Clean Steam Equipment for Pharmaceutical Use

What Is Clean Steam?

Pharmaceutical settings need to maintain excellent standards of cleanliness for equipment, process systems, and the environment. Clean steam is a sterile, safe steam that can be used to sterilize and clean items in a cleanroom or other pharmaceutical or medical setting with strict cleanliness criteria. The industry uses clean steam—rather than standard steam—for higher levels of steam sterilization and humidification.

How Is Clean Steam Used in Pharmaceutical Settings?

Steam sterilization is a critical process in medical and pharmaceutical settings. Clean steam can be used to sterilize equipment within a controlled environment. The steam sterilization process is commonly used in the following applications:

• Biopharmaceutical manufacturing: in these settings, bacteria, animal cells, or yeasts are grown to produce consistent biopharmaceutical components. A sterile, controlled environment is crucial.
• Manufacturing sterile solutions, such as injectable and parenteral solutions, ophthalmic products, and more.

To provide sterilization, clean steam is injected into any of these three containment types:

• Piping (CIP): Steam can clean and sterilize piping that is used to transport or measure fluid components to eliminate buildup.
• Autoclaves: Equipment, devices, containers, and other components are loaded into an autoclave.
• Equipment: Some equipment and enclosed spaces are built to have clean steam pumped directly into their interior.

Benefits of Clean Steam for the Pharmaceutical Industry

Clean steam makes maintaining a clean, sterile environment simple. By controlling the temperature and composition of the steam, facilities can sterilize a multitude of goods that need a consistent, no-contact clean but which may have edges, complex geometries, and small interiors that make traditional sterilization processes impossible. Some of the key benefits of using clean steam in the pharmaceutical industry include:

Reduced Corrosion Potential

Traditional cleaning processes can increase the risk of corrosion in metal parts because liquids can get trapped or process buildup may linger. Traditional utility steam by itself is known to cause corrosion, so it must be paired with corrosion-inhibiting additives. Clean steam avoids this risk, allowing sensitive equipment to operate with less risk of corrosion — resulting in higher-purity products and lower operating costs, since the machinery has a longer lifespan.

Prevention of Microbial Growth

Clean steam is a high-temperature steam that can kill organic pathogens and microorganisms that would otherwise put pharmaceutical processes at risk of contamination. Clean steam generators are built to eliminate the buildup of condensation where dangerous contaminants can linger.

Preventing Entry of Contaminants

Clean steam is sterile at the point of vaporization, but traditional steam generators and tools have multiple vulnerable points where chemical and biological contamination can enter the steam. Clean steam equipment is built to keep the steam pure throughout the entire sterilization process.

Clean Steam Units from Electro-Steam

Electro-Steam Generator Corp. is an American-made OEM manufacturer that has produced high-quality electric clean steam generators since 1952. From our compact “bench top” LG-Series to our larger, more powerful LB-Series — or any custom unit — our clean steam generators are designed to suit any application. Our units are 316L stainless steel on all wetted surfaces, with most models also available as indirect steam-to-steam units for facilities that already have utility steam in place.

All Electro-Steam generators feature adjustable pressure controls, safety valves, and automatic low-water cutoffs. Integral units have stainless steel electrical boxes, and stand-alone models have complete stainless steel cabinets. Contact us today to learn more about our offerings and discuss your clean steam needs.

Added benefits include:

• Built by an ASME Certificate holder in accordance with ASME BPVC Section I – Rules for Construction of Power Boilers (“ASME BPVC Section I”). Compliant with the requirements outlined in The National Board Synopsis of Boiler and Pressure Vessel Laws, Rules and Regulations (NB-370) Rules for Construction and Stamping section, which for many jurisdictions include but are not limited to ASME BPVC Section I, ASME CSD-1, ASME B31.1, and registration with the National Board
• UL and cUL (Canada) listed
• 99% efficient, resulting in energy and water conservation
• Low or high pressure steam in less than 15 minutes, or on demand
• A one-year warranty on all parts and a five-year warranty on the chamber

To learn more about our clean steam units or to request a quote, see the recommended models below.

Recommended Models for Pharmaceutical Applications

	Series	Available Sizes	Pressure Range
	S.S. LG-Series	10, 15, 20, 25, 30, or 40 kW	0–100 PSI
	S.S. LB-Series	40, 50, 60, 80, or 100, 120, 150, 180, or 240 kW	0–100 PSI
	V-Block Series	10, 15, 20, 25, 30, or 40 kW	0–100 PSI
	Indirect Clean Steam Generator	Sized to your existing house steam supply	Varies by facility