Ethylene Oxide testing & analysis

Reliable residual testing for regulatory confidence

 

We understand the critical importance of ensuring that life science products, particularly medical devices and pharmaceutical packaging meet the highest standards of safety and compliance. 

 

Ethylene Oxide (EO) is widely used to sterilise temperature and moisture sensitive products. However, its residues including EO itself, ethylene chlorohydrin (ECH) and ethylene glycol (EG) can pose toxicological risks if not properly controlled.

 

Our Ethylene Oxide testing services are designed to support manufacturers in verifying that residual levels of EO and any by-products remain within acceptable limits as defined by stringent international regulations.

 

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+44 (0)118 9184000
lifesciencesales@rssl.com
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Comprehensive EO residual testing

 

Our laboratory experts provide sensitive, robust, and fully validated analytical methods for the quantification of EO residuals in a vast number of different products including medical devices, pharmaceutical packaging, drug delivery systems including prefilled syringes and other drug delivery components. 

 

Our experienced scientists use a range of sophisticated analytical methods to provide accurate and reliable detection of EO and its by-products, including GC-MS, HS-GC and custom extraction methods tailored to the sample. Our methods are validated according to international guidelines and are routinely applied in support of batch release and regulatory submissions.

Expertise in regulatory compliance

 

Our EO testing aligns with key regulatory requirements, including:

 

• ISO 10993-7 for medical devices
• USP <1663>/<1664> for pharmaceutical packaging
• ICH guidelines for impurity limits
• MDR and FDA guidance

 

With decades of experience in regulatory science, RSSL can help you interpret evolving global standards, mitigate risk, and ensure your EO sterilisation processes are effectively validated and routinely monitored.


From method development and validation to routine batch release testing and troubleshooting, we work closely with your teams to deliver dependable data. We combine cutting-edge analytical instrumentation with scientific insight to deliver accurate, reliable results, even in the most complex matrices.

 

Whether you’re responding to regulatory queries, conducting routine testing, or implementing a new sterilisation process, our experts are here to support your product’s success.

Request your EO testing quote now

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Get in touch to find out how we can transform complex chemistry into reliable results for you

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