PROGRAMME

The Pharmaceutical and Medical Packaging Conference,
Copenhagen 6 and 7 May 2008

The Potential of Digital Print in the Packaging Sector
• Shorter life cycle of products
• Frequent design of changes
• Customisation and versioning
• and consequent shorter print runs
Peter Addington; Xaar, Cambridge, United Kingdom

Injection – the Easy, Safe and Simple Way
• Trend toward auto-injection
• Requirements for self-injection
• “The Medicom auto-injector” – new technology and own IP
• User  and market reactions/responses
Tanya Arp-Nielsen; Bang & Olufsen Medicom A/S, Søborg, Denmark

New Technologies in Ophthalmic Drug Delivery
• Preservative free applications
• New delivery devices
• Patient-accepted technologies
Matthias Birkhoff; Ing. Erich Pfeiffer GmbH, Radolfzell, Germany

Innovations in Healthcare Packaging
• Recent innovations in healthcare packaging
• New materials used in healthcare packaging
• A new and innovative approach to protection systems – a total approach
• A quick at some new medical device developments
Ian Buckley; Friedrich Sanner GmbH & Co KG, Bensheim, Germany

From Ready-go-Sterilize to Ready-to-Use: Validation Protocol for Sterile Plungers for Pre-filled Syringes
• Determination of the maximum acceptable dose
• Determination of the sterilization dose
• Dose Mapping
• Determination of Shelf life (ageing of plungers and packaging integrity)
Francois Dessus; Stelmi S.A., Villepinte, France

A New Microbial Barrier Test for Porous Medical Packaging Materials – Progress Report
• ISO 11607 requirements and filtration theory
• Development of a test unit and establishment of a correlation with a recognized
microbiological test
• Development of an ASTM standard test method
• Comparison with current standard test methods
Paul Fielding; DuPont Medical Packaging, Bristol, United Kingdom

Improved Technical Features for the Manufacturing of Glass Syringes for Pharmaceutical Use: A Cooperation Project
• Standard practices in pharmaceutical primary packaging production
• An innovative approach: in-house production
• Focus on technological and pharmaceutical Japanese quality requirements 
• Optimisation of the process and new solutions: a case history
Paolo Golfetto; Nuova Ompi, S.R.L., Piombese Dese (PD), Italy

High Market Requirements and their Impact on the Manufacturing of Elastomeric Closures
• High market requirements: A description and regulatory background
• How closure manufacturers can address the issue:
            Preventive measures in environment and technology
            Corrective measures in environment and technology
Renaud Janssen; Helvoet Pharma, Alken, Belgium

Practical Solutions to Readability of Labels for Multilingual Distribution
• An introduction to current legislation
• The implications of providing to a multilingual economic area
• Practical solutions for multilingual labelling
• The future of legislation and likely impacts on labelling systems
Marty Kerluk; Prisym Id, Wokingham, United Kingdom

Improved Packaging Development for Blister Packs by Using Finite Element Analysis
• Trends in blister packaging
• Typical issues in blister packaging
• Choosing the right barrier
• Optimisation of blister films
• FEA as a valuable tool to accelerate blister development
Hans-Dieter Laux; Klöckner Pentaplast GmbH & Co. KG, Montabaur, Germany

Safeguarding pharmaceutical products via integrated desiccant solutions• Different barrier options available if a device requires complete oxygen, light and moisture barrier
• Introduction
• Recent development in plastic packaging
• Market requirements
• New integrated desiccant system challenging traditional high barrier packaging systems
Gustav Levander: Gerresheimer Plastic Packaging, Værløse, Denmark

Protecting the Product of the Future: The challenges of combination Devices
• Different barrier options available if a device requires complete oxygen, light and moisture barrier
• The necessity to remove tyvek from any seal areas if we are to guarantee a total barrier
• The requirement of adding oxygen and moisture scavengers without impacting product preservation
George Mankel; Perfecseal Limited, Londonderry, United Kingdom

Efficiency in Pharmaceutical Packaging – Three case stories with different approach
• Flexibility, a definition
• Automation case
• Packaging centers
• Rework facility to support LEAN activities
Lars Olsen, NNE Pharmaplan, Søborg, Denmark

Barrier Plastic Tubes for Pharmaceutical Products
• Barrier laminate tube
• Barrier plastic tube
• Multilayer components moulding
• Barrier performance (oxygen and volatile organic compounds)
Hugues-Vincent Roy; Aisapack SA, Vouvry, Switzerland

High speed Integrity Testing and Headspace Analysis for Pre-filled Syringes
• New developments in automated syringe inspection technology
• Vacuum based in-line leak detection
• Headspace analysis based on laser absorption
• Integration into PAT (Process Analytical Technology) platforms
Gerhard Schramm; Wilco AG, Wohlen, Switzerland

Strategies for Assessment of Leachables in Parenteral Drug Products
• Common packaging materials used in parenteral Products
• The latest trends in extractable and leachable testing
• The commonalities between FDA and EU Guidelines
• The activities of the PQRI Leachable and Extractables Working Group
Heike Schulz and Diane Paskiet; West Pharmaceutical Services Deutschland GmbH & Co. KG, Eschweiler, Germany

A Unique Ready-to-use Plastic Prefillable Syringe System
• Ready-to-use plastic prefilable syringe system
• High demanding biopharmacruticals
• Silicone-free syringe systems
• Studies on silicone oil induced aggregation of proteins
• Investigations on protein absorption phenomena in prefilable syringe systems
Dirk Sobotta; West Pharmaceutical Services Deutschland GmbH & Co. KG, Eschweiler, Germany

Structural Alert Screening Assays and Target Methods to Assess Genotoxicity of Pharma Packaging Leachables
• Analytical strategies to asses and improve the safety of pharma packaging leachables
• Pragmatic approach focusing on the relevant compounds instead of peak-by-peak
identification
• Focus on genotoxicity for structural alerts aromatic amines, epoxides, aldehydes
• Tools: Physical (eg. RAMAN, biacore); separation techniques (GC-MS/LC-MS); gene-expression of cell-lines (microbial, animal, human)
Elly Spies-Faber Quality of Life, Zeist, The Netherlands

A New Transparent Specialty Co-polycarbonate With Excellent Oxygen and Water Vapor Barrier Properties
• New injection moldable material for healthcare packaging
• Combining WVTR and oxygen permeablity in one material
• Low moisture absorption and slow water diffusion
• Optical quality co-polycarbonate with excellent barrier properties
André van Zyl; Sabic Innovative Plastics, Bergen op Zoom, The Netherlands