Our 2014 posters included:
Particulates in Single-Use Bags
Mike W. Johnson, Entegris, Inc.
Isolation and Analysis of Packaging Related Impurities from Matrices Containing Polysorbate and Polyethylene Glycol Using Solid Phase Extraction in Tandem with Liquid Chromatography/Mass Spectrometry
Steve A. Zdravkovic, Dr. Matthew Bruss, James O. Mullis, Pharmaceutical Product Development, Inc
Evaluation of Extraction Results of Transdermal Pouch and Medicine Container using Accelerated Solvent Extraction (ASE) and Soxhlet
Hua Yang, Kate Comstock, and Linda Lopez, Thermo Fisher Scientific, Sunnyvale CA
High Resolution MS and mzCloud Spectra Database for Extractables Analysis
Kate Comstock and Hua Yang, Thermo Fisher Scientific. 355 River Oaks parkway, San Jose, CA
Analytical Approach to Detecting Packaging Leachables in Biopharmaceutical Products Formulated with Tween 80
Kenneth Wong, SGS
Plus, the PQRI-PODP working group displayed the following posters in the conference room:
1. Classification of Leachables and Extractables for Parenteral Drug Products: Update on the Validation and Revisions to the Proposed Classification
Douglas J. Ball, Pfizer, Inc.; Steven L. Beck, Glaxo Smith Kline; William P. Beierschmitt, Pfizer, Inc.; and Jackie Kunzler, Baxter Healthcare Corp.
2. The Use of Scientifically-Justified Threshold Levels in the Safety Evaluation of Leachables for a Small Volume Parenteral Product
William P. Beierschmitt, Pfizer, Inc.; Cindy Magee, Pfizer, Inc.; and Stephen A. Barat, Forest Research Institute
3. Investigation of an Ocular Irritation Threshold for Leachables and Impurities in Pharmaceutical Products
Mary E. Richardson, Bausch+Lomb, Inc.
4. Parenteral and Ophthalmic Drug Products (PODP) Leachables and Extractables Working Group: Study Protocol - Stage 2; Experimental Protocol for Simulation Study of Blow-Fill-Seal (BFS) PODP Container Closure Systems, Introduction and Experimental Design
Dennis Jenke, Baxter Healthcare Corp. and Thomas Egert, Boehringer Ingelheim Pharmaceuticals, Inc.
5. Controlled Extraction and Simulation Study Results
Thomas N. Feinberg, Alan D. Hendricker, Paul Cveticha, Natalja Tonkihaa, Lisa Covington, Michelle Cree of Catalent Pharma Solutions. John D. Lennon III, Lenn Carico of Becton Dickinson, Dennis Jenke, Piotr Maniak, of Baxter Healthcare Thomas Egert of Boehringer Ingelheim
6. Migration Study Test Results
Alan Hendricker, Thomas Feinberg, Natalja Tonkiha, Lisa Covington, Michelle Cree, Paul Cvetich of Catalent Pharma Solutions, Lenn Carico, John D. Lennon, III, of Becton Dickinson, Jim Castner, Pharma Interface Analysis, Piotr Maniak, and Dennis Jenke of Baxter Healthcare
7. AET Models for Parenteral and Ophthalmic Drug Products
Daniel L. Norwood, Boehringer Ingelheim Pharmaceuticals, Inc.; Scott Pennino, Boehringer Ingelheim Pharmaceuticals, Inc.; and Michael Ruberto, Material Needs Consulting, LLC
8. Thresholds and Best Practices for Parenteral and Ophthalmic Drug Products (PODP)
Diane Paskiet, West Pharmaceutical Services