Regulatory requirements for extractables and leachables studies cross multiple markets including Pharmaceuticals, Cosmetics, and Medical Devices. Extractables and leachables studies are complex and expensive to carry out. This workshop will highlight new technologies, chemistries, and software that simplify the workflow of these studies.
Join us and take advantage of this unique opportunity to engage in discussions with our scientists about the challenges encountered in your E&L analysis.
Peter Alden, Waters Corporation
|9:30am||UNIFI/QTof Screening Workflow for Confirming & Identifying Extractables
Baiba Cabovska, Ph.D., Waters Corporation
|10:15am||Extractable & Leachable Studies for Parenteral Infusion & Transfusion Products
Jianfeng Hong, Fresenius Kabi USA, Lake Zurich, IL
|11:15am||LCMS Method Development for the Analysis of E & L Compounds
Tammy Argentine, Waters Corporation
|12:00pm||Lunch provided by Waters Corporation|
|12:30pm||Tour of Waters Laboratory|
For additional information or questions, please contact Rich_DeMuro@waters.com.
Speaker Bio's and Presentation Abstracts:
|Peter Alden, Business Development Manager, Chemical Materials, Waters Corporation
Peter joined Waters in June of 1980 as a Research Chemist and quickly earned a promotion to Senior Chemist for our Chemistry Operations Group. Throughout his long career he has worked in the Ion Chromatography, Polymer and Pharmaceutical applications laboratories. In 2011 he became Senior Market Development Manager for the Americas Chemical Materials team focusing on the polymer, fine and specialty chemicals, and energy markets.
|Tammy Argentine, Chemistry Specialist, Waters Corporation
Tammy joined Waters as a Chemistry Specialist for the Midwest Region in 2006. For over 25 years she has focused on the science & promotion of chromatography products. Tammy's expert command of solid phase extraction and LC separation applications is an asset much relied on by her clients & colleagues. Tammy earned a BS degree in Chemistry from Illinois State University in Normal, IL a Masters in Business Administration from the Lake Forest Graduate School of Management in Lake Forest, IL and an MS degree in Biotechnology & Chemical Science from Roosevelt University in Chicago, IL.
LCMS Method Development for the Analysis of E & L Compounds
Developing an LC method requires a series of experiments to determine the best and most effective separation conditions. A method development strategy that is systematic in its approach can greatly simplify the process and allow the scientist to develop optimal separation conditions efficiently. In this seminar we describe a full factorial approach to screening 2 solvent systems & 5 columns to develop an E & L UPLC TQMS method. Results are shown for both an E & L standard and an extracted LDPE ophthalmic bottle. Conversion of the resultant UPLC method to an HPLC column & system for routine QC analysis is then described.
|Baiba Cabovska, PhD, Business Development Manager, Chemical Materials, Waters Corporation
Baiba joined Waters in Milford, MA as a Senior Applications Chemist for the Chemical Materials Business Unit in 2012. Focusing on extractables testing from packaging and polymer separations by UPC2 ® (supercritical fluid chromatography) she also specialized in the use of the UNIFI software platform for chemical materials screening applications. Baiba transitioned to a Business Development role for the Chemical Materials team in 2016, where she leads the E & L program. Prior to joining Waters, Baiba spent 5 years at Mannkind Corporation, where her responsibilities included E & L analysis for a dry powder inhaler device.
UNIFI/QTof Screening Workflow for Confirming & Identifying Extractables
Characterization of packaging, food contact materials, medical devices and many other consumables used in various industries is becoming more and more important due to ever increasing global regulations. The initial step in characterizing extractables from packaging includes targeted screening, i.e. testing the extracts for known compounds. This is a well-established process and is performed using a variety of analytical techniques ranging from GC-FID-MS to LC-UV-MS. However, the final packaging may also include impurities present in the starting materials or degradants formed during the molding process. The structural elucidation of these unknowns is typically a very complex and time consuming process, requiring significant expertise. The UNIFI/QTof Screening Solution provides a simple workflow that includes scientific library creation, multivariate statistical analysis, elucidation and reporting. The single platform informatics solution aids analysts in the evaluation of complex data by simplifying data review and facilitating the decision making process.
|GUEST SPEAKER: Jianfeng Hong, Fresenius Kabi USA, Lake Zurich, IL
Jianfeng Hong is a Senior Research Scientist and the manager of the Analytical Chemistry laboratory at Fresenius Kabi, USA (FK) in Lake Zurich, IL. In this role, he leads a group of analytical chemists studying the extractable and leachable profiles of materials used in FK's blood separation/storage devices and IV pharmaceutical products. His group employs a wide variety of advanced analytical instrumentation including GC/MS, UPLC/UV, Q-TOF High Resolution/Accurate Mass MS, APGC/MS and ICP/MS. He has over eighteen years of experience as an analytical chemist in the pharmaceutical and medical device industries and is a frequent speaker at domestic and international E & L conferences.
Jianfeng earned a BS degree in Chemistry from Sun Yat-Sen University in China and MS degrees in Analytical Chemistry from Sun Yat-Sen and the University of Louisville in Louisville, Kentucky.
Extractable and Leachable Studies for Parenteral Infusion and Transfusion Products
General E & L study practices for parenteral infusion and transfusion products that contact polymeric and glass materials (IV bags, pre-filled syringes, vials, filters, tubing, etc.) during their manufacture, storage and use will be described.
Case studies will be provided to illustrate:
October 25, 2017
1360 N Wood Dale Road
Wood Dale, IL 60191