Improve service and efficiency of LAL kinetic chromogenic method for a combine manufacturing product
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Polytechnic University of Puerto Rico
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.
Description
Design Project Article for the Graduate Programs at Polytechnic University of Puerto Rico
Keywords
Citation
Reyes Donatiú, S. (2018). Improve service and efficiency of LAL kinetic chromogenic method for a combine manufacturing product [Unpublished manuscript]. Graduate School, Polytechnic University of Puerto Rico.