Standard Temperature, Pressure and Process as well as Environment for Liquid Filling Line

The <...Pharmaceutical industry...> is pervaded by the validation concept, in that one has to evidence that the thing is designed, constructed, operates and performs correctly. The information in question needs to be found within the design documentation for that particular facility.

Such facilities also have qualified Safety Advisors in post that can sort out these principles locally as part of the design process prior to that information appearing in the qualification documentation that is held to ensure pharmaceutical-level compliance with national and international regulations.

• How bizarre that such a question should appear on an international Engineering forum.
• How bizarre that critical things such as temperature, pressure and vessel size information should be withheld from it.

Yes, but standards should be there to maintain validation parameters for designing. I just wanted to know if I could work those design related tasks -Which may sound bizarre.

Nitrogen use can displace oxygen so that the available oxygen falls below what is required for unimpaired mental and physical functioning...The air has about 21% oxygen and 19.5% is considered minimum requirement for human well being...So a fresh air source should be supplied in work areas where nitrogen is in use, and possibly an oxygen monitoring system for safety...

http://www.airproducts.com/microsite/Nitrogen_Blanketing/PDFs/en-use-nitrogen-safely-312-12-023.pdf

Excess nitrogen concentration (or low oxygen concentration) is not noticed, and so it is called the "Silent Killer". The desire for more air is not triggered by low oxygen concentration but by excess carbon dioxide concentration.

You might find this article interesting.

https://www.ehstoday.com/industrial-hygiene/article/21909148/nitrogen-the-silent-killer

Install an N2 sniffer at the end of the line, that’ll signal the line is fully purged.

In pharma the substance removed is not oxygen it is air which contains 21% oxygen and 78% nitrogen. It is only the oxygen component that needs to be removed but it is easier to evacuate it all as there is no practical way to separate the oxygen. You will be filling in a clean room or semi clean room environment which should have good ventilation with HEPA filtered air. The pressure depends on what you are bottling. If it is a sterile product the air pressure should be slightly positive to stop nasties from leaking into the filling room. If it is a pathogenic product like a vaccine the pressure should be slightly negative to stop the nasties from leaking out of the filling room. Spilling a small amount of nitrogen into an well ventilated atmosphere that already contains 78% nitrogen will have no detrimental health effects on operating staff. Leaking larger amounts might have an effect on the budget, pharma quality nitrogen is expensive. A low oxygen alarm should be fitted to signal a major leak of nitrogen. Nitrogen is heavier than air so fit the sensor at a low level.

The oxygen level needs to be maintained at the workplace.