Ultrasonics.Steam.Ultraclean Elma Schmidbauer GmbH

Transcription

1 Ultrasonics.Steam.Ultraclean Elma Schmidbauer GmbH

2 History Elmasolvex VA Super Elite 1948 Founded 1948 Ever since family-owned by 100%, still the case! 234 employees Kolpingstraße Elma Schmidbauer GmbH 2

3 New Headquarter (since 2014) D Singen Germany Gottlieb-Daimler Str Elma Schmidbauer GmbH 3

4 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 certification since Elma Schmidbauer GmbH 4

5 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 Elma Schmidbauer GmbH 5

6 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) Elma Schmidbauer GmbH 6

7 Business Unit OMT Optics Elma Schmidbauer GmbH

8 Ultrasonic Cleaning Systems for pre cleaning and final cleaning of surgical instruments, endoscopes and implants made of metal, ceramic and plastic Elma Schmidbauer GmbH

9 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!) Elma Schmidbauer GmbH 9

10 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 Elma Schmidbauer GmbH 10

11 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 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 Elma Schmidbauer GmbH 11

12 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!) Elma Schmidbauer GmbH 12

13 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 ) Elma Schmidbauer GmbH 13

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 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, Elma Schmidbauer GmbH 14

15 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) Elma Schmidbauer GmbH 15

16 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, Elma Schmidbauer GmbH 16

17 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) Elma Schmidbauer GmbH 17

18 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, Elma Schmidbauer GmbH 18

19 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 Elma Schmidbauer GmbH 19

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 Elma Schmidbauer GmbH 20

21 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 Elma Schmidbauer GmbH 21

22 Product portfolio x - tra modular line (pro or pre version) for In process cleaning or final cleaning with or without passivation Elma Schmidbauer GmbH 22

23 Product portfolio x - tra modular lines for In process cleaning or final cleaning Elma Schmidbauer GmbH 23

24 Product portfolio Customized systems for In-process-cleaning or Final cleaning (With or without passivation using nitric acid or citric acid) Elma Schmidbauer GmbH 24

25 Product portfolio Customized systems for inflammable solvents Elma Schmidbauer GmbH 25

26 Part positioning Elma Schmidbauer GmbH 26

27 Part positioning and contact material Elma Schmidbauer GmbH 27

28 Product portfolio Cleaning chemicals designed and product by Elma (Some listed as medical product class 1) Pure water systems (Falk) Elma Schmidbauer GmbH 28

29 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 Elma Schmidbauer GmbH 29

30 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 Elma Schmidbauer GmbH 30

31 Elma Kavimeter (Ultrasonic Measurement Unit) Measurement and judgement of cavitation noise DIN Elma Schmidbauer GmbH 31

32 Thank you for your attention! Elma Schmidbauer GmbH 32