PDA EU00193 Electron Beam Sterilization for Inline Transfer Systems
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Individual Registration
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Program Highlights
An additional highlight is the joint dinner at the end of the first training course day, where participants and trainers can get to know each other better and expand their network. Don't miss this unique opportunity and reserve the evening for this get-together.This interactive training course takes place at the Skan Academy in the newly built Skan Headquarters in Basel and E-Beam Competence Center Stein.
On the first day, the focus is on the E-Beam Systems Basics, Technology overview, and categories of Regulatory and Safety considerations followed by a Workshop Tour demonstrating on an electron beam the theory part. On the second day, participants will get to know the material effects of electron beams on various materials and how to validate an electron beam system. This is followed by case studies and hands-on demonstration of validation and electron beam effects.
During the training course, there is enough time and space for an exchange of experiences and discussions. For this reason, the training course is designed for a limited number of participants only.
Who Should Attend
- Operators
- Manufacturing Supervisors
- QA Managers
- Read-to-use packaging suppliers
Learning Objectives
Upon completion of the course, participants have understood:
- The different components of an E-Beam system
- The interactions between the different components
- The effects of Electron Beam in terms of material and sterilization
The participants have learned:
- The relevant GMP and Safety regulations
- The basic principles and effects of E-Beam systems
- How to operate E-Beam in-house in terms of radiation safety and daily operations
- Maintenance, calibration, and validation of a system
- Basics and know equipment for dosimetry
The participants can perform:
- Prepare a routine dosimetry check
- Evaluate the dose of objects
Contact
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Member Price
€ 2.090Non-Member
€ 2.090
ALL PRICES IN EURO (EUR), EXCLUDING VAT.
WAYS TO REGISTER: 1. Online Registration 2. registration-europe@pda.org
PDA MEMBERS: Please remember to log in before registering If you come from a Governmental or Health Authority Institution or from an Academic Organization, please contact registration-europe@pda.org before registering.
If you need to apply for a visa to enter the event country, PDA Europe must be informed of this fact at least 4 weeks before the start of the event.
Day 1
Wednesday, 18 September 2024
9:00
Welcome and Introduction of Trainers and Participants
9:30
Module 1: Introduction Electron Beam as Transfer Technology for Ready-to-Use in the Pharmaceutical Industry
- Electron beam – a transfer technology
- EU GMP Annex 1 requirements for transfer
- Options for Transfer - H2O2 / electron beam / NTT
- Electron beam process
- Electron beam layout and components
- History of electron beam for Ready-to-Use transfer
10:45
Coffee Break
11:15
Module 2: Technology Overview of Industrial Electron Beam Applications
- What is it and what is it not?
- Different Categories
- The SKAN electron beam engine and lamp
12:30
Lunch Break
13:30
Module 3: Basics on Electron Beams
- How do electrons behave in the atmosphere?
- Basic concepts (voltage, dose, etc) and with speed
- Radiation protection/shielding / self-shielding – why and how
- Simulations
- Initiated effects (ozone, NOx, nitric acid)
- Evidence and measurement methodology
14:30
Module 4: Regulatory and Safety Considerations
- Regulatory guidelines for pharmaceutical packaging sterilization
- Safety measures and compliance – Safety features
- Introducing electron beam in your company – what to look for (Safety officer)
- Radiation test and documentation
- Measurement devices
15:00
Coffee Break
15:30
Module 5: Workshop Tour at SKAN AG
- Isolator and electron beam
- Walk through the SKAN Assembly Hall showing examples
17:00
Q&A and Questionnaire
17:30
End of Training Course Day 1 & Networking Event
Day 2
Thursday, 19 September 2024
8:30
Transfer to SKAN Stein AG– Electron Beam Competence Centre
9:15
Welcome at Skan Stein AG
9:30
Module 6: Materials Effects of Electron Beam on Various Materials
- Metal
- Ceramics
- Polymers and other organic materials
10:30
Coffee Break
11:00
Module 7: Process Validation
- Case studies on process validation
- Challenges and solutions
- Dosimetry Demonstration
- Side effects – Residual measurement
- Step by step Dosimetry and Residual validation at customer
12:30
Lunch Break
13:30
Module 8: Case Studies
- Real-world examples of successful sterilization in aseptic pharmaceutical processing – Ready-to-Use transfer
- Different case studies
- Q&A with industry expert
14:15
Module 9: Tour at SKAN Stein Electron Beam Competence Centre
- Development of new concepts in lab space
- Electrons "Live" with camera
- Two different hands-on sessions
- Project dependent: Manufacturing example lead/steel
15:00
Coffee Break
15:15
Wrap-up Training Course
- Time for evaluation of the course
- Q&A and Questionnaire
16:30
End of Training Course and bus transfer to SKAN Headquarter
Featured Trainers
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Michael Bielmann, PhD
SKAN
Read BioMichael Bielmann, PhD
SKAN
Michael holds a PhD in Solid State Physics and an EMBA in International management. He joined SKAN Stein AG in 2021 after 7 years at ebeam Technologies where he held different business development functions around plastics and application development and sales. He assisted in the technology and business transfer from ebeam Technologies, the build-up of the ebeam competence center, and the R&D team at SKAN Stein AG. Since 2023, he has led the sales and service activities of SKAN Stein AG.
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Manfred Holzer
SKAN
Read BioManfred Holzer
SKAN
Manfred Holzer studied Mechanical Engineering and is engaged as sales manager for isolators in the pharmaceutical industry since 1995. Joining SKAN AG in 2000 he worked in various positions, e.g. as international sales & project manager, USA business coordinator. Since 2016 dedicated Sales Manager for Ireland, he also covers since 2008 the strategic product management sPM for pharma ebeam applications at SKAN.
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Andreas Kerschbaumer
Sandoz
Read BioAndreas Kerschbaumer
Sandoz
Andreas studied Technical Chemistry and Innovation Management and has held various positions in the pharmaceutical industry since 1995. He joined Novartis in 2014 as Production Manager. In 2021, he joined MS&T within the External Supply Organization for large molecules. In this role, he is responsible for the scientific and technological oversight at CMO (contract manufacturing organizations). Projects cover the entire lifecycle of a product, starting with due diligence audits, process transfer and validation, and commercial supply to the termination of the contract. Since the separation of Novartis and Sandoz in October 2023 he has covered the MS&T role for Sandoz.
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Anette Moerberl-Witte
Head of Projects & Planning, Sanofi
Read BioAnette Moerberl-Witte
Sanofi
Anette has a degree in Process Engineering. She joined Sanofi in 2004 and has extensive experience in aseptic drug manufacturing and project management. Since 2015, Anette has been leading a team of project engineers as Head of Engineering and most recently worked as a project manager for a strategic investment project in Frankfurt.
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Request InformationPLEASE READ PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.
PDA recommends the reservation at the following hotel
Holiday Inn Express
Hegenheimermattweg
179 Allschwil / Basel
Switzerland
The hotel is located five minutes walk from the training course venue.