| Usage: | Nitrogen |
|---|---|
| Purpose: | Gas Manufacturing |
| Parts: | Gas Tank |
| Application Fields: | Food |
| Noise Level: | Low |
| Machine Size: | Small |
| Customization: |
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Audited Supplier Application of nitrogen generator in pharmaceutical industry
The birth of GMP is a milestone in the history of China's pharmaceutical industry, which marks the beginning of total quality management in the pharmaceutical industry. The implementation of whole-process control of drug production, the impact of human errors on drug quality, as well as drug pollution and cross-contamination to reduce to a minimum, has become a top priority for the sustainable development of pharmaceutical industry.
Nitrogen is mainly used in pharmaceutical industry for nitrogen protection in synthetic drugs, pure nitrogen isolation in biological engineering, and nitrogen filling and sealing in preparation production. Therefore, there are high requirements on nitrogen :(1) nitrogen is required to be of high purity, generally above 99.99% (non-oxygen content in national standard), and API has a slightly lower requirement on nitrogen purity; (2) Nitrogen is required to be free of dust, heat source and colony, and can be used for injection potting; (3) Nitrogen is required to maintain constant pressure supply in the production process to ensure the normal operation of production.
Application of nitrogen generator in pharmaceutical industry
With the increasing attention to drug quality and production cost, drug manufacturers are bound to strictly implement GMP at the same time, but also in tapping the potential to reduce costs, and the successful application of pharmaceutical nitrogen machine just highlights the connotation of these two points.
At present, there are three kinds of nitrogen supply methods for pharmaceutical production: cylinder nitrogen supply, liquid nitrogen gasification and pharmaceutical nitrogen making machine. The nitrogen supplied by the cylinder is of low purity (generally 99.5%-99.9%) and contains harmful impurities such as microorganisms and pyrogens, which cannot ensure the requirements of GMP validation for nitrogen. Sterile products are required to be dust-free, microbe - free and pyrogen-free, which is difficult to guarantee for nitrogen supply in cylinders. Nitrogen has the highest cost, requires more labor and storage for slightly larger applications, and is very inconvenient to use. The purity of liquid nitrogen can meet the requirements of the process, but in the process of packaging or transportation, due to the pollution of equipment, accessories, materials and other factors, the purity is easily reduced. At the same time, it is difficult to meet the confirmation of installation, cleaning and disinfection in the pipeline and the replacement of storage tanks, and there are defects in the microbe, heat source and other items that cannot verify nitrogen. Therefore, the purity and dust content of liquid nitrogen is also difficult to ensure the requirements of GMP validation. Nitrogen is expensive.
Pharmaceutical nitrogen machine includes three systems: compressed air purification system, nitrogen system and nitrogen dust removal, odor removal, sterilization purification system. Nitrogen making host adopts low carbon austenitic stainless steel container pipe and closed shell as well as advanced and perfect nitrogen making technology and unique and simple structure design; Nitrogen purification filter group includes high efficiency dust removal filter, high efficiency odor removal filter, high efficiency bacteria removal filter. The product nitrogen can be treated to dry (dew point -45ºC), oil free (oil content &, odorless sterile,100% bacteria and phage filtered. Meet the requirements of GMP and the actual production of drugs, can produce medical nitrogen under the verification of inspection. ; 0.001 PPM), filtration accuracy 0.01
The annual cost of nitrogen supply in the three ways was calculated based on 5m3/h: the cost of nitrogen supply in the pharmaceutical nitrogen making machine was 68% of that in the liquid nitrogen supply, and 37% of that in the steel cylinder. No matter from the control of production process and strict implementation of GMP, or to reduce production costs, the use of pharmaceutical nitrogen machine for nitrogen is a reasonable choice for pharmaceutical industry.
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