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Sterilization is an essential part of the medical device manufacturing process. These materials are often used in surgeries or other medical procedures, so sterilizing them is vital for the safety of the patient. There are different methods to suit specific materials and types of devices. Here are a few of the most popular. 

How to Sterilize Medical Devices

1. Steam

Steam sterilization involves exposing a device to vaporized water. The high temperatures kill most bacteria and viruses, since these microorganisms can only survive within a specific temperature range, usually up to 145 degrees Fahrenheit. For this method to be effective, the materials need to be stable in heat and moisture. 

2. Dry Heat

medical device manufacturing

For medical devices that can handle heat but not moisture, dry heat offers an alternative. This method involves heating air with low moisture content, usually with a hot air oven. The process generally takes longer, since it is more difficult to heat air without moisture, but it can also kill more germs due to the higher temperatures used. 

3. Radiation

Radiation sterilization involves exposing medical devices to gamma rays, electron beams, or X-rays. These rays penetrate a variety of materials and kill most microorganisms. This method does not leave any radiation behind, so it is safe and efficient. It is best suited for devices that are sensitive to heat or those with complicated components that steam or heat may have trouble reaching. 

4. Ethylene Oxide

Ethylene oxide is a chemical compound that kills microorganisms. It is generally used in gaseous form to reach all exposed parts of devices, and it is often used on devices that cannot be exposed to high temperatures or moisture. However, this gas is toxic, so it can only be used in a sealed chamber. 

 

If you need medical device manufacturing services, contact Pacific Integrated Manufacturing in Bonita, CA. The company has a 50,000-square-foot manufacturing plant with state-of-the-art equipment to manage every step of the process, including manufacturing, packaging, and sterilization management. Visit the website for a full selection of medical device manufacturing services, or call (619) 921-3464 to request a consultation. 

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