Nitrogen Generators for the Pharmaceutical Industry: Importance, Applications, and Benefits

Every industry has its dangers, and the pharmaceutical industry is not exempted. Operations in the pharmaceutical industry can be susceptible to product contamination. While we all agree that maintaining health and safety can be difficult, the pharmaceutical industry is highly regulated and must meet strict standards to ensure the safety and efficacy of its products.

Nitrogen, a dry, inert gas that can be rendered sterile is vital in providing a safe environment for operations in the pharmaceutical industry. Some of this industry’s applications include nitrogen purging, nitrogen product transfer, nitrogen sparging and nitrogen blanketing.

One way to supply high-purity nitrogen gas for these operations is with onsite nitrogen generating systems. Read on to learn more about the benefits and uses of nitrogen generators for the pharmaceutical industry.

Nitrogen Generating Systems in the Pharmaceutical Industry

Pharmaceutical industries that shifted from purchasing their nitrogen gas from conventional industrial gas vendors to producing their nitrogen gas onsite using nitrogen generators were able to save up to 80% on nitrogen gas costs when compared to the cost of purchasing liquid nitrogen. For an industry that relies on high purity nitrogen gas for many of its operations, it is only wise to consider onsite nitrogen gas generation to get the required nitrogen purity level for each operation whenever needed.

Nitrogen generating systems also eliminate the need to store empty and full nitrogen cylinders or dewars, thereby freeing up valuable space within the facility.

Uses of Nitrogen Gas in the Pharmaceutical Industry

Below are some of the top uses for nitrogen gas in the pharmaceutical industry:

• Blanketing: When nitrogen gas is used to displace oxygen in ambient air and create an inert atmosphere, the process is called nitrogen blanketing. It helps to prevent oxidation and moisture contamination of pharmaceutical ingredients used during manufacturing. If volatile or flammable materials are used it will also mitigate the risk of accidental fire or explosion.
• Purging: Nitrogen purging is a technique used to remove unwanted gases or impurities from pharmaceutical equipment or containers. When nitrogen gas is introduced to the container, it flushes out any residual oxygen, moisture, or volatile compounds and ensures the product is well protected during transportation.
• Product Transfer: Nitrogen gas is often used during the transfer of pharmaceutical products between containers. This is important because during such transfers some pharmaceutical ingredients can catch fire or explode if exposed to oxygen or moisture. Nitrogen creates a safe, dry and inert atmosphere within the receiving vessel to prevent this from happening.
• Prevention of oxidation and contamination: Many pharmaceutical compounds and formulations are susceptible to degradation when exposed to oxygen or moisture contamination. Oxidation can damage products and reduce their shelf life. Nitrogen gas helps create an inert environment, minimizing the risk of contamination.

Benefits of Onsite Nitrogen Generators for the Pharmaceutical Industry

• Reduced nitrogen costs: Nitrogen gas generators can help save up to 80% of the cost spent on recurring cylinder, dewar or liquid nitrogen costs. Typical ROI on a nitrogen generator is less than 2 years.
• Safety and convenience: Onsite nitrogen gas generators eliminate the need for handling and switching high pressure nitrogen gas cylinders or liquid nitrogen dewars, thus lowering risks of workplace injuries.
• Reliability: Nitrogen generators provide a reliable source of high purity nitrogen gas on demand, giving access to a consistent supply of high purity nitrogen gas without worrying about delivery delays or running out of gas.
• Easy installation: Nitrogen generators have a small footprint and are easy to install.
• Increased efficiency and productivity: Onsite nitrogen generators produce nitrogen gas at the lowest cost possible at the required flow rates and purity levels. Downtime caused by waiting for cylinder deliveries or refills of liquid nitrogen tanks and purge losses associated with liquid nitrogen supply are eliminated.
• Improved product quality and shelf-life: Using nitrogen gas in the packaging of pharmaceutical products helps in preventing degradation and oxidation of the product therefore maintaining premium product quality and extending product shelf life.

Applications of Nitrogen Generators in the Pharmaceutical Industry

In the pharmaceutical industry, certain raw materials used are highly sensitive to oxygen and must be kept in an inert atmosphere to prevent oxidation and other reactions that can cause damage. Nitrogen is an inert gas which cannot react with other elements. Nitrogen generators can quickly separate nitrogen gas from compressed air and produce the needed amount of nitrogen with high levels of purity.

Nitrogen is used in the following manufacturing processes in the pharmaceutical industry:

• Tablet compression and encapsulation
• Injection molding and extrusion
• Fermentation and cell culture

Nitrogen gas is also used in chromatography and mass spectrometry, drug stability testing and tissue preservation to facilitate accurate and precise analysis of pharmaceutical compounds, enhance stability of the samples being tested and prevent undesired reactions or degradation of pharmaceutical products.

Choosing the Right Nitrogen Generator for the Pharmaceutical Industry

There are important factors to consider when choosing a nitrogen generator for the pharmaceutical industry including:

• Gas purity and flow rate requirements: The nitrogen purity level and flow rate requirements are important factors to understand in ensuring the right nitrogen generator is chosen for the application.
• Space and installation requirements: Another important factor to consider when installing a nitrogen generator is the space requirement. Checking for a perfect space within your facility to house the equipment is crucial.
• Maintenance and service requirements: PSA generators require minimally more maintenance and service but can efficiently produce higher nitrogen purity levels. On the other hand, membrane generators typically have lower maintenance requirements but have limitations in terms of nitrogen purity and flow rate capabilities. Membrane nitrogen generators do have greater flexibility in adjusting nitrogen purity.

Nitrogen Generators Suitable for the Pharmaceutical Industry

At Advanced Gas Technologies, we offer two types of nitrogen generators for the pharmaceutical industry.

• PSA nitrogen generators: PSA nitrogen generators use carbon molecular sieve (CMS) packed inside two pressure vessels to separate oxygen and other gases from compressed air. The CMS adsorbs the smaller molecules like oxygen, allowing nitrogen gas to pass through to the process point of use.
• Membrane nitrogen generators: Membrane nitrogen generators extract nitrogen from the air by using a semipermeable membrane. As compressed air passes through these membranes, nitrogen gas stays within the membranes and is collected, while the other gases in ambient air like oxygen permeate out of the membrane and dissipate back to atmosphere.

Choose Advanced Gas Technologies

At Advanced Gas Technologies, we supply high-quality nitrogen generators for the pharmaceutical industry. We can assess your requirements, determine the appropriate system type, and help you select the best solution. Contact us today to learn more!