17.07.2015 © Elma Schmidbauer GmbH
Ultrasonics.Steam.Ultraclean.
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
New Headquarter (since 2014)
17.07.2015 3 © Elma Schmidbauer GmbH
D-78224 Singen Germany Gottlieb-Daimler Str. 17
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
Elma Strategic Business Fields with revenue (2014)
17.07.2015 © Elma Schmidbauer GmbH 5
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. €
17.07.2015 © Elma Schmidbauer GmbH 6
• 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
Business Unit OMT
Optics
Medical Technology
17.07.2015 © Elma Schmidbauer GmbH
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
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:
17.07.2015 © Elma Schmidbauer GmbH 9
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
17.07.2015 © Elma Schmidbauer GmbH 10
Medical Technology
17.07.2015 © Elma Schmidbauer GmbH 11
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
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:
17.07.2015 © Elma Schmidbauer GmbH 12
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
Medical Technology
17.07.2015 © Elma Schmidbauer GmbH 14
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,….
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:
17.07.2015 © Elma Schmidbauer GmbH 15
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
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:
17.07.2015 © Elma Schmidbauer GmbH 17
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
Contact lenses
17.07.2015 © Elma Schmidbauer GmbH 19
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
Medical Technology
17.07.2015 © Elma Schmidbauer GmbH 20
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
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
•
17.07.2015 © Elma Schmidbauer GmbH 21
Medical Technology
Product portfolio
x - tra modular line (pro or pre version) for In process cleaning or final cleaning with or without passivation
17.07.2015 © Elma Schmidbauer GmbH 22
Medical Technology
Product portfolio
x - tra modular lines for In process cleaning or final cleaning
17.07.2015 © Elma Schmidbauer GmbH 23
Medical Technology
Product portfolio
Customized systems for In-process-cleaning or Final cleaning
(With or without passivation using nitric acid or citric acid)
17.07.2015 © Elma Schmidbauer GmbH 24
Medical Technology
Product portfolio
Customized systems for inflammable solvents
17.07.2015 © Elma Schmidbauer GmbH 25
17.07.2015 © Elma Schmidbauer GmbH 26
Medical Technology
Part positioning
17.07.2015 © Elma Schmidbauer GmbH 27
Medical Technology
Part positioning and contact material
Medical Technology
Product portfolio Cleaning chemicals designed and product by Elma
(Some listed as medical product class 1)
Pure water systems (Falk)
17.07.2015 © Elma Schmidbauer GmbH 28
17.07.2015 © Elma Schmidbauer GmbH 29
• 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
17.07.2015 © Elma Schmidbauer GmbH 30
• 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
17.07.2015 © Elma Schmidbauer GmbH 31
Elma Kavimeter (Ultrasonic Measurement Unit)
Measurement and judgement of
cavitation noise DIN 40170
Thank you for your attention !
17.07.2015 © Elma Schmidbauer GmbH 32