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PDA EU00193 Electron Beam Sterilization for Inline Transfer Systems
Registration Options
Individual Registration
Group Registration
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 SKAN in the newly built SKAN Headquarters in Basel, and at the ebeam Competence Centre Stein.
On the first day, the focus is on the electron 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 of equipment for dosimetry
The participants can perform:
- Prepare a routine dosimetry check
- Evaluate the dose of objects
Contact
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Standard Registration
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
- Ebeam – a transfer technology
- EU GMP Annex 1 requirements for transfer
- Options for transfer - H2O2 / electron beam / no-touch transfer
- Ebeam process
- Ebeam 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?
- 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)
- Radiation protection/shielding / self-shielding – why and how?
- Simulations
- Initiated effects (ozone, NO2, 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
17:00
Q&A and Questionnaire
17:30
End of Training Course Day 1 & Networking Event
Day 2
Thursday, 19 September 2024
8:00
Meeting Point SKAN AG
8:15
Bus Transfer to SKAN Stein AG– ebeam Competence Centre
9:00
Welcome at SKAN Stein AG
9:30
Module 6: Effects of Electron Beam on Various Materials
- Metal
- Ceramics
- Polymers and other organic materials
10:00
Coffee Break
10:30
Module 7: Process Validation
- Validation protocols and methodologies
- Case studies on process validation
- Challenges and solutions
- Step by step Dosimetry and Residual validation at customer
11:30
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
12:30
Lunch Break
13:30
Module 9: Tour at SKAN Stein ebeam Competence Centre
- Dosimetry demonstration
- Side effects – residual measurement
- 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
- Evaluation of the course
- Q&A and Questionnaire
16:30
End of Training Course at SKAN Stein and bus transfer to SKAN Headquarter Allschwil
17:15
Arrival at SKAN Headquarter Allschwil
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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Mathilde Jemelen
Sales Engineer, SKAN AG
Read BioMathilde Jemelen
SKAN AG
Mathilde has studied Process Engineering. After an initial work experience in the microelectronics industry she joined SKAN AG in 2020 as a Process Validation Engineer in the Process Validation Microbiology department. She performed cycle developments and microbiological qualifications of SKAN isolators all over the world as well as E-Beam Sterilization process validation. Today she supports the Sales Team as Sales Engineer.
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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.