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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.