This document describes the circumstances where sterilisation with ethylene oxide can be applied.
Keywords: Ethylene oxide, sterilisation, carcinogenic
Document history
Revised note for guidance on limitations to the use of ethylene oxide in the manufacture of medicinal products - Superseded
This Rev.1 revision revises the coverpage (only) of the Note for guidance on limitations to the use of ethylene oxide in the manufacture of medicinal products (CPMP/QWP/159/01 & EMEA/CVMP/271/01 Rev.1). None of the text of the note for guidance (guideline) has been changed, only the cover page and the format.
English (EN) (116.44 KB - PDF)
Note for guidance on limitations to the use of ethylene oxide in the manufacture of medicinal products
English (EN) (25.94 KB - PDF)
Concept paper on a proposal to limit the applicability of the CPMP/CVMP Note for guidance on limitations to the use of ethylene oxide in the manufacture of medicinal products to veterinary medicinal products - Superseded
The proposed guideline will replace 'Note for Guidance on Limitations to the Use of Ethylene Oxide in the Manufacture of Medicinal Products’ (CPMP/QWP/159/01).
English (EN) (77.08 KB - PDF)