DOXPUB 09-0055-SOP-1.0

Specifies the procedure for using Endosafe indicator vials to analyze endotoxin removal attained in Lytzen depyrogenation ovens. Includes attached data collection form, "Kinetic Turbidimetric Analysis of Endotoxin Indicator Vials." Referenced material includes USP 28:85 "Bacterial Endotoxin Tests," FDA guidance "Guidelines for Validation of the Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices," and Thermomax/Softmax Users Manual.

Product Details

Edition:

1

Published:

10/01/2004

Number of Pages:

5

File Size:

1 file , 130 KB