CT-scanning i Novo Nordisk device udvikling Jan Lasson Andreasen, Device R&D

Transcription

1 CT-scanning i Novo Nordisk device udvikling Jan Lasson Andreasen, Device R&D

2 Materials & Device Characterisation Novo Nordisk device udvikling Schweizer Kniven Begrænsninger Eksempler

3 Slide no 3 Novo Nordisk - 4 therapy areas More than 29,800 employees in 76 countries Total net turnover (2007): 5.6 billion Euro R&D spent (2007): 1.1 billion Euro Committed to environmental and social responsibility Diabetes Haemophilia Hormone replacement treatment Growth hormone therapy

4 Milestones in Our History Devices 1994 NovoFine 30 World s first 30 gauge insulin pen needle 1996 NovoPen Innovo 2002 NovoPen Jr 2001 InnoLet 2002 FlexPen

5 Slide no 5 As a result of 20 years Novo Nordisk device innovation, today 60% of insulin is sold with devices ~ about 10 million users > 3 million people use NovoPen systems (60% durable market share) > 2 million people use NovoLet and FlexPen systems (65% prefilled market share) about 500,000 people start using NN delivery systems every year

6 Slide no 6 CT-scanning a Swiss Knife in our Device Development Milestone Next Milestone document design manufacture test document assemble design Ready for assembly? Part geometry inspection Material Interior analysis Ready for test? Assembly analysis Why does it work? Failure analysis

7 Two CT-scanners in NN, site Hilleroed GE Phoenix Nanotom Zeiss Metrotom 1500 Where: DRD Competency Centre What: Part Inspection (early phase), Material Interior Analysis, Assembly Analysis, Failure Analysis Where: DMS Metrology What: Part Inspection for Mould Approval Support to 27 R&D projects + marketed products

8 Range of dimensional CT tasks Injection needles (SS) Ø 0.3 mm x 20 mm Complex plast components max Ø 20 mm x 150 mm

9 Various materials WALL THICKNESS ANALYSIS Stainless Needle PE hinge Glass Cartridge

10 The first 1000 projects (3 years) on Nanotom scanner Material interior analysis 8% Failure Analysis 23% Part Inspektion 39% Assembly Analysis 30%

11 Advantages and disadvantages Non destructive and contactless inspection Also areas which are inaccessible with CMM Simple sample fixation Quick instrument programming Scan time from 5-60 minutes per sample High res = Large files need 64 Bit workstations Suitable for few samples where high detail is needed.

12 Limitations - segmentation Low absorbing materials get distorted in combination with high absorbing

13 Limitations precision in CT- measurements Complex technology with many influences Surfaces are roughened Corners are rounded Artefacts due to large variations in wall thickness Data analysis Result depending on fitting method Datum system interpretation Flash and mould lines Uncertainty About ± 20 µm

14 Diameter [µm] 8 November 2011/jlsa CT Measurements on NN scanners in agreement with CMM mm SPHERE 1 PHOENIX ZEISS

15 Part inspection used in troubleshooting after stress testing Plastic part after wear test

16 Mould tool micro geometry details inspectable with replica scan Small mould tool cavity Groove geometry with radius 0.05 mm Flatness of fitted plan within ± 0.02 mm 2 component replica kit from Struers

17 Material Interior analysis Task Three-dimensional evaluation and visualization of the distribution of fibre in reinforced injection moulded parts Analysis Determination of diameter, length and three-dimensional distribution Input to CAE simulations models Manually examination for fibre breakage de-bonding between fibre and polymer cracks in the polymer

18 CT-scanning a helpful tool in device development because. Cut development time Component and/or interface analysis Faster trouble shooting of production equipment Injection moulding Assembly lines Improve device robustness Quicker identification of critical features Improved identification of areas for QC measurements Improved ability to identify material and process related defects Highlight failure types which cannot be found with traditional methods Improve communication between int. and ext. partners/stakeholders Quick check of moulded part geometry compared to CAD-model Quick identification of misunderstandings

19 Slide no 19 Thank you for your attention! Any Questions?