Every month, Control's editors take a specific product area, collect all the latest, significant tools we can find, and present them here to make your job easier. If you know of any tools and resources we didn't include, send them to [email protected] and we'll add them to the website.
U.S.Food & Drug Administration
This 66-slide Powerpoint presentation, "The Impact of Micro-Analytical Instrumentation on PAT Applications" by M. Koch of the Center for Process Analytical Chemistry (CPAT) at the University of Washington, covers definitions, origins of PAT, possible applications, techniques and more. The complete presentation is at http://tinyurl.com/25l3r9r.
Subscribers to this website get secure, online access to search, view, bookmark and print documents. Online documents are updated daily and multiple users can share a single license. The analyzers collection of PIP practices covers such topics as toxic gas detection systems; engineering guidelines, project implementation guidelines, field installation, bid and proposal information, acceptance testing and data sheets for process analyzers. A direct link to the collection is at http://tinyurl.com/yemg97r.
In this podcast, Control editor-in- chief Walt Boyes and executive editor Jim Montague speak to ARC Advisory Group's John Blanchard about market forces and technology trends affecting process analytical technology (PAT). For example, is it just to comply with the FDA's rules, or are there other reasons to use PAT? Go to www.controlglobal.com/multimedia/2008/034.html to access and listen to the complete recording.
PAT IN PHARMA
U.S. Food & Drug Administration
This white paper, "Guidance for Industry: PAT—A Framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance," covers in detail the background of PAT, tools for its use, and strategies for implementing PAT in pharmaceutical operations. A direct link is at http://tinyurl.com/2dnl5h9. The FDA's general web site also contains additional links to tools, committees, presentations and other information about implementing PAT systems.
BATCH MANUFACTURING AND PAT
"Integrating Quality and Process Information in a Batch Context for Semi-Continuous Processes," is a white paper from Dow Chemical. It discusses the scope and approach taken to integrate quality information from various analytical devices through a laboratory information management system (LIMS) with a real-time process information system information connected to a distributed control system (DCS). It is free, but registration is required. A direct link is at http://tinyurl.com/29jjnly.
The Center for Process Analytical Chemistry
The Center for Process Analytical Chemistry (CPAC), established at the University of Washington in Seattle in 1984, is a consortium of industrial, national laboratory and government agency sponsors, who address multidisciplinary challenges in process analytical technology (PAT) and process control through fundamental and directed academic research. Among the resources on the CPAC website are numerous links to New Sampling/Sensor Initiative (NeSSI) material, including direct links to presentations given at recent NeSSI conferences, a basic explanation of NeSSI technology, a list of NeSSI-related product manufacturers, and direct links to presentations given at recent meetings. A link to these presentations is at http://tinyurl.com/23qhcjf
PAT AND AUTOMATION
"Process Analytical Technology and Scalable Automation for Bioprocess Control and Monitoring" is a white paper from Talecris Biotheraputics (www.talecris.com) about its approach to PAT and automation, as well as examples of PAT deployed on a bioprocess. It introduces the concept of integrated and scalable automation, provides a comparison of automation concepts and explains how the selected automation effectively supports initiatives such as PAT. A direct link to the paper is at http://tinyurl.com/29flqot.