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Quality Risk Management in the Pharmaceutical Air Compressed Equipment Qualification Process
(Polytechnic University of Puerto Rico, 2013)
In the pharmaceutical industry every
product and every process associated with risks.
To maintain product quality throughout the product
life cycle, too much time and resources are
allocated. Risk is described in recent ...
Risk Prevention in Syringe Filling Line in a Pharmaceutical Manufacturing Plant
(Polytechnic University of Puerto Rico, 2013)
Risk prevention in syringe filling line
can be achieved through the implementation of
“Defense in Depth” concepts. Defense in Depth is
based on the integration of 3-layers of operational
controls which are Equipment, ...
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 ...
Smart Camera Mimics Humans Decision Making Process in a Vial Crimp Quality Automated Inspection Process
(Polytechnic University of Puerto Rico, 2013)
Crimp quality is an important attribute
in the vial filling process. It protects the sterility of
the product from manufacturing until it is dispensed.
A pharmaceutical company performed a Failure
Mode and Effect ...
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 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 ...
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 ...
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 ...
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 ...