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Improvement of Paterson Kelly V-Blender Ventilation System
(Polytechnic University of Puerto Rico, 2019)
This paper presents the successful
improvement and implementation of ventilation
system modifications in a Patterson Kelly VBlender used in Upjohn (Pfizer Division)
Pharmaceutical located at Barceloneta, Puerto
Rico. ...
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 ...
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 ...
Optimización del Proceso de Revisión de los Registros de Manufactura
(Polytechnic University of Puerto Rico, 2018)
La consistencia en la ejecución de las tareas en la industria farmacéutica es uno de los factores más importantes para obtener un producto de calidad. Se utilizó el concepto Lean y la metodología DMAIC para optimizar el ...
Serialization and the Future of Product Traceability
(Polytechnic University of Puerto Rico, 2016)
Since the beginning of pharmaceutical
products and drugs, counterfeiting has been a
worldwide issue. Packed with minimal punishment,
illegal internet sales and unsecured physical
packaging, it has grown into an estimate ...
Enhancement of Batch Review Report for Annual Product Reviews in the Pharmaceutical Industry
(Polytechnic University of Puerto Rico, 2015)
The pharmaceutical industry is required
to comply with various regulatory agencies which
determine the industry capabilities for compliance
and allow the marketing of their products.
Regardless the regulatory agency ...
Shipping and Transportation Studies to Evaluate Drug Product Quality
(Polytechnic University of Puerto Rico, 2015)
Many pharmaceutical or
biotechnological products require transport using
temperature-controlled systems to maintain their
therapeutic properties. There are presently no
official guidelines for testing pharmaceutical
products ...
Strategy for the Implementation of Raman Technology in the Raw Material Incoming Area
(Polytechnic University of Puerto Rico, 2014)
State of the art new technology to
identify raw materials is available for the
manufacturing industries to improve and accelerate
the identification process. This document will
cover the Raman technology, theory ...
Quality Risk Management Strategies for Computer Systems Validation
(Polytechnic University of Puerto Rico, 2014)
Quality Risk Management is something
that has been gaining attention in the regulated
industry because it is listed as regulation in various
regulatory agencies such as FDA, ICH, ISO, ISPE
and other involved regulatory ...
DMAIC Application to Reduce Medication Errors in a Specialized Pharmacy Process
(Polytechnic University of Puerto Rico, 2014)
Medication errors can have serious
consequences for patients, and medication safety is
essential to pharmaceutical care. Insight is needed
into the vulnerability of the working process at
specialized pharmacies in order ...