PROGRAMME

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