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Development of General Guidelines for the Pharmaceutical Manufacture Company Reaction to a Consent Decree Emitted by the Federal Drug Administration (FDA)
(Polytechnic University of Puerto Rico, 2009)
Abstract ⎯ Consent Decrees have been very popular lately. The consent decree mandates that a company start initiating change, and that change is usually associated with the way the company is manufacturing a product; 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, ...
Estudio de los Aspectos Ergonómicos en Laboratorios de Control de Calidad en Industrias Farmacéuticas
(Polytechnic University of Puerto Rico, 2009)
Abstracto - El objetivo de esta investigación es conocer, cuan efectivo son los diseños ergonómicos en laboratorios de control de calidad de las industrias farmacéuticas. En esta investigación se realizó una evaluación de ...
Optimization of On-Line Automated Dissolution System for Solid Dose Control Release Tablets
(Polytechnic University of Puerto Rico, 2009)
Abstract ⎯ An optimization of an automated dissolution system for control release tablets has been accomplished by the implementation of several variables using Six Sigma tools. Variables under evaluation includes: filter ...
Evaluation to Sleeves Used in Granulation Department for the Graduate Programs at Polytechnic University of Puerto Rico
(Polytechnic University of Puerto Rico, 2021)
The DMAIC methodology was applied to analyze a manufacturing system at Johnson & Johnson Pharmaceuticalsin Las Piedras, Puerto Rico. The methodology was used to improve the time for changing and ...
Audit Process Optimization in the Manufacturing Area
(Polytechnic University of Puerto Rico, 2021)
This project was developed to demonstrate a viable audit process optimization in the manufacturing area. The AbbVie site ubicated in Barceloneta, Puerto Rico,started with only one product back in ...
Coating Process Improvement
(Polytechnic University of Puerto Rico, 2021)
An increase in the number of events associated to AQLfailure that resulted on partial batch rejections was observed in 2020 for Tablets/Caplets formulations due to cosmetic conditions ...
Handling and Managing of Vial Rejects
(Polytechnic University of Puerto Rico, 2021)
A large accumulation of filled vial
rejects generated in an aseptic filling line of a
parenteral medication was identified to be in the
custody of the Quality Assurance department
indefinitely. Using the DMAIC methodology ...
Process Time Reduction in Manufacturing Areas: Visual Valves Identification on Manufacturing Area specifically on Media Prep Area, Media Preparation tanks to Pursue Agility on the Visual inspections required before, during and after the Media Prep Solution are Prepared
(Polytechnic University of Puerto Rico, 2022)
Time of production process and associate activities were evaluated for Media Prep manufacturing process on Juncos, P.R. The voice of the customer requested reduced time inspection process before, ...
Cleaning Validation of a Manufacturing Line using CIP-100 Detergent and a Clean-in-place Skid System
(Polytechnic University of Puerto Rico, 2022)
Cleaning Validation is a prime element of control to the cross contamination and potential carry over topic at the manufacturing industry. This process must assure the quality, safety and efficiency of cleaning ...