Transcription of Note for Guidance on Limitations to the use of Ethylene ...
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Note for Guidance on Limitations to the use of Ethylene ...
The European Agency for the Evaluation of Medicinal ProductsEvaluation of Medicines for Human Use7 W estferry Circus, Canary W harf, London, E14 4HB, UKTel. (44-20) 74 18 84 00 Fax (44-20) 74 18 85 95E-mail: 2001 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledgedLondon, 29 March 2001 CPMP/QWP/159/01 EMEA/CVMP/271/01 COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP)COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS (CVMP)NOTE FOR Guidance ON Limitations TO THE USE OFETHYLENE OXIDE IN THE MANUFACTURE OF MEDICINALPRODUCTSDISCUSSION IN THE QUALITY WORKING PARTY (QWP)
it is effective only as a surface sterilant it should be used only when justified and validated on an individual basis. Ethylene oxide sterilisation should be used only where safer alternatives cannot be used. For containers filled with aqueous products, e.g. pre-filled syringes, the need for a justification for ...
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