• flag
    • flag
    • flag
    • flag
    • flag
    • flag
    • flag
    • flag
  • Have a question? Call us: 
    +1 (800) 472-4508

    Pharmapack 2024

    January 24-25th, 2024
    Porte de Versailles – Hall 7.2
    Paris, France
    Stephanie Wojdyla
    630 640 5133
    [email protected]

    We are happy to announce Sterigenics will be exhibiting with our sister company Nelson Labs at Pharmapack – booth D58 – Hall 7.2, in Paris, France on January, 24 – 25, 2024. Join us to discuss the latest in innovation and packaging considerations. For more information, please visit: www.pharmapackeurope.com

    Please plan on joining us at the Learning Lab Theatre L20 at PHARMAPACK, to hear from our dynamic industry-leading experts.

    Kathleen Lava PhD, Senior E&L expert – Nelson LabsWednesday, January 24th 2024. 10:10-10:40AM CET
    Presenter: Kathleen Lava PhD, Senior E&L expert – Nelson Labs
    A risk-based approach towards the assessment of process-equipment related leachables (PERLs) – Case Study
    Manufacturing processes involve a complex set of plastic materials that may introduce process-equipment related leachables (PERLs) into the final product. This possibility poses potential risks to the biocompatibility, safety, or quality of the drug product. However, not all manufacturing components contribute to PERLs to the same extent. Adopting a risk-based approach involves evaluating process conditions, the type of process material used, and the composition of the process solution. This evaluation allows for the definition of relevant test requirements regarding extractables and leachables. This presentation aims to highlight the primary principles of such a risk-based evaluation through a case study.

    Bernd Zeiss, Head of Scientific Affairs and Application Technologies, GerresheimerThursday January 25, 2024 from 10:10am – 10:40am CET
    Presenter: Eric Offermann, Principal Scientist R&D, Sterigenics
    Bernd Zeiss, Head of Scientific Affairs and Application Technologies, Gerresheimer
    Prefilled Ophthalmic Syringes – New Possibilities in Terminal Sterilization
    Eric Offermann and Bernd Zeiss will speak about Nitrogen Dioxide (NO2) as a new sterilization method and an alternative to EtO gas. A joint study carried out by Gerresheimer, Sterigenics and Früh, showed that NO2 is well suited to terminally sterilize prefilled ophthalmic syringes. The following topics will be addressed in detail:

    • Comparison of EtO vs. NO2 penetration into the filled syringe.
    • Analyze gas ingress through different plunger stoppers including silicone oil-free and standard rubber plungers.
    • Scrutinize gas ingress through two different cap designs based on different elastomer properties.
    • Investigate gas permeation through COP plastic barrels compared to glass.
    • Check if the final blister has an influence on either sterilization method.