Pharmaceutical Nitrogen System Validation

Validation
#1

Dear Ankur Sir,
What are the validation test & specification for pharmaceutical Nitrogen System Validation (Using in sterile section) with ref Guideline. Please don’t ignore. I am really in a problem about Nitrogen System Validation PQ.

Best Regards,
Masud

#2

Test the Nitrogen gas as compressed air for chemical purity, oil content, moisture content and sterility.

1 Like
#3

Thanks for your short answer. But need some specifications…

#4

First you should make piping and filter station with appropriate grade. Intergrity of final filter to be performed for flow.
Pall filter be preferable
After that sampling for viable and non viable to be performed for 3 alternate days

#5

Dear Mr Masud

Please find the below link for more details on the Nitrogen Distribution system validation

http://pinbloggs.com/nitrogen-distribution-system-qualification/

Regards
Abhishek

1 Like