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Pharmaceutical Technology-02-02-2019
Pharmaceutical Technology
Spectroscopy Facilitates Lean Analysis
February 02, 2019
Peer-Reviewed
43
2
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.
Fundamentals of GMP Warehouse Design
February 02, 2019
Features
43
2
Storage and retrieval methods and the unique requirements found in building codes are crucial considerations.
Effective Root Cause Determination
February 02, 2019
Ask the Expert
43
2
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.
Process Development Best Practices for Topical Drug Products
February 02, 2019
Features
43
2
Using a QbD approach in the development and formulation of topical products will enable the drug developer to provide a robust control strategy for manufacturing.
FDA Promotes Quality Standards to Reduce Shortages
February 02, 2019
Regulatory Watch
43
2
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
43
2
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
43
2
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.
Multi-Shaft Mixer and Disperser
February 02, 2019
Product Spotlight
43
2
The Ross VersaMix is a multi-shaft mixer suited for viscous applications requiring a high level of accuracy and batch-to-batch consistency.
Sterile Boot Covers
February 02, 2019
Product Spotlight
43
2
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.
Innovations Maintain the Cold Chain
February 02, 2019
Features
43
2
Recent advancements in cold-chain technology offer improved transporting and storing of temperature-sensitive pharmaceutical products.
Advances in Engineering of Protein-Based APIs
February 02, 2019
API Synthesis and Manufacturing
43
2
New platform technologies, advanced modeling tools, and addressing patient needs are important developments.
As Technology Advances, Annex 1 Falls Short
February 02, 2019
Features
43
2
Robotic isolators and single-use technologies are gaining ground, according to aseptic processing consultant Jim Agalloco.
A User-Friendly Approach to Developing an Extended-Release Product
February 02, 2019
Features
43
2
The challenge of achieving sustained delivery of an active ingredient or nutrient can be achieved with extended-release formulations.
Paradigm Shift for Data Analysis and Interpretation
February 02, 2019
Cover Story
43
2
Leveraging vast quantities of analytical data requires digitalization and platform integration.
Changing Perceptions: An Understanding of Lyophilization Advancements
February 02, 2019
Features
43
2
Technical advances in process understanding and control must be accompanied by a change in mindset.
Analytical Method Transfer: Don’t Oversimplify
February 02, 2019
Features
43
2
When transferring a method from R&D to quality control, success hinges on discovering where “the best” and “the most reliable” intersect.
As Drug Spending Slows, Investment Must Pick Up
February 02, 2019
From The Editor
43
2
Biosimilars, pricing strategies, and technology will influence growth in spending on drugs.
Roundup of European Biosimilars Approved in 2018
February 02, 2019
Features
43
2
The market for biosimilars in Europe remains consistently robust, with 16 new biosimilars approved in 2018.
A Week is a Long Time
February 02, 2019
From The Editor
43
2
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
43
2
Various groups and stakeholders from pharma, healthcare, and government are responding to a new draft environmental risk assessment guidance from EMA.
Stimulating Discussion
February 02, 2019
Features
43
2
A new initiative has been launched to help stimulate industry discussion on innovative tech for use across the drug supply chain.
Pharmaceutical Technology North America, February 2019 (PDF)
February 02, 2019
Issue PDF
43
2
Click the title above to open the Pharmaceutical Technology February 2019 issue in an interactive PDF format.