When making Parenteral Drug Products, pharmaceutical companies are faced with the need to further investigate the materials that will be in contact with the drug product, either during manufacturing, intermediate storage, storage in its final packaging, or during the delivery of the drug to the patient. While historically, the potential safety issues were the main driver in these kinds of investigations, recently, also quality issues – i.e. for biophar-maceuticals – have become an additional concern.
This workshop will look at "Extractables & Leachables" from many different angles: Definitions, Regulatory, Material & Polymer Science, Analytical E/L Methodologies, Safety Assessments, Study Design for different parenteral primary packaging systems, as well as for injection devices.
In addition, during the workshop, a full session will be dedicated to an in-depth update on regulations, standards and recommendations in this field (PQRI, USP, ISO 10993, BPOG...).
Who Should Attend
- Pharmaceutical Packaging and Device Engineers
- Production Engineers, using SU systems
- Regulatory Affairs Officers
- Pharmaceutical R & D Managers
- Analytical Chemists, working on E/L
- Quality Assurance Officers
Upon completion of this workshop, you will be able to:
- Explain in detail the current regulatory requirements for container/closure qualification form an E/L perspective.
- Explain the upcoming changes in regulations, standards and recommendations from PQRI, USP and BPOG and how these changes could impact a future evaluation of a pharmaceutical C/C-system.
- Understand the materials of construction – and their composition – of container closure systems, and how they could impact the safety and quality of a parenteral drug product.
- Put together an evaluation program (review of provided documentation, analytical testing) of different types of parenteral drug product container/closure systems.
- Perform a safety/risk assessment of analytical results, obtained after completion of an E/L study
Dennis Jenke, PhD, Chief Executive Scientist, Triad Scientific Solutions
Dennis Jenke is the Chief Executive Scientist for Triad Scientific Solutions, a provider of science-based solutions to plastic/product compatibility challenges associated with packaging, manufacturing equipment and delivery devices in the pharmaceutical, cosmetic, food and related industries. He was a Distinguished Scientist at Baxter Healthcare Corporation where for more than three decades he lead a team whose primary responsibility includes the assessment of material/product compatibility, specifically with respect to establishing the suitability for use of packaging systems, manufacturing systems and administration devices for pharmaceutical products (for example, extractables/leachables and product ingredient binding). He has published extensively in the areas of analytical chemistry, environmental science and material/solution compatibility and serves as an expert reviewer for numerous pharmaceutical and analytical journals. He is the author of the book Compatibility of Pharmaceutical Solutions and Contact Materials; Safety Considerations Associated with Extractables and Leachables and a contributing author to the Leachables and Extractables Handbook. Dennis Jenke is a member of numerous industry groups whose charter is to establish best demonstrated practices in the area of material/solution compatibility.
Piet Christiaens, PhD, Scientific Director, Nelson Labs Europe
Piet Christiaens received his Ph.D. from the Analytical Chemistry Department of the University of Leuven (Belgium) in 1991. From 1992 to 1997, he was Lab Manager in two Analytical Contract Laboratories. From 1997 to 2000, he worked as an independent consultant with Shell Chemical Company in Houston, Texas where he conducted research on a new hydrogenation catalyst system for Hydrogenated Triblock Co-Polymers (Kraton Polymers). Since 2001, Mr. Christiaens has been Scientific Director at Nelson Labs Europe (formerly Toxikon Europe) where he develops analytical methods and protocols for both extractables and leachables studies for the Medical and Pharmaceutical Industries. Mr. Christiaens oversees all laboratory operations at Nelson Labs Europe and also supports the European business development team.
John Iannone, Director of Extractables/Leachables and Impurities, Albany Molecular Research, Inc. (AMRI)
John Iannone has a background in Biomedical Engineering from Boston University, where he later became a research engineer. Since going from Academia to Industry 13 years ago, John has assisted multiple pharmaceutical & medical device companies with the development of their product safety evaluation strategies. Previously a Technical Specialist at Toxikon, he now is the Director of Extractables/Leachables and Impurities at Albany Molecular Research, Inc (AMRI). His areas of expertise include Material Qualification & Biocompatibility, Extractables & Leachables, Chemical Characterization, and attainment of Biological or Toxicological risk assessments for medical devices, pharmaceutical container systems, bioprocessing systems, and combination products. John has given numerous technical presentations and has led several workshops on Extractable & Leachable Considerations, Biocompatibility, Microbiology, and Regulatory Testing Requirements. He also participates in the development of both industry groups’ recommendations and regulatory guidelines through Expert Panel membership, global Technical Committees, and industry collaborations. Additional responsibilities have included providing technical consultation to clients regarding unique testing requirements in an effort for them to meet global regulatory expectations.