PDA EU00193 Electron Beam Sterilization for Inline Transfer Systems

Allschwil, Switzerland
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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
Event Location
Skan AG
Kreuzstrasse 5, Allschwil, Switzerland 4123 Get Directions

Contact

Program Inquiries
Exhibition/Sponsorship Inquiries
Christopher Haertig
Training Course Inquiries
[email protected]
Registration Customer Care

Standard Registration

Member Price

€ 2.090

Non-Member

€ 2.090

See Qualifying Criteria for Member Types.

ALL PRICES IN EURO (EUR), EXCLUDING VAT.

WAYS TO REGISTER: 1. Online Registration   2. [email protected]

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 [email protected] 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

Agenda is subject to change.

Featured Trainers

  • Michael Bielmann, PhD

    SKAN

    Read Bio

  • Manfred Holzer

    SKAN

    Read Bio

  • Andreas Kerschbaumer

    Sandoz

    Read Bio

  • Anette Moerberl-Witte

    Head of Projects & Planning, Sanofi

    Read Bio

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
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