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Reducing Documentation Errors by Designing a Continuous Workflow for the In-Process of Spinal Needles
(Polytechnic University of Puerto Rico, 2022)
Good Documentation Practices are essential to maintain a robust Quality System. Many documentation errors were constantly found on acceptance records at the Product Release-to-Packaging stage. ...
Implementación de un sistema de ejecución en el área de manufactura para la reducción de desviaciones
(Polytechnic University of Puerto Rico, 2021)
Las industrias están comenzando a modernizar sus instalaciones debido a la alta demanda y las exigenciasde las agencias reguladoras. Para cumplir con los estándares de calidad, las ...
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 ...
Validation and Project Process Improvement Using DMAIC Methodology
(Polytechnic University of Puerto Rico, 2021)
Lean Six Sigma Methodology impacts positively the efficiency, customer satisfaction and quality for manufacturing and systematics process. This article provides a successful example of how the Sig Sigma ...
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 ...
Cost Improvement Tracking System to Promote a Stream Lined Program
(Polytechnic University of Puerto Rico, 2022)
This project presents the development of a process supported by a technology mechanism to facilitate the tracking and management of programs implemented by organizations to lower the cost base and/or promote ...
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 ...
Portable Raman Spectroscopy: An Improvement in the Raw Material Quality Identification Testing Method
(Polytechnic University of Puerto Rico, 2021)
An external contract laboratory performs the identification testing method of raw materials for a pharmaceutical company. Performing this current activity affects the product release timeframe and ...
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 ...
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 ...