Low Temperature Sterilization Equipment- The Alternative to High Heat Methods

Low temperature sterilization is an alternative sterilization method to traditional high heat sterilization techniques like steam autoclaving. It uses various chemical or physical processes to sterilize equipment at temperatures lower than 121°C. Some common low temperature sterilization methods include hydrogen peroxide gas plasma, ethylene oxide, ozone, and liquid chemical sterilants. These methods allow heat-sensitive items to be sterilized without damage.

Hydrogen Peroxide Gas Plasma Sterilization

Hydrogen peroxide gas plasma (HPGP) sterilization uses a mixture of hydrogen peroxide vapor, plasma, and dry heat to sterilize equipment at temperatures between 45-60°C. Hydrogen peroxide gas is introduced into the sterilization chamber and a plasma is generated using radio frequency waves, which ionizes the gas. Low Temperature Sterilization Equipment reactive species are produced that kill microorganisms by damaging their cellular structures and DNA. The process takes about 1-3 hours depending on the load. It is effective against all common microbes including prions and spores. HPGP sterilization does not leave any toxic residues and the only byproduct is oxygen and water vapor, making it safe for heat-sensitive medical devices.

Ethylene Oxide Sterilization

Ethylene oxide (EtO) gas sterilization is one of the most widely used low temperature methods. It involves exposure of equipment to ethylene oxide gas at temperatures between 40-60°C for 2-8 hours depending on load and required sterility assurance level. EtO is highly efficient at sterilizing as it easily penetrates fabrics and laminated materials. It kills microbes by alkylating their nucleic acids and disrupting cellular functions. After sterilization, residues of EtO and its byproducts like ethylene chlorohydrin must be removed by thorough aeration. While fast and effective, EtO is toxic, flammable, and suspected carcinogenic requiring special processing equipment and environmental safety procedures.

Ozone Sterilization

Ozone gas (O3) is a strong oxidizing agent that has found application in sterilizing heat-sensitive medical devices. In this process, equipment is exposed to high concentrations (5000ppm) of ozone gas at temperatures of 5-55°C for 15-120 minutes. Ozone kills microbes by oxidizing their cell walls and altering biochemical reactions inside. It breaks down into oxygen immediately after sterilization cycle leaving no toxic residue. Ozone's high reactivity also makes it suitable for disinfecting enclosed spaces rapidly without the need for aeration. However, prolonged exposure to high ozone concentrations can damage some materials like natural rubber and electronics. Careful material compatibility testing is necessary before adopting this method.

Liquid Chemical Sterilants

Various chemical sterilants dissolved in liquid form such as hydrogen peroxide, peracetic acid, and glutaraldehyde are utilized for low temperature sterilization. The equipment along with the chemical sterilant is sealed in specially designed sterilization containers or chambers. Exposure times can range from 10 minutes to 6 hours depending on the concentration of the chemical and the bioburden level. Sterilants damage biological molecules inside microbes leading to their deactivation. Liquid chemical sterilization is favored for heat-sensitive endoscopes, implants, and devices with long narrow lumens that are difficult to sterilize via other means. Stringent rinsing and drying is imperative to remove any toxic residues post sterilization. Material compatibility testing also needs evaluating.

Equipment Used for Low Temperature Sterilization

Certain specialized equipment has been developed specifically for performing low temperature sterilization safely and effectively.

Hydrogen Peroxide Gas Plasma Sterilizers

Hydrogen peroxide gas plasma sterilizers like STERRAD® and STERIS V-PRO® introduce and activate hydrogen peroxide vapor through their sealed sterilization chambers to generate sterilizing plasma using RF energy. They are tabletop units suitable for sterilizing heat-sensitive medical and surgical equipment like endoscopes. Controls allow programming different cycles for varied bioburden levels.

Ethylene Oxide Sterilizers

Modular ethylene oxide sterilizers from companies like Andersen and 3M consist of several independent processing modules including an aeration unit. Equipment is loaded on carts and pushed through the sterilizer on tracks undergoing vacuum, EtO injection, sterilization exposure and finally aeration to remove any gas residues. They provide automated barrier isolation sterilization.

Ozone Sterilizers

Ozone generators coupled with sterilization chambers are used for ozone sterilization. Companies like STERIS, Amerex and Honeywell offer ozone sterilization systems with features like ozone concentration monitoring, process control and safety interlocks. Ozone destruct units immediately break down any residual ozone after sterilization.

Liquid Chemical Sterilization Equipment

This includes specialized sterilizing containers, chamber systems as well as automated endoscope reprocessors from Olympus, Medivators and Steris using liquid chemical germicides like peracetic acid or hydrogen peroxide. Various cycle parameters like temperature, concentration and exposure time are carefully calibrated based on scientific validations.

 

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