When is ethylene oxide used

Alkylation is a chemical reaction where a hydrogen atom is replaced with a hydroxyethyl radical. This process causes the amino acids that are found in proteins to change their shape.

These proteins typically penetrate the cell membrane, forming a channel between the interior of the cell and the outside of the cell. When these proteins change their shape, it causes a breach in the cell membrane, killing lysing the microorganism. Adersen Products is standing by to answer your product or service questions. This service is available on working days between am and pm UK time.

We aim to respond within 5 minutes. Therefore, a wide variation of materials, particularly polymeric components commonly used in medical devices, can be sterilized with EO. Products can be sterilized in their final packaging, since EO will permeate the sealed films and cartons used to package the device. Standards: ISO , Sterilization of health care products — Ethylene oxide — Requirements for development, validation, and routine control of a sterilization process for medical devices.

Ethylene Oxide Support Services: In addition to ethylene oxide sterilization, STERIS AST provides our Customers with laboratory testing and technical support at every stage of the sterilization design process, from cycle development through routine processing. Testing and Validation Services Our laboratory testing and product and packaging testing services provide Customers with validation support and microbial testing, ensuring medical devices processed with EO perform as expected for the life of the product, and packaging maintains the sterility of the device until its point of use.

Ethylene Oxide Overview. Ethylene Oxide Summary. Technology Variables. Product Considerations. Possible Effects line. Exposure Time line. The US Environmental Protection Agency EPA reviews and enforces the Clean Air Act regulations for sterilization facilities that emit ethylene oxide to ensure that they protect the public from significant risk.

The FDA is actively working with sterilization experts, medical device manufacturers, and other government agencies to advance innovative ways to sterilize medical devices with lower levels of currently used agents, and employ new agents or alternatives, while maintaining device safety and effectiveness.

On July 15, , the FDA announced two public innovation challenges to encourage development of novel sterilization methods, which could include new devices or new modalities that are safe and effective for sterilizing medical devices:. On November 25, , the FDA announced that 46 applications were received and 12 participants selected for the challenges.

Refer to each challenge page for details on the selected participants and next steps. Meeting materials are available on the Advisory Committee Meeting Announcement page. One recommendation from the advisory committee meeting is for device manufacturers to begin, as soon as possible, reducing the amount of paper such as the labeling and instructions for use manuals that is included in the sterile device package.

An ethylene oxide sterilized medical device must be sealed in a carefully designed gas-permeable package that enables the ethylene oxide gas to enter. When the sterilization load encompassing all the materials inserted into the sterilizer chamber with the device includes a large amount of paper with the device, it hinders the ethylene oxide getting to the device and generally means that more ethylene oxide is required.

Because of this, the FDA is encouraging device manufacturers to move to electronic materials where feasible and safe for device users. Manufacturers also share best practices for responsibly producing, shipping, and handling ethylene oxide. Ethylene oxide is most commonly used in the production of other chemicals including the production of solvents, antifreeze, detergents, adhesives, polyurethane foam and pharmaceuticals.

A small but important use of ethylene oxide is the sterilization of surgical and medical equipment, including the sterilization of personal protective equipment. Read more about ethylene oxide sterilization uses. Ethylene oxide is present in the environment and is created by various sources, including plants and the heating of cooking oils.

The human body also converts ethylene to ethylene oxide. Exposure to ethylene oxide varies across urban, suburban and rural environments.

Ethylene oxide emissions from industrial manufacturing and other applications are strictly regulated under federal and in some cases state and local laws.

OSHA has set exposure limits for employees working in facilities where ethylene oxide gas is present. In addition, employers must provide appropriate protective clothing and equipment to employees who may be exposed to ethylene oxide. There is minimal cancer risk for the general population because most people are not exposed to significant quantities of ethylene oxide.

In fact, one comprehensive lifetime exposure study of workers in ethylene oxide production facilities found no statistically significant excess cancer risk due to ethylene oxide exposure.

The ethylene oxide assessment also includes errors in modeling historical exposures to ethylene oxide.