally, Seal-Scan® provides advanced digital imaging software tools for process control which offers in-depth seal quality analysis.

Seal-Scan features two scan modes:

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

Technology Overview

The test beings by scanning the pouch seal or package material between two focused ultrasonic sensors. Ultrasonic waves propagate through single or multiple layers of bonded materials. As the ultrasonic waves propagate through different mediums, it causes reflections of sound waves, which reduces/eliminates signal strength. The level of signal passing through the seal is a function of the quality of the seal. Various types of defects; leaking and non-leaking, process-related and random are detectable.

Seal scan has two scan modes (L-Scan and C-Scan) that is capable of producing Opto-Acoustic images as well as detailed statistical analysis. 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 online inspection. C-Scan produces multiple scans (along X and Y-axis of seal area) that provide a high-resolution ultrasonic image of the seal structure. This technology can be integrated into a pouch production line via the Seal-Sensor for 100% fully automated on-line seal defect detection.

Benefits of Seal Scan Technology

• Deterministic inspection method producing quantitative results.
• Works for any material and combinations, regardless of color, transparency, print, surface finish and porosity.
• Produces high resolution Opto-Acoustic image of seal.
• Characterizes overall quality and uniformity of the seal.
• ASTM Test Method F3004 and FDA recognized standard for seal quality inspection.

Packaging has always been an indispensable factor in the pharmaceutical manufacturing process. Since most pharmaceutical products come under high-risk category, appropriate packaging is vital to prevent product deterioration. Faulty or damaged packaging can cause oxygen, moisture, microorganisms or other harmful substances to enter the product- making it unfit for use. Given the sensitive nature of pharmaceutical products, package inspection testing holds high relevance. Let us now understand what CCI techniques are being offered by PTI for pharmaceutical package testing.

Techniques to ensure CCI

1. Vacuum Decay technology

Vacuum Decay is a non-destructive Container Closure Integrity Test (CCIT) method that is highly effective in detecting leaks in nonporous, rigid and flexible packages. It is a simple test method that challenges container integrity based on fundamental physical properties. As the name suggests, this test is conducted by drawing vacuum on a package within a test chamber and monitoring the vacuum level for any decay, which would indicate a leak. The standard vacuum decay leak test method (ASTM F2338), developed using PTI's VeriPac instruments, is recognized by the FDA as a consensus standard for container closure integrity (CCI) testing. The test method is listed in ISO 11607 and referenced in the United States Pharmacopeia Chapter on CCI (USP Chapter 1207). PTI has revolutionized Vacuum Decay technology with its s next generation of improvements in the form of PERMA-VAC technology and VeriPac FLEX Series.

PERMA-VAC Technology is a single or dual vacuum transducer technology, which has higher test sensitivity for providing accurate and reliable results. This method can be applied to flexible and semi-flexible packages alike.

The VeriPac FLEX series are innovative packaging inspection systems specifically for flexible packages. These are available in different configurations to accommodate various package specifications, capable of detecting leaks down to the 10 to 20 micron range.

Benefits of Vacuum Decay technology

2. MicroCurrent HVLD Technology

High Voltage Leak Detection (HDLV) is a Container Closure Integrity test method that utilizes high voltage leak detector system for evaluating integrity of nonporous packages. The latest evolution in the HVLD technology, PTI’s MicroCurrent HVLD is revolutionary technology, a non-destructive, non-invasive CCI technique which can precisely detect any leak in a wide range of liquid filled products including extremely low conductivity sterile water for injection (WFI) and proteinaceous products with suspensions.

This method operates by scanning a sealed container using electrode probes to detect the presence of any leak. By analyzing a change in the current flow, the test operator can detect Defect in the container as well as its approximate location. PTI's MicroCurrent HVLD uses about 50% less voltage and exposes the product and environment to less than 5% of the voltage compared to conventional HVLD technologies. This technology can be easily shifted from offline to 100% inline testing application, thereby simplifying the inspection and validation process.

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)
• Low voltage exposure to the product and environment
• Listed in USP Chapter <1207> 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
• Offline and 100% online inspection at high production speeds

Medical device packaging plays a fundamental role in safeguarding the product and retaining its quality throughout its shelf life. A package containing medical devices should not only reach the hospital defect free, but it also must withstand sitting on a shelf, possibly for years, without breaking down. Therefore, medical device packaging should be in line with international regulations and quality standards. In order to ensure quality of medical device packages, manufacturers reply on package integrity and seal quality test methods. Although the market offers a complete range of inspection techniques, it is important for manufacturers to choose the appropriate one based on packaging material used and sensitivity levels required.

The ideal solution is a non-destructive method for inspecting the physical properties of the seal and a non-subjective analysis to determine the seal quality. PTI’s Airborne Ultrasound technology (ASTM Test Method F3004-13) uses a transmission of high frequency sound waves through the pouch seal area, providing a simple pass or fail result of seal quality. A linear scan analysis of the seal area will detect channel defects, misaligned seals, incomplete and missing seals immediately after the package has been sealed. If the system detects a package defect, the product can immediately be removed from the packaging and reworked. Process related defects can be addressed and corrected immediately, which significantly reduces the quantity of defective packages produced.

Package inspection using Seal-Scan technology

PTI's Seal-Scan® is a non-destructive Airborne Ultrasonic technology (ABUS) that inspects and analyzes pouch seals offline. Seal-Scan® is a semi-automatic inspection system with x-y drive, used for the detection of seal defects, seal characterization and material analysis. This technology utilizes the ASTM Test Method F3004 for seal quality and integrity evaluation. .Seal-Scan® is a deterministic, quantitative, high-resolution method that inspects pouch seals for defects and seal integrity for consistency. Testing using a Seal-Scan® is non-destructive, non-invasive, and requires no sample preparation. Seal-Scan® provides advanced digital imaging software tools for process control which offers in-depth seal quality analysis. PTI has designed several configurations of SEAL-SCAN® for both offline inspections to accommodate various package specifications, test sensitivity and package handling requirements.

Technology overview

Under this method, the pouch seal or package material is scanned between two focused ultrasonic sensors. Ultrasonic waves pass through single or multiple layers of bonded materials. Ultrasonic propagation through different mediums causes reflection of sound waves and reduces/eliminates signal strength. Seal Scan technology can detect different types of defects including leaking and non-leaking, process-related and random are detectable. This technology can produce Opto-Acoustic images as well as detailed statistical analysis by either of two scan modes (L-Scan and C-Scan). 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 online inspection. C-Scan produces multiple scans (along X and Y-axis of seal area) that provide a high-resolution ultrasonic image of the seal structure. This technology can be integrated into a pouch production line via the Seal-Sensor for 100% on-line seal defect detection.

Benefits of Seal Scan Technology

• Deterministic inspection method producing quantitative results
• Works for any material and combinations, regardless of color transparency, print, surface finish and porosity
• Produces high resolution Opto-Acoustic image of seal
• Characterizes overall quality and uniformity of the seal

Package validations for medical devices play a significant role in ensuring safe and effective use of products when they reach the patient. Packaging for these safety-critical products must withstand the rigors of the manufacturing process, storage, and the distribution cycle. Package integrity is crucial to maintaining sterility for medical devices, especially those that are to be used during medical procedures or implanted into patients. This is because even a minute defect in the package can affect sterility of the device and cause health risk to the patient. Given below is a list of non-destructive package inspection techniques that help maintain highest quality standards.

CCI techniques offered by PTI

Vacuum Decay technology

Vacuum Decay is a non-destructive package inspection technique that offers the ability to inspect both the entire body of the package and seals for micro leaks and defects. The technology proven to provide reliable, reproducible, repeatable, and accurate quantitative results, is recognized by the FDA as a consensus standard for container closure integrity testing (CCIT). Vacuum Decay leak test method is an ASTM Test method (ASTM F2338) that was developed using PTI instruments, it is listed in ISO 11607 and referenced in the United States Pharmacopeia Chapter on CCI (USP Chapter 1207).

Technology overview

Vacuum Decay test method is simple in practice and challenges container integrity based on fundamental physical properties. The samples are placed in a closely fitting test chamber, equipped with external vacuum source. A pre-determined vacuum level is selected depending on test sample and level of sensitivity required. The next step involves evacuating the test chamber and test system dead space for a pre-determined period. Differential pressure transducers are used to monitor change in vacuum level for a specified period. A pressure increase beyond predetermined pass/fail limit indicates container leakage.

Advantages of Vacuum Decay technology:

• Non-destructive package inspection system
• Accurate and reliable results
• Definite pass/fail result based on quantitative test data 
• Accommodates multiple packaging formats
• Eliminates destructive, subjective testing methods 
• Effective in detecting even minute leaks 

Airborne Ultrasound technology

Airborne Ultrasound technology is a non-destructive Container Closure Integrity test used to examine seal quality for defects. It is an ASTM Test Method F3004 and FDA recognized standard for seal quality integrity testing. These tests are primarily conducted to provide advanced seal quality inspection of pouches, flexible packages and tray seals. Airborne Ultrasound technology is a non-destructive and non-invasive seal quality inspection technique suitable for many materials including Tyvek, paper, foil, film, aluminum and plastic. Airborne Ultrasound technology offers a comprehensive approach to evaluate seal quality even in conditions where a seal has a defect but may not leak.

Technology overview

Under this method, ultrasonic waves are propagated through the package seals as they move along the sensor head. This causes reflections of sound waves. The signal strength is either eliminated or reduced in the presence of any defect/leak. Such variations in signal strength are closely monitored to identify the defects.

Benefits of Airborne Ultrasound technology

• Non-destructive, non-subjective, no sample preparation
• Accurate and reliable results
• Deterministic package inspection technique 
• Works on multiple packaging formats and materials 
• Economical cost-effective solution for seal integrity testing
• Can be applied to 100% inline seal quality testing

Package integrity testing may be understood as a set of techniques used to protect the contents of a package from potential physical, chemical and microbial threats. It plays a crucial role in determining and maintaining sterility and shelf life of pharmaceutical products, medical devices, and food and nutrition products. Since such products are extremely sensitive to external environmental conditions, even a minute breach in the package can cause micro-organisms, reactive gases or other harmful substances to enter the product. This can result in serious health issues to the end user and affect brand loyalty of manufacturing companies. As such, testing for leaks is an important aspect of the manufacturing process.

Historically, manufacturers relied on destructive testing methods like Water Bath or Dye Ingress as well as other unreliable methods such as Visual Inspection to test integrity of packages. However, such tests lacked accuracy and reliability in test results. Moreover, being destructive testing methods, it caused damages to the package being tested making it unfit for use. These limitations of destructive techniques prompted manufacturers to opt for non-destructive testing methods that do not harm the product and provide reliable, repeatable and quantitative rest results. Reduction in waste coupled with material cost advantage gives non-destructive methods an practical edge over destructive test methods. Examples of non-destructive testing methods include Vacuum Decay technology, Airborne Ultrasound technology and Microcurrent HVLD technology.

VeriPac test systems for precise and reliable package integrity testing

PTI’s VeriPac series are non-destructive, non-invasive inspection systems for leak detection and package integrity testing. These systems reduce waste and provide operators with a clear understanding of package quality. The VeriPac test system produces real time results from precise quantitative measurements that identify packaging defects before critical process issues get out of control. Tests can be performed in any sequence and even repeatedly on a single sample. Good packages can be returned undamaged to the packaging line. Testing is more reliable, sensitive and efficient than destructive methods. VeriPac series utilizes the ASTM approved patented Vacuum Decay leak test method F2338, recognized by the FDA as a consensus standard for package integrity testing.

Technology Overview

PTI’s VeriPac leak testers connect to a test chamber that is specially designed to contain the package to be tested. The package is placed inside the test chamber to which vacuum is applied. The absolute 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. The test cycle takes only a few seconds, results are non-subjective, and testing is non-destructive to both product and package. The sensitivity of a test is a function of the sensitivity of the transducer, the package design, the package test fixture and critical test parameters of time and pressure. Test systems can be designed for manual or fully automated operation. This inspection method is suitable for laboratory offline testing, QA/QC statistical process control, automated batch or 100% inline testing.

Benefits of VeriPac series

• Non-destructive, non-subjective, no sample preparation
• Deterministic, quantitative test method
• Defect detection down to 0.2 ccm
• High level of sensitivity, repeatability and accuracy
• Short cycle time provides operator with PASS/FAIL result
• Small footprint and modular portable design
• ASTM test method and FDA standard
• Referenced in USP 1207 guidance

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.

The World Health Organization (WHO) has stated that healthcare associated infections pose the highest risk in the delivery of healthcare services globally. This causes a serious threat to millions of patients worldwide every year. Therefore, ensuring sterility of medical devices is an important way to reduce the risk associated with faulty medical devices in hospitals and other healthcare settings.

Appropriate packaging and packaging materials are crucial to help preserve sterility of medical devices. Conventionally, medical device manufacturers relied on manual visual inspection as a method for assuring quality. However, such methods lacked accuracy and reliability in test results. To overcome the limitations of traditional test methods, manufacturers moved towards deterministic Container Closure Integrity testing (CCIT) methods that ensured quantitative and accurate test results.

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 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 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. 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.

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.

Seal integrity plays a vital role in ensuring the quality of packaging products. Even a minute defect in the seal can initiate a leak, which can compromise the quality of the product and directly affect its shelf life. It can also result in huge financial losses to the manufacturer. That being said, manufacturers give considerable importance to conducting appropriate seal integrity tests to ensure package integrity at every stage of its lifecycle.

Seal integrity testing methods can be classified into two- Destructive testing methods and Non-Destructive testing methods. Since under Destructive methods, the packages may get destroyed, its popularity has steadily declined over the past few decades due to this waste and high cost. “There is a huge shift in the industry towards deterministic and quantitative test methods,” says 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 quality inspection techniques offered by PTI:

Vacuum Decay technology is a non-destructive Container Closure Integrity test (CCIT) method, used for seal quality inspection in nonporous, rigid or flexible packages. With the ability to detect leaks down to the sub-micron level, , Vacuum Decay technology is identified as one of the most practical vacuum-based leak detection methods. Its ability to provide quantitative, reliable and repetitive test results make it ideal solution for seal quality inspection in Pharmaceutical, Medical Device and Food and Nutrition industries.

Under this method, the sample packages are first placed in a close fitting evacuation test chamber that contains an external vacuum source. The vacuum levels and changes in vacuum over a pre-determined time are closely monitored. 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 changes in the absolute and differential vacuum indicate the presence of leaks and defects within the package.Over the past few years, Vacuum Decay technology has seen great advancements in the form of PTI’s PERMA-VAC technology and VeriPac FLEX Series.

The next generation PERMA-VAC technology is a single or dual vacuum transducer technology that has made the VeriPac line of test systems the most sensitive vacuum-based leak tests available in the market. It has higher test sensitivity for providing accurate and reliable results and can be applied to rigid and semi-flexible packages alike. PTI’s PERMA-VAC technology ensures the most stable test measurement ever achieved through vacuum decay.

Airborne Ultrasound technology is yet another seal quality inspection technique, 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.

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