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;y!lr. UC <br /> ak:iitcr Packa <br /> StenIizaIion T <br /> Stcririzanon pouit ...m, s, ... <br /> UcX16 $caleo to their p'ai:Ka�cti vittCJ3 Cl) - <br /> caxes circ placed inter larger'boxes ann <br /> chamber where all items are sterilized, <br /> Tne Zvor is then closed and scaled Th <br /> .cakcd. (Step 4) <br /> ?r,c ti;mperavire is Srt bcomcca C_sI ;� I III; ;S Qvlic wttt} <br /> ��lrin the steam temperature ,s iowcr than 30.01/9 Kh, the sicarn is r <br /> temperature is heated to 50.00%Rh.The,cpntrol iirliji i rnjainta <br /> ;Step 6} <br /> Form ° l-T-Uaic is cQmpietcd vrrlt' <br /> Sicps 6& 7 are repeated, (Step 8 <br /> Air is vacuumed out of the room;(Swp V) <br /> ?rrssurc is set at 3.0 KPa —20.0 kPa, (Slcp !,i <br /> -4'hcn the pressure roaches Oetween 3,UKNt1 Linj 20 OKPz:, tt,c .acuurrlwg a1wp <br /> • <br /> Room is kept at current condition for 3.5 ininuics. (Step 12� <br /> :{ Outer seals are checked again for leaks.(Step 13 ' <br /> lfwhen the air is vacuumed out, the moisture level is lower than 30,0°lo� ja, then telt cunt` <br /> must be brought back and Maintained bt:twecn 30% and 80% Rh. (Step.f11 <br /> !'TC gas is then released irtlo the chamber. (Step 15) <br /> ETT stays in the ehamborAr approximately 8,5 hours,(Step 1t7) <br /> Computers monitor reactions throughout process.'(�icp `17j <br /> t ,alarm sounds when 8,S hours is completed. (Step IS) <br /> AIr is Vacuumed again from the chamber. (Step 19) <br /> Prrs ure is set 4130.0 KFa for 5 minutes. (Sttfp 20) ; <br /> Air is replaced in the chamber,(Step 21) <br /> Air is vacuumed again.(Step 2 ) <br /> iS2 <br /> Steps 21 & 22 are repeated 3 times. (Step 23) <br /> �Cr Form _ 1-T•date is re-complctd.(9tepa <br /> : Operator prints computer printedY l T-t3f HI <br /> moor Is released and opened. (Step,26) <br /> rrvcucts are rcmovcd from chamber anti ndiQat <br /> Process must be re•cornpleted, (Step 27) <br /> Eacti box is labeled with the date the proress is compl i <br /> All ETO sterilized items are guararttrcd to stay stcrilc for 2 years or the lctrgt' <br /> w'�kage. <br /> • .�rc a cuyt, ;,ry locat,an ii�vay drQrtt LlirC4, sur° 3igi�t <br /> Sgpiy FLEA Registration 9: 2085835 <br /> Supply FDA Operator 10: 902 <br /> ­A.�� <br />