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4fiuane'rr lt{Ita
i n v t -N 1 8 5 : ro
&*tA.&.rtr&a&Gr|hlb**tIIr v r II{tItIII
Thevialcontains00,OO'000U vlalAdd5mlLRW 100, 0'000 U vial+ 5 =20'00'000EU ml) Stock
olution)
* Vortex or 15 minutes'Takedilutionubes 2x 75mm'abel A' and 8"ln ube A'Add0'1ml (stock) 0'9mlLRw= 1
0'1ml A)+ 0'9mlLRW -- 1
* Determinehe number f Ampoules rvials o be testedAddo, lml f romtube(B) toeachof theampou|esorVi . l | s .Airdryandseal heampoules'Mark ials efore eepingnoven)Keep two uittt (unbtktO)aside as positive ontrolsand use
the restDepyrogenation' -
* Allow hevials o go through hedepyrogenationycleas peryourrequirement
Allowhevialsocool o roomemperatureAdd1mlLRW oeach fbaked ials ndvortex or 10minutes
lMP)Take0.1ml romeach fbaked ia ladd0'1mlof ysate'(Sensitivity'12SEU/ml)
For esting ositiveontrol' dd1mlLRW o heunbakedial'vortexor 10minutes
: rb(n),2,oo,oooUml: 100 B), O,OO0U ml
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The estmethod mploysheSemi-Qualitativeel estwhichmakes seof LimulusAmebocyeLysateLAL) whichclotsn thepresencef endotoxin.Nameof the CompanY-Date -Validationof :-
Expiry fLAL:LRW: Expiry fCSE:LAL Reconstitutionn: CSEReconstitutionOn;EndotoxlnChallenge ot No:Date: Potency:HeatingBlockTemP:End:Oven TunnelMake:Temperature
Resulis- TESTCOMPLIES DOESNOTCOMPLIES SPERUSP BP
Details f theReagents.LAL LotNo:No:
TestdonebYName& SignwithSeal
CSE otNo: LRWLotExpiry f
ExpiryTime
I P ,Approved Y
ame& Sign vithSeal
Time Start:
ReviewedYName& SignwithSeal