Extractables and Leachables USA 2013

  • ID: 2671533
  • Book
  • Region: United States
  • 138 Pages
  • Smithers Information Ltd
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These proceedings cover all the presentations from this second E&L USA conference. Organized by Smithers Rapra the conference once again brought together the pharmaceutical supply chain and discussed the latest research in minimizing the risks associated with extractables and leachables.

The conference provided a unique opportunity to learn about the latest developments from industry practitioners and working groups to meet regulatory requirements and ensure compatibility in drug-package combinations.
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Paper 1
Introduction to extractables and leachables
Sukhy Toot, Product Manager - Medical Devices, Smithers Rapra NA

Paper 2
Regulatory perspective
Dr Ingrid Markovic, Biologist, CBER, FDA PAPER UNAVAILABLE

UPDATES FROM INDUSTRY WORKING GROUPS

Paper 3
PQRI-PODP working group update
Diane Paskiet, Associate Director, Scientific Affairs, West Pharmaceutical Services
PAPER UNAVAILABLE

Paper 4
The United States Pharmacopeia and the issue of leachables and extractables: past, present
and future
Dr. Daniel L. Norwood, Distinguished Research Fellow, Boehringer Ingelheim Pharmaceuticals, Inc.

Paper 5
Risk management concepts and strategies applied to materials quality
Dr Bobbijo Redler, Principal Scientist, Merck & Co and member of IPAC-RS material working group

E&L APPLICATIONS & CONSIDERATIONS

Paper 6
Risk Based Assessment of Extractable and Leachable Substances from Single-Use Systems
Including case studies of:

A buffer filtration system inclusive of mix bag > filters > connectors > receiving bags
A final filling assembly inclusive of formulation bag > filter > reservoir bag > tubing manifold etc.
Ross W. Acucena, Regulatory Consultant, Services & Solutions, Process Solutions Business Unit,
EMD Millipore PAPER UNAVAILABLE

Paper 7
Product equivalency for medical devices; case studies for biodegradable and permanent
implantable devices

Case 1: Analytical data will be presented for evaluating the effect of a manufacturing site change for a
biodegradable implantable device

Case 2: Analytical evaluation process will be presented for a permanent implant. Method validation aspects will be
discussed
Dr. Gyorgy Vas, Principal Scientist, Johnson&Johnson Global Supply Chain

Paper 8
Extractable and leachable studies of twist-off ports (T.O.P.) used for blood pack containers

Results of ICP/OES testing on TOP
GC/MS, UPLC/UV and UPLC/MS with determination of accurate mass
Inconsistencies between the leachable and extractable studies
Jianfeng Hong, Chemistry Laboratory Manager, Fenwal, a Fresenius Kabi Company

E&L CASE STUDIES ON PARENTERALS

Paper 9
E&L’s from elastomeric components for parenteral packaging: Understanding the impact of
process parameters and sterilization methods

Impact of processing parameters and environmental stresses on elastomeric components
Analytical techniques used to capture variation in extractables and leachables
Relationship between impact of stresses on E&L profiles and other material properties
Douglas Cusato, Staff Scientist, Upstream Product and Technology Development, BD Medical -
Pharmaceutical Systems PAPER UNAVAILABLE

Paper 10
Extractable and leachable study of container closure/delivery systems for parenteral
medications
Samuel O Akapo, Ph.D, Senior Manager Analytical R&D, Teva Pharmaceuticals

TOXICOLOGICAL PERSPECTIVES ON E&LS

Paper 11
Determining acceptable levels of leachables into pharmaceutical products – a toxicological
perspective
Allan W. Ader, Ph.D., DABT, Vice President and Principal Toxicologist, Safebridge Consultants Inc

Paper 12
Case studies of toxicology risk assessment of extractables and leachables
Dr. William Beierschmitt, Regulatory Strategy Lead, Worldwide R&D, Drug Safety R&D, Pfizer
PAPER UNAVAILABLE

Paper 13
Current status of the ELSIE; demonstration of the practical use of the ELSIE safety database
for the rapid assessment of risk from a controlled extraction study
Doug Ball, Research Fellow, Pfizer

MATERIALS COMPOSITION AND QUALITY

Paper 14
Correlating material composition to extractables and then to leachables

Including proposals that close correlations can be established between:
1. A material of construction’s ingredients and it’s extractables;
2. A packaging system extractables and extractables from its materials of construction;
3. A packaging system’s extractables and the packaged drug product’s leachables
Dr. Dennis Jenke, Baxter Distinguished Scientist, Baxter Healthcare, Co-contributor; Michael
Ruberto, Ph.D. Material Needs Consulting, LLC

Paper 15
Characterization of E&L associated with pharmaceutically relevant materials: some
analytical challenges and case studies

Approaches to characterizing E&Ls in complex mixtures encountered with the evaluation of pharmaceutically
relevant materials.
Case studies illustrating examples and analytical challenges
Douglas Kiehl, Senior Research Scientist, Eli Lilly & Company PAPER UNAVAILABLE

CHALLENGES IN E&L STUDIES

Paper 16
(Halo)butyl rubber oligomers in pharmaceutical rubbers

- Origin and formation of (halo)butyl rubber oligomers
- Postulated versus confirmed structure of the different oligomers
- Detection in E&L studies: Analytical techniques and methods
- Obtaining analytical standards for impurity testing: Analytical and toxicological importance and consequences
- Toxicity of rubber extracts / (halo)butyl rubber oligomer standards: Preliminary results
Dr. Piet Christiaens, Scientific Director, Toxikon Europe

Paper 17
Case studies relating to implantable medical device and biologic products

- Structure elucidation of an unknown extractable compound from a filter used in biopharmaceutical manufacturing
- Challenges of E/L studies of hydrogel polymer device
Yijun Lu, Ph.D. & Kelly Chen, Ph.D., Analytical Characterization, Applied Science & Technology,
Global Surgery Group, Johnson&Johnson PAPER UNAVAILABLE

Paper 18
Analytical challenges associated with high toxicological risk compounds (Nitrosamines):
Raising the Safety Concern Threshold

- Nitrosamines
- High toxicity risk compounds
- Mass Spectrometry
- Raising the SCT
Dr. Alan Hendricker, Principal Scientist, Structural Chemistry, Catalent Pharma Solutions
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