Thursday, December 4, 2008

Aseptic Processing Resource Center

Podcast: Jim Akers on Aseptic Processing
PharmaManufacturing.com
In this podcast, Jim Akers discusses trends in aseptic processing, including the reduction of the human element and the rise of automation.

Jim Akers Knows Your Dirty Secrets
PharmaManufacturing.com
We’re on the cusp of an aseptic processing sea change, Akers says, and you are to thank for it.

Report from BIO 2006
PharmaManufacturing.com
This article, adapted from our "On Pharma" weblog, summarizes a number of the key pharmaceutical-related presentations from the BIO 2006 show, which was in Chicago from April 9 through 12.

A New Vaccine Supply Strategy
PharmaManufacturing.com
Not one solution, but a combination of new technologies and simple approaches will be needed to prepare for the onslaught of flu and other diseases.

More Articles »

White Papers: In Depth Research

Residual Solvents by HT3 Headspace in Reference to USP 467 with a Comparison of Static Versus Dynamic Headspace Analysis
Author: Teledyne Tekmar
Posted: 09/22/2008
Residual solvents in pharmaceuticals are defined as volatile organic chemicals that are used or produced in the manufacture of drug substances, excipients or in the preparation of drug products. Because residual solvents do not provide therapeutic benefits, they should be removed, to the extent possible. Drug products should contain no higher levels of residual solvents than can be supported by safety data. Looking forward to the implementation of a revised USP 467 method, Teledyne Tekmar evaluated the new protocol, therefore this application will comply with the procedure and criteria changes set forth in the USP30 NF25, Second Supplement (effective December 1, 2007) and the interim revision announcement.

Online Reaction Monitoring of Inprocess Manufacturing Samples by UPLC
Author: Waters Corp.
Posted: 07/10/2008
Process Analytical Technology (PAT) is a critical component in manufacturing, relied upon to ensure product quality and improve process yields. In this white paper, Waters Corp. discusses the use of novel Waters technology for online reaction monitoring of inprocess manufacturing samples, which allows for simultaneous quantification of APIs and process impurities.

More White Papers »


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