Process Operations Resource Center

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Studying Outliers to Ensure Ingredient and Product Quality
Out-of-trend results from APRs offer unique insights into ingredients and finished products.

Therapeutic Dose: Sampling: Good News, Bad News
Changing from the status quo to meaningful testing will satisfy both FDA and ASTM.

MedImmune in Frederick: Using Ordinary Tools in Extraordinary Ways
MedImmune’s approach may help take the blame off automation for plant startup delays.

Imaging the Blending Process
Hyperspectral imaging can be used to optimize blending, by monitoring the distribution of excipients and APIs in formulation.

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White Papers: In Depth Research

Special Report: Heat Transfer Fluids: Do's, Don'ts, and Best Practices
Posted: 02/14/2011
Heat transfer fluids—from mineral oils to synthetic and organic-based formulas—are the lifeblood of many critical operations within the process industries. This special, interactive PDF looks at how plant personnel can better understand various fluids and fluid properties, and track the performance of their entire heat transfer system.

Mitigating Process Risk and Cost by Immobilizing Activated Carbon
Author: 3M
Posted: 01/24/2011
Drug manufacturers use activated carbon to reduce reaction impurities and de-colorize active ingredients. Its use, however, may result in operator exposure to carbon dust, high maintenance and cleaning costs, and difficulty in removing carbon from the process stream. 3M Purification's Zeta Plus Activated Carbon cartridge series minimizes this risk by immobilizing the activated carbon. This paper describes typical pharmaceutical applications for Zeta Plus, how the optimal carbon type and media grade are chosen for those applications, and best practices for carbon filtering during process scale-up.

Satisfying GMP with Handheld Near-Infrared Analyzers in the Pharmaceutical Industry
Posted: 01/11/2011
Handheld near-infrared analyzers significantly enhance workflow and productivity. This application note discusses uses for handheld near-infrared analyzers in multiple areas of the pharmaceutical life cycle including applications in the discovery, clinical, incoming raw materials inspection, in process checking/control, package verification and post production phases. Download application note.

Handheld Raman Instruments for Pharmaceutical Raw Material Inspection: From the Lab to the Loading Dock
Author: Thermo Scientific
Posted: 08/31/2010
The purpose of this paper is to discuss the application of Raman spectroscopy to the unique requirements of raw material testing. In order to do so we will answer the following questions: What is and why perform identity testing? What are the incentives to speed up testing? Should we consider modifying the testing process? How does the Thermo Scientific TruScan handheld Raman instrument perform ID testing? How well does TruScan work for common raw materials? Can this be deployed in a regulated pharmaceutical environment?

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