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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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...