There has been much speculation and discussion of the universe of organic extractables; its size, its constituents, the nature of those constituents, etc. Knowledge about the universe is critical to establishing best practices for E&L.

In an effort to at least start the process of charting the organic extractables universe, Nelson Labs addressed the question of “what do we know about the universe from experience within that universe?” by performing a retrospective review of the many extractables studies that it has performed in the last several years. Study results were reviewed to establish what organic extractables had been reported in the studies performed over that period of time and how often the individual extractables were reported. Additional information about these extractables, including the methods they were detected with and their key analytical characteristics [e.g., relative response factors, retention indices (for GC/MS compounds) were abstracted from the compiled data and physiochemical characteristics of the extractables were collated from various sources.

The results of this data collection and analysis process will be discussed and the use of the information to establish best practices will be considered.

Presented by Dennis Jenke, Principal Consultant of Nelson Labs EU

Dr. Dennis Jenke is the Chief Executive Scientist at Triad Scientific Solutions LLC, a consulting organization that provides integrated, science-based, and practical E&L solutions to the pharmaceutical, cosmetic, food industries. Dr. Jenke retired as a Distinguished Scientist from Baxter Healthcare Corporation where, for nearly 35 years, he was responsible for developing and defending E&L tactics and strategies. He is widely published on E&L and related topics and is an active member of national and international standard setting organizations. Dr. Jenke is currently a Principal Consultant with Nelson Labs EU, where he interfaces with the Nelson Labs staff and clients to design, implement and report science-based, effective, efficient and complaint E&L studies and programs.

Followed by a live Question and Answer Session

Sponsored by Nelson Labs

Nelson Labs is a global leader in microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries. Nelson Labs serves over 4,000 customers across 15 facilities in the United States, Mexico, Asia, and Europe.  We provide our customers with mission-critical testing services, which assess the quality, effectiveness, and end-to-end sterility of products and, ultimately, the impact of the products on patient safety. These services are necessary for our customers’ regulatory approvals, product releases, and ongoing product performance evaluations.  We have over 800 laboratory tests supporting our customers from initial product development and sterilization validation, through regulatory approval and ongoing product testing for sterility, safety, and quality assurance.  Pharmaceutical lab testing services include microbiology, biocompatibility and toxicology assessments, extractables and leachables evaluations of pharmaceutical containers, sterilization validation, sterility assurance, packaging validation and distribution simulation, and facility and process validation.  We also provide expert advisory services to help customers navigate the regulatory requirements applicable throughout their product’s lifecycle. We are regarded as a best-in-class partner with a strong track record of collaborating with customers to solve complex issues.