hello everybody! This is my first discussion, and I am hoping that someone with experience can help me.
I have to define the test parameters for leak testing of Single Use bags used in Pharmaceutical which volumes range from 50 ml up to 500 ml.
I am using the most popular leak pressure test method used for On Line Leak Testing in Manufacturing which is Pressure Decay (e.g USON Leak Tester).
To start I am focused in One Size only. The leak size has been defined by the customer as 20µm.
I don't know how to calculate or how to establish the settings for testing. These are the settings that I have to calculate:
Pressure: Which pressure I should use to start with? or how can I calculate this pressure having the Leak Size of 20µm?
Decay: This is the most important setting I think
Pressure % Tolerance
Please any help that you can give me will be highly appreciated.
Note: I have already read any possible study research, article, publications, forums discussions available in internet (hours of research) but I can't find anything specific on how to establish these settings.
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