Barrier Systems & Requirements For Sterile Manufacturing - Annex 1 Draft
Become a Sponsor and/or Exhibitor
Registration Options
Individual Registration
Group Registration
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.
Registration
Pricing Options
Standard Registration
Member Price
$59GovernmentMember Only
$59
Health AuthorityMember Only
$59
Early Career ProfessionalMember Only
$59
StudentMember Only
$59
AcademicMember Only
$59
Non-Member
$59
Sponsor information will be available soon
We're currently finalizing our list of sponsors and will share the details shortly.
Become a Sponsor and/or Exhibitor
Amplify Your Presence and Reach Your Customers!
Become a Sponsor
Elevate your brand and maximize your exposure by becoming a sponsor at the Barrier Systems & Requirements For Sterile Manufacturing - Annex 1 Draft! Connect with industry leaders, showcase your products and services, and establish your company as a key player in the field.
Request InformationBecome an Exhibitor
Boost your brand and visibility by becoming an exhibitor at the Barrier Systems & Requirements For Sterile Manufacturing - Annex 1 Draft! Connect with industry influencers, showcase your products and services, and position your company as a key player in the field.
Request InformationHave a question or need assistance?
Send us a message, and our team will get back to you shortly. We're here to help!