Blogs

Pouch packaging is a versatile and flexible form of packaging that utilizes materials like films and foils to create sealed pouches capable of containing a variety of products, including pharmaceuticals. These pouches can be designed in different shapes and sizes, offering adaptability to the specific requirements of the packaged goods.

Pouch packaging has become increasingly prevalent in various industries, and its significance is particularly pronounced in the life science sector. In the pharmaceutical and medical device industries, pouch packaging serves several critical purposes. It ensures the protection of medical products from external factors such as light, moisture, and contaminants, preserving their efficacy and shelf life. Pouches also provide a convenient and user-friendly way for patients to access and use their medications. Additionally, the lightweight and compact nature of pouches can contribute to cost-effective and sustainable packaging solutions.

What is Pouch Seal Inspection and Why is it Important?

Pouch seal inspection is the process of thoroughly examining the seals of pouches to ensure they are intact and free from defects. The seals play a vital role in maintaining the integrity of the packaged product, preventing contamination, and preserving its quality. Any compromise in pouch seal integrity can lead to issues such as product spoilage, reduced efficacy, or even potential harm to consumers. Thus, stringent quality control measures, including pouch seal inspection, are imperative in the pharmaceutical industry.

Pouch Seal Integrity Testing Using Seal-Sensor Technology:

Seal-Sensor™ represents a cutting-edge Airborne Ultrasonic Technology designed for seamless online applications, ensuring the non-destructive inspection of final pouch seals. This innovative method stands out for its deterministic, quantitative, rapid, and reliable approach to identifying defects in pouch seals.

Unlike traditional visual inspections, Seal-Sensor™ has the capability to detect a range of issues that may be imperceptible to the naked eye, such as incomplete seals, partial or weak areas, and various other common defects. Despite these defects appearing visually acceptable, they can significantly impact the quality, value, and shelf-life of the packaged product.

The technology operates efficiently with a single linear scan, known as the L-Scan, which completes in less than one second. This quick process not only ensures minimal disruption to production but also delivers a PASS/FAIL result immediately. Furthermore, Seal-Sensor™ provides quantitative, traceable data, offering a comprehensive analysis of the seal quality.

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

Class III medical devices in the United States are subject to stringent regulation by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act. These devices, characterized by their high-risk nature, include those vital to sustaining human life or preventing health impairment, as well as those posing potential, unreasonable risks of illness or injury.

Examples of Class III devices encompass implantable pacemakers, specific prosthetic devices, and innovative technologies such as certain in vitro diagnostic devices. Classification is determined by factors like intended use, indications, and associated risks. Due to their complexity and critical roles in medical procedures, Class III devices undergo a rigorous pre-market approval (PMA) process.

Manufacturers must furnish extensive scientific and clinical evidence to demonstrate a device's safety and efficacy before it can be marketed. This robust regulatory framework ensures that Class III medical devices meet the highest standards for safety and performance, safeguarding patient health.

Packaging for these devices plays a critical role in maintaining the integrity of the product, ensuring it reaches the end user in a safe and effective condition. The packaging of Class III medical devices faces unique challenges due to the stringent regulatory requirements and the critical nature of the enclosed products. Ensuring the integrity of the packaging is essential to prevent contamination, maintain sterility, and safeguard the efficacy of the medical devices.

How to Ensure Container Closure Integrity of Class III Medical Device Packaging

Container Closure Integrity (CCI) is a vital aspect of ensuring the reliability of Class III medical device packaging . CCI testing involves assessing the seals and closures to confirm they effectively prevent the ingress of contaminants and maintain the sterility of the device. This testing is crucial to meeting regulatory standards and ensuring patient safety.

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 single digit microns.
• 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

The packaging industry is undergoing constant evolution, with a key emphasis on maintaining product safety and quality. Pouch seal inspection holds a pivotal role in ensuring the freshness and safety of packaged goods. Any shortcomings in the sealing process can lead to compromised product quality, impacting consumer satisfaction and brand reputation. Conventional inspection methods often struggle to identify microscopic defects or inconsistencies in seals, necessitating the adoption of advanced technologies for a more comprehensive examination.

In response to this challenge, PTI has introduced the Seal-Sensor PQX, an advanced technology designed to revolutionize pouch seal inspection.This innovative solution addresses the limitations of traditional methods by providing a more thorough and precise evaluation of pouch seals.

By incorporating the Seal-Sensor PQX into their operations, manufacturers can enhance their ability to identify and rectify potential sealing issues before products reach the market. This not only safeguards product quality but also contributes to fostering consumer confidence and protecting the brand's reputation.

Inspecting Pouch Seals with Seal-Sensor PQX Technology

The Seal-Sensor PQX is a fully automated technology for inspecting and handling pouch seals. Equipped with an integrated conveyor, seamlessly connectable to your production line, this innovation utilizes PTI's Seal-Sensor Airborne Ultrasonic technology for swift online scanning of the final pouch seal. Accredited as an ASTM Test Method F3004 and an FDA consensus standard, the Seal-Sensor technology guarantees a meticulous inspection of seal quality.

Seal-Sensor™ employs Airborne Ultrasonic technology to scrutinize the final pouch seal, ensuring a 100% online, non-destructive examination. This deterministic, quantitative, and rapid approach provides a reliable means of inspecting pouch seals for potential defects. Seal-Sensor excels at detecting incomplete seals, identifying partial or weak areas in seals, and uncovering various defects that may not be apparent visually but can significantly impact product quality, value, and shelf-life. In under a second, a single linear scan (L-Scan) of the pouch seal delivers a clear pass/fail result along with quantitative, traceable data.

Featuring a full-screen HMI for displaying real-time test result data during pouch scanning, the Seal-Sensor PQX ensures efficient and accurate quality control. Operating at inspection speeds of up to 350 mm/sec, this system incorporates a built-in reject chute to swiftly remove any flaws from the production line. Additionally, a built-in stack light simplifies the determination of pass/fail outcomes for operator monitoring. Even at high outputs, the quick linear scan facilitates an immediate check and verification of seal quality, with test data generated within seconds.

Benefits of Seal-Sensor PQX

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

Low head space packages are a common type of packaging used for a variety of products, including pharmaceuticals, medical devices, and food. These packages are designed to have a minimal amount of space between the product and the packaging material, which can help extend the shelf life of the product and protect it from contamination. Low head space packages are typically made of a flexible material, such as film or foil. The material is then sealed to the product, creating a tight seal that helps to preserve the product's integrity.

However, low head space packages can also be more susceptible to leaks, which can lead to sterility breaches, product spoilage and contamination. Therefore, it is important to ensure that these packages are properly sealed to prevent leaks and contamination. VeriPac 410 is a non-destructive seal and leak detection system that can help ensure the integrity of low head space packages.

Applications of low head space packages

Low head space packages are used in a variety of industries, including:

• Pharmaceutical industry: Low head space packages are used to package pharmaceuticals, such as tablets, capsules, and transdermal patches.
• Medical device industry: Low head space packages are used to package medical devices, such as, suture packaging.
• Personal care industry: Low head space packages are used to package personal care products, such as serums, lotions and creams packaged in sachets and pouches.

Low Head Space Package Inspection Using Force Decay Technology

Force Decay serves as a quantitative method for detecting leaks, especially in packaging with low headspace. The applicable packaging formats encompass non-porous materials, such as films, laminates, or foils. This method, being non-destructive, leaves the sample packages undamaged and unaltered. Following the completion of the test, the packages can seamlessly return to the batch without the need for disposal.

The testing system employs nested tooling to position the package consistently and restrict the unmeasured expansion of the package under examination. Initiating the test involves creating a vacuum in the test chamber, prompting the package to expand within it. Vacuum levels are continuously monitored throughout the test cycle, evaluating the package using the ASTM F2338 vacuum decay leak test method.

Multiple packages can undergo testing in a single test cycle, with the force decay measurement system discerning any defective packages. Defective packages exhibit a decay in the expansion force or vacuum level during the test cycle. The location of the defective package or cavity is then pinpointed. Force decay proves most effective when assessing multi-cavity package formats.

PTI’s VeriPac 410 inspection technique leverages force decay technology for non-destructive seal and leak detection in blister packs, sachets, and pouches with low headspace. VeriPac 410 functions as a vacuum based Container Closure Integrity test (CCIT) method, capable of testing multiple packages in a single test cycle. The force decay measurement system identifies any defective packages. This technology accurately measures force by observing the surface deflection of a package during a typical vacuum-based test cycle. The force measurement capability enables the VeriPac 410 series to pinpoint which package is defective while also conducting leak tests on packages with minimal headspace. Force decay remains the most effective technology, particularly in the assessment of multi-cavity package formats. This technology is scalable from the laboratory to automated inline inspection platforms.

Benefits of Force Decay leak testing

• Non-destructive and non-invasive
• Non-destructive, non-subjective, no sample preparation
• The test protocol is programmed into the testing unit with high degree of repeatability.
• Multiple packages can be tested in a single test cycle
• The test is operator independent and can be performed with minimal training
• Supports sustainable packaging initiatives
• Optimal solution for in-process testing
• Cost effective with rapid return on investment