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 to 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. 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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