Steam is often used to remove harmful bacteria from products and equipment. However, manufacturing companies have found that steam isn’t always effective. Manufacturers use different methods to sterilize the tools, including electron beams, ethylene oxide, and gamma irradiation. These forms of sterilization are common in the industry and known for their effective results.

What Sterilization Methods Are Used in Medical Device Manufacturing?

1. Electron Beam Sterilization (E-beam)

E-beam irradiation leaves behind no residual chemicals, making it environmentally-friendly.

The process involves using electrical currents to produce high energy electrons. The electrons are then accelerated to nearly the speed of light. Since the E-beam treatment is fast, the sterilization process completes in only a few minutes.

2. Ethylene Oxide Sterilization (EtO)

Gases are also used by manufacturing companies.

Some medical tools, like endoscopes, need to be disinfected but are sensitive to heat and moisture. Manufacturers use EtO sterilization on these products.

During EtO, temperatures range from 25°C to 55°C, keeping the temperature low. Due to the lower temperatures, the sterilization process is longer.

EtO is highly effective against even the most resistant microorganisms. Their chambers are very large, sterilizing high volumes of equipment at once.

Typically, the process has three steps.

The first step is preconditioning, which establishes and maintains the temperature and chamber pressure. Since EtO gas is only effective in humid environments, the chamber’s humidity is raised through steam or hot water. The humidity does not affect the items or equipment about to be sterilized.

In the second stage, sterilization begins. The gas joins the steam, ensuring the temperature remains balanced. The gas covers every facet of the equipment, ensuring it is disinfected.

The final step is the longest in the EtO process. The manufacturer aerates the chamber for 48 hours to evaporate the gas.

3. Gamma Irradiation Sterilization

Gamma irradiation sterilization is similar to EtO, as it doesn’t significantly increase the temperature of devices exposed to it.

Gamma irradiation kills bacteria or affects its DNA, making it unable to reproduce.

While powerful, it does not leave behind radiation on any of the devices, making them safe to use.

For 20 years, Pacific Integrated Manufacturing Inc. in Bonita, CA, has used advanced equipment in their expansive 50,000-foot plant to create and assemble materials. This manufacturing company produces high-quality products and observes strict sterilization procedures to ensure the safety of their products. For more information on their services, including assembly kitting and material procurement, reach out to them at (619) 921-3464. Visit their website to learn more about their company.