Residual Ethylene Oxide Testing

Sterilizing Disposable Medical Devices, Container Closure Systems, Pharmaceutical APIs, Herbal Products, and Spices with Ethylene Oxide (EO) is a common practice across industries commonly due to its extensive material compatibility. However, the side effect of using EO as a sterilization agent is that it may leave a residue on the devices post-sterilization.

These residues include:

• Ethylene oxide (EO): the residue post sterilization.
• Ethylene chlorohydrin (ECH): the residue that may form when EO comes into contact with free chloride ions.
• Ethylene glycol (EG): the residue that may form when EO comes into contact with water.

Several factors may impact the levels of Ethylene Oxide residuals following sterilization, such as packaging type, the material of components, sterilization cycle parameters, and load density, thus it can be difficult to ascertain whether a product would be safe for use.

EO, ECH, and EG residues have harmful effects like irritation, mutagenicity, carcinogenicity, organ damage, and reproductive side effects. Therefore, it is important to set an allowable limit for EO, ECH, and EG in a product before its use, the International Organization for Standardization (ISO) has set allowable limits for residual EO, ECH, and EG in individual EO-sterilized products and procedures for their measurements. Failing to provide proof of their content can cause safety concerns and may delay the launch of products, and can also create supply chain issues for the manufacturer.

Shiva Analyticals through cutting-edge technology and validated methods ensures that your products are safe and free from the harmful effects of Ethylene Oxide residuals. Our team has over 20 years of experience in testing for Ethylene Oxide residuals with different product matrices as per the ISO 10993-7 testing requirements.

Please feel free to contact us, and our team of experts shall be happy to assist you with the testing of your products for Ethylene Oxide residuals.