The Pioneer of Modern Leak Testing

Seven things medical device manufacturers should consider before buying a leak tester

#1 Cycle Time is Impacted by Multiple Variables
Most medical device manufacturers have high-volume production lines and want fast cycle times to ensure the most efficient manufacturing process. A shorter cycle time can negatively impact reliability and repeatability, which should never be sacrificed for speed. Cycle time is also impacted by many factors, including test part volume, geometry, materials, test pressure, leakage rate, and environment. All of these factors can have a significant effect on the type and quantity of test equipment required.

#2 Complexity of Testing Requirements
Quite often a medical device will require more than one type of test, sometimes several. This will naturally increase the cycle time and reduce throughput. To some extent, modern leak test equipment can mitigate the effect by combining more than one technique in a single tester and utilizing sequential or step programming. For example, a check valve would require a body test, along with testing from both directions to test opening and closed seat, as well as flow, at design specification. This would require three discrete tests and each one could be programmed to abort the test sequence on failure, if desired.

#3 Use of the Tester
Medical device leak testing can be labor intensive, with operators often responsible for manual part delivery, handling, testing, and sorting. It’s important that testers are designed for maximum ease of use, with an intuitive user interface and simplified menu structure. The results should be non-subjective and clearly displayed to avoid the risk of false rejection or acceptance. Many parts can only undergo a single test, so the part needs to be handled correctly the first time. Parts that include materials with no elastic memory might only test satisfactorily once. Furthermore, the nature of the test may require a destructive test, as is the case with burst testing. It is important the tester produce an accurate result to avoid unnecessary waste.

#4 Tester Features
Increasingly, customers are looking for advanced tester features such as data handling, fieldbus communication protocols, network communication, onboard data, analytics, statistics, and security protection for programs, user authentications and individual passwords. Furthermore, increased speed and resolution continue to be a requirement. To improve cycle time and throughput, independently started test channels can help. One leak tester can then be shared by several operators, each of whom may start their own test or sequence independently.

#5 Tester Flexibility
Because a leak tester may be used to test multiple medical device product lines, the tester should accommodate a wide range of multifunctional testing, including pressure, vacuum, flow, occlusion, burst, and crack, without sacrificing high performance, fast cycle times, and exceptional repeatability. Also, the ability to perform both part integrity and performance tests in a single instrument is helpful, because it simplifies maintenance and makes scaling operations easier.

#6 Regulatory Compliance
Within the medical device manufacturing industry, regulations have been becoming increasingly more stringent since the late 1990s, and that trend continues today. The cost of not complying with local regulations can be very high, including the loss of a certificate of compliance. Standards such as 21 CFR Part 11, EU GMP Annex 11, and others address electronic record keeping and signatures, including time stamps, user authorization, audit trails, historical tracking, work flows, and traceability. It’s important to make sure that all new testing equipment is in compliance with these guidelines, as it is very expensive to upgrade non-compliant equipment to current standards.

#7 Global Support
Widespread consolidation of companies within the medical device industry has created challenges relating to the manufacture of products in multiple world areas. Leak testers must accommodate multiple languages, and be easy to use for a wide variety of skill sets. Leak tester manufacturers must have the ability to duplicate testers so they can be installed in manufacturing facilities in multiple locations. Medical devices can be manufactured in remote facilities, making it hard to ship testers across borders, which translates into challenges with shipping testers back for calibration. Testers should incorporate self-diagnostics that monitor the health of the instrument and include built-in communications protocols to make remote monitoring and troubleshooting easy. Instruments should be designed to minimize tolerance errors and include the ability to change out ports – NPT or BSPP – for international flexibility.

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Joe Pustka

Director Applications Engineering

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