Barrier Systems & Requirements For Sterile Manufacturing

Barrier Systems & Requirements For Sterile Manufacturing – Annex 1 Draft – A Webinar Series by PDA Asia Pacific
The Annex 1 Draft from the European Commission EC is an international supported document 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.

Event/Webinar Name: Barrier Systems & Requirements For Sterile Manufacturing – Annex 1 Draft – A Webinar Series by PDA Asia Pacific
Webinar Date: July 14, 2020 | 3:00 PM – 4:30 AM | Singapore Standard Time
To register please click https://pda-asiapacific.eventbank.com/event/barrier-systems-requirements-for-sterile-manufacturing-annex-1-draft-24097/