Barrier Systems & Requirements For Sterile Manufacturing - Annex 1 Draft

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The Annex 1 Draft from the European Commission EC is an international supported document where for instance PICs Member states are involved and for that reason the interest of the outcome of the document is of global interest. In June 2020 the PDA Ptc Technical Report "Points to Consider for the Aseptic Processing of Sterile Pharmaceutical Products in Isolators" was published with 85 pages on guidance how to work with aseptic Isolators.

The Webinar will cover the discussion about Barrier Systems, like Isolators. Barrier Systems, like Isolators, are the first choice from the regulatory authorities to prevent the direct access from the operators to the aseptic critical zone. Attendees will learn what the difference is between a Restricted Access Barrier System (RABS) and an Isolator. The aseptic critical zone in an Isolator, air flow and air design requirements in the critical zone, surface decontaminating requirements with vaporized Hydrogen Peroxide vH2O2, and Glove management for Isolator Gloves will be part of the webinar.

  • Regulatory Trends for Aseptic Manufacturing
  • Draft Annex 1 Requirements for Aseptic Processing
  • PDA´s Points to Consider on Isolators
  • RABS and Isolators
  • Isolators: Technology, Design and Qualification, Critical Zones/Air Flow, Contamination Control Strategy, Glove Test, Surface Decontamination with Vaporized H2O2 and more.

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