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Theme: Inhalation
Devices for Medicine Delivery
Manufacture Requirements and Characterization
The Seminar has
been arranged in collaboration with
Ola Nerbrink, Novo Nordisk A/S, Denmark
The seminar lectures
include:
Responding to Nasal and Pulmonary Drug Delivery Trends
Nasal dispensing systems
Unit and bi-dose systems
Regulatory aspects
Pulmonary drug delivery systems
Renι Bommer; Ing. Erich Pfeiffer GmbH, Radolfzell, Germany
Platform Strategy for Medical Device Development
Optimizing nebulizer systems for specific applications
Thomas Gallem: Pari GmbH, Mόnchen, Germany
Development, Industrialisation and Manufacturing of Inhalation Devices
Wolfgang Gruenauer and Peter Schneider; Wilden AG, Pfreimd, Germany
Breathing New Life into Asthma Therapy
Relevance of pulmonary compliance in asthma therapy
Introducing Dose counting
New Opportunities with Integrated Electronic Features
Christian Husegaard; Bang & Olufsen Medicom a/s; Kgs. Lyngby, Denmark
Regulatory Considerations During Selection and Testing of Inhaler Componentry Materials
Overview of material selection
Current regulatory guidance
Testing considerations including leachable and extractables testing
Future Trends
Steve Nichols; Aventis Pharma Ltd. Holmes Chapel, Cheshire, United Kingdom
In vitro characterisation technologies
Liquid aerosol assessment techniques
Solid particle assessment
Regulatory approved methodologies
Ola Nerbrink; Novo Nordisk A/S, Hillerψd Denmark
Elastomer Compositions for Pharmaceutical Applications
Physical properties Chemistry, filler dispersion, mechanical properties, ageing
Sealing performance HFA sealing device shot weight
Toxicity USP tests
Extractives analysis characterising of the acetone extracts by GC-MS
Daljit Ohbi, Bespak Europe Ltd., Milton Keynes, United Kingdom
Micro and Nano-technology
Interacting with High Precision Moulding in Next Generation Mechanical ADI
Systems
Material
selection
Manufacturing methods
and industrialization
Interaction between
technologies in final assembly
Principle ADI system
build up and selection of primary package
Jeroen Wissink; Medspray, Enschede, The Netherlands and
Mats Persson; SHL Medical, Nacka Strand, Sweden
Characterization and
Qualification of Inhalation Drug Product Systems: Container Closures and
Devices
Chemical characterization
Leachable/extractables
Functional/performance aspects
ISO and FDA aspects
Scott Young et al.; West Pharmaceutical Services, Lionville, PA, USA.
Theme:
Advanced Materials
● Device Applications ● Sterilisation ●
Processing ●
Biological Evaluation ● Bioactive Materials ●Validation
● Research & Development
Parylene, a Biostable Coating for Medical Applications
Description of process
Parylene properties
Present and future applications
Kjell Askerfalk; Para Tech Coating Scandinavia AB, Jδrfδlla, Sweden
Sulfone Polymers for Medical Applications
Properties vs. performance requirements
Repeated sterilization
Stringent multi-use and single-use
Typical applications
Jean-Baptiste Bonnadier; Solvay Advanced Polymers Belgium, Oudenaarde, Belgium
New Materials for Healthcare and Diagnostics
Christian Bonten et al.; Basf AG, Ludwigshafen, Germany
Thermocontact Welding of Polyolefine Films
Material characteristics
Welding Technology
Parameter set-up and control
Gerald Brunner; Kiefel AG, Freilassing, Germany
Microfluidic Systems in Polymer Materials Research, Prototyping and Integration
Rapid prototyping methods
Sealing and bonding microfluidic systems
Integration of optical waveguides
Packaging and Interconnections
Frederik Bundgaard; Technical University of Denmark, Kgs. Lyngby, Denmark
Creating New Chemistry in and on Silicone Surfaces
"Printable" silicone surface
"Teflon" like surface
Ultra-hydrophilic inorganic coating
Interpenetrating polymer Network (IPN) in silicone material
Hydrophilic polyvinylpyrrolidone (PVP) syrface
Thomas Christensen and Martin Alm; Nanon A/S, Brψndby, Denmark
Silicones in Medical Applications
Silicones and siloxanes:
definitions
Silicone fluids and
silicone elastomers: Physicochemical properties
Historical applications
New developments: liquid
silicone rubber, modified surface,
controlled drug release
Andrι Colas; Dow Corning Corporation
Development of a New Poly (urethane urea) for Medical Applications
Introduction to polyurethane chemistry
Biocompatibility
Design possibilities
Typical applications
Katrin Gisselfδlt; Artimplant AB, Frφlunda, Sweden
Bioresorbable Polyhydroxyacids in Trauma Surgery Present Status
Polyhydroxyacids
Processing
Internal fixation devices
Scaffolds for tissue repair and regeneration
Drug delivery
Sylwester Gogolewski; AO Research Institute, Davos, Switzerland
Cycloolefin-Copolymers
(COC): An Innovative, Transparent Plastic Material for Applications in Medical
and Diagnostic
Structure and manufacturing
Typical product properties
Medical and diagnostic applications
Regulations and biocompatibility
Sterilisation and processing
Michael Grimm; Ticona GmbH, Kelsterbach, Germany
PEEK Polymer Based Carbon Fibre Composites for Surgical Applications
Methods, materials
Testing; MRI imaging;
Composite flow moulding
Results and future outlook
Roland Groeger; Invibio Ltd., Thornton Cleverlys, Lancs. United Kingdom
Calibration of Dosimeters at 80-120 keV Electron Irradiation
Calorimeter for dose standardization
Energy losses and heating in air gap
Effects of dose distributions within dosimeter
Jakob Helt-Hansen and Arne Miller; Risψ National laboratory, Roskilde,
Denmark
Application of Polymethylmethacrylate (PMMA) in Dental Medicine: Status and Future Developments
The basic idea
Biocompatibility
PMMA as implant material or as drug delivery device
Future developments
Luc W.J. Huys; R.T. Mat, Brugge, Belgium
Resorbable Polymers for Medical Applications - an Inventory
Polyglycolid (PGA)
Polyactid (PLA)
Polycaprolacton (PVL)
Polydioxanon (PDO)
Poly (hydroxybutyrat (PHB)
Poly (lactid-co-glycolid (PLGA)
Harald Liedtke; Boehringer Ingelheim Pharma KG, Ingelheim, Germany
E-Beam Sterilisation Technology
Surface treatment
Sterilization
Dosmetry
Materials modification
Stephen Morley; Getinge Infection Control, Getinge, Sweden and
Thιo Sadat; Linac Technologies S.A.S., Orsay, France
The Choice of Plasticiser for Medical Applications
Plasticisers in medical applications
Motivation for new product development
Plasticiser migration and comparison with existing plasticizers in
clinical nutrition
Rainer Otter; BASF AG, Ludwigshafen, Germany
ThermoplasticElastomers Compounds (SBS and SEBS) in Medical Application
General presentation of TPE
Advantages of TPE in medical devices
Gary Pollard; VTP (Vita Thermoplastic Polymers), Manchester, United Kingdom
Medical/Protective Device Applications Benefiting from Thermoplastic Poly Urethane (TPU) Film
TPU-processing advantages
Medical requirements
Barrier properties
Protective structures
Dirk Schultze; Epurex Films GmbH & Co. KG, Walsrode, Germany
Bioresorbable Poly-lactide/Calcium Phosphate Composite Devices for Bone Fixation and Regeneration
Production of poly-lactide/calcium phosphate composite materials
Processing of Poly-lactide/calcium phosphate composites by injection
moulding
Impact of composite production method on physical, mechanical and
microstructural properties of moulded composite
Biological applications and implications
Naseem Theilgaard; Danish Technological Institute, Centre for Plastics Technology, Taastrup, Denmark
New Systems Platform for Zero Defect Production of Safety Critical Molded Parts
Process analysis and production
monitoring system for injection
moulding
Benefits of cavity pressure measurements of injection moulding
Good / Bad parts segregation based on the cavity pressure signature
in injection moulding
Typical cavity pressure sensors used for small technical high
precision plastics parts
Max P. Waser; Kistler Instrumente AG, Winterthur, Switzerland
Latest Innovations in Polyolefines (PO) for Medical and Pharma Applications
Comparison PP PE polymers for medical applications
Latest innovations in PP from stiff to soft polymers
Recent application advances medical pouches/lamination films and
blisters
Future industry needs vs. PO manufacturer response
Anton Wolfsberger; Borealis GmbH; Linz, Austria
