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

Loading...
Thumbnail Image

Date

Journal Title

Journal ISSN

Volume Title

Publisher

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 Improve service and efficiency of LAL kinetic chromogenic method for a combine manufacturing product [Unpublished manuscript].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.

Endorsement

Review

Supplemented By

Referenced By