Table of Content
Heya!!! My dear folks. It’s yet another day on earth, and you may think this is yet another blog on the web. But let me tell you, it is not what you think! This short blog is a quick summary of applications of Pure Steam in Biotechnology.
Right from the basics of Pure Steam to its applications, this blog has everything you need. What’s more? We also tried to answer some FAQs at the end of the blog.
Keep Reading, and Keep Learning!
What is Pure Steam?
Unlike conventional steam, pure steam undergoes rigorous processes to eliminate impurities, contaminants, and non-condensable gases. The source water is often treated to ensure the water is free from any impurities. Distilled or RO water is primarily heated above 100℃ for the phase transition from water to vapour. As a result, the steam generated is pristine and sterile, just as required for critical processes. This steam only has water in vapour form and complies with regulatory standards.
TSA has been serving pharma and biotech companies for more than 20+ years. The Pure Steam Generator is a one-of-its-kind system that surpasses all steam quality tests and delivers enhanced performance and energy savings. When working with TSA, you don’t have to worry about product quality or compliance. The Pure Steam Generator complies with USFDA 21 CFR part 11 and GAMP 5.
Click here to check the Pure Steam Generator.
How is pure steam used in Biotechnology?
- Maintains sterility in Bioprocessing
Bioprocessing is the creation of valuable products using living matter like cells, cellular components, viruses, or even an entire organism. The products include biofuels (produced from algae), antibiotics (produced by mold) like penicillin, and beverages like Beer (produced by yeast). As bioprocesses have varied critical applications, it is evident that sterility is critical and maintained at every step of these processes.
In Bioprocesses, Pure Steam is required to maintain the aseptic conditions during the equipment sterilisation, media preparation, and other critical processes. Pure steam prevents any event of microbial contamination while ensuring the integrity of sensitive biological materials.
- Ensures Pharma Product Purity
The pharmaceutical industry is a critical player in Biotechnology that heavily relies on pure steam to guarantee product purity. Pure Steam is needed to sterilise equipment and sanitise the cleanroom, its walls, floors, and equipment to meet stringent regulatory requirements.
Besides this, pure steam is also needed for media and solution preparation, sterile manufacturing processes in CIP and SIP systems, and sterilisers and autoclaves. Pure steam safeguards the quality and efficacy of pharmaceuticals.
- Maintaining Cell Culture
Cell culture is the heart of most of the biotechnological processes. It is paramount to maintain these cell cultures and prevent any contamination or cross-contamination while handling these cultures. Pure steam is used in autoclaves to sterilise mediums and vessels and for solutions to maintain sterile environmental conditions.
- Quality Control and Regulatory Compliance
Quality Control and Regulatory compliance are of fundamental significance in the realm of biotechnology. The application of pure steam in processes guarantees the quality control and compliance of the product with regulatory standards.
Summary
And here we end the blog! Kudos to you guys to keep reading it till here. To help you more, I am adding the summary of this blog here.
As you already know, pure steam is ultra-pure and pristine in nature. This pure steam is essential in the critical biotech processes requiring sterile environments. Such methods include fermentation, bioprocessing, sterilising mediums, solutions, and cleanroom surfaces. The pure steam helps to ensure product quality and guarantees quality control and compliance with the regulatory standards.
FAQs
A: When a packed medium or vessel is placed into an autoclave, it is exposed to the pressurised steam at 121°C for a specific period. When pure steam is used for sterilisation, thermal energy from high-pressure saturated steam is used for the denaturation of DNA and to destroy the enzymes to kill microorganisms on the surface of the vessels or in the medium.
A: A CIP system refers to a Clean-in-Place system, and SIP refers to a Sterilize-in-Place System. These systems utilise pure steam to clean and sterilise the process equipment.
A: In the pharmaceutical industry, pure steam is steam generated from Distilled water or RO water to ensure the water is pure and does not have volatile additives like amines and hydrazines. This pure water makes sure the steam generated is pure as well.
