XCell® ATF 2 and 4 Stainless Steel Housings
SG-SSATF24 rev 1
8.3.2 Tube set kits
Tube set kits are manufactured under the Repligen Quality Management System certified under
current revision of ISO 9001:2015. All product-contact components are USP Class VI, (USP<88>)
and/or ISO 10993 tested and free of animal derivatives or are compliant with EMA/410/01
guidelines. Single use tubing set kits conform to ANSI/AAMI/ISO 11137-1/ -2 guidelines for VDmax25
to provide a minimum sterility assurance level (SAL) of 106 for an established irradiation dose. Tube
set kits meet the current USP bacterial endotoxin test (USP<85>). Aqueous extracts contain <0.25
EU/mL as determined by the limulus amebocyte lysate test (LAL) and meet the current USP
particulate matter in light obscuration particle count tests (USP<788>).
9. Appendix B: Spare parts
Table 11. XCell® ATF 2 spare parts
Part Number
Description
A2-PA1 Pump Hemisphere, Air Side, ATF2
D2-S1 Diaphragm, Pump, ATF2
SC-2.5 Clamp, Sanitary, 2 1/2" TC
ZZ-ATF2-A2-PL1 Pump Hemisphere Assembly, Liquid Side, ATF2
A2-SMP3-ASM Vent Port Stem Assembly ATF2/4
A2-AIR-F let Assembly 45 deg Female Pipe Elbow
F-AIR2 Air Filter, ATF2
SG-075-E Sanitary Gasket, 3/4" TC
SC-075 Clamp, Sanitary 1/2-3/4" TC
NA F2 2 Micron PS Hollow Fiber (Not included)
ATF2-A2B-TC Silicone Tubing W/ TC Ends, ATF2
NA 7/16-20 Straight Thread x 9/16-18 Swivel
NA 9/16-18 Swivel Thread x 1/8-27 NPT Male Connector
TU-SS-3/8 OD TUBING, Air Inlet Line, 3/8" SS x Tube x 2.5 LG AISI
D2-S1 Diaphragm, Pump ATF4
A2-SMP3-ASM sampler Port Stem Assembly, ATF2/4