Search
Now showing items 11-20 of 55
Quality Alerts Notifications Evaluation and Response Solution for Sites to Communicate Computer Systems Potential Issues in an Alignment Form and Integrated Process
(Polytechnic University of Puerto Rico, 2020)
The Quality Alert Process is used
to communicate IT or computer system related
situations that have the potential to adversely impact
regulatory requirements (e.g. product quality,
patient safety, record integrity and ...
Setup Time Reduction in the Water for Injection Sampling Process on the Pharmaceutical Industry
(Polytechnic University of Puerto Rico, 2020)
This work consists in the development of
a new WFI sampling route that will bring several
important benefits to the pharmaceutical industry.
Reduction in the setup time will improve daily
operations in terms of efficiency, ...
Enhancements to Cardinal Health NPS Lab to USP-787 Standards
(Polytechnic University of Puerto Rico, 2020)
As the world develops and populations
expand, new diseases arise at an exponential rate.
This research is based on employing new
modifications to NPS (Nuclear Pharmacy Services)
Laboratory at Cardinal Health, Inc. ...
Molecular Weight Test Method Validation and HPLC System Qualification
(Polytechnic University of Puerto Rico, 2020)
The Molecular Weight (Mw) Test
Method is performed by a contract laboratory.
Performing the method externally affects the
product release timeframe and represents
additional costs when the results are required to ...
Mejoras al Proceso de Reemplazo e Inventario de Filtros Utilizando la Metodología Lean Six Sigma
(Polytechnic University of Puerto Rico, 2021)
Los Buffers son sustancias químicas que se utilizan durante el proceso de purificación de la molécula de insulina. Para garantizar la calidad de los buffers que se distribuyen hacia el proceso de purificación, se utilizan ...
Cost Improvement Process - LAL Sample Selection Procedure
(Polytechnic University of Puerto Rico, 2021)
The Cost Improvement Process for LAL (Limulous Amoebocyte Lysate) Sample Selection Procedure was identified with the purpose of reduction of cost and increase in revenue. This process was analyzed and overviewed, estimating ...
Proceso de Mejora de Solicitud de Ventanas para Muestreo de Gases y Agua en Cuartos Asépticos en Edificios de Manufactura
(Polytechnic University of Puerto Rico, 2021)
En este análisis se encontró la causa raíz de la problemática que se tiene en cuartos asépticos de manufactura, el obtener ventanas para la toma de muestras de agua y gases con facilidad. Con la utilización de la metodología ...
Controlled Environmental Area Room B Relayout for Acuity X4 Subassemblies Manufacturing Line Transfer
(Polytechnic University of Puerto Rico, 2021)
Boston Scientific is part of a competitive environment and strives to find methods to reduce cost, waste and improve quality. A methodology for reduction is Lean manufacturing. This methodology is used to reduce “muda” ...
Release by Exception Project Design Optimization
(Polytechnic University of Puerto Rico, 2021)
Pharmaceutical companies are trying to improve the adverse effects that technology brings with the change in documentation. Going from a paper record to an electronic record is a new challenge that must be absorbed and ...
SICD Terminal Ring Cracks Reduction
(Polytechnic University of Puerto Rico, 2021)
A medical device manufacturing line of cadioverter/defibrillators utilizes a mechanical process called staking to join two metal components as part of the electrode manufacturing process. The staking process exerts a ...