BASF Plastics for Healthcare and Diagnostics : understanding your needs
Thomas WilesHead of Industry Management Healthcare & Diagnostics Styrenics Europe
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BASF Plastics for Healthcare and Diagnostics
Agenda
Challenges in the medical technology market
Advantages of specialized HD products –Service Package
Plastics for Healthcareand diagnostics: transparency andgood service
Product Safety
22
BASF Plastics for Healthcare and Diagnostics
Agenda
Challenges in the medical technology market
Advantages of specialized HD products –Service Package
Plastics for Healthcareand diagnostics: transparency andgood service
Product Safety
33
BASF Plastics for Healthcare and Diagnostics
Source: Smith Medical, Medistat. Note: Europe data comprised of the following countries: UK, France, Germany, Italy, Spain, Belgium, Netherlands, Sweden, Norway, Finland, Denmark, Poland, Hungary, Czech Republic, Switzerland
Europe9% GDP spend on healthcare400M population17% population >= 652.25M hospital beds
USA16% GDP spend on healthcare300M Population13% population >= 651m hospital beds 63% market via group purchasing
China6% GDP spend on healthcare1.3b population8% population >= 653m hospital beds
Japan8% GDP spend on healthcare125m population21% population >= 651.8m hospital beds
Macroeconomics
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BASF Plastics for Healthcare and Diagnostics
2009 - Billion € (Percentage of BASF sales)
Chemicals 14.2 (25%)
Agricultural Products & Nutrition 5.0 (9%)
Oil and Gas 10.5 (18%)
Plastics 13.5 (23 %)
Other 3.1 (5%)
Performance Products
11.7 (20%)
BASF- Group 50,7 billion Euro
BASF – The Chemical CompanyThe world’s leading chemical company
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BASF Plastics for Healthcare and Diagnostics
Challenges in the medical technology marketMarket overview: The Health Care Industry
Sources: Nanomedicine 2006-2011, a visiongain report, 2006 and European Science Foundation: Nanomedicine - An ESR-European Medical Research Councils (EMRC) Forward Look Report, 2005 AMCG, Pharmaceutical Advisors
Medical Devices (€ 168bn)
Drug Delivery Systems (€ 89bn)
Pharmaceuticals (€ 423bn)(without Drug Delivery Systems)
Health Care Industry € 680bn
In-vitro Diagnostics (€ 40bn)
In-vivo Diagnostics (€ 74bn)
Tissue Engineering (€ 19bn)Implants (€ 37bn)
Devices and MedicalEquipment (€ 145bn)
Drug Delivery Systems (€ 220bn)
Health Care Industry (2006 – 2015)
20152006In-vitro Diagnostics In-vivo Diagnostics
Tissue Engineering Implants
Dev. & Med. Equipment
Product Examples
Drug Delivery Systems
€ 257bn € 535bn
Medical Devices (€ 315bn)
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BASF Plastics for Healthcare and Diagnostics
Challenges in the medical technology marketConsumption in the medical industry
PS 20%
PP 13% PE 25%
Others 15%
PVC 27%
PBT, PET 3%
Others 2%
TPE 2%
POM, LCP 3%
ABS, SAN 3%
PC 2%
Total ca. 3.700 ktAAGR (2005-2010) approx. +7% p.y.
Others consumption 600 kt
Source: Plastics Europe 2006
World 2005 Market Europe : 1.220 kt
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BASF Plastics for Healthcare and Diagnostics
0
500
1000
1500
2000
2500
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 S1 S2 S
3 S4
S1S2S3S4
Years
Volume
Volume
Pre
clin
ic
Res
earc
h
App
. req
uest
ed
Phas
e I
Phas
e III
Phas
e II
App
rove
d
Research – 2 years Phase III – 2 years
Pre clinic – 2 years Application requested – 1.5 years
Phase I – 2 years Approved – 2 years
Phase II – 1.5 years
Polymer Demand vs. Drug Product Lifecycle
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BASF Plastics for Healthcare and Diagnostics
Willingness of raw material
manufacturer to supply a certain
plastic
Continuous product supply
No significant product change
Food contact compliance
36 month notice before
replacement or change
European Pharmacopeia
Drug Master File
Biocompatibility Tests
USP Class VI
Monitoring of Extractable
Profiles
Composition of the polymer
Japanese Pharmacopeia
Biocompatibility Tests ISO
10993
36 month shelf live
Challenges in the medical technology marketCustomer Demands / Requirements for Plastics
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BASF Plastics for Healthcare and Diagnostics
Agenda
Challenges in the medical technology market
Advantages of specialized HD products –Service Package
Plastics for Healthcareand diagnostics: transparency andgood service
Product Safety
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BASF Plastics for Healthcare and Diagnostics
Advantages of specialized HD products–Service PackageUnderstanding Your Market
Your market:
Highly regulated
Extremely term development
Expensive approval procedures
SAFETY FOR THE PATIENT
Our offer:
SAFE MATERIALS!
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BASF Plastics for Healthcare and Diagnostics
Advantages of specialized HD products–Service Package Shared Responsibilities
Medical Device orMedical Device orPharmaceutical CompanyPharmaceutical Company MoulderMoulder Plastics SupplierPlastics Supplier
Ensure suitability for intended use
Biocompatibility testson final part
Approval for final part
Ensure suitability of raw materials
Stock materials
Constant product quality
Basic suitability tests
Long term supplyEnsure suitability of final part
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BASF Plastics for Healthcare and Diagnostics
Our intention not to change the formulation* in the long term. (Except for necessary adjustments due to regulatory changes.)
Our obligation to inform customers at least 36 months in advance of any changes to resin formulations*.
We oblige our own suppliers to ensure the purity of their ingredients.
Advantages of specialized HD products–Service PackageHD Service Package
Support of worldwide approvals for pharmaceutical and medical applications as well as for food contact.
Testing the compatibility of the plastic to specific chemicals.
Application technology support (processing, design, calculation).
*as defined in DMF
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BASF Plastics for Healthcare and Diagnostics
Advantages of specialized HD products–Service PackageMore Safety and Less Efforts for the Customers
“No change of formulation”
Long time supply
Tested material
Reduces testing work
Safe planning
Reduces approval efforts
BASFMedical Device or Pharmaceutical Company
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BASF Plastics for Healthcare and Diagnostics
The Healthcare and Diagnostics (HD) Industry TeamServing the industry since 2006
Sabine Vogt(+49 621 60-
49143)Regulatory Affairs
Anne-Sophie Roidot(+34 93 496-4149)
France, Spain
Marcus Anders(+49 621 60-45264)
New Business development
Pacôme Mancel
(+33 1 4964 5109 )France
Thomas Wiles(+49 621 60-59349)
Head of Team
Pia Dahlin(+45 40 784001)
Nordic
Elena Ferradas-Garcia(+39 335 1861786)
Italy
Geoff Nelson(+44 783 1438809)
UK, Ireland
Gunter Schobel(+49 172 7437048)
Germany, Switzerland
Birgit Münch(+49 621 60-47808)
New Business development
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BASF Plastics for Healthcare and Diagnostics
Agenda
Challenges in the medical technology market
Advantages of specialized HD products –Service Package
Plastics for Healthcareand diagnostics: transparency andgood service
Product Safetyand Regulatory Affairs
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BASF Plastics for Healthcare and Diagnostics
Pharmaceutical and Medical Applications
EU Pharmacopeia (EP 6th Edition, Chapter 3.2.2 “Plastic Containers and Closuresfor Pharmaceutical Use”)
Japanese Pharmacopoeia (JP 14th Edition, General Information, “11. Plastic Containers for Pharamceutical Products”)
US Pharmacopeia (USP Biological Reactivity Test Class VI)
Biocompatibility Tests (Cytotoxicity according to ISO 10993-51)
Drug Master File (DMF)
1 For Terlux® 2802 HD, additional tests according to USP guidelines are available* approvals for natural or uncolored base materials respectively
Product Safety and Regulatory Affairs Regulatory Requirements*
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BASF Plastics for Healthcare and Diagnostics
2 Has not been applied yet for Terlux® 2812 HD* approvals for natural or uncolored base materials respectively
Food Contact Applications
EU Directive 2002/72/EC as amended (Commission Directive “relating to plasticmaterials and articles intended to come into contact with foodstuffs”)
Bedarfsgegenständeverordnung (German Ordinance on articles of daily use) inthe revised version of December 23, 1997 as amended
21 CFR Food Additive Regulations (FDA Compliance)2
Product Safety and Regulatory Affairs Regulatory Requirements*
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BASF Plastics for Healthcare and Diagnostics
Other Applications
Kosmetikverordnung (cosmetic ordinance) in the revised version of 07.10.1997 as amended
Heavy Metals (CONEG - Coalition of North Eastern Governors) for the January 1, 1994, EU Directive 94/62/EEC on heavy metals, EU Directive 2000/53/EC on end-of life vehicles as amended
BSE/TSE Transmittance (no risk materials are used in the production, monomers / ingredients are of petrochemical origin, additives from animal origin are in accordance with the “Opinion of the Scientific Steering Committee of Feb. 19-20 1998”, the “Note for Guidance on Minimising the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Medicinal Products” of March 25 1999 (CPMP/BWP/1230/98) or WHO/CDS/VPH/95.145 respectively.)
Product Safety and Regulatory Affairs Regulatory Requirements*
* approvals for natural or uncolored base materials respectively
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BASF Plastics for Healthcare and Diagnostics
… is the contact point for Regulatory Affairs departments of customers or OEMs.
Issuing all HD conformity certificates
Maintaining the existing DMFs and LOAs
Creating new Drug Master Files
Coordinating analyses and biocompatibility tests with institutesand laboratories
Safety assessments of our products
Extractable evaluation and assistance in determining limit values
Leachable modeling, safety assessments for the planned applications of our customers
Product Safety and Regulatory Affairs Regulatory Requirements *
* approvals for natural or uncolored base materials respectively
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BASF Plastics for Healthcare and Diagnostics
Classification of Medical Devices EU
Permanentpermanent
Bloodtissue, bone
Implant Devices
(Risk-) Class
Type of Body Contact
Type of Device Example
artificial heart valveprosthetic joints, nails, plates
ContactDuration
III II b
permanent prolongedlimited
tissue, boneblood pathcirculatingblood
External deviceswith contact to theinternal body
dental bridges, crownsinfusion/transfusiondialyzer
II a II aII a or II b
limitedlimited
Mucosalskin
Surface device contact lenseselectrodes, stethoscope
II aI
limited (>24h), prolonged (> 24h < 30d), permanent (> 30d)
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BASF Plastics for Healthcare and Diagnostics
Classification of Pharmaceutical Packaging USA
Oral Tablets and Oral (Hard and Soft Gelatin) Capsules
Topical Powders; Oral powders
Topical Solutions and Suspensions; Topical and Lingual Aerosols; Oral Solutions and Suspensions
Low
Ophthalmic Solutions and Suspensions;Transdermal Ointments and Patches; Nasal Aerosols and Sprays
High
Sterile Powders and Powders for Injection; Inhalation Powders
Inhalation Aerosols and Solutions; Injections and InjectableSuspensions
Highest
LowMediumHigh
Likelihood of Packaging Component-Dosage Form InteractionDegree of ConcernAssociated with the Route of Administration
FDA Guidance for Industry
Source: FDA Guidance for Industry, Container Closure Systems for Packaging Human Drugs and Biologics, May 1999
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BASF Plastics for Healthcare and Diagnostics
Category 3 but no implants: exceptional sale for very special products (no commodities) after detailed safety assessment with special contracts possible
Category 1 Plastic supply
Category 2 Plastic supply with special contracts (Disclaimer).For commodities in individual cases only
Product Safety and Regulatory AffairsSelected Sales with Respect to End Application
NO PLASTIC SUPPLY FOR IMPLANTS !
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BASF Plastics for Healthcare and Diagnostics
Agenda
Challenges in the medical technology market
Advantages of specialized HD products –Service Package
Plastics for Healthcareand diagnostics: transparency andgood service
Product Safetyand Regulatory Affairs
2424
BASF Plastics for Healthcare and Diagnostics
Plastics for Healthcare and diagnosticsOur Products with Customer Service Package
Terlux® 2812 HD(Transparent ABS high flow)
Ultraform® W2320 003 PRO(POM high flow)
Terlux® 2802 HD(Transparent ABS)
Luran® HD(Transparent SAN)
Ultraform® S2320 003 PRO(POM)
Terluran® HD-15(Opaque ABS)
Service Package
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BASF Plastics for Healthcare and Diagnostics
Plastics for Healthcare and diagnosticsTerlux® HD: the Alternative to Polycarbonate (PC)
Combination of properties:
Excellent transparency
Good mechanical properties like tensile strength and stiffness
High impact strength(Falling dart impact strength and Izod impact strength comparableto standard ABS. Better than SAN and PMMA.)
Good resistance to chemicals and environmental stress cracking: comparable to ABS, superior to PC (depending on the chemical agent)
Outstanding surface quality, excellent feel and appearance
Easy processing(like ABS and much better than PC)
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BASF Plastics for Healthcare and Diagnostics
Transparent ABS (MABS) for the housing and the internal parts of the externally worn control unit (Terlux 2802 HD)
Sterilisable and resistant to chemicals
ActiGait® employed in rehabilitation medicine
Manufacturer: Otto Bock Healthcare, Berlin, Germany
Plastics for Healthcare and diagnosticsOur Products made of Terlux® HD
Transparent MABS, Terlux® 2812 HD Higher melt volume flow rate than Terlux® 2802 HD.
Can be more easily processed, e.g. multi-cavity tools.
Allows the economically efficient production of particularly complex transparent components.
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BASF Plastics for Healthcare and Diagnostics
Plastics for Healthcare and diagnosticsTerluran® HD-15 – Our “Broadband” ABS
Combination of properties:
Improved chemical resistance
High impact strength
Good mechanical strength and stiffness
Good environmental stress cracking resistance (ESCR)
Outstanding surface quality, excellent feel and appearance
Good processability
High scratch resistance
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BASF Plastics for Healthcare and Diagnostics
High gloss and scratch resistance
Improved resistance to chemicals
Optimized toughness and rigidity values
Easy to process by injection molding
Plastics for Healthcare and diagnosticsInhaler Made of Terluran® HD-15
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BASF Plastics for Healthcare and Diagnostics
Plastics for Healthcare and diagnosticsLuran® HD: The Alternative to PMMA
Outstanding transparency and color brilliance
Heat resistance
Good chemical resistance
Stress cracking resistance
Thermal shock resistance
Scratch resistance
Sterilizable (ethylene oxide, gamma radiation)
Combination of Properties
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BASF Plastics for Healthcare and Diagnostics
Existing ApplicationUrine container
Possible Applications
Disposables (screw and plug-in connectorsfor single-use medical products)
Measuring chambers and flow chambers
Requirements
Chemical resistance (fat, solvents, acids, alkalis, salts)
Transparency
Plastics for Healthcare and diagnosticsUrine Container Made of Luran®
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BASF Plastics for Healthcare and Diagnostics
The first engineering plastic by BASF, optimized for medical applications
PRO: Profile Covered Raw Materials Only: only special, strictly controlled precursor products are used
High crystallinity
Ideal combination of strength, stiffness and toughness
Outstanding tribological properties, i.e. low friction and wear
Low fatigue under mechanical stress
Excellent chemical and hydrolysis resistance
Withstands sterilization with hot steam, plasma and ethylene oxide
High dimensional stability
Good processability
Plastics for Healthcare and diagnosticsUltraform® S2320 PRO and Ultraform® W2320 PRO
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BASF Plastics for Healthcare and Diagnostics
Our offer:
Service package
Several plastics with a wide range of properties
Long experience in plastics
Your market:
Highly regulated
Extremely long lasting development
Expensive approvalprocedures
HD grades that meet
your requirements
Health Care & Diagnostics Team