Ethylene oxide sterilization is widely used for its microbiological effectiveness, both for medical devices and pharmaceutical products.
Ethylene oxide is a CMR substance (carcinogenic, mutagenic and reprotoxic) and it is essential to analyse the EO residues to ensure this compound elimination and its potential cleaning-up residues metabolites.
The requirements relating to the residues of oxide-sterilized medical devices are subject to the NF EN ISO 10993-7 standard.
The allowable limits for each device are expressed in average daily dose to the patient (mg/day)/.
CARSO Pharmaceutical analyses the sterilization residues
- Ethylene oxide
- Ethylene hydrochloride
- Ethylene glycol…