How to prepare sterile medical clean gas?

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In the medical field, maintaining a sterile environment is critical to ensuring patient safety and preventing the spread of infection. One of the key aspects is the preparation of sterile medical clean gases for use in various medical procedures and equipment. The process combines process filtration and sterilization technology to remove contaminants and ensure the gas meets necessary purity standards.

Sterility is critical because if trapped bacteria are present, they may colonize the surface of the filter media and begin growing or migrating within the media, contaminating the process and final product.

In this article, we will explore the step-by-step process for preparing sterile medical clean gases and the importance of effective filtration in maintaining a sterile medical environment.

Why must the gases used in the biopharmaceutical and medical industries be sterile?

In the realm of pharmaceutical manufacturing, the stringent demand for uncompromising purity and sterility of compressed air and fluids is paramount. The quality and safety of pharmaceutical products are held to the highest standards, necessitating a controlled and pristine production environment.

Microorganisms present a formidable challenge, potentially compromising the efficacy and safety of pharmaceuticals. Hence, ensuring the integrity of pharmaceutical products and aligning with regulatory mandates is of utmost importance. To achieve this, rigorous measures are implemented to guarantee the sterility and exceptional purity of all liquids and gases utilized in the manufacturing process.

In response to this need, advanced sterilization filtration techniques are employed. These techniques employ specialized filters, including sterilization-grade filters, which are designed to remove or inactivate microorganisms. The filters are crafted from materials capable of withstanding various sterilization methods without compromising their performance.

This commitment to ensuring the purity and sterility of compressed air and fluids underlines the pharmaceutical industry’s dedication to producing safe and effective medications, upholding the highest standards of quality, and safeguarding the health and well-being of patients worldwide.

What is Sterilization Filtration?

In process filtration applications, “sterility” is a fundamental concept, denoting the complete absence of live bacteria or any other microorganisms within the filter media.

This concept is pervasive in industries like food, beverage, and pharmaceuticals, where maintaining sterility is of paramount importance. The reason for its criticality lies in the potential consequences of the presence of trapped bacteria. These microorganisms could colonize the surface of the filtration media, initiating growth and migration through the media, thereby contaminating the entire process and the final product.

To ensure sterility, a specific process is implemented, involving the passage of liquids or gases through a sterilization filter meticulously designed for the purpose of capturing and eliminating microorganisms. Sterilization filters are constructed from materials carefully chosen for their ability to withstand rigorous sterilization techniques, such as exposure to heat or chemical agents, all without compromising their structural integrity.

The dedication to maintaining sterility in these industries reflects a commitment to producing products of the highest quality and safety standards. The deployment of Sterilization Filters is a cornerstone in ensuring that the production processes remain free from microbial contamination, safeguarding the integrity of the final product and assuring consumers that the utmost care has been taken to meet stringent purity and sterility requirements.

Sterilization of medical compressed air

Air filtration sterilization is currently the most commonly used method of air sterilization in the fermentation industry, which uses filtration media to intercept fine dust and microorganisms, to be in the pharmaceutical industry for gas exchange when the gas sterilization filtration, to ensure that the gas through the respirator and the outside world isolation, smooth discharge, and outside the tank microorganisms and particles will not enter the tank, so as to achieve the purpose of sterilization.

At the same time, it also uses physical retention method to remove bacteria from liquid or air to achieve the purpose of sterility. Mainly used for serum, antibiotics and other heat-resistant biological products and air sterilization.

According to the different mechanisms of sterilization, it is divided into absolute filtration sterilization and relative filtration sterilization. The so-called absolute filtration sterilization refers to the pore size of the filtration medium is smaller than the particle size of the filtered dust and microorganisms, etc. When the air passes through this kind of medium, the dust and microorganisms are retained on the medium so as to realize the sterilization method.

To maintain cartridge performance and extend their life, a pre-filter is usually installed on the inlet side of the sterile filter to remove large particles and reduce the load on the cartridge. After the pre-filter treatment, the actual sterilization and filtration part of the process takes place.

We often use PTFE Membrane Pleated Cartridges. The excellent chemical compatibility of PTFE membranes makes them suitable for sterilization and filtration of strong solvents, corrosive liquids and oxidizing liquids, and they are highly efficient at trapping microorganisms and particles while allowing pure gases to pass through.

GasFlow EPTF Filters and Stery PTF Filters are designed to remove more than 99.99998% of bacteria-sized contaminants. They effectively remove bacteria from compressed air and are supplied with Stainless Steel Filter Housings. The stainless steel filter housings can be electrolytically polished to ensure a high degree of finish throughout the filter and are designed to protect compressed air systems that require sterile air.


In the pharmaceutical and medical fields, the need to maintain sterility has become even more important. The need for pure compressed air and fluids is not just a preference, it is a strict requirement. It is an aspect that cannot be ignored, as the efficacy and safety of pharmaceutical products is of paramount importance and has a direct impact on the health of the patient.

Sterility is key, and sterile filtration is the very embodiment of sterility. This method relies on specially designed filters to precisely remove microbial contaminants, ensuring the quality of the product that ultimately reaches the patient.

In pursuit of uncompromising standards, we invite you to contact us today. Sanitek’s expertise in sterile filtration can help you not only achieve efficient microbial removal, but more importantly, create and maintain sterile pharmaceutical and medical environments.

Your commitment to quality and safety resonates with us, and we stand ready to be your partner in this critical area. Contact us today to ensure that your pharmaceutical and medical processes meet the highest standards of sterility and purity, ultimately safeguarding patient health and improving the quality of care.

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