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

This free webinar will familiarise attendees with Restricted Access Barrier System (RABS) technologies. An excellent opportunity to receive detailed information about barrier systems with a main focus on isolator technology, particularly since the implementation of EU GMP Annex 1.

★★★★★ "It is perfect with RABS and ISOLATOR model design for the clean room, Air handling units and classif... more"

Recorded on 6 March 2024 »

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Format: Recorded webcast
CPD: 1.5 hours for your records
Certificate of completion

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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 training (Good x Practice) course collection, which features a variety of topic areas to ensure you comply with the most recent quality guidelines. For more information on the latest EU GMP regulations, see our GMP training course covering the Annex 1.

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

Lukas Munzinger
Syntegon Technology GmbH

Lukas Munzinger started his career with an apprenticeship in 2001 with Bosch Packaging Technology to become an industrial technician for fill/finish packaging machinery. From 2007 until 2011 he finished his bachelor's degree in industrial engineering and business administration at the University of Applied Sciences in Karlsruhe, Germany. Since 2011 he was working in international sales for fill/finish equipment machinery with Syntegon (formerly Bosch Packaging Technology). His market responsibilities were mainly in Latin American countries, but he was also handling complex isolator projects around the globe. From 2017 to 2018 he worked as a Business Developer in Panama City, Panamá. Since December 2022 he has been the global product manager for Barrier Systems and Isolator Technology as well as Depyrogenation Tunnels at the Syntegon site in Crailsheim, Germany. Overall, Lukas has more than 12 years of experience in the primary packaging industry for pharmaceutical fill/finish lines and contributed to many successful customer projects and installations all over the world.

More details

Recorded on 6 March 2024

Free

14:00-15:30 UK (London) (UTC+00)
15:00-16:30 Paris (UTC+01)
09:00-10:30 New York (UTC-05)
Course code 14278