EO Residual Testing

EO Residual Testing

Ethylene Oxide (EO) residual testing for sterilized medical devices and pharmaceutical packaging is a critical safety requirement. Testing per ISO 10993-7 and USP standards ensures EO levels are within safe limits before products are released for patient use or drug packaging.

We use GC-headspace analysis for accurate detection of EO, ECH (ethylene chlorohydrin) and EG (ethylene glycol) — the primary EO sterilization byproducts — with results traceable to certified reference standards.

Analytes Tested

• Ethylene Oxide (EO) — the sterilizing agent
• Ethylene Chlorohydrin (ECH) — primary reaction byproduct, more toxic than EO
• Ethylene Glycol (EG) — hydrolysis product in the presence of moisture

Products & Devices Tested

• Single-use sterile medical devices
• Catheters, IV tubing and infusion sets
• Surgical gloves and wound care products
• Implantable devices and prostheses
• Pharmaceutical primary packaging (blister films, stoppers)
• Combination products
• In-vitro diagnostic devices

Analytical Method

Samples are extracted and analyzed by GC with headspace sampling and FID or MS detection. The method is validated per ISO 10993-7 Annex guidance and USP <1232>. Extraction conditions (solvent, temperature, time) are selected based on device material and geometry.

Regulatory Limits & Standards

ISO 10993-7:2008 specifies maximum allowable limits of EO and ECH based on device contact type — limited exposure (24 hours), prolonged exposure (24 hours to 30 days), and permanent contact (more than 30 days). USP <661> and USP <1232> provide guidance for pharmaceutical packaging materials.

Report & Compliance

All test reports include detailed extraction conditions, calibration data, detected levels, and comparison against ISO 10993-7 limits. Reports are suitable for CDSCO, FDA 510(k), CE Technical File, and other regulatory submissions.