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Topic: Container Closure Integrity by Dye Ingress  (Read 2803 times)

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Offline dougschmidt

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Container Closure Integrity by Dye Ingress
« on: February 19, 2018, 04:45:19 PM »
I am seeking a test method and validation strategy for performance of dye ingress testing for container closure integrity verification. I understand the basics of the analysis, but looking for guidance on a few specifics.
1) best process for inserting microtubes for validation and number of sizes.
2) methylene blue dye formulation
3) pressure of vessel

Thanks

Offline wildfyr

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Re: Container Closure Integrity by Dye Ingress
« Reply #1 on: February 19, 2018, 07:20:39 PM »
You are going to need to give us way more details about what exactly your are trying to do.

Offline Arkcon

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Re: Container Closure Integrity by Dye Ingress
« Reply #2 on: February 19, 2018, 10:08:00 PM »
You can find an overview of the procedure by reviewing the USP recommendations: https://www.gmp-compliance.org/gmp-news/usp-chapter-1207-container-closure-integrity-testing

The specifics is specialized information, and people generally charge to develop and validate a method for a particular application.
Hey, I'm not judging.  I just like to shoot straight.  I'm a man of science.

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