www.pall.com 3
4. Extractables ............................................................................................................................................... 17
4.1 Introduction ........................................................................................................................................... 17
4.2 Summary of the Test Method ................................................................................................................ 17
4.3 Results .................................................................................................................................................. 18
4.3.1 Kleenpak Presto Sterile Connector Extractables Summary .......................................................... 18
4.4 Conclusion ............................................................................................................................................ 19
5. Biological Safety, Cleanliness and Physicochemical Tests ................................................................... 19
5.1 Introduction ........................................................................................................................................... 19
5.2 Biological Reactivity Tests, in vitro, USP <87> ...................................................................................... 20
5.2.1 Introduction ................................................................................................................................. 20
5.2.2 Summary of the Test Method ...................................................................................................... 20
5.2.3 Results ........................................................................................................................................ 20
5.2.4 Conclusion .................................................................................................................................. 20
5.3 Biological Reactivity Tests, in vivo, USP <88> ....................................................................................... 20
5.3.1 Introduction ................................................................................................................................. 20
5.3.2 Summary of the Test Method ...................................................................................................... 20
5.3.3 Results ........................................................................................................................................ 21
5.3.4 Conclusion .................................................................................................................................. 21
5.4 Physicochemical Test as per USP <661> ............................................................................................. 21
5.4.1 Introduction ................................................................................................................................. 21
5.4.2 Summary of the Test Method ...................................................................................................... 21
5.4.3 Results ........................................................................................................................................ 21
5.4.4 Conclusion .................................................................................................................................. 21
5.5 Particles Release Test, USP <788> Particulate Matter in Injections ....................................................... 22
5.5.1 Introduction ................................................................................................................................. 22
5.5.2 Summary of the Test Method ...................................................................................................... 22
5.5.2 Summary of the Test Method ...................................................................................................... 22
5.5.4 Conclusion .................................................................................................................................. 22
5.6 Endotoxin Test, USP <85> ................................................................................................................... 22
5.6.1 Introduction ................................................................................................................................. 22
5.6.2 Summary of the Test Method ...................................................................................................... 22
5.6.3 Results ........................................................................................................................................ 22
5.6.4 Conclusion .................................................................................................................................. 22
6. Shelf Life Studies ...................................................................................................................................... 23
6.1 Introduction .......................................................................................................................................... 23
6.2 Summary of the Test Method ................................................................................................................ 23
6.3 Results .................................................................................................................................................. 23
6.3.1 Leak Test .................................................................................................................................... 23
6.3.2 Burst Test .................................................................................................................................... 24
6.3.3 Bacterial Liquid Soiling Test ......................................................................................................... 24
6.3.4 Extractables ................................................................................................................................. 24
6.4 Conclusion ............................................................................................................................................ 24