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PharmTech
February 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.

FEATURED WHITEPAPER

Bringing Business and Data Integrity Benefits to an Organization

Bob McDowall, Gunnar Danielson; Mettler-Toledo Analytical GmbH

This whitepaper will demonstrate that an investment in an instrument data system including validation can bring substantial business benefits to both a laboratory and its parent organization.

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Quality

21 CFR Part 11/Annex 11 Compliance

LabVantage Solutions Inc.

Learn the requirements for 21 CFR Part 11 and Annex 11 compliance, as well as the new draft guidance on temporary data, and how LabVantage software supports customer compliance.

2018 Pharma Quality Outlook

Michael Mooney; SPARTA SYSTEMS

This report examines the results of a Pharmaceutical Technology survey on 2018 quality goals and obstacles. The report findings offer insight into how quality teams can impact company-wide performance in 2018.

Controlled Environment Cleaning

Michael Dougherty; Perfex Corporation

Understand disinfection and cleaning procedures in critically controlled environments and how to optimize your TruCLEAN Mopping System for maximum contamination control in this whitepaper.

Manufacturing

Analysis Using Counter-Rotating Twin Screw Extruder

Brian Haight, Charlie Martin, Augie Machado, Abbe Haser, Feng 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).

Pharmaceutical Cleaning Validation

Malcolm McLaughlin; Alconox

A comprehensive description of how to perform cleaning validations in the pharmaceutical industry. This paper focuses on the calculations as well as the process.

Excipients

Porous Silica Creates New Applications and Markets

Craig Leidholm, senior vice president of Materials Manufacturing; TruTag Technologies, Inc.

Silica is well known in the pharmaceutical industry as an excipient, but there is another class of silica excipients that are of interest in pharmaceuticals—porous silica.

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