1.0 OBJECTIVE To lay down a Procedure for testing of Endotoxins in

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1.0
OBJECTIVE
1.1
2.0
SCOPE
2.1
3.0
Microbiologist
ACCOUNTABILITY
4.1
5.0
This SOP covers the operation procedure for testing of Endotoxins in Finished
Product.
RESPONSIBILITY
3.1
4.0
To lay down a Procedure for testing of Endotoxins in Finished Product.
Head - Quality Control
PROCEDURE
5.1
5.2
5.3
5.4
5.5
5.6
5.7
5.8
Take the sample (product diluted to 2-fold of MVD) 50l each in endotoxin free
tubes by micropipette fitted with disposable tip. Keep all the sets in duplicate for
product positive and product negative.
Add 50l of reconstituted Control Standard Endotoxin diluted to 2 in positive
tubes and 50l of LAL reagent water in negative tubes.
Add 100 l of reconstituted LAL reagent to each test tube in turn starting with
negative control.
Once prepared shake the rack of tubes to ensure mixing of the sample and lysate.
Insert the tubes in heating block for incubation at 37°C + 1 for a period of 60
minutes.
After incubation remove the test tubes and invert smoothly and note down the
result as positive or negative. A positive test is defined as a firm clot that
maintains its integrity upon inversion. Rest of the result considers as negative.
Enter the details in Bacterial Endotoxin Test Report in Annexure –I
Enter the details of material receipt and usage in Annexure –II
END OF DOCUMENT
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