Pharmaceutical is a very diverse industry. Hence, Nitrogen gas finds use in many different processes and applications, starting from basic raw material preparation, all the way to final product packaging.
Nitrogen has almost inert gas like properties and it is difficult for Nitrogen to react with other elements easily. Nitrogen is abundantly available. This abundance and ability to separate nitrogen from other gases easily using PSA Nitrogen process and cryogenic separation process, means that Nitrogen is a relatively cheap gas to produce in large quantities at high purity levels. (See How a nitrogen generator works)
In the pharmaceutical industry, raw materials such as APIs, inactive ingredients and other chemicals, that may be sensitive to oxygen need to be kept in an inert atmosphere to prevent exposure to oxygen and subsequent spoilage that result from oxidation.
During storage and movement of such oxygen-sensitive materials through processing, Nitrogen is used as purging gas. Nitrogen is often used in the transferring of pharmaceutical products. The use of a safe, inert gas to transfer liquid or powder pharmaceutical materials is necessary, as these materials can be hazardous if improperly handled.
During production of sterile pharmaceutical products, atmospheric contamination needs to be avoided. In such cases, positive pressure is created with Nitrogen. Positive pressure creation prevents ingress of air, thereby eliminating risk of contamination.
Nitrogen is often used in the packaging of medical supplies to help maintain sterility and cleanliness of the product.
Nitrogen is used to purge oxygen from the packaging before it is sealed, creating an environment made of high purity N2 gas, which will also help preserve and protect the product during transport. For drug products which are prone to oxidation (even by oxygen present in air) or hydrolysis (even by moisture present in air), nitrogen is used while packing. During the packing process, void space is likely to remain in the pack before sealing. Oxygen or moisture present in the air in this void space of the sealed pack, will likely degrade the drug product. To reduce the effect of oxygen or moisture, nitrogen is used to replace the air in the void space and thus increasing the stability/shelf life of the drug product.
Nitrogen is used to keep products dry and sterile, hence improving their durability. Test kits for doctors’ offices, blood supplies, specimen containers and other medical devices are some examples of items frequently packaged with N2 gas.
Blanketing with Nitrogen can also help preserve or improve the quality of the pharmaceuticals and other medical products. Blanketing with N2 gas essentially displaces the oxygen present with Nitrogen, so there is little to no chance of oxygen’s harmful side effects. Corrosion, rust, oxidation and other significant reactions can occur when oxygen is present and reacts with other materials. This can seriously alter or damage the products being handled or manufactured. In the pharmaceutical and medical industries, it is imperative that conditions for the safe handling and manufacturing of products be preserved.
Nitrogen gas also plays an essential role in fire suppression in an obviously volatile manufacturing environment. Many chemicals used in the manufacturing process are highly volatile or flammable and some may experience spontaneous combustion on exposure to air. In handling of all such chemical ingredients, Nitrogen is very effective in prevention of atmospheric exposure.