Medical devices packaging - integrity tests

GOOD VALIDATION PRACTICE (cGVP) PROCESS VALIDATION
1

Hi,

I’m going to validate the sealing process and I have question about integrity test.
I found information that package integrity testing includes dye leak, vacuum leak and bubble leak testing. Visual control can be included as well.
My question is: do I have to perform all these tests (dye leak, vacuum leak and bubble leak)? Or can I choose only one of them? Is there any regulatory requirements which says that?

I would appreciate any hepl.

Marta

2

Hello Marta,
Dye leak test is applicable only if your device contains any solution. But if it is just a metal thing, its not suitable.
Bubble point test is applicable only if your pack can be immersed in water or any suitable liquid.
Based on the type of product and profile of your packaging, select the suitable leak test method

Regards
Veerraju N
nvr.veeru@gmail.com

3

I use leak test method.