การทดสอบรอยรั่วเป็นขั้นตอนสำคัญในการผลิตอุปกรณ์ทางการแพทย์ เพื่อลดความเสี่ยงของการปนเปื้อนและรับประกันประสิทธิภาพของผลิตภัณฑ์
ความสำคัญของการทดสอบรอยรั่ว
การทดสอบรอยรั่วเป็นส่วนหนึ่งของกระบวนการควบคุมคุณภาพ (QA) ในอุตสาหกรรมการแพทย์ เพื่อป้องกันการปนเปื้อนและรับประกันประสิทธิภาพของผลิตภัณฑ์ การทดสอบรอยรั่วแบ่งออกเป็น 2 ส่วนหลัก: การทดสอบบรรจุภัณฑ์ทางการแพทย์ และการทดสอบอุปกรณ์ทางการแพทย์
วิธีการทดสอบรอยรั่วทั่วไป
การทดสอบรอยรั่วแบบลดแรงดัน (Pressure decay leak testing): ใช้สำหรับทดสอบอุปกรณ์ทางการแพทย์ เช่น สายสวน
การทดสอบรอยรั่วแบบสูญญากาศ (Vacuum decay leak testing): ใช้สำหรับทดสอบผลิตภัณฑ์และบรรจุภัณฑ์โดยการสร้างสุญญากาศในห้องทดสอบ
การทดสอบการไหล (Leak/flow testing): ใช้สำหรับทดสอบอุปกรณ์ทางการแพทย์ที่มีข้อกำหนดด้านการไหล เช่น สายสวนและท่อระบายอากาศ
Ensuring Patient Safety: The Importance of Leak Testing Medical Devices and Packaging
Reducing the possibility of cross contamination and ensuring the efficacy of packaging or equipment, leak testing is an integral part of any test and measurement process for medical devices.
Why leak testing is so essential
Leak testing is a critical part of the QA process when it comes to manufacturing for the medical industry, as it is a crucial step in preventing contamination and ensuring product efficacy. There are two main areas of leak testing when it comes to the medical sector.
Testing medical packaging
Medical packaging is incredibly important. It is often expected to ensure a sterile condition, so that the contents can reach medical professionals and patients in a ready-to-use state. This could be packaging for medical devices, such as syringes and swabs, or packaging for pharmaceuticals themselves.
A leak in packaging can leave the contents vulnerable to the ingress of microorganisms such as bacteria alongside air, which can create a potentially harmful situation for the recipient.
In addition to sterility, there’s also a question of preservation. Well-sealed, vacuum packages can help increase the lifespan of particular drugs and it is of upmost importance that pharmaceutical companies know the limits and capabilities of such packaging, so that they can accurately predict the conditions of the pharmaceuticals on delivery.
Testing medical devices
Testing is, of course, also essential for medical devices. A blockage or a leak in a medical device could have huge implications for patient safety. There are a huge number of medical devices currently in production and a wide variety of ways in which a leak could cause issues. However, some of the most crucial leak testing occurs in those medical devices that are used to transport or extract fluids or gases to or from specific body parts.
In these devices, any leak could result in seepage that could prove detrimental – or even fatal – for the patient. This means that the integrity of the device is of the highest importance and leak testing is essential.
Common leak testing in medical fields
Pressure decay leak occlusion
Occlusion testing can be a valuable process for leak testing very commonly used medical devices, such as catheters. Between mass flow leak testing, back pressure occlusion leak testing and pressure drop occlusion testing, you can get a thorough and reliable picture of the efficacy of your device.
Vacuum decay leak testing
This method works the opposite way to pressure decay testing. The product of packaging being tested is placed in a test chamber and vacuum and the air surrounding it is extracted. If the pressure within the chamber is recorded as having increased, that would indicate a leak.
Leak/flow testing
The flow test method determines whether there is a leak or not by measuring the rate at which air is flowing or passing through a device or item. It is very useful for testing medical; devices that have critical flow requirements, including catheters and ventilation tubes.
Find out more about the various processes in our handy guide to leak testing.
Leak testing solutions
When you’re looking for reliable testing instruments to add to your set up, we can help. Check out the TM Electronics Integra Flex, a pressure decay leak tester that’s available as a rackmount industrial model or as a benchtop. It’s easily configurable to perform either pressure or vacuum decay leak tests, as well as occlusion testing, on a wide array of devices and components.
Also available is the TM Electronics WORKER Integra™ leak tester, perfect when you’re in need of an everyday leak, flow and occlusion tester. This one-to-four channel, bench-top, high resolution leak test instrument has a small footprint and is very easy to operate.
Leak testing medical products and packaging with Industrial Physics
We’ve been providing packaging, material, and product test and measurement solutions for almost 100 years and our knowledge of the medical sector is far reaching. Discover our range of medical testing solutions and do let us know if you have any questions at all. We’ll be happy to help you get the right set-up for your lab or production line.
#FlowTesting #LeakTesting #MedicalDevices #FlexiblePackaging
#pressuredecay #vacuumdecay #medicalmanufacturing #pharmaceuticalmanufacturing
