Selected article for: "drying process and medical device approval"
Author: Li, Ling; Long, Jing; Li, Long; Cao, Huijuan; Tang, Tingting; Xi, Xinghua; Qin, Ling; Lai, Yuxiao; Wang, Xinluan
Title: Quantitative determination of residual 1,4-dioxane in three-dimensional printed bone scaffold
  • Document date: 2017_7_17
    • ID: qd2te842_55
    Snippet: Three-dimensional printing porous scaffolds are promising regenerative strategies for bone defect repair in orthopaedics [6, 7] . As a newly developed medical product, safety issues are considered as the most important ones. As a Class 2 solvent with less severe toxicity, content of residual 1,4-dioxane in the novel 3D printing PLGA/TCP scaffolds should be rigorously controlled according to international regulations, such as Chinese Pharmacopoeia.....
    Document: Three-dimensional printing porous scaffolds are promising regenerative strategies for bone defect repair in orthopaedics [6, 7] . As a newly developed medical product, safety issues are considered as the most important ones. As a Class 2 solvent with less severe toxicity, content of residual 1,4-dioxane in the novel 3D printing PLGA/TCP scaffolds should be rigorously controlled according to international regulations, such as Chinese Pharmacopoeia [26] , International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use [27] and United States Pharmacopoeia [28] . In this work, we firstly developed an HS-GC-MS method for testing 1,4-dioxane in PLGA/TCP porous scaffolds. It is an important file in medical device approval and registration. It has been applied as an enterprise standard to optimise the drying process of scaffolds and monitor the quality of scaffolds in the industrialisation process.

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