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