Pharmaceutical Technology February 2018

February 2018 | Volume 42, Issue 2
Pharmaceutical Technology February 2018 Issue
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By Pharmaceutical Technology Editors
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Cover Story
New technologies, such as NIR and Raman, enable online measurements of blending and content uniformity in the production of solid dosage forms.
Layout and supply details must be considered when implementing a fully disposable biopharmaceutical manufacturing process.
A systematic framework and software are needed to implement material traceability in continuous pharmaceutical tablet manufacturing.
X-ray powder diffraction exploits the interaction between x-rays and matter to study the structural and microstructural properties of materials.
Experts share insights on the various methods used for purity and impurity analysis of therapeutic proteins.
Steve Hayward, product marketing manager at BIOVIA, Dassault Systèmes, discusses the importance of both technology and people in the modern laboratory.
This article explores lab data integrity violation trends, as well as a sampling of the latest technologies that can help avoid them.
Proposed guidance documents assist drug manufacturers in qualifying single-use systems for commercial drug production.
While more companies are embracing taggants, researchers are developing new technologies that will be extremely difficult to reproduce.
Peer-Reviewed Research
The following study describes a methodology to establish, control, and characterize an aerosolized bioburden within a test chamber and determine the settling rate of the bioburden.
Regulatory Watch
Greater clarity and harmonization in ATMP regulations are needed to promote the development and commercialization of these therapies.
Manufacturers tackle regulatory and competitive issues to develop complex therapies and biosimilars.
Regulations and industry guidelines focus on ensuring excipient safety by specifying risk assessments and shared responsibility.
From The Editor
Hospitals form not-for-profit drug company to combat drug shortages and high prices.
Ask the Expert
Regardless of the phase of development and the level of GMPs being applied, there should be adequate controls and knowledge to assure patient safety, according to Susan Schniepp, fellow at Regulatory Compliance Associates.
Product Spotlight
By Pharmaceutical Technology Editors
The Flexicon PF7 peristaltic tabletop aseptic liquid-filling machine from Watson-Marlow Fluid Technology Group is suitable for GMP-regulated biotechnology and pharmaceutical operations.
By Pharmaceutical Technology Editors
Ross, Charles & Son's Tumble Blenders now offer protective light curtains that provide automatic safety shutoff whenever an operator crosses a defined security boundary.
By Pharmaceutical Technology Editors
Colorcon's Opadry SGR, Rapid Sugar Film Coating System, is an aqueous, high-gloss sugar film coating system for pharmaceutical products.
By Pharmaceutical Technology Editors
LogTag has added two new devices to its temperature data logger series.
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