Container Closure Integrity & Sterility Test - The Dye Immersion Method

[Marc]

In Reply to Parent Post by rogerheffington

Did you get this?

My assumption is you can provide a legal place to obtain it.

Just to remind folks, we do not share copyrighted materials here.

[rogerheffington]

Hi Marc,

I'm sorry that I did not make myself clear (my fault!). What I meant to ask was if he had gotten the dye immersion test instructions that he wanted. I have had to write this test procedure before (it's relatively simple) and I was going to offer the procedure, if he still needs it. I don't have the actual test method from that standard-no need.

I would not suggest anything improper-that would be disrespectful to you!

[Marc]

No problem. I appreciate the offer to help, and if you want to attach the test procedure it will be appreciated.

Things are kinda weird copyright wise these days so I have to make sure no one takes a snippet of innocent text and makes it into a something it isn't.

My apologies for butting in as I did. I'm glad you understand my post.

[rogerheffington]

Hi Marc,

Here's the procedure... short and sweet (just like me!)

Roger

[Marc]

Thank you, Roger! I appreciate it, and as time goes on I'm sure others will thank you as well.

[Ajit Basrur]

In Reply to Parent Post by rogerheffington

Hi Marc,

Here's the procedure... short and sweet (just like me!)

Roger

Thanks rogerheffington

[dhjohnson]

In Reply to Parent Post by jigar dave

Hello everyone.

I am looking for a scientific method for container closure integrity test and sterility test.

These tests i want to perform on vials filled by liquid, which is similar to sterile water.

I select Dye immersion method by visual inspection but i don't get method.

Any one can provide dye immersion method or any other appropriate method?

Or some source where i can get written method and which i can use as my reference document.

I tried in USP website but i can not access test method there.

Any suggestions will be appreciated. Please help as i am still student and this is my first question here. I hope i can improve my knowledge. I have still some more question on Validation but this one is immediately require.

Thank You.

Regards,
Jigar Dave

Hi Dave,

I was wondering if you ever got a direct answer to your question. I too, am looking for a dye immersion test method for container closure. Are you able to help me or provide me a little direction. The FDA guidance doc does not provide me what I need. Thanks in advance! Deidra

[dhjohnson]

Thanks Marc! Deidra