On-Line Liquid Chromatography
as a Process Analytical Technology
The November 2006 CSSC meeting will be held at the Yankee Silversmith Inn in Wallingford, CT.
The meeting will feature a technical presentation by
Rick E. Cooley of the Process Analytics Center of Excellence at Dionex
Corporation, as well as hors d'oeuvres and a cash bar. The cost of the meeting is
$25 ($15 Students and Emeritus) and is to be paid at the event.
Abstract:
A desired goal of the FDA’s PAT framework is to design and develop well understood processes that will consistently produce a pre defined product quality. The technology tools that support achievement of this goal can be classified into four main areas: multivariate data analysis, process analyzers, process automation and control, and knowledge management. Process analyzers have played a significant role in chemical manufacturing for over 60 years by providing “real time” measurement of product quality attributes which enable the process operating parameters to be continuously adjusted to maintain optimal process efficiency and product quality.
Liquid chromatography (LC) based analyzers are an example of the types of measurements that have been adapted from the laboratory to on line applications. Although LC is widely utilized in the pharmaceutical industry laboratory for monitoring product quality attributes, it is less widely recognized as a process analytical technology. Liquid chromatography’s attributes of high resolution and low detection limit can be particularly advantageous when on-line measurement of analytes in a highly complex process matrix is required or when quantitation of low level impurities is necessary. The value of on line LC measurements have been demonstrated several times during its 25+ year history through applications in nuclear and fossil fuel power generation and the chemical, petrochemical, and pharmaceutical industries.
This presentation will include examples of on line LC applications in pharmaceutical processes involving both small and large molecules. The examples will be used to explain how on line LC has been utilized for monitoring to increase process knowledge and as an enabling technology for process automation and control to increase process efficiency and reduce process variability.
Specific topics to be covered during the presentation are:
Attributes of LC that make it a valuable process analytical tool
Applications where these attributes are particularly valuable
Overview of the capabilities of a typical on line LC analyzer
Review of on-line LC applications in the semiconductor, power generation, and chemical industries
Detailed discussion of examples of on-line LC applications in the pharma and biopharma industries
Biography:
Rick Cooley -- Process Analytics Center of Excellence, Dionex Corporation
Rick Cooley is currently the manager of the Process Analytics Center of Excellence at the Dionex Corporation. He assumed this position in March 2005 after retiring as team leader of the Process Analytical Measurement Technology group and corporate leader of process analytics at Eli Lilly and Company where he was employed for over 30 years. Rick has been involved in the development, installation, and support of on-line chromatographic and spectroscopic analyzers to provide closed loop control of bulk API processes since 1981. He has published and presented on automated laboratory instrumentation, on line HPLC, and process automation utilizing process analytics including a chapter on on line LC in the text: Analytical Instrumentation - Practical Guides for Measurement and Control. He is a Senior Member of the Instrumentation and Automation Society of America (ISA), founding organizer of the Pharma Process Analytics Roundtable, a guest lecturer on process analytics at the National Institute of Pharmaceutical Training and Education hosted at Purdue University, a member of the FDA's Process Analytical Technology Advisory Sub-Committee, as well as, a participant on PAT committees associated with PhRMA, PDA, ASTM, and USP. Rick has been actively involved with the International Forum on Process Analytical Chemistry (IFPAC) conference since 1993 as a presenter, board member, session organizer, and conference chairman.
