Nitrogen is used to protect most compounds and active pharmaceutical ingredients from oxidation in the manufacturing process as well as in the production nitrogen is also used in the manufacturing process to provide a contaminant-free environment, nitrogen purity for pharmaceutical industry is required to be according to the application of the pharmaceutical grade nitrogen, pharmacopoeias and the quality of the product.
Dealing with a wide variety of pharmaceuticals, they require accurate nitrogen purity requirements to ensure the integrity of the products are maintained during processing, manufacturing, and storage. Nitrogen usage must be sourced to minimize oxygen content, reduce the oxidation, and establish appropriate control measures in cleaning and process control. However, a high percentage of nitrogen gas purity does not determine appropriateness.
Not all pharma processes are the same. Nitrogen purity for pharmaceutical industry is dictated by the final use, pharmacopoeial criteria, and pharmacopeial monograph. For example, the USP-NF monograph for pharmaceutical grade nitrogen has a different minimum nitrogen assay value than the European pharmacopoeia monograph, and some processes require much higher purities and close impurity control.
According to the USP-NF monograph, the minimum assay requirement for nitrogen purity 99% vol. but this does not necessarily satisfy the criteria for USP nitrogen purity standards. Nitrogen must also satisfy impurity requirements and other chemical quality requirements to ensure its appropriateness for its intended pharmaceutical application.
The European pharmacopoeia nitrogen monograph states at least 99.5% nitrog
en. In addition to the assay, suppliers must remember to take account of the requirements of impurities tests and specifications to help establish consistent gas quality for suitable pharmaceuticals.
Nitrogen gas purity levels in pharmaceutical processes can exceed the minimum requirements for the various nitrogen gas grades available, and need to be controlled. High purity nitrogen gas (such as high purity nitrogen or nitrogen purity 99.9%) can be used when oxygen sensitive processes are involved. It is also important to have control of residual oxygen, humidity and other impurities for some processes, at the levels required.
The following table talks about the technical specifications of the PSA nitrogen generator.
| Sr. No. | Model | LPM | SCFM (N2) | Nm³/hr | Air SCFM | Nm³/min |
|---|---|---|---|---|---|---|
| 1 | N2AS310 | 48 | 1.8 | 2.88 | 12.3 | 0.33 |
| 2 | N2AS312 | 64 | 2.4 | 3.84 | 16.5 | 0.44 |
| 3 | N2AS314 | 80 | 3 | 4.8 | 20.1 | 0.54 |
| 4 | N2AS316 | 125 | 4.7 | 7.52 | 32 | 0.85 |
| 5 | N2AS318 | 185 | 6.2 | 9.92 | 42.4 | 1.13 |
| 6 | N2AS320 | 224 | 8.4 | 13.44 | 57.3 | 1.53 |
| 7 | N2AS322 | 259 | 9.7 | 15.52 | 65.6 | 1.75 |
| 8 | N2AS324 | 285 | 10.7 | 17.12 | 72.9 | 1.94 |
| 9 | N2AS326 | 373 | 14 | 22.4 | 95.4 | 2.54 |
| 10 | N2AS328 | 459 | 17.2 | 27.52 | 118.7 | 3.11 |
| 11 | N2AS330 | 557 | 20.9 | 33.44 | 141.9 | 3.78 |
| 12 | N2AS332 | 613 | 23 | 36.8 | 156.5 | 4.17 |
| 13 | N2AS334 | 680 | 25.5 | 40.8 | 173.5 | 4.63 |
| 14 | N2AS336 | 920 | 34.5 | 55.2 | 234.5 | 6.25 |
| 15 | N2AS338 | 1072 | 40.2 | 64.32 | 273.6 | 7.3 |
| 16 | N2AS340 | 1285 | 48.2 | 77.12 | 327.9 | 8.74 |
| 17 | N2AS342 | 1587 | 59.5 | 95.2 | 404.4 | 10.78 |
| 18 | N2AS344 | 1859 | 69.7 | 111.52 | 474 | 12.64 |
| 19 | N2AS346 | 2144 | 80.4 | 128.64 | 548.6 | 14.58 |
| 20 | N2AS348 | 2581 | 96.8 | 154.88 | 658.4 | 17.56 |
| 21 | N2AS350 | 3184 | 119.4 | 191.04 | 812.1 | 21.68 |
| 22 | N2AS352 | 3789 | 142.1 | 227.36 | 968.2 | 25.77 |
| 23 | N2AS354 | 4258 | 159.6 | 255.36 | 1085.2 | 28.94 |
| 24 | N2AS358 | 5197 | 194.9 | 311.84 | 1325.4 | 35.34 |
Nitrogen gas for pharmaceutical manufacturing quality determines the right conditions, especially where contact with oxygen and cross-contamination could influence product characteristics.
Nitrogen blanketing can be added to tanks, vessels and process equipment to expel the pharmaceutical from contact with the surrounding air. This not only prevents oxidation but also helps to maintain product stability. The quality of pharmaceutical nitrogen gas is determined by the material being handled, the residual oxygen levels allowable and the blanketing system in operation.
Nitrogen purging purges oxygen and other damaging gases from piping, vessels and equipment prior to production and storage. Factory supplied liquid high purity nitrogen may be used where complete or near complete absence of impurity contamination is desired. Reduce the risk of impurity contamination at the point of use.
Did You Know?
Nitrogen makes up approximately 78% of Earth's atmosphere. Despite its natural abundance, pharmaceutical manufacturing requires carefully controlled nitrogen purity because even small amounts of oxygen or moisture can affect sensitive products and manufacturing processes.
Nitrogen purity testing is about finding out the amount of nitrogen and testing the applicable impurity specifications. Nitrogen purity determination can be assisted using oxygen analysers to measure residual oxygen and moisture analysers or other appropriate methods to quantify additional contaminants. Adequate frequency, qualification of the testing method, sample representative and calibration of analysers, documentation of results and quality control parameters are important aspects of nitrogen purity monitoring.
Here are some of the major factors affecting nitrogen purity are:
All this can impact the final gas quality. Contamination can be introduced via storage vessels, delivery piping and poorly maintained connections so it is essential that the PSA nitrogen generator is selected, operated and maintained in line with purity, flow rate and impurity specifications required.
Case Study: Sustaining Nitrogen Purity in Pharmaceutical Processing
Challenge: A pharmaceutical manufacturing facility employs a nitrogen source to the equipment which covers the storage tanks and for oxygen production processes. Fluctuations in the nitrogen purity or additional oxygen or moisture can influence the processes and the products.
Solution: The purity, volume and operating conditions of the on-site PSA plant are kept in check and monitored in operation to meet the stipulated quality of nitrogen.
Outcome: A properly designed and monitored nitrogen generation system allows the facility to have better control of its nitrogen supply, lessen reliance on external gas supplies, and support the continuous production process.
Airox Technologies is a PSA nitrogen generator Manufacturers in India their solutions are used by many industries which need a controlled supply of nitrogen. PSA nitrogen generator systems can be designed based on the purity and capacity requirements for specific applications. Airox Technologies provides on-site nitrogen generation, engineering, service support, and helps businesses determine the right nitrogen supply arrangements. Pharmaceutical manufacturers can learn more about our systems to see how they are configured and operated.
There are two factors to consider when choosing the right nitrogen purity for pharmaceutical industry applications:
To determine the ideal generation system to meet your physical and biochemical process requirements, manufacturers should compare the impurities limits to the pharmacopoeial specifications, as well as the process sensitivity to point of use gas quality.
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Contact or visit Airox Technologies to learn more about the ideal PSA nitrogen generator configuration for your business needs. |
How pure must nitrogen purity 99.9%? No. The purity required can change depending on the use, standard, impurity limitation, and production process demands.
USP nitrogen requires a minimum nitrogen assay of 99.0%, with 99.5% specified in the relevant European pharmacopoeia nitrogen monograph (which include other specifications).
Yes, conditionally. A PSA nitrogen generator for pharmaceutical industry applications is validated for quality of gas produced, according to the requirements of impurity separation and control, and applications monitoring.
Residual oxygen can be validated using oxygen monitoring to prevent unwanted oxidation and retention of the set quality of gases during pharmaceutical manufacturing.
In accordance with the process risk, regulatory requirements, process validation and quality-control processes, continuous monitoring may be used for a critical process.
Yes. PSA nitrogen can be generated by Airox Technologies as required by nitrogen purity, capacity and application.
