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Today, we shine a light on one of the most essential systems in the pharmaceutical world, called pure steam generators. This blog discusses the crucial workings of a pure steam generator and the reasons you need one.
But before diving deep into the discussion, let’s understand what a pure steam generator is precisely.
What is a pure steam generator?
A pure steam generator is a system/device that produces high-quality, purified steam. This steam is generated using water, which complies with the regulatory standards. It is sterile and free from impurities, minerals, particles, and chemicals. Its characteristics make it suitable for critical processes where contamination could prove detrimental.
Now that I have introduced you to Pure Steam Generators let’s discuss how it works in the section below.
How a Pure Steam Generator Works?
The distillation of purified water generates pure steam. In this section, we discuss the working of a pure steam generator.
1. Water Purification:
Since pure steam seeks its application in critical processes where ultra-high purity and sterility are significant concerns, the raw water is treated first to ensure the high-purity steam is guaranteed.
The process begins with a water purification system; reverse osmosis is usually the most reliable technique, followed by others like deionisation and distillation.
2. Heating:
This purified water is further heated in a chamber or a heat exchanger. Depending on the generator’s design, the heat source can be electricity, gas, or other methods.
3. Steam Generation:
When the water is heated, it transitions from liquid to steam. This steam is expected to be free from contaminants, like minerals and microbes, otherwise present in regular steam.
4. Separation:
This step separates the generated steam from any remaining liquid water to ensure the resulting steam is of high quality and meets the desired purity standards. Any non-condensable gases present in the water are also separated and removed. It is essential as pure steam should primarily consist of water vapour.
5. Quality Control:
Throughout the process, there are often built-in sensors and controls to monitor the quality of the steam. These sensors and controls measure parameters like pressure, temperature, and purity.
Why do you need a Pure Steam Generator?
Besides the stringent quality and safety standards required in the pharma and biotech industries, you need a pure steam generator for several other reasons. This section highlights the prime reasons to buy a pure steam generator:
1. Sterilisation:
Pure steam is required to sterilise pharmaceutical manufacturing equipment, containers, and surfaces. This sterilisation process is critical to ensure pharmaceutical products are free from microbial contamination. TSA provides a one-of-a-kind purification system that surpasses all steam quality tests and delivers enhanced performance and energy savings. Click here to know more.
2. Clean-in-Place (CIP) Systems:
Clean-in-place systems are sustainable in many pharmaceutical processes, especially biotech and aseptic manufacturing. A CIP system uses Pure steam to clean and sanitise various components and piping without disassembling the manufacturing unit.
3. Humidification:
Specific pharmaceutical processes require critical levels of humidity maintenance. Free from impurities, pure steam is used for controlled humidification to ensure product quality and consistency.
4. Injection Water for Pharmaceutical Grade Products:
Water for injection (WFI) of the highest purity is required to produce injectable pharmaceuticals. A pure steam generator is often part of the WFI generation system, providing high-purity water for pharmaceutical formulations.
Water For Injection System by TSA
5. Avoiding Product Contamination:
Regular boiler steam may contain impurities and additives unsuitable for pharmaceutical manufacturing. A pure steam generator ensures that the steam used in critical processes is free from contaminants, thereby ensuring the integrity of the final product.
6. Compliance with Regulatory Standards:
Pharmaceutical manufacturers are subjected to strict regulatory standards and Good Manufacturing Practice (GMP) guidelines. Using a pure steam generator helps companies comply with these standards, thus ensuring pharmaceutical products’ quality, safety, and efficacy.
Pure Steam Generators provided by TSA are available in various models with flow rates ranging from 50 to 1500 kgs per hour and are also compliant with USFDA 21 CFR part 11 and GAMP 5. Click here to check the product.
7. Consistent Product Quality:
A Pure Steam Generator ensures the product’s consistent quality by eliminating the risk of introducing unwanted substances during manufacturing. Product quality is essential for pharmaceutical companies to meet regulatory requirements and maintain their reputation for producing reliable and safe products.
8. Preventing Corrosion and Scaling:
Since the pure steam comes in contact with the surfaces of the equipment, it is of utmost importance to have pure steam; otherwise, the equipment is susceptible to unwanted corrosion and scaling. Any damage to the equipment compromises the integrity of pharmaceutical manufacturing processes and could be a source of contamination in the product.
Conclusion
Muchas Muchas Muchas Gracias a mis amigos y amigas! Thank you for reading this blog till the end.
In conclusion, the pure steam generator is one of the critical components in the pharma and biotech industry. This pure steam generator uses high-purity water to generate steam to ensure the steam generated is free from contamination. This water is heated above 100℃ to achieve phase transition. When the steam is produced, it is separated from the rest of the liquid and other gases to maintain its purity. Quality check is done to ensure its purity. A pure steam generator is needed for sterilisation, humidification, and CIP/SIP systems to maintain consistent quality and comply with regulatory standards.
FAQs
1. What is pure steam in the pharmaceutical industry?
A: In the pharmaceutical industry, Pure steam is generated from distilled water. This steam is free from any impurities, hence termed Pure Steam.
2. What is the function of pure steam in an autoclave?
A: Pure Steam is often required for sterilisation in the autoclave. It uses thermal energy from high-pressure saturated steam to denature DNA and destroy enzymes to kill the microbes on the surfaces of devices. Usually, a packed device is placed into the autoclave, and pressurised steam is introduced at 121°C for a specific period.
3. What are the requirements for pure steam?
A: Pure steam is essentially required to be free from contaminants and is generated when ultra-pure water, like Distilled water or RO water, is heated above 100°C.
4. What is pure steam used for?
A: Pure steam is typically used in pharmaceutical manufacturing processes, CIP/SIP systems, Clean room humidification, Injection solvent, and transfusion.
5. What is the chemical formula for steam?
A: Since pure steam is only water, its chemical formula is H2O.
