Welkom! Lighthouse Worldwide Solutions Benelux BV. Deeltjes depositie en oppervlakte reinheid. 12 & 13 oktober 2015

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1 Welkom! Lighthouse Worldwide Solutions Benelux BV Deeltjes depositie en oppervlakte reinheid 12 & 13 oktober Mededelingen van huishoudelijke aard: Toilet 1 e verdieping en Beneden bij entree Nooduitgang trap voor en achter; bordjes volgen WiFi LWS_Guests, Passwoord: GSM Foto s Roken Presentaties Liefst uit of stil stand Geen probleem Liefst op terras, links naast kantine Beschikbaar op 2 1

2 Programma uur Ontvangst en koffie/thee uur Korte Introductie Martin Derks uur Reinheidsclassificatie en meting Bronnen en depositie mechanismen Koos Agricola uur Verschillende methoden voor het meten van deeltjes depositie en oppervlakte reinheid Martin Derks uur Koffie pauze uur Presentatie van onderzoeken naar de relatie tussen deeltjes depositie en airborne deeltjes Cees van Duijn uur Ontwikkeling van de APMON en wereldwijde ervaringen tot nu Jan Gerbrands uur Demonstraties van de verschillende methoden en gelegenheid tot het stellen van vragen 13:00 uur Afsluiting met een broodjeslunch in de kantine 3 Lighthouse Benelux Boven Leeuwen: 1800m² Cleanroom Technologie Van Heemstraweg 19a Expeditieweg

3 Manufacturing Center Medford, OR Locations Lighthouse Benelux Korea (SunWoo) Service Center LWS Pennsylvania Japan (Kondoh) Headquarters R & D Fremont, CA Training Center LWS Phoenix, Arizona Lighthouse EMEA Lighthouse Thailand Lighthouse Facilities and Key Partners Design and Manufacturing in USA Direct Sales and Support in 12 Offices in 8 Countries Sales through our Valued Partners in 27 Countries Lighthouse Malaysia Lighthouse China: Shanghai, Shouzhou, Shenzhen Lighthouse Singapore Lighthouse Philippines 5 Wat doet Lighthouse Benelux Levering van Cleanroom Meetinstrumenten Levering van Cleanroom Meetsystemen Leveren van Kalibraties en Service voor bovengenoemde instrumenten en meetsystemen 6 3

4 Cleanroom Meetinstrumenten Handheld Portable Liquid Batch Microbial 7 Cleanroom Meetinstrumenten 8 4

5 Cleanroom Meetinstrumenten 9 Cleanroom Meetinstrumenten 10 5

6 Cleanroom Monitoring systemen 11 Cleanroom Monitoring systemen 12 6

7 Ziekenhuis Monitoring systemen Lighthouse Monitoring Systeem Operatiekamer CSA Apotheek Nucleaire Afd. Hematologie IVF Stamcellab Klinische Chemie Bacteriologisch L Isolatie kamers 13 Kalibratie Services K

8 ? Vragen? 15 Verschillende meetmethoden Lighthouse Worldwide Solutions Benelux BV Deeltjes depositie en oppervlakte reinheid 12 & 13 November

9 Contamination Monitoring Solutions: Contamination: "Any foreign material or energy that has a detrimental effect on a product or process ISO14644-Series Contaminant Air Cleanlinessby. SurfaceCleanlinessby. Particles ACP: Air Cleanliness by Particle concentration SCP: Surface Cleanliness by Particle concentration Chemicals ACC: Air Cleanliness by Chemical concentration Nanoparticles ACN or nacp: Air Cleanliness by Nanoscale Particle concentration SCC: Surface Cleanliness by Chemical concentration Viables ACV: Air Cleanliness by Viables SCV: Surface Cleanliness by Viables 9

10 Afhankelijk van grootte 10 tot 1000 meer op oppervlakte dan airborne Totaal aantal deeltjes in een Cleanroom ISO Class Table Maximum concentration limits (particles M 3 of air) for particles equal to and larger than the considered sizes shown below: (a) ISO Classification Number(N) 0.1µm 0.2µm 0.3µm 0.5µm 1.0µm 5.0µm ISO 1 b 10 d 2 d d d e ISO d 4 d e ISO 3 1, d 8 e ISO 4 10,000 2,370 1, e ISO 5 100,000 23,700 10,200 3, d,e,f 29 ISO 6 1,000, , ,000 35,200 8, ISO 7 c c c 352,000 83,200 2,930 ISO 8 c c c 3,520, ,000 29,300 ISO 9 c c c 35,200,000 8,320, , µm should be zero according to ISO/DIS Table1notes; d) Sampling and statistical limitations for particles in low concentrations make classification inappropriate e)... Greater than 1 micron particles make classification at this particle size inappropriate due to potential particle losses in sampling system f) Specify particle size in association with ISO Class 5, the marcoparticle discriptor M may be adapted. 10

11 Min. req. Sample locations Number and selection of locations: ISO :1999 (surface area) FDIS :2015 Acc. To Table No Random selection No UCL calculations Evenly divided over cleanroom mtr N 27 ] Area of cleanroom (m2) Less than or equal to Min number of sample locations to be tested NL >1000 Equation A Minimum required Sample locations FOR SMALL ENCLOSURES LESS SAMPLING POINTS FOR LARGE ENCLOSURES MORE SAMPLING POINTS

12 Classificatie van deeltjesdepositie: ISO? Particle Deposition Class Units in particles per square meter per hour PDC Class 1µm 5µm 10µm 20µm 50µm 100µm 200µm 500µm Deeltjesdepositie wordt gemeten als Particle Deposition Rate (PDR) Deeltjes Depositie Classificatie 12

13 Personeel als grootse vervuiler 5 tot 10 miljoen huidcellen per dag (30 gram) 2300 micro organisme per cm² 25µm vallende deeltjes 5µm zwevende deeltjes Tussen 5µm en 25µm overgangsgebied Active Particle Fall Out GMP/FDA The recommended size of solid media is 90 mm in diameter (approximate internal area 64 cm²) for settle plates 13

14 Verhouding tussen oppervlakte reinheid en klasse Reinheid na huishoudelijke vaatwas; maximaal SCP 6 Reinheid na cleanroom reiniging SCP 5 Reinheid na precisie reiniging (b.v. ultrasonic cleaning) maximaal SPC 4 14

15 Surface CFU Cleanliness GMP/FDA Risk Based Approach The recommended size of contact plates is 55 mm in diameter (approximate internal area 25 cm²) Rodac Contact afdruk Microbiological Sampling Air samples (90mm) Surface swabs (55mm) Personnel swabs 15

16 Waar? Hoeveel? Hoe vaak? 16

17 Surface Swap 10 Seconde cm² 0,1ml buffer enten op Agar bodem USP methode GMP Monitoring: Trend Action - Alert Onderzoek huisflora Type Bacteriën Reinigingsmiddel valideren Contacttijden Middel/oppervlakten reductie > 4*10log (5min) Desinfectiemiddelen Onder flow (EU GMP klasse A): 70/30 Sterile IPA ACTION LEVEL ALERT LEVEL Alert Level 34 (70% isopropyl alcohol) Clean room (EU GMP klasse D, C en B): 70% ethanol en 0,125% H 2 O 2 0 Test #1 Test #2 Test #3 Test #4 Test #5 Test #6 PASSING LEVEL Test #

18 Surface Cleanliness qualification method GSA Grade 4 cat. 1, 2 & 3 UV-A Blacklight inspection GSA Fluorescentie UV light source Camera Filter λ 375nm λ 400/500 nm 18

19 UV Surface Particle Counter UV Surface Particle Counter 38 19

20 PartSense - Camera system - measured area is 0,32 cm 2 - Size and number of Particle - 5 tot 1000µm 39 APMON: Advanced Particle Deposition Monitor Action inside cleanroom = Particle Generation 20

21 APMON: Advanced Particle Deposition Monitor - Optical holographic image - measured area is 25 cm 2 - Size and number of Particle - 20 tot 1000µm - 5 minute sampling rate - Wireless - Battery > 1 week Particle Deposition Monitor SAC Glass CD shape witness plate, measured area is 49cm 2 14µm Uses machine vision to determine: Particle size distribution Length / Width of particles Particle deposition Level (PDL) Particle Deposition Rate (PDR) Percentage Area Covered (PAC) or ppm Images of particles. Can determine the change between subsequent measurements. 21

22 Particle Deposition Monitor SAC Omneo Deposition Monitor Glass Credit Card shape witness plate, measured area is 5cm 2 21µm Uses machine vision to determine: Particle size distribution Length / Width of particles Particle deposition Level (PDL) Particle Deposition Rate (PDR) Percentage Area Covered (PAC) or ppm Images of particles. Can be used with sticky pads. 22

23 Omneo Deposition Monitor Omneo Deposition Monitor 23

24 Omneo Deposition Monitor Omneo Deposition Monitor 24

25 Omneo Deposition Monitor Surface Particle Probe Counter Indirect via Air For Particles 0.1µm tot 25µm 25

26 Boulder Particle Counter for large particles For Particles 5.0µm Automobile, Aerospace, Paint Spray booth, Molding/Forming Applications Size Channels: 5 µm 10 µm 25 µm 40 µm 50 µm 100 µm 26

27 Removal Efficiency Improved by using Ionized Air Thank You 27