MEDICAL
DEVICE packaging
TESTING
Medical devices, such as IV sets, catheters, infusion bags, hypodermic needle packs, respiratory devices, and wound drainage systems, are an integral part of modern healthcare, providing critical support and treatment to millions of patients around the world. The safety and efficacy are therefore incredibly important and crucial, which can be compromised if they develop leaks. Medical device packaging testing is a vital part of ensuring the quality and integrity of these devices, helping to identify leaks and other defects that could compromise its performance or safety.
The importance of medical device packaging testing
Why medical device packaging testing? Medical devices play a crucial role in healthcare by aiding in diagnosis, treatment, and monitoring of diseases and medical conditions. They are subject to strict regulations and standards, which makes medical device package testing important for several reasons:
- Patient safety: Devices that are not leak-tested can be dangerous to patients as leaks can cause malfunction, failure or even harm to patients.
- Compliance: Leak detection of medical devices is a requirement in many countries, and manufacturers are required to conduct leak testing to ensure that their products comply with the industry standards and regulations.
- Quality assurance: Medical device package testing is an essential part of the quality assurance process and helps to identify defects or manufacturing issues that could compromise the performance and reliability.
- Cost savings: Identifying and fixing leaks earlier during the production process can save money by reducing the need for reworks and product recalls.
- Reputation: A leak in a medical device can harm a patient which will damage the reputation of the manufacturer. Medical device leak testing helps to ensure the safety and reliability of medical devices, which can enhance the reputation of the manufacturer in the market.
Non-destructive medical device package testing
Medical devices can be tested using destructive and non-destructive testing methods. Non-destructive testing of your devices allows you to access the quality, integrity and performance of materials and components without damaging or destroying them.
Non-destructive medical device packaging testing is increasingly used for safety, cost-effectiveness, efficiency, accessibility and compliance reasons. Curious how manufacturers can ensure the safety and efficacy of their devices while minimizing costs and improving efficiency with non-destructive leak testing? Read it in our white paper.
Medical device leak testers
Oxipack developed several leak testers which can be used to check the integrity of different types of pharmaceutical packaging. Our non-destructive medical device package integrity testing solutions are meticulously designed to address the critical challenges posed by packaging defects. We combine advanced technology with in-depth industry knowledge to offer a range of testing methods that ensure your medical devices are safe, reliable, and fully compliant. These medical device packaging testing applications ensure that medical devices meet stringent quality standards and regulatory requirements, providing reliable and accurate results to verify the integrity of the devices and their associated packaging.
Stationary Leak Tester
Flexible packaging, for example catheter packaging or infusion bags, can be testing in the Stationary Leak Tester. This medical device leak tester is measuring according to the vacuum decay method (ASTM F2338). The red button lights up when a leak is detected, and the green button lights up when a package is approved and deemed leak-free.
Stationary Leak Tester
Stationary Leak Tester XS
Stationary Leak Tester XS or M
Some medical equipment is packaged in rigid packaging, such as trays or other hard plastic containers. A custom-made insert is created for these types of medical device packages. This leak tester follows the same testing procedure, using the vacuum decay method. A red light indicates a leak, while a green light shows that the package is approved and can put back into the production line.
Vacuum Leak Tester
In the case of vacuum packs, for example vacuum-sealed pouches, bags, and containers, a vacuum leak tester will be used. We use different methods for different types of vacuum packaging, so please feel free to contact us for more information.
Vacuum-Sealed Leak Tester
The Rotator
The Rotator
Of course, the leak detection process for medical equipment can also be automated. For example, flexible packaging can be tested for leaks 100% and fully automatically using the Rotator, which is capable of testing up to 120 packages per minute.
Medical device packaging testing is, therefore, crucial in a production and quality control process. For advice on which medical device leak tester is best suited for your type of packaging, please feel free to contact us for personalized assistance and recommendations.