Performance qualification report of nitrogen attached

Nitrogen-PQ.pdf (288.0 KB)

Dear sir,

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Dear Sir,

How much purity of Nitrogen is required in solid dosage forms and API manufacturing facility? Is it acceptable 97% purity of Nitrogen?

Kindly give me your feed back.

Thanking you

Pulla Reddy Karnati

Please refer pharmacopoeia regarding purity limits.

Dear Sir,

One of the auditor has objected to perform the microbial test for Nitrogen Gas which is having 99.5%. but i did not understood properly why we should not perform the Microbial count. Can you explain me what are the logics are behind them. I thought that person also know you and he told me about you. I have discussed about your answers.

Looking for your prompt reply.

Thanking you

Pulla Reddy Karnati.

There is no need to perform the microbiological test, because there shoulndt be any microbes!

The most common bacteria that could contaminate anything is aerobial. At that nitrogen concentration thereĀ“s no chance an aerobial bacteria could survive (that is why you use nitrogen in aseptic filling). At any rate, it could be contaminated with anaerobial bacteria, but your laboratory of analisys should have the infrastructure to allow the cultivation of this kind of bacteria or you wouldnt even notice it.

Dear sir

Pls provide IQ,OQ AND PQ of the nitrogen distribution system(Nitrogen filter) as early as possible.

Thanks & Regards

Suresh sisodiya
Manager QA