Pharmaceutical Technology’s Pharma Knowledge Resources Newsletter:
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PharmTech
May 2018
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In This Issue

Build your pharma development and manufacturing knowledge base with the latest whitepapers, application notes, posters, and other educational resources from bio/pharma industry suppliers.

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FEATURED WHITEPAPER

Analysis Using Counter-Rotating Twin Screw Extruder

Brian Machado, Abbe Haser, Feng Haight, Charlie Martin, Augie Zhang; Leistritz Extrusion

Various extrusion operating conditions and formulations were used to enhance the solubility and recovery of Meloxicam (MLX) in copovidone to near 100% on a counter-rotating twin screw extruder (TSE).

Supply Chain

Battling Counterfeit Medicine Through Packaging Serialization

Mario Scigliano, Christian Ahlmark; CordenPharma International

This whitepaper discusses informative packaging serialization requirements and deadlines with keys to combating worldwide drug counterfeiting. Topics include supply-chain serialization techniques like microscopic RFID tags, security labels, invisible inks, and track-and-trace technologies.

Regulatory Considerations for Incorporating PCID into SODF Drugs

Michael O’Neill, Chief Science Officer; TruTag Technologies, Inc.

Diverted and falsified drug products create safety risks in the supply chain. On-dose authentication methods can assign special code libraries to groups, lots, or manufacturing segments of product and can complement serialization.

Regulatory

How to Write to Regulatory Agencies When Things Go Wrong

Martin Lush; NSF International, Pharma Biotech

Responding to severe regulatory criticism? Need some essential guidance? This whitepaper by Martin Lush includes step-by-step guidance on how to write to regulatory agencies when things go wrong.

Quality

Five Ways Quality Impacts the Bottom Line [Video]

Sparta Systems, Inc.

Total cost of quality is a term used to determine the resources needed to prevent poor quality. Generally, three quarters of these costs come from outside of the quality department. To increase company-wide operational efficiency, quality teams must implement systems and processes to communicate and collaborate with internal and external partners. Watch this video to learn five ways quality teams can lower costs and increase profitability.

Three Critical Processes for Improving Quality Management in the Life Sciences

Brenda Percy; EtQ

This whitepaper explores the three most critical functions for automation in a life-science organization so you can smoothly transition to an effective quality management process while increasing effectiveness and efficiency.

Cell Therapy and Right-First-Time Manufacturing

Emerson

Cell therapy manufacturers depend on a manufacturing execution system (MES) system to provide accuracy, flexibility, and stability needed to ensure right-first-time production is achieved every time in this revolutionary and complex environment.

Controlled-Environment Cleaning

Michael Dougherty; Perfex Corporation

Understand the difference between cleaning and disinfection procedures in controlled environments and how to optimize your TruCLEAN Mopping System for maximum contamination control.

Applications in Pharmaceutical Manufacturing

Alconox, Inc.

The use of aqueous cleaning in pharmaceutical manufacturing can provide numerous benefits in terms of effectiveness, minimal surface residue, and easier cleaning validation.

Manufacturing

Get to Market Faster

Dick Winkelmayer, Brendan Lucey; ILC Dover

Upgrading to modern single-use powder handling in your process gets your product to market without time wasted on complicated weigh and dispense steps, cleaning validations, or worries about powder in the air and in the room.

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