Leak detection is evolving for the production of medical devices, with quality requirements getting stringent as modern research methods now become available. In the medical sector, leak testing is highly important because product leakage can be life-threatening for patients and can provide suppliers with substantial liabilities. In the manufacture of surgical consumables, medical implants, and medical instruments, a number of leak detection methods are widely used. There are different dry-air test methods at one end of the continuum, under which an object is pressurised and separated from the pressure source and then monitored to detect any leakage, usually by detecting a decrease in pressure.Such dry-air strategies, such as limited sensitivity and precision and the failure to identify the position of leaks, may have serious deficiencies. The use of helium as a tracer gas is at the opposite end of the spectrum, with specially built mass spectrometers. To detect leaks ten thousand times smaller than the leaks found by the dry-air monitoring techniques, the helium-based system is extremely reliable and sensitive enough. Helium testing has, however, proved particularly difficult and costly for all but the most challenging uses for medical equipment. In all situations, successful leak testing relies on careful analysis and appraisal of the possible application. Here are some important factors need to be considered:
1. Volume of the parts
Medical instruments range from very compact and solid to wide and very fluid and elastic (greater than two litres). In order to accommodate bigger components, the tester must be compact enough to have a test volume that can stay sensitive for processing while maintaining the filling circuit level limited.
2. Geometry of the parts
Medical instruments often have a very peculiar geometry; tubing, pumps, stopcocks, transducers, enclosures and modules are often contained inside modules. Not only does this make the test itself difficult, but the essential essence of fixing and regulation is stressed.
3. Material of the parts
Sometimes, polymers and plastics can behave in strange ways. Elasticity will make repeatable testing very difficult in which certain pieces begin to stretch, taking a long time to settle, after achieving the required test pressure. This impact is often referred to as “compliance.” Fixturing or part control to decrease part displacement is one of the measures to limit the elasticity effect. In the development of such fixtures, however, precaution should be observed because the pieces will seal themselves either by intrinsic elasticity or under pressure against the fixture.
4. Safety & Comfort
In patient safety and convenience, Leak Rate Medical devices play a critical role. In order To minimise illness or improper treatment, cross contamination, air or gas ingress/egress would almost definitely be prevented using these devices. The leaking is detrimental to patient recovery throughout private long-term care products. For this purpose, precise determination and estimation of leaks is important and the standards for medical devices are among the tightest specifications faced with by leak test specialists, though differing immensely from one product to another. Ecosystem Of production and testing of a clean room ensures that the leak tester and fixture must agree with the requirements of the clean room.
Methods of Leak Testing in Medical Sector
Leak testing verifies that a formulated substance is integral. Tests range from pressure measurement and decay of pressure to disruptive burst testing and testing of the bubble break point. The inspection of goods for leakage uses two simple approaches.
● Distilled water is often used as a pressure medium for hydraulic pressure testers and delivers up to 2,000 psi. These instruments are used in surgical tubing, rubber fittings, polymer balloons and other parts for burst testing, fatigue testing and compliance assessment.
● With pure dry nitrogen, gas pressure leak testers run. For final product testing, they are usually used so the nitrogen gas does not contaminate the product.
● The preferred methodology for leak testing in most industries is pressure decay or mass flow using oxygen. A simple water immersion test, where the operator checks for the outflow of air in the form of bubbles, is perhaps the most common type of leak test in all industries. The bubble test is the oldest method for leak monitoring. Immersed in a water tank is a pressurised object. It leaks if bubbles escape from the object.
Product testing is an indispensable part of the device development phase throughout the medical industry. Leak testing, in particular, has become essential for suppliers of medical equipment as safety requirements have become exceedingly rigid. It is a significant and frequently difficult task to select the right leak-detection process. Contact Mikro Innotech Pvt. Ltd. for more information or assistance on the numerous leak-testing procedures. There are several ways to increase quality assurance, reduce the expense of testing and decrease the likelihood of product defects in the Medical Sector.