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Scientific Articles and Publications Related to Tempris

  • Dr. Andrea Weiland-Waibel:
    Continued Process Verification of a Lyoproduct

    Critical Quality Attributes are linked to the critical formulation temperature and critical product parameters. Process robustness testing during development is explained and the implementation into the regulatory documents as well as an overview on cpv of the product analysing the lyocycle as well as the critical quality attribute residual moisture is shown.

    (Conference Paper February 2020; Conference: Freeze-Drying Technology Summit, Vienna, Austria)

  • Dr. Andrea Weiland-Waibel:
    Wireless Temperature Measurement in Lyo Process Development, Validation and Production

    Wireless temperature measurement during lyo process development, validation and production with the aim to apply process control. This is performed by the determination of product temperature Tp in critical positions (“hot” and “cold” spots). Also it is explained how this approach was implemented into the Common Technical Document (CTD) regulatory submission and that it was successfully approved. How to use the Tp measurement as a key element of the continuous process verification is also demonstrated.

    (May 2019; Die Pharmazeutische Industrie 81(5):719)