Pharmaceuticals Gases play an indispensable role in the pharmaceutical and biotechnology industries, supporting critical processes in manufacturing, storage, and research. Their precise applications demand high-purity levels to ensure product safety and efficacy. Here, we delve into the types of gases used, their roles, and the importance of stringent purity standards.
Why Gases Are Needed in Pharmaceuticals and Biotechnology
In the pharmaceutical sector, gases are essential for creating sterile environments, maintaining stability, and ensuring accurate drug formulations. Similarly, in biotechnology, gases are vital for processes like fermentation, cell culture growth, and cryopreservation.
Industrial gases are required from production to packaging of modern medicines, ensuring that quality is maintained across the product lifecycle.
Furthermore, speciality gases are needed for modern laboratory equipment employed in the development of new pharmaceuticals.
Key Gases and Their Applications
Oxygen is critical in bioreactors and cell culture processes, promoting cell growth and enhancing biochemical reactions. Oxygen enriched air is also used to feed the aerobic fermentation processes to increase yield efficiency.
Liquid oxygen can be supplied for this application, and the use of vaporizers between the storage tank and the bioreactor ensures that the oxygen is delivered to the fermentation broth at an appropriate temperature.
2. Nitrogen (N₂):
Nitrogen provides an inert atmosphere to prevent oxidation during drug manufacturing and storage. It is used for purging and blanketing applications, ensuring product longevity. Pharmaceutical grade Nitrogen is used in blister packs to prevent the oxidation of medicines.
Recovery of solvents used in biotechnology (e.g. in fermentation broths) can be achieved quite efficiently using liquid nitrogen in cryogenic processes. This results in less wastage of expensive processing agents and reduces potentially harmful emissions to the ambient air
3. Carbon Dioxide (CO₂):
Carbon dioxide helps regulate pH levels in cell cultures and is a key component in cryopreservation of biological samples, ensuring the stability of sensitive compounds.
4. Helium (He):
Known for its inert properties, helium is crucial in cryogenics, such as cooling MRI systems, and in research for maintaining sample integrity under low temperatures. A common device for pharmaceutical research-the nuclear magnetic resonance spectrometer (NMR) requires liquid helium to activate its superconducting magnet that is the source of the energy field used to form spectral images of the compounds to be analysed.
5. Hydrogen (H₂):
Hydrogen is used in analytical instruments like gas chromatography for precise measurement and analysis of compounds.
6. Argon (Ar):
Argon is utilized to protect sensitive pharmaceuticals and biotechnology products from contamination and oxidation during production and storage.
A range of specialty gases such as high purity Nitrogen and Helium are utilized in sophisticated lab instrumentation used to detect fake medicines.
Purity Standards for Gases
Pharmaceutical and biotech applications demand ultra-high-purity gases, typically 99.999% or higher, to avoid contamination and ensure process reliability. Impurities in gases can compromise product quality, alter research outcomes, and even pose health risks. Regulatory standards such as ISO, FDA, and GMP outline the acceptable purity levels for different applications, ensuring consistent safety and efficacy.
Conclusion
From ensuring safe drug production to advancing cutting-edge biotechnological research, gases are the unseen heroes of the pharmaceutical and biotech industries. Their diverse applications, coupled with stringent purity requirements, make them indispensable to modern science. OxyMed understands the unique requirements of the pharmaceutical and biotechnology sectors. With a focus on delivering ultra-pure gases and customized solutions, we help businesses achieve operational excellence.
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