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PharmTech
October 2016
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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.

FEATURED WHITEPAPER

Mapping Strategy Fundamentals

Rotronic

This Rotronic technical note covers the basic considerations for developing a mapping project strategy. See examples of an incubator and room mapping strategy.


Analytical

Increasing the flexibility of T-Wave Ion Mobility

Jonathan Jones, Eleanor Riches, Michael McCullagh, Jonathan P. Williams, Emma Marsden-Edwards; Waters Corporation

The ability to substitute other ion mobility buffer gases instead of the typically used N2 can provide enhanced ion mobility (IM) resolution, increased sample coverage, and improved confidence in IM measurements.

Manufacturing

How to Source Pneumatic Conveying Systems for Pharmaceutical Excipients, APIs, and other Powders that are "Difficult-to-Move"

David Kennedy; VAC-U-MAX

This technical paper addresses key topics and design trends to consider when designing a sanitary pneumatic conveying system for batch and continuous processes. This application note defines difficult powders and their respective poor flow properties, addressing the challenges in moving these powders into the conveying line from the pick-up point, feeding excipients and APIs at a constant rate, and discharging material to from the material receiver, while maintaining a dust-free processing environment.

Effect of Extrusion Parameters on Solid Dispersions

C. Martin, J. DiNunzio, J.M. Keen, A. Machado, J.W. McGinity, H. Sandhu; Leistritz Extrusion

The objective of this research is to investigate the extrusion process space in co-rotating and counter-rotating extruders, which is critical in ensuring the properties of pharmaceutical solid dispersions.

Supply Chain

Combatting Product Diversion with the Mighty Microtag

Peter Wong; TruTag Technologies, Inc.

Unauthorized product diversion directly attacks your bottom line and erodes patient safety. Learn how on-dose authentication can safeguard your drug products, provide key business informatics, and improve your financials.


Regulatory

The Risk Management Guidebook: Strategies, Tools for Success and Other Insights

Tim Lozier; EtQ

What can companies do to prevent risks from occurring? The answer lies in having an automated risk management system. This guidebook provides you with a selection of our risk-based literature, all in one place.

Integrating cGMP with ISO 9000 Quality Management System

John MacLauchlan; Impact Analytical

There can be significant value in integrating an overall quality management system (QMS) with compliance to regulations such as 21 CFR Part 210 and 211.


Outsourcing

Determination of Amino Acid Composition of Pharmaceutical Products

Natalia Belikova, Ph.D.; SGS

This whitepaper outlines the development of a liquid chromatography method for simultaneous determination of approximately 20 amino acids in simple and complex mixtures that complies with the system suitability requirements of the Ph. Eur. general chapter (2.2.56).


Quality

Pharmaceutical Cleaning Validation

Malcolm McLaughlin; Alconox, Inc.

This whitepaper provides a comprehensive description of how to perform cleaning validations in the pharmaceutical industry. This paper focuses on the calculations and the process.


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