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4fiuane'rr lt{Ita

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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

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Time Start:

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