E-Beam for surface decontamination of pre-sterilized syringes

3-4 May 2016

Basel, Switzerland

Course No 15276

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Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

Manfred Holzer, SKAN
Steen Kreinbrink, ebeam Technologies
Arne Miller, DTU Nutech
Dr Daniel Müller, GMP/GDP Inspectorate Local Government
Liwia Rajpert, SKAN
Patrick Vanhecke, GSK Vaccines
Thomas Zinn, Sandoz

Objectives

You get to know the principles of using continuous E-Beam systems for the surface decontamination of tubs
You become familiar with the critical process steps that have to be clarified within the framework of the qualification and validation of these systems
In case studies you can share your colleagues’ first-hand experiences
In workshops / live demos at SKAN you can discuss the pros and cons of using these systems with experts from industry, authority and science

Background

With regard to sterile finished medicinal products, above all high-priced products in the field of biotechnology, there is a clear trend towards ready-to-use syringes.

The ready-to-use syringes in tubs are sterilised at the syringe manufacturer’s site and distributed in bags. Still, when they are introduced into the isolator, certain microbiological risks arise for the filling process in the isolator. For this reason, after having been unwrapped, the tub is introduced into the isolator through an E-Beam tunnel in order to ensure the outer sterilisation of the tub.

Here, apart from the high costs caused by acquisition, operation and maintenance, the use of E-Beam systems also requires careful consideration of the consequences the radiation has for the packaging material and its environment.

Target Group

The event is made for decision makers in pharmaceutical companies and their suppliers who use the E-Beam technology in connection with pre-filled syringes or who intend to do so in the future.

The number of participants is limited. Please understand that, for competitive reasons, not all firms can register their employees for this event.

Programme

Technology & Application
Technology history
E-Beam technology
Basic technology (Science)
Construction lamp etc.
Lifetime
Application areas
Sterilization
Products

E-Beam from an inspector’s point of view
Relevant GMP guidelines (aseptic processing)
Regulatory view on
- pharmaceutical application of e-beam tunnels
- alternative methods for material transfer
(sterilisation, decontamination, disinfection)
Experience from inspections (including observations & discussion points)

Nature of radiation and dosimetry basics
Gamma / X-ray / E-Beam
Types of radiation facilities
Absorbed dose
Dosimeters
Calibration
Measurement traceability and uncertainty
Guide on the use of low energy electron beams for microbiological decontamination of surfaces

Case study GSK Vaccines
GSK User Requirement Specifications
Description of the line
Design of E-Beam Tunnel
IQ/OQ Qualification
Performance Qualification
- Dose Mapping
- BI’s sterilization
- Ozone

Case study Sandoz
Equipment selection
Timeline
Layouts
Validation
Project experience

Practical Validation of an E-Beam
Dosimetry with dosimeter film
Dosimetry with Biological Indicators
Kill Kinetic
Dosimetry Strategy
Residuals
Good Documentation Practice – E-Beam Validation

Workshops / Live Demos / Plant tour

E-Beam basic’s, features, history, case studies
Basics of E-Beams
Features of an E-Beam line
History & number of E-Beam world wide for p
harmaceutical applications
Latest layouts / case studies with E-Beam for
pre-sterilized syringes (Layout / Room Concept)

Live Demos:

Detail explanation of electron accelerator Technology
Complete engine
EBLab

Detail demonstration of E-Beam syringe line
Tub run through with dosimeter

Detail explanation of validation equipment
Testing equipment incl. evaluation of dosimetry of tubs

Plant Tour at SKAN with different types of equipment
E-Beam & isolator filling-line for pre-sterilized syringes
Large scale vial and freeze dryer isolator line
PSI-L clinical filling isolator
PSI-M Sterility testing isolator
Glove Testing Unit’s
SKANFOG Room-To-Room Material transfer hatch

The workshops / Live Demos / Plant tour will take place at SKAN AG in Allschwil on 4th May. At appr. 15.30 h, a bus shuttle service will bring the participants to the airport, the train station or the hotel.

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