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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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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


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

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Reviews of IPI's In the Light of Annex 1: Use of Barrier Systems for Aseptic Pharmaceutical Manufacturing training course

It is perfect with RABS and ISOLATOR model design for the clean room, Air handling units and classification of surrounded area as per Annex I.

Mar 6 2024

Mahmood Tolba
TQM Manager , Allmed

Mar 6 2024


Mahmoud Sedeek
Validation manager, Allmed

Mar 6 2024

I think that the speaker was very prepared on the topic and the speech was very fluent

Erika Bava
QA Assistant, Bioindustria L.I.M.

United Kingdom

  • Advanced Healthcare Ltd Unit 2-4
  • Arecor
  • AstraZeneca
  • Autolus
  • Barnsley Hospital NHS Foundation Trust
  • Bradford teaching hospital foundation trust
  • Bradford Teaching Hospitals Foundation Trust
  • Bradford Teaching Hospitals NHS Foundation Trust
  • Bradford Teaching Hospitals NHS Trust
  • Cumberland Infirmary Carlisle
  • Fresh Pak
  • Gateshead Health NHSFT
  • Guy's and St Thomas' NHS Foundation Trust
  • Hammersmtih Medicines Research
  • HCA Healthcare UK
  • HCA UK
  • HealthTrust Europe
  • Hull University Teaching Hospitals NHS Trust
  • Hull University Teaching Hospitals Trust
  • James Cook University Hospital
  • Lancashire Teaching Hospitals NHS Trust
  • Leeds Teaching Hospitals
  • Leeds Teaching Hospitals NHS Trust
  • Leeds Teaching Hospitals Trust
  • Liverpool University Hospitals Foundation Trust
  • LOC (HCA Healthcare UK)
  • lth
  • LTHT Leeds
  • Medical Physics Department
  • Mid
  • Mid Yorkshire Hospitals
  • National Health Service
  • Newcastle upon Tyne Hospitals NHS Foundation Trust
  • Nhs
  • NHS Highland
  • Norbrook Labs
  • North Cumbria Integrated Care NHS Foundation Trust
  • North Cumbria integrated care NHS trust
  • North East & Yorkshire NHS Pharmaceutical Purchasing Consortium
  • North Tees and Hartlepool NHS Foundation Trust
  • North Tees and Hartlepool NHS, Quality Control Laboratory
  • North West Pharmaceutical Quality Assurance
  • Northern Care Alliance
  • Northern Lincolnshire and Goole NHS Foundation Trust
  • Northumbria Healthcare NHS Trust
  • Pharmacy - UHNT Medical Director
  • Salford Royal NHS Hospitals
  • Sheffield Children's Hospital
  • Sheffield Teaching Hospitals
  • Sheffield Teaching Hospitals NHS Foundation Trust
  • South Tees Hospitals NHS FT
  • South Tyneside and Sunderland foundation trust
  • South Tyneside and Sunderland NHS Foundation Trust
  • SPS England
  • Stockton Quality Control Laboratory
  • The Christie NHS Foundation Trust
  • The Rotherham NHS Foundation Trust
  • The Rotherham NHS Foundation Turst
  • university hospital of hartlepool
  • University Hospitals Plymouth NHS Trust
  • Vernacare
  • WUTH
  • York and Scarborough Teaching Hospitals NHS Foundation Trust


  • Bioindustria L.I.M.
  • Bioindustria LIM
  • Morimatsu Italy
  • SIFI spa

Saudi Arabia

  • Jamjoom Pharmaceuticals Company
  • Jazan university
  • Najran University
  • Pharmacy student
  • Student


  • Novo Nordisk
  • Statens Serum Institut
  • Zealand Pharma
  • Zealand Pharma A/S


  • Allmed
  • Arab Caps
  • Mash premiere
  • Orchidia pharmaceutical industries


  • Dr. Reddys
  • Kevin
  • Klenzaids
  • Knovea pharmaceutical pvt ltd


  • Abbott Healthcare Products B.V
  • Gennvax Egypt
  • Ve


  • Grifols
  • Grifols S.A.
  • Grifols SA

United States of America

  • Purdue


  • Pharmapark Productions OÜ
  • Pharmapark Prodution


  • PMT GmbH
  • PMT Partikel-Messtechnik GmbH


  • Antibiotice
  • Antibiotice SA


  • Wollenweber GMP/GDP-Services


  • Profarma

Congo, Democratic Republic Of



  • Pfizer CentreOne


  • Syntegon Technology K.K.


  • Kaunas University of Technology


  • Malta Medicines Authority


  • Laboratorios Pisa


  • BASI- Pharmaceutical


  • Billev Pharma East


  • Gensenta Pharma

Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra Beer

Aleksandra BEER
Training expert

Yesim Nurko

Training expert

+44 (0)20 7749 4749