Challenges the Pharmaceutical Industry Faces While Working with Gases

The pharmaceutical industry is reliant on gases for everything from synthesis to processing to packaging. Impurities in these gases can have disastrous implications due to the need for ultra-high purity at all levels of the pharmaceutical supply chain.

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This article will give an insight into the significance of purity in pharmaceutical gases and how Air Products' pharmaceutical-grade gases provide an easy solution.

Common Pharmaceutical Gases

Various different gases are integral to the pharmaceutical industry, the most important among them being nitrogen, oxygen, and carbon dioxide.

Nitrogen is the most often utilized inert gas (apart from air) and serves a multitude of tasks throughout the pharmaceutical manufacturing process.1 Inerting is one of nitrogen’s principal uses; it protects sensitive chemical precursors, reagents, or products from reactive oxygen and other chemical species in the air.

Nitrogen is also employed in this regard during packing where it provides an oxygen- and moisture-free environment within blister packs and vials, which protects pharmaceuticals from deterioration.

Nitrogen is also used as a pressurizing agent to check for leaks in process equipment (pipes, tanks, and vessels), to transfer fluids from storage tanks, and as a carrier gas in chromatographic analysis.

During the production of pharmaceutical molecules, oxygen is a critical reagent. To reduce the danger of combustion, oxygen is usually added in the form of “synthetic air”, which is a combination of roughly 10% oxygen with nitrogen.2

In biopharmaceutical applications, oxygen is also utilized to enrich the environment within incubators, enhancing cell culture growth rates and productivity.

For organic compound extractions, carbon dioxide is widely utilized under supercritical conditions. This method was initially created to decaffeinate coffee, but it is currently used in a variety of pharmaceutical syntheses.3, 4 Carbon dioxide can also act as an inert gas, performing some of the same functions as nitrogen.

The Importance of Purity in Pharmaceutical Gases

Purity is a metric that indicates how well users can understand a substance’s genuine identity.5 Impurities fundamentally undermine the industry’s aims in the sense that the purpose of any pharmaceutical synthesis is to generate a specific chemical. The significance of purity in the pharmaceutical industry and pharmaceutical gases cannot be overstated.

Pharmaceutical gas contaminants can have a variety of effects.

Impurities in gas chromatography carrier gases (such as oxygen and moisture) are a major bottleneck in the accuracy of chemical analyses during research, thus establishing a “noise floor” below which no detail can be observed.

Impurities in process gases (nitrogen, carbon dioxide), solvents (supercritical carbon dioxide), and reagent gases (oxygen) have the potential to react chemically with precursors and products throughout the synthesis process. These haphazard undesired reactions can reduce yields, create toxic compounds, and jeopardize the synthesis’s integrity.

Eventually, following synthesis, the presence of undesired moisture or oxygen in pharmaceutical packaging can significantly diminish the shelf-life of drugs, subsequently rendering them unfit for use.6

As a result, materials for clinical use must be thoroughly characterized and fulfill the purity criteria set out by international pharmacopoeial and regulatory frameworks.

Pharmaceutical-grade gases from Air Products are designed to meet and surpass these specifications, ensuring solid performance in both analytical and research applications.

The pharmaceutical-grade gases by Air Products meet the standards of European directives 2001/83/EC and 2001/82/EC, as revised by Directives 2004/27/EC and 2004/28/EC, which govern the usage and quality of Active Product Ingredients (API).

These gases eliminate the need for expensive onsite filtering and moisture removal, and they can be utilized in any pharmaceutical application with total confidence.

Air Products BIP® gases have built-in filtering technology to give the lowest possible levels of essential contaminants for the most demanding pharmaceutical applications. Impurity levels in BIP® gases are as low as 10 ppb total hydrocarbons, 10 ppb oxygen, and 20 ppb moisture.

In all pharmaceutical applications, Air Products gases minimize ambiguity and assure consistent performance. Get in touch with a member of the team to find out more.

References and Further Reading

  1. Sandle, T. Microbiological Assessment of Compressed Gases in Pharmaceutical Facilities. Journal of Validation Technology 21, 1–8 (2015).
  2. Hone, C. A., Roberge, D. M. & Kappe, C. O. The Use of Molecular Oxygen in Pharmaceutical Manufacturing: Is Flow the Way to Go? ChemSusChem 10, 32–41 (2017).
  3. Kaiser, C. S., Römpp, H. & Schmidt, P. C. Pharmaceutical applications of supercritical carbon dioxide. Pharmazie 56, 907–926 (2001).
  4. Kitada, K. et al. Supercritical CO2 extraction of pigment components with pharmaceutical importance from Chlorella vulgaris. J. Chem. Technol. Biotechnol. 84, 657–661 (2009).
  5. Pauli, G. F. et al. Importance of Purity Evaluation and the Potential of Quantitative 1H NMR as a Purity Assay. J. Med. Chem. 57, 9220–9231 (2014).
  6. Hunt, D. G. Moisture Permeation of Pharmaceutical Packaging. (2013).

This information has been sourced, reviewed and adapted from materials provided by Air Products PLC.

For more information on this source, please visit Air Products PLC.


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