basf plastics for healthcare and diagnostics ......basf plastics for healthcare and diagnostics :...

BASF Plastics for Healthcare and Diagnostics : understanding your needs

Thomas WilesHead of Industry Management Healthcare & Diagnostics Styrenics Europe

11

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


Agenda




Product Safety

33


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

44


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

55


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)

66


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

77


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

88


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

99


Agenda




Product Safety

1010


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!

1111


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

1212


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

1313


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

1414


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

1515


Agenda




Product Safetyand Regulatory Affairs

1616


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*

1717


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


1818


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.)


* approvals for natural or uncolored base materials respectively

1919


… 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

2020


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)

2121


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

2222


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 !

2323


Agenda




Product Safetyand Regulatory Affairs

2424


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

2525


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)

2626


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.

2727


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

2828


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

2929


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

3030


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®

3131


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

3232


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

basf plastics for healthcare and diagnostics ......basf plastics for healthcare and diagnostics :...

Documents