Ultrasonics.Steam.Ultraclean. 17.07.2015 Elma Schmidbauer GmbH
History Elmasolvex VA Super Elite 1948 Founded 1948 Ever since family-owned by 100%, still the case! 234 employees Kolpingstraße 2014 17.07.2015 Elma Schmidbauer GmbH 2
New Headquarter (since 2014) D-78224 Singen Germany Gottlieb-Daimler Str. 17 17.07.2015 Elma Schmidbauer GmbH 3
Assembly halls for industrial systems 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 17.07.2015 Elma Schmidbauer GmbH 4
Elma Strategic Business Fields with revenue (2014) Watch & Jewellery Laboratory & Industry 8,2 Mio. 11,6 Mio. MEDICAL (Medical Manufacturing Hygiene Solutions-hospitals Optics) Optic & Medical Technology Medical Healthcare 16,1 Mio. 17.07.2015 Elma Schmidbauer GmbH 5
Four factors for a successful cleaning For example: ELMA Ultrasonic Elma US Kavimeter Pressure nozzle Mechanics Temperature Process temperature ( c) Chemistry Time Cleaning agent (ph) Elma clean products Process time Time (sec) (per process step) 17.07.2015 Elma Schmidbauer GmbH 6
Business Unit OMT Optics 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 17.07.2015 Elma Schmidbauer GmbH
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!) 17.07.2015 Elma Schmidbauer GmbH 9
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
Standard process for final cleaning of surgical instruments 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 Cleaniness tested by: Bioburden, TOC, Cytotoxicity, Endotoxin, Passivity 17.07.2015 Elma Schmidbauer GmbH 11
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!) 17.07.2015 Elma Schmidbauer GmbH 12
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
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,. 17.07.2015 Elma Schmidbauer GmbH 14
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) 17.07.2015 Elma Schmidbauer GmbH 15
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
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) 17.07.2015 Elma Schmidbauer GmbH 17
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 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 17.07.2015 Elma Schmidbauer GmbH 19
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 17.07.2015 Elma Schmidbauer GmbH 20
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
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
Product portfolio x - tra modular lines for In process cleaning or final cleaning 17.07.2015 Elma Schmidbauer GmbH 23
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
Product portfolio Customized systems for inflammable solvents 17.07.2015 Elma Schmidbauer GmbH 25
Part positioning 17.07.2015 Elma Schmidbauer GmbH 26
Part positioning and contact material 17.07.2015 Elma Schmidbauer GmbH 27
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
IPC for system and process control 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 17.07.2015 Elma Schmidbauer GmbH 29
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 user 17.07.2015 Elma Schmidbauer GmbH 30
Elma Kavimeter (Ultrasonic Measurement Unit) Measurement and judgement of cavitation noise DIN 40170 17.07.2015 Elma Schmidbauer GmbH 31
Thank you for your attention! 17.07.2015 Elma Schmidbauer GmbH 32