Surgical Sealant Package Integrity Test for Glass Vial Filled Product

H

Hendel

#1
Hello all!
I would appreciate your assistance with the following:
Our product (surgical sealant) is designed to be aseptically filled into a glass vial (<10ml volume), capped with a rubber stopper and a crimped aluminum cap. We are finding difficulties defining the right method to test the package integrity method for it. I understand that two common methods are dye penetration test and microbial ingress test. Yet, we were unable to locate the reference for such test at the standards and or the guidelines (US or European ones).
Therefore, I would appreciate much your input regarding the common and acceptable method to perform it. Considering both methods are acceptable, we will prefer at our current stage the dye penetration test as it shouldn’t require the product to be sterile (as opposed to the microbial ingress test) - right?!
Thanking you in advance!
Hendel
 
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H

Hendel

#3
Thanks for the fast response.
Yet, this standard does not cover all requirements for packaging for products manufactured aseptically (as in my case); in such cases, additional requirements are necessary to ensure that the packaging and packaging process do not present a source of contamination of the product.
Thus, I'm looking for guidlines/standards with such additional requirements.
Thanks,
Hendel
 

Ronen E

Problem Solver
Staff member
Moderator
#4
Thanks for the fast response.
Yet, this standard does not cover all requirements for packaging for products manufactured aseptically (as in my case); in such cases, additional requirements are necessary to ensure that the packaging and packaging process do not present a source of contamination of the product.
Thus, I'm looking for guidlines/standards with such additional requirements.
Thanks,
Hendel
Hi,

I have also looked for such methods (beyond ISO 11607) in the past, and unfortunately I am not currently aware of any such standards that would match your description. However, if you are interested in developing a test method then I can make some suggestions, based on my experience and past quests. Please let me know if this is of any interest for you.

Cheers,
Ronen.
 
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