To lay down a Procedure for testing of Endotoxins in Finished Product.
1.0 PURPOSE
1.1 To lay down a Procedure for testing of Endotoxins in Finished Product.
2.0 SCOPE
2.1 This SOP covers the operation procedure for testing of Endotoxins in Finished Product.
3.0 RESPONSIBILITY
3.1 Microbiologist
4.0 ACCOUNTABILITY
4.1 Head - Quality Control
5.0 PROCEDURE
5.1 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.
5.2 Add 50?l of reconstituted Control Standard Endotoxin diluted to 2? in positive tubes and 50?l of LAL reagent water in negative tubes.
5.3 Add 100 ?l of reconstituted LAL reagent to each test tube in turn starting with negative control.
5.4 Once prepared shake the rack of tubes to ensure mixing of the sample and lysate.
5.5 Insert the tubes in heating block for incubation at 37°C + 1 for a period of 60 minutes.
5.6 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.
5.7 Enter the details in Bacterial Endotoxin Test Report in Annexure –I
5.8 Enter the details of material receipt and usage in Annexure –II
END OF DOCUMENT
Microbiology, procedure, endotoxin testing materials, endotoxins in finished product
