Medical Device Sterilization Methods

Choosing a sterilization method is one of the most important steps in developing a medical device.

Medical device sterilization methods.

A list of recognized sterilization standards appears at fda s center for devices and radiological health cdrh s web site. However since 1950 there has been an increase in medical devices and instruments made of materials e g plastics that require low temperature sterilization. At worst poor sterilization can lead to transmission of infectious diseases causing patient illness and even death. Steris applied sterilization technologies ast offers the medical device industry s most comprehensive array of contract sterilization options using gamma irradiation electron beam irradiation x ray irradiation and ethylene oxide sterilization.

While eto is a very effective sterilant cd has many benefits over eto for a variety of applications. Medical device sterilization chlorine dioxide gas clo 2 cd has been providing true sterilization similar to eto for medical devices for over 25 years. However compliance to. Firms may elect to comply with these standards.

E beam s medical sterilization methods are the most efficient and proven solutions in the industry offering many advantages over other processes such as ethylene oxide. Medical devices are sterilized in a variety of ways including using moist heat steam dry heat radiation ethylene oxide gas vaporized hydrogen peroxide and other sterilization methods for. 27 28 ethylene oxide treatment is generally carried out between 30 and 60 c 86 and 140 f with relative humidity above 30 and a gas concentration between 200. Most medical and surgical devices used in healthcare facilities are made of materials that are heat stable and therefore undergo heat primarily steam sterilization.

Sterilization by ionizing radiation primarily by cobalt 60 gamma rays or electron accelerators is a low temperature sterilization method that has been used for a number of medical products e g tissue for transplantation pharmaceuticals medical devices. Medical devices are complex so the choice of sterilization technology must take into consideration the device s design material product packaging and final packaging. Electron beam sterilization e beam sterilization is a safe effective and efficient processing technology used to sterilize a wide variety of disposable medical devices. Medical device as a manufacturer we understand your need to deliver trusted sterile medical devices to your customers and end users around the globe.