January 13 - 17, 2014
Renaissance Hotel and Palm Springs Convention Center Palm Springs, California

A Community Dedicated to the
Evolving Field and Future of Biotherapeutics
2014 Archived Content

SHORT COURSE 11: EXTRACTABLES AND LEACHABLES: FUNDAMENTALS AND APPLICATIONS TO BOTH FINAL PACKAGING AND SINGLE-USE SYSTEMS

 

Tuesday, January 14 | 5:00-8:00 pm



This short-course will aim to outline the considerations and direction taken when evaluating and understanding Extractables and Leachables present in either Single Use Systems or Final Packaging. The course will be begin with outlining key fundamentals of material chemistry and typical leachable sources, while also highlighting properties that govern migration of these compounds. Further incorporation of industry recognized "best practices" with these concepts will introduce evaluation strategies and explain the thought process in designing appropriate analytical studies to assess these systems. Throughout the course, strategies to overcome typical obstacles encountered in such E&L programs will be illustrated. Finally, resources associated with establishing suitable testing criteria and safety assessments will be presented.

Introductions and Course Objectives

  • Defining the Challenges
  • What are Extractables and Leachables?
  • Key USP Requirements
  • Risks vs. Rewards of Testing

 

Material Overview

  • Types of Material
  • Understanding Polymers: Chemistry and Mechanical Properties
  • Additives that Enhance Polymer Properties, Additive Transformation and Degradation Chemistry
  • Typical Extractables Profile for Polymers, Metal and Glass
  • Managing the Polymer Supply Chain
  • The Materials Assessment

Overview of E&L Best Practices

  • PQRI: Inhalation Drugs, Parenterals, Ophthalmics
  • Bioprocess Systems Alliance (BPSA): Single-Use Equipment

 

Controlled Extractables Testing (CES)

  • Factors that Effect Migration of Chemicals from Polymers
  • Designing an Efficient CES: Solvents, Time, Temperature, Techniques
  • Analytical Methods for Analyzing Extracts

Leachables Studies

  • Goals of Study
  • Analytical Methods, Thresholds
  • Correlating Leachables to Extractables
  • Dealing with Unknown Peaks
  • Toxicological Assessment of Leachables

 

Instructor:

Michael A. Ruberto, Ph.D., President, Material Needs Consulting, LLC

John Iannone, Program Manager and Technical Specialist, Toxikon Corporation

 

Speaker Biographies

 

Michael A. Ruberto, Ph.D., President, Material Needs Consulting, LLC 

Dr. Michael Ruberto is the President of Material Needs Consulting, LLC which provides consulting services to manage the development and commercialization of medical devices and packaging, with a special emphasis on material selection, extractables and leachables, and supply chain management. He is an active member of various pharmaceutical working groups that have developed “best practices” for characterizing and evaluating the safety of container closure systems and packaging for several different drug dosage forms. Some of these teams include: • PQRI Orally Inhaled and Nasal Drug Product E&L Working Group • PQRI Parenteral and Ophthalmic Drug Product E&L Working Group • United States Pharmacopeia (USP) Packaging and Storage Expert Committee Dr. Ruberto was formerly the Head of Regulatory Services for North America at Ciba Specialty Chemicals where he was responsible for world wide notifications of new products, food contact notifications, and regulatory compliance of Ciba chemicals. He also designed leachable and extractable studies for the FDA approval of medical devices, packaging, and labels used on drug containers. Dr. Ruberto was previously the Director of Analytical Research, where he led a full service analytical laboratory that specialized in performing testing associated with the development and commercialization of new products including chemical characterization, migration studies, applications support, and technical service. Dr. Ruberto was employed by Ciba for fifteen years where he has performed numerous migration studies to support FDA and European Union indirect food contact notification for various additives, pigments, and polymers. He was part of a team commissioned to establish a Good Laboratory Practice (GLP) and Good Manufacturing Practices (GMP) program in Ciba’s Analytical Research Department and served as GLP Study Director for many product characterization and Base Set studies needed for global product registration of novel additives. Dr. Ruberto received a B.S. with thesis from Stevens Institute of Technology and a Ph.D. in Analytical Chemistry from Seton Hall University.

 

John Iannone, Program Manager and Technical Specialist, Toxikon Corporation 

John Iannone is a Technical Lead and Program Manager at Toxikon Corporation. Since joining Toxikon in 2004, Mr. Iannone has assisted several drug and medical device developers with the development of product safety testing strategies. His areas of expertise include biocompatibility testing of combination devices, material characterization, and study design for custom microbiological and extractable/leachable studies. His responsibilities focus on providing technical support in client interface regarding unique testing requirements and facilitation of sound technical risk assessments of medical devices. Prior to joining Toxikon, Mr. Iannone received his Biomedical Engineering degree from Boston University, where he later became a research engineer in the College of Engineering.


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