Canada cGMP-2009 Edition（environmental)文献.pdfVIP

Health Canada / Health Products and Food Branch Inspectorate 7. Radiation sterilization is used mainly for heat-sensitive materials. Since drugs and packaging materials are radiation-sensitive, this method is permissible only when, prior to use, evidence has confirmed the absence of any damaging effects on the material. 8. Ethylene Oxide sterilization is used only when other methods are not practicable. Evidence must be available to show the absence of any damaging effect on the drug when this method is used. The conditions and time