Conference Day 2 Agenda - Friday May 9th

Extractables and Leachables would like to thank our main sponsor, SGS, for their support towards this agenda.

Breakfast

  1. Continental breakfast will be served

Leachables in Prefrilled Syringes

  1. Opening remarks from Chair

  2. The value of the "simulated study" as a tool to predict leachables in Prefilled Syringes

    Carsten Worsoe, R&D Specialist Extractables and Leachables, CMC Analytical Support, Novo Nordisk

    • Relationship between extractables, simulated leachables and leachables
    • What is the optimal tool/study to predict leachables in a prefilled syringe?
    • How to perform a simulated study for a prefilled syringe
    • Case studies on simulated studies in prefilled syringes
  3. Q&A Session

  4. Networking refreshment break and chance to view posters

Evaluation of packaging materials and manufacturing systems

  1. Designing analytical method strategies based on test article materials of construction and total organic carbon (TOC) reconciliation

    Dr Sarah J. Robinson, Principal Scientist, VR Analytical

    • Determining the appropriateness of an analytical strategy via TOC reconciliations
    • Case studies of TOC guiding the application of additional analytical testing
  2. Evaluation of the migration behavior of some odor causing chemicals potentially present in packaging materials used in a pharmaceutical industry

    Dr Gyorgy Vas, Research Fellow/Manager of Trace Organic Analytical Laboratory, Intertek

    • How to prevent the contamination of the finished product?
  3. A compilation of safety impact information for extractables associated with materials used in pharmaceutical packaging, delivery, administration and manufacturing systems

    Dr Dennis Jenke, Baxter Distinguished Scientist, Baxter Healthcare

  4. Lunch

Case studies: E&L in single-use systems, implantables and medical devices

  1. Standardization of extractables testing for qualification of single-use process equipment components

    Jerold Martin, Chairman of the Board and Technology Committee, Bio-Process Systems Alliance (BPSA) and Sr. Vice President, Global Scientific Affairs, Pall Life Sciences

    • How are suppliers working with users to establish practical and scientifically based standardized procedures
  2. Extractables & leachables of packaging materials for permanent implantable medical devices: analytical challenges and case studies

    Ying Jiang, Sr. Scientist, Analytical Characterization, Applied Science & Technology, Global Surgery Group, Johnson & Johnson

    • Technical challenges for coated glassine paper and vinyl resins
    • Considerations regarding extraction conditions for "dry" and "wet" packages
    • Analytical characterization of the extractables
  3. Extractable and leachable studies for medical devices for blood separation related technology

    Jianfeng Hong, Chemistry Lab Supervisor, Research and Development, Medical Devices Division, Fresenius Kabi, USA LLC

    • Case study of E&L analyses of a leucodepletion filter
    • Discussion of risk assessment of E&L compounds
  4. Closing remarks

  5. Close of Conference