2
Contents
1 Validation Overview ................................................................................................................................................................... 3
1.1 Introduction....................................................................................................................................................................... 3
1.2 Summary of Conclusions................................................................................................................................................. 3
1.2.1 Extended Duration Testing ..............................................................................................................................................3
1.2.2 Extractables Testing ........................................................................................................................................................3
1.2.3 Probe Insertion Testing....................................................................................................................................................3
1.2.4 Mold Tool Validation ........................................................................................................................................................3
1.2.5 Assembly Process Validation ..........................................................................................................................................3
2 Extended Duration Testing....................................................................................................................................................... 4
2.1 Introduction....................................................................................................................................................................... 4
2.2 Summary of Methods....................................................................................................................................................... 4
2.3 Results.............................................................................................................................................................................. 4
2.4 Conclusion........................................................................................................................................................................ 4
3 Extractables Testing .................................................................................................................................................................. 4
3.1 Introduction....................................................................................................................................................................... 4
3.2 Summary of Methods....................................................................................................................................................... 4
3.3 Results.............................................................................................................................................................................. 5
3.4 Conclusion........................................................................................................................................................................ 6
4 Probe Insertion Testing ............................................................................................................................................................ 6
4.1 Introduction....................................................................................................................................................................... 6
4.2 Summary of Methods....................................................................................................................................................... 6
4.3 Results.............................................................................................................................................................................. 6
4.4 Conclusion........................................................................................................................................................................ 6
5 Mold Tool Validation.................................................................................................................................................................. 7
5.1 Introduction....................................................................................................................................................................... 7
5.2 Summary of Methods....................................................................................................................................................... 7
5.3 Results.............................................................................................................................................................................. 7
5.4 Conclusion........................................................................................................................................................................ 7
6 Assembly Process Validation .................................................................................................................................................. 7
6.1 Introduction....................................................................................................................................................................... 7
6.2 Summary of Methods....................................................................................................................................................... 7
6.3 Results.............................................................................................................................................................................. 8
6.4 Conclusion........................................................................................................................................................................ 8