Clean Steam, also known as Pure Steam, is sterile steam used to clean and sterilize items in pharmaceutical settings as well as humidification of clean rooms where drug processing occurs.
A traditional boiler creates “dirty” steam, or Plant Steam, that contains corrosion inhibitors and other chemicals and impurities. These chemicals are necessary as that steam and condensate typically traverse black iron pipes, where with the absence of chemicals, would rust and create leaks quickly.
If this dirty plant steam is used for direct contact on processing equipment, the left over oils and residues on the the equipment can lead to unsanitary conditions and patient harm.
In contrast, a Clean Steam Generator is used create steam with minimal bioburden and minimal contamination, and at high enough quantity to be used in pharmaceutical processing.
Uses of Clean Steam
Clean steam is used in production autoclaves to sterilize glassware and other equipment. It can be injected into bioreactors and other large vessels as part of a SIP (Steam In Place) or CIP (Clean In Places) procedures. With control of the pressure and duration, the clean steam effectively sterilizes the surfaces.
Additionally, certain manufacturing processes within the Clean room may require steam for temperature control. To reduce the risk of contamination if a seal, diaphragm, or gasket failure, clean steam is sometimes used. The heat exchangers used are typically a stainless steel shell and tube heat exchanger with the steam being in the shell.
How is Clean Steam Made?
Clean Steam is made boiling high quality water to steam. The water used depends on the requirements of the end process, but is typically WFI or USP grade purified water. The idea is that it is purified and treated in a way where there isn’t condensed gases or minerals dissolved. To heat up the water, the clean steam generators use plant steam or electric depending on the manufacturer. Using natural gas and diesel is being phased out due to greener alternatives and motives.
For pharmaceutical-grade, all steel used is high quality stainless steel. The pressure vessel is typically inspected and ASME stamped.
The clean steam generator and distribution system is commonly a validated system and there are quality checks with sampling and monitoring of the clean steam to ensure the generator and system are working as it should.
and there are quality checks with sampling and monitoring of the clean steam to ensure the generator and system are working as it should.
and there are quality checks with sampling and monitoring of the clean steam to ensure the generator and system are working as it should.
Clean Steam Generator Manufacturers
Here’s a short list of some of the major producers of Clean Steam Generators:
- Spirax-Sarco – Clean Steam Generators
- Meco – Pure Steam Generators
- Electro-Steam – Point-of-use Clean Steam Generators
- Mueller – Clean Steam Generators + condenser option for WFI co-generation