A luer connector is a small apparatus that enables the connection of intravenous drug delivery devices and accessories. It might be fair to say that this little invention has improved patient safety like no other and is helping to standardize connectivity in a large part of the medical device industry. Over use of luers have been the cause of connectivity mistakes and the need to control design and specifications. This is achieved by compliance with ISO 80369 Small Bore Connector Standards, of which there are several sub sets that deal with specific types of medical devices including ISO 80369-7 which covers luer connectors and ISO 80369-20 which describes common test methods.
ISO 80369-7 states that:
“Luer connectors shall be evaluated for leakage using either the leakage by pressure decay test method or the positive pressure liquid leakage test method.”
“Luer connectors evaluated for fluid leakage by pressure decay test method shall not leak by more than 0.005 Pa*m3/sec while being subject to an applied pressure of between 300 kPa and 330 kPa over a hold period between 15s and 20s using air as the medium. Manufacturers may use a greater pressure.”
Compliance may be checked by using the tests specified in Annex B of ISO 80369-20. These require the reporting of the pressure change and the leak rate.
A long-time medical device manufacturing client reached-out to Uson to supply a leak test instrument capable of facilitating compliance with part 20, and automatically calculate measurements that can be time consuming and vulnerable to human error.
Some of the other specific requests included:
These are the laws of physics that were used to satisfy our customer’s requests:
Ideal Gas Law Review
Boyles Law Review
The OptimavT air leak tester was chosen for this application because of its powerful PROGRAM JUMP, MATH and STEP functions. By working closely with the client’s quality assurance and regulatory affairs teams our application development team developed a series of program steps and register entries that would perform the necessary calculations automatically and, using the clients own accept reject criteria, segregate good and bad parts by pass and reject results.
To solve the leak rate equations and make the Accept/Reject decision the following Optima vT step types were utilized:
Below is a snippet of the OptimavT register Set 1 showing some of the registers used to perform these tasks:
*The above snippet is only a few lines of register entries and calculations.
It is anticipated this will save the customer hundreds if not thousands of man hours in the lab by automating the compliance check of their products to this specification. How many hours might you save with a setup such as this?
This application is an excellent example of the thinking behind the design of the OptimavT. Our product development team designed an instrument so versatile that it can combine the attributes of a leak tester, a PLC and a computer in one neat package.
For aiding compliance, taking the headache out of leak test calculations, removing the scope for human error, and providing fast, reliable results to complex problems, OptimavT leads the class.
If you have a complex leak or flow testing application that you use some help with please contact the Uson Applications Team at 281-671-2000 or click here to email us about your application.
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