chris vince technical and applications manager ensinger ltd showcase 2011/6chri… · manchester -...

MediWales Members’ Showcase – 12th October 2011

Plastics for Medical and Life Science Technology

Chris Vince Technical and Applications Manager

Ensinger Ltd

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Founding year 1966 CEO Klaus Ensinger Dr. Roland Reber Headquarter Nufringen Employees ca. 1,700 Turnover ca. 280 Mio. € Sales and production sites 35 Certifications ISO 9001 ISO 13485 (For Compounding, Semi-finished products, Profiles, Injection Moulding & Machining)

The company group

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Ensinger families worldwide

Brazil

USA

China

Japan

Sweden

Poland

Italy

Czech

Austria Spain

France

UK

GERMANY

Singapore

Custom cast

Injection moulding

Semi-finished products

Building products

Machining

Profiles

Com- pounds

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Ensinger UK - Locations

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Bishop’s Stortford - 1998

Bridgwater Trig Engineering - 1994

Birmingham - 2001

East Kilbride - 2000

Manchester - 1993

Waterlooville - 1990

● - Manufacturing Sites

Tonyrefail UK Headquarters – 1987 Ensinger Precision Engineering - 2003

• 2 UK manufacturing locations: Tonyrefail, South Wales Bridgwater, Somerset

• 55000 sq ft manufacturing area.

• Combined workforce 135+.

Ensinger Precision Engineering

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Ensinger Precision Engineering

EPE has recently invested in the installation of a new cleaning room. This incorporates a multi-stage ultrasonic cleaning process, rinse & drying.

Certification to ISO 13485 is expected to be completed in the next few months.

EPE currently manufacture and are approved suppliers for a number of the large UK based orthopaedic & medical device companies.

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Medical Requirements

Physiology • FDA conformity • Biocompatibility as in USP 23 Class

VI/ ISO 10993 • FDA Drug (DMF)/ Device Master

File (MAF) Listing • FDA-conforming pigments

Resistance to • Sterilisation • Chemicals • Hydrolysis • High Temperatures • Radiation

Tribology • Low friction • Minimum wear tendency • Good dry-running characteristics on

metal

Electrical • Dielectrical loss factor • High flash-over resistance • Good trickle-current resistance • Conductivity or insulation

Mechanical • Strength and stiffness at high

temperatures • Low creep tendency • High precision

Miscellaneous • Barrier characteristics • Manufacturing precision • Low water absorption • Low thermal expansion

Plastics in Medical Technology

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Analytical Equipment Instrumentation LT Implants Delivery Systems

• pumps • housings • motors • dialysis

hardware • sterilizing

hardware

• chromatography

components • chemical testing • biohazard

handling

• laparoscopy • surgical handles • surgical tools • endoscopy

• stent balloons • catheters • tubing • drug delivery • blood contact (dialysis) • temp. implants (dental)

• orthopedic • dental • cardiovascular • neurology • pharmaceutical

TECAPEEK TECAPEEK CLASSIX

FDA-compliance

not intended for direct blood and tissue contact

PEEK-OPTIMA®

USP VI compliant resin,

Every batch tested & certified

ISO 10993 approved

Prolonged ( 30 days)

Option to prolong up to

180 days (via Invibio ™)

TECAPEEK MT

ISO 10993 tested,

based on periodic tests

Limited ( 24 hours)

Applications for Different PEEK-Grades

Increasing health risk and liability

Implants

Permanent (> 30 days)

Distribution: Invibio™

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Thank you very much for your attention !