2019 ASEPTIC PROCESSING SUMMIT

The ISPE Australasian Affiliate and PDA Australia Chapter are excited to present our annual joint Aseptic Processing Summit in Melbourne on 19th and 20th Sep 2019.  As always, we hope to provide the ideal forum to discuss some of the challenges which face us in our industry and look at ways that these may be handled internationally.   The event this year will bring some key international experts representing our leading industry associations with a focus on Aseptic Process and Facility Design, and Contamination Control Practices. We will take a look at emerging Global GMP regulations, current industry standards and some exciting new approaches to meeting our product quality requirements.

Who Should Attend?

  • Quality control staff, microbiologists, operations managers, cleanroom managers, regulatory managers, and validation practitioners, engineers, managers and staff involved in the manufacture of sterile/non-sterile medicinal products or medical devices.
  • Technical professionals, management, vendors and operations personnel who support sterile manufacturing operations.

Agenda

  • Thursday 19th Sep

    Aseptic Processing & Facility Design*

    • 08:00 – 08:30 Registration and coffee
    • 08:30 – 08:45 Welcome and Introductory Remarks Richard Denk
    • 08:45 – 09:30 FDA-EMA Aseptic Requirements Annex 1 Richard Denk
    • 09:30 – 10:00 Aseptic Processing ISO Requirements TBA
    • 10:00 – 10:30 Break
    • 10:30 – 11:15 Requirements for Highly Potent/toxic Aseptic Processing Richard Denk
    • 11:15 – 12:00 Aseptic Isolator Design, Air Handling Unit Richard Denk
    • 12:00 – 13:00 Lunch – Sponsor TBC
    • 13:00 – 13:30 Cycle Development/Decontamination Cycle for H2O2 Richard Denk
    • 13:30 – 14:00 PUPSIT Micheal Schafferius
    • 14:00 – 14:45 Dispensing of Highly Potent Substances and Special Aseptic Processes Koji Ushioda
    • 14:45 – 15:15 Break
    • 15:15 – 15:45 Modular Aseptic Fill & Finish Application Koji Ushioda
    • 15:45 – 16:15 GMP Requirements for Stopper Processing Thomas Jochimsen
    • 16:15 – 17:00 Cleaning Requirements of Non-product Contact Surfaces in Aseptic Isolators and Cross Contamination Requirements Richard Denk
    • 17:00 – 17:20 Q&A All speakers
    • 17-20 – 19:00 Networking drinks and canapés Sponsored event

    *Schedule times may be varied during the course with the agreement of delegates to ensure content is adequately covered

  • Friday 20th Sep

    Contamination Control & Risk Based Cleaning and Disinfection*

    • 08:00 – 08:30 Registration and coffee
    • 08:30 – 08:45 Welcome and Introductory Remarks Jim Polarine
    • 08:45 – 09:30 A Risk Based Cleaning and Disinfection Program Jim Polarine
    • 10:00 – 10:30 Break
    • 10:30 – 12:00 Contamination Control in Process Equipment - Biofilm Generation and Remediation Richard Chai
    • 12:00 – 13:00 Lunch – Sponsor TBC
    • 13:00 – 14:00 Current Debates and Challenges Regarding Disinfectant Validation and Methods to Circumvent Them Jim Polarine
    • 14:00 – 14:45 Case Studies - Rouge Formation and Remediation Richard Chai
    • 14:45 – 15:15 Break
    • 15:15 – 16:00 Case Studies in Fungal and Bacterial Spore Excursions Using a Risk Based Approach Jim Polarine
    • 16:00 – 16:45 Cleanroom Start Up and Bringing the Cleanroom Online After Worst Case Events Richard Chai
    • 16:45 – 17:00 Q&A and Summit Session Close Jim Polarine & Richard Chai

    *Schedule times may be varied during the course with the agreement of delegates to ensure content is adequately covered