ultrasonics.steam.ultraclean. - edeltec tecnologia · 2016-05-19 · din iso en 13485 certification...
TRANSCRIPT
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17.07.2015 © Elma Schmidbauer GmbH
Ultrasonics.Steam.Ultraclean.
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History
17.07.2015 2 © Elma Schmidbauer GmbH
Super Elite
1948
Elmasolvex VA
2014
Kolpingstraße
Founded
1948
Ever since
family-owned
by 100%,
still the case!
234
employees
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New Headquarter (since 2014)
17.07.2015 3 © Elma Schmidbauer GmbH
D-78224 Singen Germany Gottlieb-Daimler Str. 17
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17.07.2015 © Elma Schmidbauer GmbH 4
Elma get into the “TOP 100” most
innovative companies in Germany
DIN ISO EN 9001 certification since 1994
DIN ISO EN 13485 certification since 2003
Assembly halls for industrial systems
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Elma Strategic Business Fields with revenue (2014)
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Watch & Jewellery
Laboratory & Industry
Medical Healthcare
Optic &
Medical Technology
MEDICAL
(Medical Manufacturing Hygiene
Solutions-hospitals Optics)
8,2 Mio. € 11,6 Mio. €
16,1 Mio. €
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• Process time
• Time (sec) (per process step)
• Cleaning agent (pH)
• Elma clean products
• Process temperature (°c)
• For example:
• ELMA Ultrasonic
• Elma US Kavimeter
• Pressure nozzle Mechanics Temperature
Time Chemistry
Four factors for a successful cleaning
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Business Unit OMT
Optics
Medical Technology
17.07.2015 © Elma Schmidbauer GmbH
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17.07.2015 © Elma Schmidbauer GmbH
Ultrasonic Cleaning Systems for
pre cleaning and final cleaning of
surgical instruments, endoscopes
and implants made of metal,
ceramic and plastic
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Medical Technology
Process chain in production
Medical or surgical instruments made by stainless steel
Last step: Cutting, turning, milling, grinding, polishing
(In-process cleaning) (Quality control)
Next step: Quality control or for further processing (next grinding or polishing step)
Typical contaminations:oils,grease,coolants particles,fingerprints, polishing (MDS requested to select the chemistry!)
Next step:
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Medical Technology
Process chain in production
Last step: Quality control
Final-Cleaning with or without passivation
Next step: Packaging or final rinsing/drying/Steriliazation
Typical contaminations: rest of polishing or lapping residue, particles, fingerprints, Marking from laser engraving,…
Information to passivation needed: nitric acid or citric acid and also concentration and process temperature requirement
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Medical Technology
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Tank 1 Tank 2 Tank 3 Tank 4 Tank 5 Tank 6 Tank7 Tank 8
Cleaning
65°C
Cleaning
65°C
Rinsing
50°C
Passivation
55°C
ASTM 967-05
Rinsing
50°C
Rinsing
50°C
Rinsing
50°C
Drying
120°C
Elma Clean
275d&S or
270 d&s (Depending on
polishing material)
Elma Clean
275d&S or
270 d&s (Depending on
polishing
material)
Soft city
water
Elma Clean
115 C
(Citric based
passivation)
or nitric acid
Soft city
water
Di-water DI-water
Cond: < 2,5µS/cm
Hot air
with HEPA
filter
Ultrasonic 25/45
kHz
Ultrasonic
25/45 kHz
Ultrasonic
25/45 kHz
Ultrasonic
25/45 kHz
No Ultrasonic
with nitric acid
Ultrasonic
25/45 kHz
Ultrasonic
25/45 kHz
Lift-Out
Standard process for final cleaning of surgical instruments
Cleaniness tested by: Bioburden, TOC, Cytotoxicity, Endotoxin, Passivity
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Medical Technology
Process chain in production
Medical implant (Metal)
Last step: Cutting, turning, milling, grinding, polishing
(In-process cleaning) (Quality control)
Next step: Quality control or for further processing (next grinding or polishing step, blasting,)
Typical contaminations: oils, grease, coolants particles, fingerprints (MDS requested to select the chemistry!)
Next step:
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Medical Technology
Process chain in production
Last step: Quality control
Final-Cleaning with or without passivation
Next step: Packaging or final rinsing/drying/Sterilization
Typical contaminations: rest of polishing or lapping residue, particles, fingerprints, Marking from laser engraving,…
Information to passivation needed: nitric acid or citric acid and also concentration and process temperature requirement (ASTM 967-05)
17.07.2015 © Elma Schmidbauer GmbH 13
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Medical Technology
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Possible standard process for final cleaning of metallic implants
Tank 1 Tank 2 Tank 3 Tank 4 Tank 5 Tank 6 Tank7 Tank 8
Cleaning
65°C
Rinsing
50°C
Passivation
55°C
ASTM 967-
05
Rinsing
50°C
Rinsing
50°C
Rinsing
50°C
Rinsing
50°C
Drying
120°C
Elma Clean
275d&S or
270 d&s (Depending on
polishing material)
Soft city
water
Nitric acid Soft city
water
Di-water Di-water DI-water
Cond.: < 2,5µS/cm
Hot air
with HEPA
filter
Ultrasonic
25/45 kHz
Ultrasonic
25/45 kHz
Ultrasonic
25/45 kHz
Ultrasonic
25/45 kHz
Ultraschall
25/45 kHz
Lift-Out
Cleaniness tested by: Bioburden, TOC, Cytotoxicity, Endotoxin, Passivity,….
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Medical Technology
Process chain in production
Medical implant (Plastic)
Last step: Blank drilling, milling, turning, ….
(In-process cleaning) (Quality control)
Next step: Quality control or for further processing (next treatment step)
Typical contaminations: dust, plastic particles, treatment fluids
(MSDS requested)
Next step:
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Medical Technology
Process chain in production
Medical implant (Plastic)
Last step: Quality control
Final-Cleaning
Next step: Packaging or final rinsing/drying/Sterilization
Typical contaminations: particles, fingerprints,….
17.07.2015 © Elma Schmidbauer GmbH 16
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Medical Technology
Process chain in production
Medical implant (Ceramic)
Last step: Blank drilling, milling, turning, grinding, polishing
(In-process cleaning) (Quality control)
Next step: Quality control or for further processing (next treatment step) and crack testing
Typical contaminations: dust, ceramic particles, treatment fluids
(MSDS requested)
Next step:
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Medical Technology
Process chain in production
Medical implant (Ceramic)
Last step: Quality control
Final-Cleaning
Next step: Packaging or final rinsing/drying/Sterilization
Typical contaminations: particles, fingerprints,….
Cleaniness tested by: Bioburden, TOC, Cytotoxicity, Endotoxin,
17.07.2015 © Elma Schmidbauer GmbH 18
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Contact lenses
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ATEX rated systems
using inflammable
solvents like IDA,
Ethanol, PEG,EL…
For example to
extract (Solvent) and
hydrate (Di-Water)
contact lenses from
unpolymrisate
monomers
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Medical Technology
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Elma advantages
From individual units to modular systems to the project-specific design,
coupled with a range of own cleaning chemicals (which is partly
already registered as a medical device class 1)
Plant control in the field of user-management & Audit Trail to FDA
Sensors with calibration certificate, Online power control from US
Generator
Measurement ultrasound (handheld version) or as an integration (Still
in R&D)
Elma Kavimeter
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Medical Technology
Product portfolio
Serial units mostly P – Line
with double frequency 37/80 kHz
And selectable power.
Future: USB Inferface
Elma Solvex for micro parts
(like screws, dental implants)
Pure solvent based process
Inflammable solvents useable
with flash Point ≥ 12°C
•
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Medical Technology
Product portfolio
x - tra modular line (pro or pre version) for In process cleaning or final cleaning with or without passivation
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Medical Technology
Product portfolio
x - tra modular lines for In process cleaning or final cleaning
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Medical Technology
Product portfolio
Customized systems for In-process-cleaning or Final cleaning
(With or without passivation using nitric acid or citric acid)
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Medical Technology
Product portfolio
Customized systems for inflammable solvents
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Medical Technology
Part positioning
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Medical Technology
Part positioning and contact material
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Medical Technology
Product portfolio Cleaning chemicals designed and product by Elma
(Some listed as medical product class 1)
Pure water systems (Falk)
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• Industrial PC
• PC with flash card
• UPS for data backup
• VPN connection for
LAN connection to
onside network or
remote diagnostic
• USB interface
• Windows 7 E
• HMI 15” Touch-Panel
with fully visualization
and SCADA
• Product identification
• Lot ID Recording
• Working data recording
• MES connection
• OEE Option
• Electric power
management
IPC for system and process control
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• FDA CFR 21 Part 11 User administration,
User groupe,
Audit-Trail,
Signature,
Recipe -management,
RFID Login Option,
Data-Volume and storage
location in agreement with
user
IPC for system and process control
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Elma Kavimeter (Ultrasonic Measurement Unit)
Measurement and judgement of
cavitation noise DIN 40170
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Thank you for your attention !
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