rubberized
Industrial
- Oct 13, 2008
- 1
Hi,
I'm a quality enigneer at a medical devices factory. For some time now we've had problems with a rubber membrane, for which we can barely obtain a required backpressure. The membrane passes the suppliers and IQC backpressure tests, however, once it is being assembled in the manufacturing line the membrane fails to pass the backpressure test. Among one of the factors that affects the membrane, is a leak test perform in the manufacturing line in which compresses air is applied to the membrane (the other factor is related to another component), as the backpressure decreases an average of 1 psi if the leak test is performed. The material specification is as follows:
Shall conform with compound number 3504740 or any other approved equivalent natural amber rubber compound. The material shall be compounded
in 30 lb. batches. The supplier is allowed to vary the sulfasan
content between 0.4% and 0.6% to achieve the correct back pressure. Part must be
subjected to a chlorination process in order to eliminate surface tackiness.
Now that I have explained most of what I have the (modest) knowlege of in this particular subject. I would like to know if there is something the supplier could change in his process that could yield a higher backpressure reading in the manufacturing process. Please keep in mind that this is for the surgical industry and that radical changes to components and processes are very hard to be approved.
Thank you
I'm a quality enigneer at a medical devices factory. For some time now we've had problems with a rubber membrane, for which we can barely obtain a required backpressure. The membrane passes the suppliers and IQC backpressure tests, however, once it is being assembled in the manufacturing line the membrane fails to pass the backpressure test. Among one of the factors that affects the membrane, is a leak test perform in the manufacturing line in which compresses air is applied to the membrane (the other factor is related to another component), as the backpressure decreases an average of 1 psi if the leak test is performed. The material specification is as follows:
Shall conform with compound number 3504740 or any other approved equivalent natural amber rubber compound. The material shall be compounded
in 30 lb. batches. The supplier is allowed to vary the sulfasan
content between 0.4% and 0.6% to achieve the correct back pressure. Part must be
subjected to a chlorination process in order to eliminate surface tackiness.
Now that I have explained most of what I have the (modest) knowlege of in this particular subject. I would like to know if there is something the supplier could change in his process that could yield a higher backpressure reading in the manufacturing process. Please keep in mind that this is for the surgical industry and that radical changes to components and processes are very hard to be approved.
Thank you