In the Light of Annex 1: Use of Barrier Systems for Aseptic Pharmaceutical Manufacturing Training Course

Overview

The industry of aseptic pharmaceutical manufacturing, i.e. manufacturing companies as well as related equipment suppliers and engineering companies, have been pretty busy in evaluating the impact of the revised EU GMP guide Annex 1, which came into force on 25 August 2023.
 
Even before its release, Annex 1 has triggered many heated debates on how it will influence existing aseptic manufacturing processes. These debates have further intensified after publication in August 2022. On the one hand, some paragraphs leave a lot of room for interpretation. On the other hand, the industry fears over-regulation.
 
But what impact will the new EU GMP Annex 1 really have on sterile filling and processing operations? How will it change the way we work in the pharmaceutical industry? And which technologies are particularly suitable? 
 
One topic, addressed at the very beginning of the Annex 1 guideline in ''Chapter 2 Principle", is that "The use of appropriate technologies (e.g. Restricted Access Barriers Systems (RABS), isolators, robotic systems, rapid/alternative methods and continuous monitoring systems) should be considered to increase the protection of the product from potential extraneous sources of endotoxin/pyrogen, particulate and microbial contamination such as personnel, materials and the surrounding environment, and assist in the rapid detection of potential contaminants in the environment and the product."
 
This is a clear indication that Restricted Access Barrier Systems (RABS) or isolators should be used for new equipment to be installed in aseptic pharmaceutical manufacturing.
 
This webinar will familiarise attendees with barrier system technologies and discuss the complexities involved. 

This course is part of our GxP (Good x Practice) training course collection, which feature a variety of topic areas to ensure you comply with the regulations and quality guidelines.

Beneftis of Attending

By participating in this webinar, you will receive detailed information about barrier systems with a main focus on isolator technology.

• Gain an overview of the justification for using barrier systems
• Discover the differences between RABS and Isolators
• Understand how an isolator is characterised
• Learn the difference between aseptic and high potent isolators
• Hear about isolator air management

Who Should Attend

Sterile Medicinal Product Manufacturers in the following departments:

• Quality Assurance
• Quality Control
• Manufacturing
• Aseptic Filling
• Regulatory Affairs
• Maintenance
• Engineering

This webinar will also be of interest to:

• Regulatory Authority Inspectors / Auditors
• Pharmacy, chemistry, engineering students and new graduates

Register now