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Change Control Routed with Missing Information Delaying Approval and Implementation Date
(Polytechnic University of Puerto Rico, 2022)
The approval of manufacturing change control for MedDevice Inc., is currently acting lower than target(15 business days). Based on a 12-months data review, the lead time of approval of a change is approximately ...
Monomer’s Residuals Test Elimination for Soft Acrylic Buttons at Polytechnic University of Puerto Rico
(Polytechnic University of Puerto Rico, 2022)
In the cataract surgery, the natural lens in the eye is replace with an Intraocular Lens. Five monomers (EA/EMA, TFEMA, EGDMA, UV Chr) are mixed to produce the soft acrylic lens. Residual monomer testing ...
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 ...
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 ...
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 ...
Mejoras al Proceso de Empaque parala Jurisdicción de China
(Polytechnic University of Puerto Rico, 2022)
En los últimos dieciocho meses, el mundo ha confrontado retos con el suministro de materia prima. En esta empresa no es la excepción, además, la productividad redujo, los desperdicios aumentaron y el tiempo de ...
Mejoras Al Diseño Establecido en el Proceso de Empaque para la Industria Biofarmacéutica con el fin de Minimizar Errores Humanos
(Polytechnic University of Puerto Rico, 2022)
En una línea de manufactura, el 83.3% de los operadores concuerda con que el proceso de documentación es complejo, lo que
aumenta la incidencia de errores humanos. El propósito de este estudio es identificar posibles ...
Optimization in the Account Registration Process in Automated Equipment
(Polytechnic University of Puerto Rico, 2022)
Over the years technology has increased in the manufacturing areas. Companies have moved to obtain automated equipment for the manufacture of their products. In the pharmaceutical industry, this equipment has been implemented ...
Workflow Management in the Batch Record Review Process
(Polytechnic University of Puerto Rico, 2022)
The review of Batch Records creates a story of the materials, manufacturing, and packaging involved in the production of
biopharmaceuticals. The Master Batch Record details who, when, where, and how each process stage is ...
Feasibility Study of Proposed Manufacturing Layout Re-design to Improve Process Capacity and Reduce Cycle Time of a Downstream Operation of Product A
(Polytechnic University of Puerto Rico, 2022)
Lean Six Sigma tools and methodologies are widely used in today’s work environments. The use of a Lean Six Sigma approach provides organizations more flexibility and efficiency to improve their competitiveness. At the ...