ultrasonics.steam.ultraclean. - edeltec tecnologia · 2016-05-19 · din iso en 13485 certification...

17.07.2015 © Elma Schmidbauer GmbH

Ultrasonics.Steam.Ultraclean.

History

17.07.2015 2 © Elma Schmidbauer GmbH

Super Elite

Elmasolvex VA

Kolpingstraße

Founded

Ever since

family-owned

by 100%,

still the case!

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)

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. €

• 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

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:

Medical Technology

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

Medical Technology

Tank 1 Tank 2 Tank 3 Tank 4 Tank 5 Tank 6 Tank7 Tank 8

Cleaning

Rinsing

Passivation

ASTM 967-05

Rinsing

Drying

120°C

Elma Clean

275d&S or

270 d&s (Depending on

polishing material)

Elma Clean

275d&S or

polishing

material)

Soft city

Elma Clean

(Citric based

passivation)

or nitric acid

Soft city

Di-water DI-water

Cond: < 2,5µS/cm

Hot air

with HEPA

filter

Ultrasonic 25/45

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

Medical implant (Metal)

Last step: Cutting, turning, milling, grinding, polishing

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:

Medical Technology

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)

Medical Technology

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

Rinsing

Passivation

ASTM 967-

Rinsing

Drying

120°C

Elma Clean

275d&S or

polishing material)

Soft city

Nitric acid Soft city

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

Medical implant (Plastic)

Last step: Blank drilling, milling, turning, ….

Next step: Quality control or for further processing (next treatment step)

Typical contaminations: dust, plastic particles, treatment fluids

(MSDS requested)

Next step:

Medical Technology

Medical implant (Plastic)

Final-Cleaning

Typical contaminations: particles, fingerprints,….

Medical Technology

Medical implant (Ceramic)

Last step: Blank drilling, milling, turning, grinding, polishing

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:

Medical Technology

Medical implant (Ceramic)

Final-Cleaning

Typical contaminations: particles, fingerprints,….

Cleaniness tested by: Bioburden, TOC, Cytotoxicity, Endotoxin,

Contact lenses

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

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

Medical Technology

Product portfolio

x - tra modular line (pro or pre version) for In process cleaning or final cleaning with or without passivation

Medical Technology

Product portfolio

x - tra modular lines for In process cleaning or final cleaning

Medical Technology

Product portfolio

Customized systems for In-process-cleaning or Final cleaning

(With or without passivation using nitric acid or citric acid)

Medical Technology

Product portfolio

Customized systems for inflammable solvents

Medical Technology

Part positioning

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)

• 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

• 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

IPC for system and process control

Elma Kavimeter (Ultrasonic Measurement Unit)

Measurement and judgement of

cavitation noise DIN 40170

Thank you for your attention !

ultrasonics.steam.ultraclean. - edeltec tecnologia · 2016-05-19 · din iso en 13485 certification...

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