Click to join or renew
ISPE Logo - Click to go to the ISPE home page

eLearning


Search

for

Log in
Name: Development and Validation of an Aseptic Disconnector for Silicone (Pt) Tubing ( WEBASEPTIC )
Description: Validation of aseptic disconnector for Silicone Tubing is important for your operation! Attend this live webinar to see the presentation of recommended case study best practices in conducting a validation test for an aseptic disconnector for silicone tubing.

Objectives:
From buffer and media preparation, cell culture operations, purification operations up to final formulation, filtration and transfer, the aseptic disconnection is a key element during manufacturing processes. A case study validation is discussed based on a stringent validation process from functional to characterization of the aseptic disconnector. The disconnector technology allows an aseptic disconnection after fluid transfer in non classified and classified environments while maintaining the product sterility. In this validation test we will show that the aseptic disconnector qualified by applying the most stringent and innovative industry test regimes.

At the conclusion of this session, participants will be able to:
  • Understand the process steps recommended for validation.
  • Define the importance for validation with a focus on the bacterial challenge test and test representative of customer applications.
  • Understand the positioning regarding various technologies to define the best solution according to the application.

  • Who should attend - (job types / titles):

    Validation engineers & managers, Production engineers & managers, Technical engineers & managers, R&D engineers & managers, Product manager, purchasing managers

    Presenter Biography:

    Myriam Bengaoui, Global Program Manager Associate, Sartorius Stedim Biotech, Aubagne, France.

    Her product portfolio includes sterile connectors, welding and sealing equipments and single-use transfer sets. She has 5 years of experience in engineering and marketing in the Biopharmaceutical industries and has been involved in many industrial projects for design, implementation and validation of single-use systems.

    Myriam started her career in 2005 as a Process Engineer with GlaxoSmithKline Biologicals, Belgium. In 2007, she joined Sartorius Stedim Biotech as a Process Development Engineer for Fluid Management Technologies.

    Myriam is a Process Engineer graduated from the “Ecole des Mines” of Albi, France.
    URL:
    CEUs: .075
    Member Price: US Dollar        EURO
    Non Member Price: US Dollar        EURO
    Instructors:
    Copyright 1997- International Society for Pharmaceutical Engineering   |   Privacy Policy   |   Terms of Use