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Development and Validation of an Integrity Test Method
Development and Validation of an Integrity Test Method
Development and Validation of an Integrity Test Method for a Sterile Connection Device
Single-use systems are known to offer a variety of advantages to users within biopharmaceutical manufacturing. The adoption of single-use systems requires suppliers to provide the industry with adequate single-use alternatives of existing and non single-use technologies. Sartorius Stedim Biotech developed a new connector for sterile fluid transfer that has been qualified applying the most stringent and innovative test regimes. This presentation will focus on the development and validation of an integrity test method for the Opta® SFT sterile connector.Participants will have a better understanding on how to use the sterile connector by receiving an extensive walk-through of the product and learning its applications. Participants will also receive a overview on validation with a focus on the air flow test, the bacterial challenge test and the connection between the two. At the conclusion of this session, participants will be able to:
  • Apply the use of a sterile connector and its integration into GMP manufacturing environments
  • Recognize key points of the 100% integrity test method and learn the features of the Opta® SFT sterile connector

  • Speaker Biography
    Myriam Bengaoui is a Product Manager Associate for Fluid Management Technologies at 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.
    Discounted member price: 49.00
    Your price: 149.00
    You could save 67.1%
    This self-paced, pre-recorded course includes a downloadable presentation for note-taking, engaging graphics, links to regulatory information, assessments to measure your comprehension and the ability to start and stop at any time, beginning where you left off.

    ISPE CEUs are provided once you achieve an 80% passing grade and complete the evaluation as required.

    Approximate Course Duration: 40 minutes (this is a self-paced course)

    *NOTE* You will have 5 calendar days to access and complete this course from time of purchase.

    ISPE CEUs: .50 ISPE CEUs will be awarded upon successful completion of grading requirements

    Member Price: $ 49.00 / € 45.00
    Non Member Price: $ 149.00 / € 136.00

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