HANGZHOU NUZHUO TECHNOLOGY GROUP CO.,LTD.

PSA one-step method nitrogen generator: It refers to the process where air, after being compressed, filtered and dried, directly enters the carbon molecular sieve (CMS) adsorption tower for nitrogen and oxygen separation. The purity of the produced nitrogen directly meets the design target (99.5%-99.999%). This is the most fundamental PSA process.

Nitrogen generation system with added purification equipment: usually refers to the two-step method. The first step is that the PSA main unit first produces nitrogen of a lower purity (such as 95%-99.5%). The second step is to conduct deep purification through additional purification equipment (such as catalytic deoxygenation + drying or membrane separation, etc.), ultimately producing ultra-high purity nitrogen (such as higher than 99.999%, while reducing the oxygen content to extremely low levels, such as <1ppm, and lowering the dew point to below -60℃).

To make a choice in the pharmaceutical industry, not just technology, comprehensive decision must be combined with quality risk and regulatory compliance.

1.Degree of the specific use of nitrogen : Non-critical/indirect contact craft: such as pneumatic sealing equipment, packaging line, such as dynamic air of purity is not high (99.5%), one-step method is economic and efficient option.

Key/direct contact craft, such as aseptic filling line on the product coverage, the reaction kettle inert protection (to prevent oxidation), the drying process of nitrogen protection, bioreactor gas supply, etc. These processes require extremely low levels of oxygen and moisture in the nitrogen to prevent the risk of product degradation, deterioration or explosion. The two-step method with purification equipment must be selected.

 2.The pharmacopoeia and GMP requirements: many pharmacopoeia is clear standards for medical nitrogen (such as oxygen content, moisture, microorganism, etc.). The User Requirements Specification of pharmaceutical enterprises sets strict internal standards, which are often far higher than what can be achieved by the one-step method. The two-step method is the most reliable way to meet these verification standards.

3.The life cycle cost and risk management: Although one-step method initial investment and operation cost is low, but if the standards for purity do not cause pollution of the batch, scrap or production disruptions, its loss far exceeds the equipment price difference. Two-step method high investment can be regarded as buying insurance, ensure the continuous, stable and the compliance of key process operation, reduce the quality risk.

In summary, the preferred system is one with purification equipment (two-step method), especially in the fields of sterile preparations, high-end apis, biopharmaceuticals, etc. This is currently the mainstream and standard configuration in the pharmaceutical industry, especially for enterprises that pursue high-quality standards and international compliance. It can provide stable and ultra-high-purity nitrogen, fundamentally eliminating process risks caused by nitrogen quality and easily coping with regulatory audits.The application scenarios of one-step method PSA are limited: it is only recommended for non-critical and non-direct contact auxiliary purposes in factories, and it must undergo strict quality risk assessment and approval. Even in these scenarios, a complete online monitoring and alarm system needs to be equipped.

If you are interested in PSA oxygen/nitrogen generator, liquid nitrogen generator, ASU plant, gas booster compressor.

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Email: Riley.Zhang@hznuzhuo.com