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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 the pharmaceutical industry, the safety and efficacy of products are of utmost importance, and maintaining these qualities throughout the distribution and storage chain is a critical aspect of ensuring public health. One key element in achieving this goal is the rigorous implementation of Container Closure Integrity (CCI) testing.

CCIT refers to the evaluation of the ability of a pharmaceutical package to prevent the ingress of contaminants, as well as the escape of the product, ensuring that the package maintains its integrity over time. This process is essential in safeguarding the quality and safety of pharmaceutical products, as any compromise in the packaging can lead to contamination, degradation, or other adverse effects on the medication.

Traditional Container Closure Integrity (CCI) assessment has heavily relied on destructive testing methods, such as water bath and dye tests. These approaches involve immersing packaging materials in water or applying dyes to identify potential leaks. However, these methods present significant drawbacks. They are time-consuming, requiring substantial resources for testing and result analysis, which is highly subjective and varies from operator to operator. This prolonged process can hamper production efficiency and delay product release.

Moreover, the accuracy of these methods is questionable, as they may not reliably detect all types of leaks. The subjective nature of human interpretation in analyzing results leads to potential inconsistencies and misinterpretations. Additionally, the destructive nature of these tests contributes to product loss and waste, escalating production costs and raising environmental concerns.

In the context of a growing emphasis on sustainable practices, there is a rising demand for alternative, non-destructive, and objective CCI testing approaches that can address these limitations and align with contemporary production and sustainability standards.

CCI Testing using Vacuum decay technology

To guarantee integrity and consistency of packages, the ability to precisely detect leaks and defects is necessary. Over the years industry has seen an increasing demand for non-destructive package integrity testing methods. One such method is Vacuum Decay technology.

Vacuum Decay is a test method that has been proven over decades as the most practical and sensitive vacuum-based leak test method. It is a simple test method that challenges container integrity based on fundamental physical properties. Vacuum Decay technology creates reliable and accurate quantitative results with a pass or fail determination and has been established as a non-destructive deterministic alternative method to the blue dye test. 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 testing. The test method is listed in ISO 11607 and referenced in the United States Pharmacopeia Chapter on CCI (USP Chapter 1207)

How does Vacuum Decay Technology work?

Under this method, the leak testers are first connected to a test chamber that is specifically designed to hold the package to be tested. Vacuum is applied to the package placed inside the test chamber. Using single or dual vacuum transducer technology test chamber and level of vacuum are monitored along with a 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. This inspection method is suitable for laboratory offline testing and can be designed for manual or fully automated operation. The test cycle is non-destructive to both product and package and takes only a few seconds. It provides significant savings by not wasting products for a leak test and generates a return on investment in under six months for many products.

Key Benefits of Vacuum Decay Technology

• Non-destructive and non-invasive
• No sample preparation
• ASTM approved test method
• FDA Recognized Consensus Standard
• Allows for increased sampling
• Quantitative results
• Eliminates cost and waste of destructive testing
• Test results can be easily validated
• SPC laboratory testing or online applications