Recent Posts by Dave Kralovetz Medical Market Specialist

The updated Sentinel Blackbelt: Most powerful single-channel benchtop leak tester on the market

Manufacturers around the world rely on the multi-functional Sentinel Blackbelt. Why? With so many standard features and available options, it’s easy to customize a leak test for a wide variety of scenarios. Read More

Leak Testing Considerations for Catheters

Pressure decay testing is most commonly used in catheter leak testing. Of course, there are some test variations to accommodate different types of catheters, so you need to have the right pressure decay leak test system for the specific type of catheter. This blog post will review leak testing ... Read More

How to choose the right method for testing medical devices for blockage

There are many important applications for blockage testing in the disposable medical device manufacturing industry. These include catheters, tubing sets, valves, needles, restrictors/regulators, microfluidic chips, respiratory components, suction therapy devices, and more.  The main methods used ... Read More

Medical device manufacturing: Test instrument features to help ensure compliance in the era of Industry 4.0

Contract manufacturers in the medical device space must comply with complex regulatory requirements such as the U.S. Food and Drug Administration’s Title 21 CFR Part 11, as well as the European Medicines Agency’s comparable Annex 11. These guidelines extend to the manufacturing, testing, packaging ... Read More

Is a leak rate required for pressure decay testing?

A common question we hear is whether a volumetric leak rate, such as standard cubic centimeters per minute (sccm), is required to carry out pressure decay leak testing. The short answer is no. But while it’s not mandatory, it may be helpful to have. First, let’s revisit how a pressure decay test ... Read More