Auflistung Manufacturing Engineering Nach Schlagwort "Pharmaceutical industry--Quality control"
Anzeige der Dokumente 1-20 von 30
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Application of DMAIC Methodology to Improve the Utilization of an Industrial Glassware Washer System in a Biopharmaceutical Industry
(Polytechnic University of Puerto Rico, 2009)Abstract ⎯ This article describe how the problem solving approach of Define, Measure, Analyze, Implement and Control (DMAIC) is applied to increase the utilization of an industrial glassware washer system in a Biopharmaceutical ... -
Computer System Validation CSV in Data Integrity Implementation Strategies for Pharmaceutical Industry
(Polytechnic University of Puerto Rico, 2018)Computer System Validation CSV in Data Integrity refers to the completeness, consistency, and accuracy of data. Complete, consistent, and accurate data should be attributable, legible, contemporaneously recorded, original ... -
Cycle Time Reduction using Lean Manufacturing Techniques for a Solid Pharmaceutical Product
(Polytechnic University of Puerto Rico, 2009)Abstract ⎯ The purpose of this project was to demonstrate that the Lean Manufacturing techniques could be applied to a Solid Pharmaceutical Product in order to reduce the cycle time. During the year 2007, the Solid ... -
Data Integrity Implementation Strategy for Pharma Industry
(Polytechnic University of Puerto Rico, 2017)Data integrity is fundamental in a pharmaceutical quality system which ensures that medicines are of the required quality as decisions on product quality are made based on the data. Electronic data and computerized ... -
Design Project for Process Improvement of the Manufacturing of Electrode Ring –Monolithic Controlled Released Devices (MCRDs)
(Polytechnic University of Puerto Rico, 2021)Medtronic Rice Creek Pharmaceutical Operations at Fridley, Minnesota currently build the Electrode Ring, Monolithic Controlled Released Device (MCRD) assembly which is sent to Medtronic Villalba ... -
Determination of In-Processing Manufacturing Impact into Elution Rate of Drug Eluting Steroid Collars
(Polytechnic University of Puerto Rico, 2012)Abstract - The Food and Drug Administration provides regulations for combination products. The medical device industry needs to comply with these regulations specifically in products containing drug. One of the many ... -
Development of a Generic Pharmaceutical Solid Dosage Form Using Quality by Design (QbD)
(Polytechnic University of Puerto Rico, 2014)The Pharmaceutical Generic Sector has been growing over the past years and it is expected to surpass brand drugs in sale over next years. The FDA now recommends Quality by Design to develop Generic Drugs. The present work ... -
Development of Bulk Shipping Studies in Pharmaceutical Industry
(Polytechnic University of Puerto Rico, 2012)Abstract ⎯ A bulk shipping study in the pharmaceutical industry consists in monitoring and analyzing the environmental conditions (e.g. temperature and relative humidity) during shipping and transportation of the drug ... -
Development of Effectiveness Program through the Use of Productivity Metrics
(Polytechnic University of Puerto Rico, 2014)The Overall Plant Effectiveness Program has the purpose to improve the production capacity and optimize operations performance in an Active Pharmaceutical Ingredient (API) manufacturing plant. It requires a complete analysis ... -
Engineering Study for the Feeding Operation Process of a Continuous Manufacturing Line
(Polytechnic University of Puerto Rico, 2016)The use of continuous operations in solid-dosage manufacturing is growing rapidly and bringing benefits within pharmaceutical industry. One of the benefits that the continuous operation provides is that the development ... -
Evolutionary vs. Revolutionary: a Snap Shot of the Current Tendencies in Pharmaceutical Industry and the Impact of Process Analytical Technology and Continuous Manufacturing Processes
(Polytechnic University of Puerto Rico, 2013)Food and Drug Administration (FDA) challenges the pharmaceutical industry to innovate itself and introduce ever higher quality standards through the use of technology. Development of continuous manufacturing systems ... -
H&K Capsule Filling Equipment Reliability
(Polytechnic University of Puerto Rico, 2013)Encapsulation is a process whereby the dose is charged into a hard gelatin capsule; powder, pellets, tablets or combinations of two or more of these may be filled into the capsules. Capsules provide a convenient way ... -
Implementación de Estrategias para lograr Cero- Errores o Defectos En las Operaciones durante Proceso de Granulación
(Polytechnic University of Puerto Rico, 2012)Sipnósis- Un producto realizado con errores en documentación, pone en riesgo la efectividad, autenticidad y la integridad del mismo. Es por esto que debemos evitar cualquier desviación en el proceso, realizando una ... -
Implementation of a Calibration Wireless System in a Pharmaceutical Facility
(Polytechnic University of Puerto Rico, 2012)Abstract - Regulated industries such as Pharmaceutical, Biotechnology and Medical Devices require a Calibration Program, to guarantee the product quality. The objective of this project was to design Calibration Wireless ... -
Implementation of a Special USB Device for the Reduction of Time to Access Computers Remotely in HVAC Testing
(Polytechnic University of Puerto Rico, 2012)Abstract ⎯ This article describes the application of the five Six Sigma methodologies known as the five DMAIC phases Define, Measure, Analyze, Improve and Control using the application of HVAC (Heating, Ventilation and Air ... -
Lean and Safe Manufacturing for an Antidepressant Tablets Coating Process
(Polytechnic University of Puerto Rico, 2009)Abstract - The Lean and Safe Manufacturing Process (6S event) was selected for implementation in an antidepressant tablets coating manufacturing process. The coating process was identified due to the utilization of toxic ... -
Manufacture and Evaluation of an Experimental 37.5 kg Scale Batch of 0.103% w/w Ethinyl Estradiol Triturate (Formulation Number WC3074-01I)
(Polytechnic University of Pueto Rico, 2016)Actavis Fajardo, is a Pharmaceutical company dedicated to the manufacturing and packaging of oral contraceptive products. Ethinyl Estradiol is an intermediate product used to incorporate Ethinyl Estradiol active in ... -
Mejora en el Proceso de Limpieza en los Equipos de Manufactura
(Polytechnic University of Puerto Rico, 2022)Durante estudios de tiempo en los procesos en una farmacéutica en Puerto Rico se identificó un tiempo prolongado en la ejecución de limpieza de la Compresora que es compartida con varios productos .Por esta razón ... -
Modifications to the Purified Water Storage and Distribution System Polytechnic University of Puerto Rico
(Polytechnic University of Puerto Rico, 2013)The Purified Water is identified to play an integral role in manufacturing operations. Careful considerations and good manufacturing practices must take place in order to minimize contamination and bacterial load. It ... -
Optimization of pharmaceutical product production lots at granulation manufacturing stage
(Polytechnic University of Puerto Rico, 2018)The customer of ABD Company wants the CY product to meet 7% 40 mesh requirement in 80% of the lots requested. The company has two granulators that are used for the manufacturing of the product but one of them typically ...