Improve service and efficiency of LAL kinetic chromogenic method for a combine manufacturing product

Abstract

A new supplier is now validated according to the requirements on the USP <85> Bacterial Endotoxin Test, USP <161>, ANSI/AAMI ST72:2011. This validation is conducted in order to comply with manufacturing and customer needs. This company for over a hundred (100) years is dedicated to produce medical devices and advance the delivery of healthcare. Considering this information, we need to be persistent on our deliveries and to comply with this the validation of Supplier 2 is necessary. This validation become in a positive outcome when a time of test is reduced, then the documentation process is easier and faster. Also an economic yield is reflected. Key Words  ANSI/AAMI, DMAIC, Inhibition/Screening/Enhancement, KQCL, LAL, LWR, MVD, Pyrogen, USP.