Themes: RFID • Closures • Design • Leachables • Anti-counterfeiting • New EU Legislation • Inhalators • Testing • Desiccants • Labelling • Migration • Extraction • Shelf Life
Inspection of Cylindrical Printed Devices
• Number of cameras
• Illumination
• Optical problems
• Software design including user interface
• Validation
Henrik Birk; JLI Vision A/S, Søborg, Denmark
Innovations in Polymer Films for Medical Packaging
• Medical plastics used in health-care packaging
• Medical plastics used for medical product design and function
• Medical plastics used for flexible and rigid medical packaging
• Medical plastics for the design of one-time-use product or for a product to be used
again and again
• Medicall plastics formulated to stand-up against sterilization, transportation, storage and delivery
of the product
• Use of medical plastics as utilized for medical and surgical procedures
• Medical plastics as utilized in coatings, adhesive layers, laminations, extrusions and co-extrusions
Robert J. Bockserman, Conatech Group, Inc., Creve Coeur, MO, USA
Item-level Authentication through the Whole Supply Chain
• Securing supply chain
• Combining supply chain visibility with brand protection
• How to use HF, UHF and barcodes together?
• Benefits for each party in the supply chain
Marcus Dehlin, Stora Enso, Karlstad, Sweden
Analytical Strategy to Asses the Safety of Extractables and Leachables of Pharma Packaging
• New strategies for safety assessment: focus on genotoxicity
• Dedicated analytical protocols to screen for structural elements and functional groups
• Case-study: demonstration proof-of-principle
William van Dongen et al.; TNO Quality of Life, AJ Zeist, The Netherlands
Compliance Packaging for Pharmaceuticals
• Drivers of compliance packaging
• Packaging as an essential part of a drug
• Hoe child resistance requirements influence pharmaceutical packaging
• Specific packaging trends for pharmaceuticals in the EU and in the US
• Pharmaceutical packaging solutions for global drug developments
Andreas Graf; Sigpack Systems AG, Beringen, Switzerland
A Challenging Task – Industrialisation of a Dry Powder Inhaler
• Market overview
• Requirements for dry powder inhalers
• Mile stones in the development phase
• Industrialisation process
• Validation of the device
• Summary
Harald Grün; Balda
Medical GmbH & Co. KG, Bad Oyenhausen, Germany
Future Oriented Materials for Prefilled Syringe Components
• Introduction of elastomeric closures via RTPs
• Influence of irradiation on permanent deformation of elastomeric closures
• Influence of irradiation of functional properties of elastomeric closures
• Influence of irradiation extractable profiles of elastomeric closures
Renaud Janssen, Helvoet Pharma, Belgium NV, Alken, Belgium
Advanced Vapor Phase Polymer Coatings for Medical Device Packaging and Protection
• Vapor phase coatings for medical devices
• Medical electronics
• Advances in medical device packaging
• Protection of medical device from corrosion and harsh environment
Rakesh Kumar; Specialty Coating Systems, Indianapolis, IN, USA
Anti-counterfeiting, the USA and European Perspective
• The current stand of the FDA and the EFPIA
• The role of covert and overt technologies
• Practical methods adopted
• The future
Paul Osborne;
Hapa-Laetus UK, Huntingdon, United Kingdom
A Novel Nasal Spray Pump for Preservative-Free Drug Formulations
• Preservatives in nasal sprays: the ‘pros’ and ‘cons’
• The regulatory perspective
• Market outlook
• Design approaches for multi-dose nasal spray pumps
• Freepod
• Additional benefits of using freepod
• Performance and challenge test data
• Future trend
Herve Pacaud;
Valois Pharm, Marly-le-Roi, France
Influence of Radiation Sterilisation on Flexible Packaging Materials for Pharmaceutical and Medical Products
• Gamma and e-beam sterilisation
• Influence to mechanical properties
• Influence to sealing properties
• Influence to odours/smell
Erwin Pasbrig; Alcan Packaging Singen GmbH, Singen, Germany
Unique Packaging Solutions for Prefilled Syringes
• Modern elastomeric closures for prefillable syringes
• Silicone free prefillable syringe systems
• Prefillable syringe systems and components for sensitive proteins
• The increased value of coated elastomeric items and plastic syringe barrels for modern drugs
Mike Schaefers; West Pharmaceutical Services Germany, Eschweiler, Germany
Interaction of Parenteral Biopharmaceutical Products with Drug Delivery Device Components
• Effect on stability and activity
• Effect of tungsten and other heavy metal ions on the activity and stability of drug molecules,
way to avoid this contamination
• pH-shift related issues and stabilization of WFI syringes
• Loss of activity due to silicone contamination and ways to reduce the quantity of free silicone
Thomas
Schoenknecht; Gerresheimer Bünde GmbH, Düsseldorf, Germany
Developing New Concepts Based on End-user Understanding
• What is user driven development/innovation?
• How can the user influence the packaging based on experience from a combined
device-packaging project
• Methods for examining end-user needs in early project phases
• Using end-user needs and desired outcomes to set the project direction
Arne Stjernholm
Madsen; Novo Nordisk, Hillerød, Denmark
Signe Lagoni; Coloplast, Kokkedal,
Denmark
RFID – In Pharmaceutical Supply Chains
• Present overall status for mandated RFID use with large retailers/drugstores with special
emphasis on pharma
• Item tagging / logistic tagging
• Frequencies HF or UHF
• RFID initiatives combating fraud and counterfeiting
• Present status for the US implementation of e-pedigree
• FDA requirements and examples of complying with them
• Presentation of the Danish RFID testcenter
Jens Christian
Sørensen, Danish Technological Institute, Tåstrup, Denmark
Pharmaceutical Packaging for Freeze-dried Drugs
• Analysis of stresses in freeze drying process
• Mathematical simulation
• Optimization of geometries
Juergen Thuerk; Schott Schweiz AG, St. Gallen, Switzerland
Security Labelling
• Anti counterfeiting
• Tamper labelling
• Security features
• RFID labels
Sven Tolsma; UPM Raflatac, PV de Meern, The Netherlands
Development of Accessibility towards Packaging with a Commercial Focus
• National working group
• The National Consumer Agency Accessibility towards packaging
• Project with business cases
• Principles from food products – medical products
Lene Witte; The Danish Rheumatism Association, Gentofte, Denmark
Interactive and Intelligent Pharmaceutical and Medical RFID Packaging
• Medication monitoring, patient diary and reminding
• Disposable home lab for identifying and monitoring diseases
Danevert Aasbrink; Cypak AB, Stockholm, Sweden