Container Closure Integrity & Sterility Test - The Dye Immersion Method

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

Re: Container closure integrity test and sterility test

Welcome to the Cove.

I understand that you are in a hurry to get an answer but it is midnight (about 2am US time) and the majority of our users are asleep. Be patient, some one will come along with an answer by tomorrow morning (US time).

In this connection, your duplicate post will be deleted as it is redundant.

Re: Container closure integrity test and sterility test

Would this FDA site/page answer your needs?

Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products

Re: Container closure integrity test and sterility test

Thanks Harry,

I already read that guidance document which help me to select the test but it does not provide the test method.

For example The dye immersion method i can use.

I have the basic information and concepts about the dye immersion test but not the formal documented accepted procedure which would be valid for an official study. I am aware that there is a method in BP but i am unable to access its online version.

And I am happy if some can provide the document with any other appropriate test method or source which i can use in my reference.

I am using the test for Validation purpose but I do not have any idea whether do i need to validate the test method as well or not. I am doing validation as per TGA requirements may be I will find the answer in some of validation guidance document by TGA. So this is not a question I am worried about.

What i need is the test method(procedure) online. I am sure that is in BP. But I don't have hard copy as well. Help me if some one can provide me online.

Thanks again Harry. Hope to see some beneficial document from someone.

Dave, thanks for the explanation. I edited the thread title accordingly.

Can somebody help out?

One problem here is that the "test methods" are called out in various standards, which are proprietary documents available from the standards bodies. (ASTM, ISO, etc.)

Perhaps I'm mis-interpreting, but my understanding from the O.P. is that it's a request for copies of such standards.

One legitimate avenue for a student would be to visit their technical library and access the needed standards there.

Thank You,

But in my university library BP is not available May I need to arrange a copy of BP from somewhere.

Thank You all of you.

Did you get this?

rogerheffington said:

Did you get this?

Click to expand...

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

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

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!