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General Description

Sterilization Units include steam sterilizers (i.e. autoclaves) , cold sterilizers, gaseous autoclaves, and Ultraviolet autoclaves and sterilizers.

Summary of Federal Requirements

The federal regulations applicable to hospital sterlizers (40 CFR 63, Subpart WWWWW) only apply to the operation of ethylene oxide sterilization facilities at a hospital that is an area source of hazardous air pollutant (HAP) emissions. These regulations require that ethylene oxide sterilization facilities sterilize fulll loads of items having common aeration time, except under medically necessary circumstances. A medically necessary circumstance is defined as "circumstances that a hospital central services staff, a hospital administrator, or a physician concludes, based on generally accepted medical practices, necessitate sterilizing without a full load in order to protect human health." These regulations also include recordkeeping and reporting requirements. NOTE: An area source is a stationary source of HAP emissions that is not a major source. A major source is a stationary source that emits or has the potential to emit 10 tons per year (tpy) or more of any HAP or 25 tpy or more of any combination of HAP. 40 CFR 63, Subpart O also addresses ethylene oxide emission standards for sterilization facilities, but they do not apply to ethylene oxide sterilization operations at stationary sources such as hospitals, doctors offices, clinics, or other facilities whose primary purpose is to provide medical services to humans or animals. For other types of sterilizers, their emissions from vents, waste chemicals, and cleaning solutions used may be regulated under air permits, wastewater pre-treatment requirements, or hazardous waste regulations.

Both dry heat and steam heat autoclaves are available. Steam autoclaves are far more common, using heated, vaporized water to kill pathogens. Dry heat autoclaves use dry heat to sterilize instruments. They are used in cases where heating is the preferred method of pathogen destruction, but moisture could damage the inserted instruments, either through immediate contact or rust generation.

Chemical sterilizers (i.e., cold sterilizers and vapor) are used in situations where heating could damage sensitive instrumentation, including plastic and rubber devices, fiber optics, etc. They do require external venting systems to remove the chemical agents from the sterilizer. These fans or drain systems may be integral to the device, although some models can be connected into existing exhaust systems.

Cold sterilization autoclaves use a cold sterilization liquid to sterilize the contents. Liquids such as Peracetic acid, Formaldehyde, Propylene oxide, Hydrogen peroxide, Chlorine dioxide, and Glutaraldehyde are used. Cold sterilants and disinfectants such as glutaraldehyde, or "gluts," are pesticides and may be toxic at very low concentrations.

Vapor Sterilizers have often used ethylene oxide gas in the past. Now, many medical facilities are switching to the less dangerous ozone or vapor phase hydrogen peroxide methods of vapor sterilization.

If it is necessary to dispose of small quantities of chemicals used in sterilization tasks, contact your local POTW to see if the sewage treatment system can handle the amount you have. If not, these chemicals must be disposed of as hazardous waste. Ethylene Oxide is classified by EPA as a probable human carcinogen; also a smog forming agent, and explosive/flammability hazard.

Ultraviolet autoclaves and sterilizers produce UV light exerting a lethal effect on unwanted disease causing organisms. They can destroy pathogens, bacteria, mold spores, yeast, protozoa, fungi and algae.

Plasma sterilizers using a mixed chemical plasma device using peracetic acid or Hydrogen peroxide plasma may also be used.

Summary of State Requirements

Many states have promulgated regulations on how sterilizers must be operated and the records which are required to be kept.

California Air Resources Board has adopted a policy to stringently control the amount of ethylene oxide released from sterilization activities. California requires a control efficiency of at least 99%. See the Board's Final Regulation Order for more information.

States may also specifically regulate the ash residue from the burning of hospital/medical/infectious waste.

Laws and Statutes

Clean Air Act
Clean Water Act
Resource Conservation and Recovery Act

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Regulatory Sources
40 CFR 63.10382 through 63.10448
National Emission Standards for Hazardous Air Pollutants for Source Categories, Subpart WWWWW: National Emission Standards for Hospital Ethylene Oxide Sterilizers
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Last Updated: July 05, 2017