If you’re involved in product engineering and development of catheters, you are aware of the importance leak testing plays in ensuring performance, safety and quality of the product. While every application has its own set of unique considerations, it is important to note that the foundation of identifying the right equipment and creating effective test procedures lies in understanding the fundamentals of leak testing. Through many years of experience assisting hundreds of clients with their leak testing specifications and equipment for thousands of catheter products, our experts have identified and addressed the three most common mistakes made by catheter manufacturers when creating test specifications and how to avoid them.
We’ve deemed this #1 of the three leak testing mistakes we’ve outlined in this article, and for good reason. Without the leak rate, you’ll be unable to identify the proper leak testing equipment and leak testing process. In short, the leak rate is “square one” when it comes to the testing process. In the past, application studies were a fundamental part of the R&D process. However, a new trend has emerged in the last several years where device manufacturers look to the leak testing equipment manufacturers to outline testing specifications for their part.
There have been several theories thrown around as to why and how this has become the trend, however we’ll save that topic for another article. While leak test equipment manufacturers certainly have the expertise to determine the right leak rate and define testing specifications for a given part, there are too many variables for a “one-size-fits-all” testing method. The only viable way to properly identify the correct leak rate and leak testing specification is to perform an application study. By evaluating the part, fixture, volume, and permeability of the material, a combination of tests can be done at different pressures to determine the appropriate leak rate so any defects can be identified. Once the correct leak rate is established, you can move forward with the appropriate leak testing equipment to ensure optimum product quality during production.
What do you do if you don’t have the expertise to determine the correct leak rate for your application? This is when it’s time to call the professionals. At Uson, our experts are familiar with similar parts and materials, and how each typically reacts under certain conditions. This can expedite the process when determining what tests are needed in order to calculate the proper leak rate. Making application studies part of the R&D process on the front-end streamlines leak testing protocol development on the production side. This reduces inefficiencies and ultimately results in the highest quality products.
This leak testing mistake is typically the direct result of pressures to cut costs. When trying to save money, it’s only natural for both R&D and the production team to make the following assumptions when suggesting they use existing leak testing equipment:
Assuming the above statements are correct can lead to a host of problems. While it’s true that many leak testing machines are capable of performing the same test methods, it’s risky to assume that the unit is best suited for testing a particular part, unless application studies reveal this is, in fact, the case. Different units are typically configured for specific types of tests on unique parts and while you may discover that you already have a tester that will perform the tests you need, it is not safe to assume this without proper evaluation.
So what about the different testing needs of R&D versus production? First, these two departments have very different goals. R&D is focused on doing whatever it takes for as long as it takes to identify a leak in the part, while production is focused on speed–creating quality products in as little time as possible. Because of their inherently different perspectives, these two teams may require two different types of leak testing equipment. As frustrating as it may seem, a tester already in your inventory may meet the needs of one team, however it’s unlikely it will suit the needs of both. It’s crucial to consider the needs of both departments when selecting testing equipment because while it may create the illusion of saving you money, the end result will prove otherwise. To ensure you’re getting the correct tester for each team, enlist the help of a professional.
Although we’ve made this leak testing mistake #3 on our list, it doesn’t mean that it is less significant. As stated above, the R&D team is typically focused on product performance and quality, while production is focused on the efficiency of the manufacturing process, and the scalability or ability to manage increased demand. These two perspectives lend themselves to entirely different test equipment requirements. The result is the development of a leak testing specification that simply will not work in a production environment. This can lead to an entire rework at the 11th hour to meet production goals, resulting in a gross waste of time, resources, potential delays and a possible loss in revenue.
Bridging the gap between production testing needs during the R&D phase is essential, although curiously not the norm. While there are many manufacturers who have discovered the value of aligning R&D with production, many still have not. Communication between the two departments and defining leak testing needs for full scale production during R&D allows for identification of the right test equipment before the product goes into production. The production process is therefore more streamlined and scalable because the proper equipment has already been specified.
With over 50 years of experience in leak testing, we’ve seen and accomplished a lot. Our leak testing experts have helped hundreds of companies avoid these leak testing mistakes. Uson’s team has identified the right equipment and testing procedures for thousands of catheter leak testing applications. Our comprehensive suite of fully customizable leak testers provides a platform that is scalable from R&D to production with a wide operating envelope that can be modified to accommodate future projects. You can rest assured you’ll avoid any risks when you outsource your leak testing needs to one of our professionals.