Medical equipment manufacturers rely heavily on their leak testing, so here’s what you need to know about these complex solutions!
Medical equipment manufacturers develop all sorts of products that save patient lives, which is why top-quality products are absolutely necessary—and why device failures are potentially life-threatening.
The Zaxis team understands how high-performance leak testing solutions for medical equipment manufacturers require impeccable accuracy, sensitivity, and stringent quality assurance requirements. And when it comes to products like medical fluid bags, there are many unique challenges that can occur on a production line.
Medical fluid bags are known for their flexible materials and variable sizes, and it’s no secret how leak testing these bags is 100% necessary to ensure effective operations and patient care. Leak testing medical fluid bags is always a lot easier said than done, which is why our experts have developed this how-to guide to support your manufacturing team’s cycle time and process management requirements!
Understanding The Process For Leak Testing Medical Fluid Bags
We support medical equipment manufacturers with leak testing a wide variety of medical products, including:
- Catheter tip seals
- Multi-Lumen catheters
- IV pumps
- Filters
- Tubing sets
- Ventilators
- One-way check valves
- And much more!
But when it comes to medical fluid bags, there are certain challenges that often arise with leak testing these flexible materials. This is why careful controls and designs are required to ensure accurate test results, and medical equipment manufacturers must follow the below five steps to ensure successful pressure decay leak testing processes:
1. Properly Loading Medical Fluid Bags For Leak Testing
The first step for leak testing medical fluid bags is to properly load the bags for the leak testing process.
This usually means that the bag will be carefully placed in between restraining plate fixtures, which minimize the volume within the pressurized bag and reduce issues like material stretching and elastic creep during the actual leak testing.
Your team’s operator will then need to insert a connector device into the fluid bag’s open ports, which is connected to your preferred air leak tester. This connection needs to be 100% secure, because it allows for sealing and pressurization during the test.
2. Stabilization & Detecting Large Leaks
The leak testing cycle will be ready to begin during this step, and the good news for your manufacturing team is that the testing sequence will be fully automated when you invest in our state-of-the-art products.
When the fill timer eventually expires, an isolation valve inside the leak tester will close and subsequently trap pressure inside the medical fluid bag. The bag will remain pressurized for a pre-established amount of time in order to guarantee accurate test results.
3. Detecting Small Leaks
After your leak test’s stabilization time has expired, the resulting pressure decay is recorded and compared to pre-determined minimum and maximum pressure limits that’ll ultimately help you differentiate good parts and rejects.
This is an incredibly important step of the process, because it’ll help you determine if small leaks are present. And when it comes to medical fluid bags, even the tiniest of leaks can jeopardize patient safety—which is why manufacturing teams must be extra careful while recording the pinpoint accuracy of their test results!
4. Venting The Medical Fluid Bag’s Pressure
Once the leak test’s timer has expired, the trapped pressure within the medical fluid bag will be carefully vented.
It’s important to remember that a tiny amount of air is often left inside bags after they’ve been leak tested, which means they’ll be slightly inflated. This can sometimes make it difficult to properly remove a bag from in between the restraining plates, which is one reason why vacuum decay leak testers are very popular for medical equipment manufacturers!
5. Viewing Leak Test Results
Once the medical fluid bag has been properly vented, your test results will be shown on your leak tester’s display screen.
It should be relatively clear whether or not a bag has passed or failed, which means that your operators will immediately know if a bag should be passed down the production line or placed into a reject container.
Zaxis Offers State-Of-The-Art Vacuum Decay Testers For Medical Equipment
As we mentioned in an earlier section, vacuum decay leak testing is incredibly popular within the medical industry. And when you partner up with Zaxis, we’ll be sure to keep your team’s versatility and usability in mind as we pair you up with the right multifunctional leak testers to support your manufacturing needs.
Some of our most popular leak testing devices that feature vacuum decay capabilities include:
Reach Out To Our Leak Testing Specialists To Learn More About How We Support Medical Device Manufacturers!
All of us at Zaxis are incredibly proud to support medical device manufacturers with our top-quality leak testing equipment, and we also support many other industry solutions as well.
We understand how you might have questions on your mind as you’re preparing to make leak testing investments, so feel free to reach out to us online or give us a call at 801-264-1000 to speak with our renowned experts today about how we can support your company’s unique leak testing requirements!
