Pharmaceutical Technology-02-02-2019

Pharmaceutical Technology

Spectroscopy Facilitates Lean Analysis

February 02, 2019

Peer-Reviewed

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Spectroscopic-based control methods were introduced as equivalent alternative methods, first to a gas chromatographic method to monitor an in-process solvent exchange step and second to a potentiometric titration method to release a process input material for drug substance manufacturing.

Effective Root Cause Determination

February 02, 2019

Ask the Expert

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Getting to the root of the cause can prevent future problems, says Susan Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.

FDA Promotes Quality Standards to Reduce Shortages

February 02, 2019

Regulatory Watch

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Policies emphasize the importance of ensuring data integrity in the United States and abroad.

Small-Batch Aseptic Fill/Finish System

February 02, 2019

Product Spotlight

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The Flexicon FPC60 peristaltic fill/finish system from Watson-Marlow Fluid Technology Group can use a variety of modules that allow users to create their own customized filling solution to suit small-batch applications.

Automatic Desiccant Inserter

February 02, 2019

Product Spotlight

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The Pharmafill PS1 Packserter desiccant inserter from Deitz Company features a proprietary cut length sensor system that automatically verifies the desiccant, oxygen absorber, or other packet has been properly fed from the continuous strip before allowing it to be cut for inserting.

Sterile Boot Covers

February 02, 2019

Product Spotlight

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Kimberly-Clark Professional’s Kimtech A5 Sterile Boot Covers with Clean-Don Ties and Vinyl Edge provide reliable sterile protection for ISO Class 5 or higher cleanrooms.

As Drug Spending Slows, Investment Must Pick Up

February 02, 2019

From The Editor

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Biosimilars, pricing strategies, and technology will influence growth in spending on drugs.

A Week is a Long Time

February 02, 2019

From The Editor

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Political instability is causing uncertainty in Europe and wreaking havoc with US regulatory timeframes.

Spotlight on Assessing the Environmental Impact of Medicines

February 02, 2019

Regulatory Watch

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Various groups and stakeholders from pharma, healthcare, and government are responding to a new draft environmental risk assessment guidance from EMA.

Pharmaceutical Technology North America, February 2019 (PDF)

February 02, 2019

Issue PDF

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Click the title above to open the Pharmaceutical Technology February 2019 issue in an interactive PDF format.