Nanotechnologies and SMEs - a case study

Transkript

1 Nanotechnologies and SMEs - a case study 1 st Conference June 3, 2009 Stuttgart, Germany March 25,

2 Nanomaterials Intermediate products Products Production of nanoscale structures in unprocessed form Intermediate products with nanoscale features Finished goods incorporating nanomaterials ( nano-enabled products) TÜV SÜD Industrie Service GmbH 2

3 NT companies worldwide North America: > 1,050 ( ~ 975 in the USA, ~ 75 in Canada) Europe: > 300 (~ 100 in Germany) UK & Germany: largest SME activities and big business investment Asia-Pacific: > 250 ( ~ 90 in China, followed by South Korea, Japan, Australia) TÜV SÜD Industrie Service GmbH 3

4 Agenda 1. What we do and the kind of nanorisks we need to manage 2. How we manage these nanorisks (hands on approach) TÜV SÜD Industrie Service GmbH 4

5 Question: How can the functionality of nanoparticles unfold in real world products? Value chain Nanoparticle- Producer Nanoparticle- User Buy my nanoparticles! How to incorporate them in my product?? Names Degussa and Vernel used as illustrative examples only TÜV SÜD Industrie Service GmbH

6 Combining existing strengths with new technology to tackle a specific part of the nanoparticle processing value chain Value chain Nanoparticle- PRODUCER E.g.: Surface modification of nanoparticles ensures ability to process and compatibility with products ( ready-to-use ) Nanoparticle- USER Dispersion device Surface modifier TÜV SÜD Industrie Service GmbH

7 Typical processes needed in the nanoparticle processing value chain Customer Product Tailored Process Functional Colloid Nanoparticles Surface modifier (SM) Solvent/ Matrix TÜV SÜD Industrie Service GmbH

8 Buhler PARTEC main fields of activity Revenue breakdown by type of business By material By application High performance pigment nanodispersions Carbon nanodispersions Easy-to-clean Soft structure nanodispersions 22% 6% 5% Rest** 28%* 34% 67% Transparent mineral UV protection 11% 28% Metal oxide nanodispersions* Mechanical reinforcement * Mainly ZnO, TiO 2, Al 2 O 3, ZrO 2 and also SiO 2 ** Emerging applications TÜV SÜD Industrie Service GmbH 8

9 The Problem TÜV SÜD Industrie Service GmbH

10 Corporate Buhler as equipment and plant manufacturer does not intrinsically have a HSE department TÜV SÜD Industrie Service GmbH

11 Agenda 1. What we do and the kind of nanorisks we need to manage 2. How we manage these nanorisks (hands on approach) TÜV SÜD Industrie Service GmbH 11

12 management risk elimination, but the management to keep the risks As Low As Reasonably Practicable RISKS ARE ALARP = RISK MANAGEMENT RISK ELIMINATION TÜV SÜD Industrie Service GmbH

13 Our risk management system is based on 4 elements MSDS RAS Monitoring Safe Production TÜV SÜD Industrie Service GmbH

14 How we practice our nanospecific risk management 1 st quarter 2 nd quarter 3 rd quarter 4 th quarter PARTEC production Uzwil, CH QM / ISO 9001 PARTEC R&D Saarbrucken, D MSDS PI RAS 1 st Certification Sept Recertification Aug MSDS Clusterlist PARTEC management team Monitoring Report Monitoring Monitoring Monitoring RAS Report RAS Report RAS Report RAS 1 st meeting 2 nd meeting 3 rd meeting 4 th meeting advisory board RAS Monitoring Report State of S & T nanorisks TÜV SÜD Industrie Service GmbH

15 The RAS define the input for the monitoring radar, the Clusterlist defines the input for the foresight monitoring radar Herstellschritte Clusterlist Anwendungszweck Anwendungsmärkte Material Produkt Matrix ZnO NanoSunguard BAO S D Butylacetat 25% X X X H X ZnO X NanoSunguard Similar BAS X X S risk profile DX (X) Butylacetat within subclusters X 20% X X X H X ZnO X NanoSunguard BGP X X S DX (X) Butylglykol X 25% X X X H X ZnO X NanoSunguard EOP X X S DX (X) Ethanol X 25% X X X H X ZnO X Clusters NanoSunguard EOS X X / subclusters S D X (X) defined Ethanol X together with risk advisory board 25% X X X H X X X X X (X) X ZnO NanoSunguard MEO S D MEK 20% X X X H X X X X X (X) X ZnO NanoSunguard Regularly XYS S updated D Xylol(since business changes 25% X also ) X X H X X X X X (X) X ZnO X n.n. X X S DX (X) Water X 25% X X X H X ZnO X n.n. X X S DX (X) Water X 25% X X X H X ZnO X n.n. X X S DX (X) Isopropanol X 25% X X X H X ZnO X n.n. X X S DX (X) Isopropanol X 25% X X X H X ZnO X n.n. X X S DX (X) Shellsol D60 X X 50% X X X H X g Mahlprozess Dreiwalzwerk Fällung (Alkoxy) Hydrothermal Trocknung Position Trockenmahlung Cluster Zentrifugieren Teilcluster Sol-Gel (Hydrolyse) Compoundierung Mischen Chemische Modifikation UV-Schutz Farbechtheit Photokatalyse Standard (S) / Massgeschneidert (M) Easy-toClean Indexmatching Produktform: Dispersion (D), Masterbatch (M), El. Leitfähigkeit Pulver (Pu), Paste (Pa) Mech. Verstärkung Rheologie Schleifkorn Röntgenopazität Nukleierung Farben & Lacke Kunststoffe Textilien Fasern Abrasives Füllgrad Keramik < 20nm Elektronikbauteil nm Diverse > 100nm Dentalmaterialien < 20nm Kosmetik nm > 100nm Soft (S) / Hard (H) Clusterlist reflects possible future products SMSM Polymerisch Oligomerisch Currently more than 500 entries 9 clusters with 28 subclusters Primärpartikelgrösse Agglomeratgrösse Modifizierung TÜV SÜD Industrie Service GmbH 15

16 The RAS define the input for the monitoring radar, the Clusterlist defines the input for the foresight monitoring radar Clusterlist Cluster Subcluster No RAS exists for subcluster RAS for subcluster already exists In production or production due shortly Cluster Cluster advisory board PARTEC management team Minutes A appraisal critical Issue RAS immediately for new product Complete RAS immediately with new product B appraisal non critical Threshold rule applies No RAS if quantity less than kg No RAS if revenue < 50 kchf TÜV SÜD Industrie Service GmbH 16

17 RAS are issued with a two step assessment process RAS Assessment 1: Are further nanomaterial specific tests required? Assessment 2: Perform HSE risk assessment according to conventional risk analysis methods RAS TÜV SÜD Industrie Service GmbH 17

18 Consideration of the state of science & technology in order to decide whether additional tests are required advisory board α = Expected/estimated damage β = Portability/analogy of data TÜV SÜD Industrie Service GmbH 18

19 Criteria for the evaluation of publications Base of knowledge PC data, in vitro or in vivo data, longtime experiences Transferability of the database in vivo: principle of similarity (similarity to hb) in vitro: exposition relevant information, general information Comparison of publications How many publications are available? Are the results similar? Rating of the publication Reputation of journal and author(s) Transferability to the product Are the possible incorporation paths discussed properly? TÜV SÜD Industrie Service GmbH

20 Assessment of β = Assessment of relevance Criterion Appraisal Portability fulfilled Limited Questionable β1 β1 β4 β3 β4 β2 β β2 β2 β3 β2 β3 β1 a β β3 β3 β2 β1 β2 β1 b Consistent expert β4 β4 β1 β1 opinion β2 β2 β b β β3 β3 c β4 β4 Accredited source β4 β3 β β3 β2 β c β2 β1 β β a TÜV SÜD Industrie Service GmbH 20

21 2 nd Assessment: Conventional risk analysis using the root cause method and same in conjunction with α and β Staubkontamination (Lunge) SiO2 Massive Freisetzung SiO2 durch Brand im Lager Frequency of occurrence Einlagern Transport Basisursachen Umfüllen Kausalanalyse Schadensereignis Unfall Sicherheitsfunktion 1 Gefährdung ok Sicherheitsfunktion 2 Umfüllen Präventive Maßnahmen Transport Einlagern Kurzschluss Schweregrad Brandstiftung Vulnerabilität Bewusstes Fehlverhalten Kurzschluss Barrieren Konsequenzanalyse Konsequenzen / Schadensausmaß Brand im Lagerraum Elektrostatische Funkenbildung Brandstiftung Prozessfehler Rohmaterial SiO2 Brand in der Produktion Bewusstes Fehlverhalten Elektrostatische Funkenbildung Hautkontamination SiO2 Massive SiO2 Freisetzung durch Brand in Produktion Potential damage TÜV SÜD Industrie Service GmbH 21

22 Frequency of occurrence Inhalation E The issue is tackled with the guiding principle schw ere Schädigung Ingestion α = 3 od. 4 E dermal the less you know, the more dangerous the material is by definition A Staubkontamination (Lunge) SiO2 Einlagern Umfüllen Umfüllen Einlagern Hautkontamination SiO2 TÜV SÜD Industrie Service GmbH Auswirkung βauf Menschen Root cause analysis for incorporation path Analogieschluss Art der Schädigung Schadenspotenzial nicht möglich bekannt D α = 2, 3 od. 4 Inhalation C Ausw irkungen leichte Schädigung Ingestion auf Tiere sind α = 2 C ausreichend bakannt dermal (in vivo Tier) A ß = 3 nicht möglich B Inhalation A keine Ingestion Schädigung A Massive Freisetzung SiO2 durch Brand im Lager α = 1 dermal A nicht möglich E Inhalation D Kurzschluss Brandstiftung schw ere Schädigung Ingestion Transport α = 3 od. 4 D Brand im Lagerraum dermal A Schadenspotenzial nicht möglich Bewusstes Fehlverhalten Elektrostatische Funkenbildung bekannt D α = 2, 3 od. 4 Inhalation C leichte Schädigung Ingestion Ausw irkungen Rohmaterial SiO2 α = 2 B auf Menschen Ausw irkung auf Zellen dermal nicht ausreichend oder Zellkulturen A untersucht sind bekannt nicht möglich ß = 1, 2 od. 3 (in vitro) C ß = 2 Brandstiftung Inhalation B Kurzschluss Prozessfehler keine Ingestion Schädigung A Transport Brand in der α Produktion = 1 dermal A nicht möglich Bewusstes Fehlverhalten Elektrostatische Funkenbildung C Nur Materialeigenschaften Inhalation bekannt, auf Ausw ir- C kungen auf Menschen Ingestion kann nicht geschlossen C w erden (PC-Daten) dermal Massive SiO2 Freisetzung durch Brand in Produktion ß = 1 A nicht möglich F Inhalation F schw ere Schädigung Ingestion α = 3 od. 4 E dermal A Schadenspotenzial nicht möglich Potential damage bekannt D α = 2, 3 od. 4 Inhalation Ausw irkungen D auf Menschen leichte Schädigung Ingestion ausreichend untersucht α = 2 C (in vivo Mensch) dermal ß = 4 A nicht möglich keine A Schädigung α = 1 Schadenspotenzial α Inkorporationsweg Schadensausmass F 22

23 Consideration of safety systems and containment barriers rounds off the picture of the risk assessment matrix Safety systems Barriers TÜV SÜD Industrie Service GmbH 23

24 Staubkontamination (Lunge) SiO2 Einlagern Umfüllen Umfüllen Einlagern Hautkontamination SiO2 Massive Freisetzung SiO2 durch Brand im Lager Transport Transport Kurzschluss Brandstiftung Bewusstes Fehlverhalten Kurzschluss Massive SiO2 Freisetzung durch Brand in Produktion Brand im Lagerraum Bewusstes Fehlverhalten Elektrostatische Funkenbildung Brandstiftung Prozessfehler Rohmaterial SiO2 Brand in der Produktion Elektrostatische Funkenbildung The RAS ( Assessment Sheet) is the central document 4 RAS issued in first year Typically documents with 20 pages RAS Is also used in the context of EU REACH as risk analysis TÜV SÜD Industrie Service GmbH 24

25 The monitoring systems manages changes required for the RAS and acts as an early warning system for future products Monitoring Report General part RAS Documents all news, trends, actions, regulations, perception and the like relevant for a comprehensive risk appraisal Documents new findings per RAS Documents changes made Documents 360 risk analysis Clusterlist Documents new findings that might impact the assessment of future products TÜV SÜD Industrie Service GmbH 25

26 What is interesting here for? - assessments in situations of uncertainty - Judgements of similar situations - Monitoring risks what are relevant parameters? TÜV SÜD Industrie Service GmbH 26