PDA Electron Beam Sterilization for Inline Transfer Systems Training Course

19 Mar - 20 Mar 2025
Skan AG
Allschwil, Switzerland

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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
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.

Agenda

Discover What's Happening Each Day
Day 1 19 Mar Day 2 20 Mar Training
Wednesday, 19 March

Wednesday, 19 March 2025

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

Thursday, 20 March

Thursday, 20 March 2025

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

PDA Manage Your Isolator for Aseptic Processing Training Course
19 Feb - 20 Feb
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Venue Details and Accommodations

PLEASE 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.

Skan AG

Kreuzstrasse 5
Allschwil, Switzerland 4123 Switzerland
Make a Reservation Online

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.

How to Get Here
By Air Closest Airport: EuroAirport Basel-Mulhouse-Freiburg.
By Car Skan offers free parking lots at Kreuzstrasse 5, 4123 Allschwil, Switzerland
By Other Options By Train: Unlock discounted pricing and simply use the provided link below.
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€2,200

Non-Member

€2,200

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