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Introducing a Test Method of Determining the Best Heatseal Parameters of Flexible Packaging Materials of Sterile Medical Devices

WU Ping YU Xiao-hui Dong Dan-dan Shandong Quality Inspection Center for Medical Devices(Ji'nan 250101)  
ISO 11607-2:2006 requires the validation of the seal process of sterile barrier system of sterile medical devices.Determination of the best heatseal parameters of packaging materials is one of the most important contents of the validation.This paper introduced the test method given in ASTM 2029 by an actual test in laboratory,built a heatseal curve of heatseal strength-temperature in different heatseal conditions,with actual samples to determine the best heatseal parameters of flexible packaging materials of medical devices.
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