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Pharmaceutical Technology Featured Whitepapers
February 2015

Featured Whitepaper: Vaisala
Risk-Assessment Strategy for Validating Environmental Monitoring Software
Sponsored By: Vaisala

In this pre-recorded 30-minute webcast, Vaisala’s Senior Regulatory Expert Paul Daniel explains how to use risk-assessment tools to determine the validation requirements of computerized environmental-monitoring systems. This information will help you determine what to test and how to defend your decisions during an audit.

 
Outsourcing
   
  OUTSOURCING
   
 

Effect of Binder Type on Dry Granulation and Tablet Compression Properties of a Model Formulation
Authors: Anshul Gupte, Michael Dehart, and Rahul Haware
Sponsored By: Metrics Contract Services

The purpose of the investigation was to compare the impact of roller compaction processing parameters and resulting tableting properties of roller compacted granules of specific binders.

 
MANUFACTURING
   
  MANUFACTURING
   
 

Product Manufactured for Its Intended End Use
Author: Dora Meissner
Sponsored By: BioSpectra

The goal of manufacturing a product for its intended end use provides an additional level of security to the product.

 

Cleaning Validation for Pharmaceutical Manufacturing
Author: Malcolm McLaughlin
Sponsored By: Alconox

This whitepaper describes the why, what, and how to do cleaning validations in the pharmaceutical industry. This paper includes who should be involved, what type of data needs to be generated, limit determination, and equations needed for calculating needed values, as well as how to use the equations.

 
Excipients
   
  EXCIPIENTS
   
 

Comparison of HPC, PVP in Fluidized Bed Granulation
Authors: Kenji Sugisawa and Shinichiro Tsue
Sponsored By: Nippon Soda Co., Ltd.

We prepared both high and low drug load tablets of acetaminophen by fluidized bed granulation using a special low viscosity grade of HPC (HPC-SSL) and Polyvinylpyrrolidone (PVP K30). Tablet properties and drug release are compared.

 
Analytics
   
  ANALYTICS
   
 

Analysis of Cortisone Acetate Tablets by Nexera UC SFC
Sponsored By: Shimadzu
This application note presents an analysis of cortisone acetate tablets according to the USP monograph. The original normal phase method was transferred to an SFC method using both conventional and high-speed columns to determine whether the SFC method can meet criteria and reduce costs.

 
Standars and Regulations
   
  STANDARDS & REGULATIONS
   
 

Improving Product Quality with Risk Assessment Tools
Author: Brenda Percy
Sponsored By: EtQ Inc.

With the product lifecycle moving so fast, many organizations may ask the question: How can we effectively measure quality? The answer is risk management. Learn the elements of risk management and how they help to identify, prevent, and mitigate risk throughout an organization.

 
Pharmaceutical Training
   
  PHARMACEUTICAL TRAINING
   
 

Foaming via Melt Extrusion for Improving the Grindability of Extrudates and Dissolution Rate of Oral Dosages
Authors: G. Terife, C. Martin, C. G. Gogos, and N. Ioannidis
Sponsored By: Leistritz

Significant development efforts are occurring that utilize twin-screw extruder (TSE) technologies as part of unique foam extrusion systems for emerging bioplastics and pharmaceutical products.

 
Poster
   
  POSTER
   
 

Effect of Binder Type on Dry Granulation and Tablet Compression Properties of a Model Formulation
Authors: Anshul Gupte, Michael Dehart, and Rahul Haware
Sponsored By: Metrics Contract Services

The purpose of the investigation was to compare the impact of roller compaction processing parameters and resulting tableting properties of roller compacted granules of specific binders.