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SOP for Bacterial Endotoxin Test

Objective
To lay down a procedure for the Bacterial Endotoxin Test.

Scope
The procedure of this SOP shall be applicable for the Microbiology Department of XYZ Ltd.

Responsibility
Microbiologist

Accountability
Q.C. Manager


Procedure
  • Wash all glassware with purified water twice than with distilled water once.
  • Cover all the glassware with aluminium foil.
  • Heat all the glassware to be used for the Bacterial End toxin test at 240°C for 2 ½ hrs. so as to make it dehydrogenated.
  • Weigh the samples.
  • Prepare the dilution of the sample and control standard endotoxin.
  • Dilute the LAL reagent with 1.2 ml LAL reagent water.
  • Place the tubes over the heating blocks.
  • First, put water for NPC and CSE for PPC.
  • Now dispense the samples followed by LAL reagent.
  • Place two tubes as blank.
  • Incubate at 37 ± 1°C.
  • Observe the tube after exactly one hour the PPC should have the gel formation (firm gel) and NPC along with blank should not have.

Abbreviations
SOP: Standard Operating Procedure
QC: Quality Control
QA: Quality Assurance

Annexure
Nil

Revision History
Nil

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