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Pharm Tech
September 2016
Volume 28, No. 9
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SUPPLIER QUALITY

Offshore Supplier Quality: Trust, But Verify

Agnes Shanley

Training and mock audits are the key to preventing data integrity issues with partners offshore, but the process must start at home.
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API SYNTHESIS & MANUFACTURING

The Search for a Greener Fluorination Reaction

Cynthia A. Challener

Researchers at GlaxoSmithKline report a greener and lower-cost route to chiral fluorolactams that is suitable for scale up.
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PARENTERAL MANUFACTURING

Sterile Injectables Shortages: Can Innovation End A Crisis?

Agnes Shanley

The media blitz surrounding drug shortages has stopped, but critical medications that have no substitutes remain in short supply. Can new approaches turn this situation around?
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PharmTech Europe September Issue
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FORMULATION

De-activating the Ticking Bomb of Brain Diseases with Nanomedicines

Melina Figueiredo, Diana M. Leite, Aikaterini Lalatsa

Nanoparticulate technologies are showing promising potential in delivering both small-molecule drugs and biomacromolecules across the blood brain barrier.
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VISUAL INSPECTION TECHNIQUES

Taking a Closer Look at Parenteral Contaminants

Gretchen L. Shearer, PhD

Visual inspection of parenteral vials is the first step in a root cause investigation.
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MANUFACTURING AUTOMATION

The Internet of Things for Pharmaceutical Manufacturing

Jennifer Markarian

In the pharmaceutical factory of the future, data collected by internet-connected manufacturing equipment improves operational efficiency.
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FACILITY RENOVATION

How to Get the Most Out of Facility Renovations

Eric Bohn

Renovating a facility requires careful design and a plan to minimize production interruption.
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MODULAR MANUFACTURING

New Directions in Modular Manufacturing

Caroline Hroncich

Industry experts discuss recent trends in modular manufacturing.
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PEER-REVIEWED RESEARCH

Best Practices for Cleaning Validation Swab Recovery Studies

Richard J. Forsyth

Swab recovery parameters are reviewed in detail to define best practices and highlight common mistakes to assure successful recovery studies using a risk-based approach.
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ASEPTIC MANUFACTURING

Debating the Role of RABS and Isolators in Aseptic Manufacturing

Fintan Weston

While isolators may offer advantages in high-speed commercial manufacturing lines, RABS continues to be a flexible alternative solution for small-scale production of drugs for clinical use.
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OUTSOURCING REVIEW

Innovation vs. Capacity: How CMOs Compete

Jim Miller

The strategies of a innovation-driven CMO may be different than a capacity-driven CMO.
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TROUBLESHOOTING

Maintaining Hygienic Diaphragm Valves

Paul McClune

A process-specific preventative maintenance program improves productivity and reliability.
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ASK THE EXPERT

Root Cause Analysis–Finding the Root of the Problem

Siegfried Schmitt

Siegfried Schmitt, principal consultant, PAREXEL International, discusses how to find the root cause of the problem.
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REGULATORY WATCH

New Regulations for Combination Products

Sean Milmo

The new regulations aim to introduce greater consistency and uniformity in the assessment and approval of medical devices and in-vitro diagnostics across the European Union.
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FROM THE EDITOR

Of Price and Pen

Adeline Siew, PhD

Pricing of a lifesaving allergy treatment raises concerns.
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PRODUCT SPOTLIGHT

Tumble Blenders Include Improved Safety Features

Tumble Blenders from Ross, Charles & Son now come standard with motors equipped with a electro-magnetic brake.
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Analyzer Automates Cell-Culture Chemistry Analysis

The BioProfile FLEX 2 from Nova Biomedical is a cell-culture chemistry analyzer that allows for automated cell-culture analysis for small-volume culture systems.
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Data Logger Provides Ultra-Low Temperature Readings

The OM-CP-CRYO-TEMP ultra-low temperature data logger from Omega Engineering records temperatures as low as -86 °C.
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Liquid Handling System for Automatic Particle Characterization

The FlowCam ALH automated liquid handling system from Fluid Imaging Technologies is a particle imaging and analysis system that automatically detects, images, and characterizes individual particles and microorganisms.
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Events

14th Annual Pharmaceutical IT Congress

28-29 September, 2016 | London, England

CPhI Worldwide

4-6 October, 2016 | Barcelona, Spain

PDA Visual Inspection Forum

25-26 October, 2016 | Berlin, Germany

more events
 
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