Agenda. Scope ISO IS : Flowchart. IS : Flowchart. Onderbouwd inschatten en rekenen aan cleanrooms

Size: px

Start display at page:

Download "Agenda. Scope ISO IS : Flowchart. IS : Flowchart. Onderbouwd inschatten en rekenen aan cleanrooms"

Malcolm Shelton
5 years ago
Views:

1 Agenda Onderbouwd inschatten en rekenen aan cleanrooms Mark Niesen Expert NL WG 4 - ASML 1. Background ISO Design process air contamination control Segregation concepts concepts equations Cleanrooms and associated controlled environments ISO Part 1: Classification of air cleanliness Part 2: Specifications for testing and monitoring to prove continued compliance with ISO Part 3: Test methods Part 4: Design, construction and start-up Part 5: Operations Part 6: Vocabulary Part 7: Separative devices (clean air hoods, glove boxes, etc.) Part 8: Classification of air cleanliness by chemical concentration Part 9: Classification of surface cleanliness by particle concentration Part 10: Classification of surface cleanliness by chemical concentration Scope ISO14644 specifies requirements for the design and construction of new and to be modified cleanroom installations Primary consideration is cleanliness by particles in air. Air cleanliness attributes such as chemicals, nano-size and viable particles should be considered. Surface cleanliness attributes could also be considered The standard should provide a conceptual approach, will not be engineering guide and does not contain solutions Energy management design approaches are identified, to support an energy efficient cleanroom design. IS : Flowchart Idea IS : Flowchart Idea Scope ISO Requirements Design Construction Annex A Guidance on requirements A.1... A.x Annex B Guidance on design B.1... B.x Annex C Guidance on construction C.1... C.x Contimination Air cleanliness Scope ISO Requirements Design Construction Annex A Guidance on requirements A.1... A.x Annex B Guidance on design B.1... B.x Annex C Guidance on construction C.1... C.x Start-up Annex D Guidance on start-up D.1... D.x Start-up Annex D Guidance on start-up D.1... D.x Operations & maintenance Operations & maintenance 1

2 Material air lock Personnel air lock Material air lock Personnel air lock 5. High level floor plan Material Personnel air lock air lock Corridor 5. High level floor plan 6. Process analysis: critical/sensitive area s + source strength (people + devices) 7. Segregation concept Material Personnel air lock + air lock + Corridor High level floor plan 6. Process analysis: critical/sensitive area s + source strength (people + devices) 7. Segregation concept 8. concept 9. equations (ACR value) 2

Segregation concepts Complete room = critical zone Contimanation applies to whole room unidirectional Contimanation control concept applies to local critical zone n-unidirectional Flow supply air:

3 Segregation concepts Complete room = critical zone Contimanation applies to whole room unidirectional Contimanation control concept applies to local critical zone n-unidirectional Flow supply air: unidirectional. Displacement n-unidirectional Dilution Example of a box in box contamination zone: Dilution. zone: Displacement. concept Complete room = critical zone Contimanation applies to whole room unidirectional Complete room = critical zone Contimanation applies to whole room unidirectional Contimanation control concept applies to local critical zone n-unidirectional Contimanation control concept applies to local critical zone n-unidirectional Flow supply air: unidirectional. Displacement Flow supply air: unidirectional. Displacement n-unidirectional Dilution n-unidirectional Dilution zone: Dilution. zone: Displacement. concept zone: Dilution. zone: Displacement. concept Typical ventilation concepts per industry Typical ventilation concepts per industry Applications UDF whole room (vertical or horizontal) UDF only in local critical zone n UDF whole room Applications UDF whole room (vertical or horizontal) UDF only in local critical zone n UDF whole room Semi-conductor (electronics) Semi-conductor (electronics) ISO class < 6 ISO class local > ISO class room ISO class > 6 ISO class < 6 ISO class local > ISO class room ISO class > 6 Health care Operating theatre + ultra clean instrument lay-up area s Operating theatre = instrument lay-up area's clean and general clean area's Health care Operating theatre + ultra clean instrument lay-up area s Operating theatre = instrument lay-up area's clean and general clean area's Life science (GMP) Bio safety Food UDF -whole room : only applicable for Flow cabinets, RABS and Isolators. Typical grade A in B: aseptic filling Biosafety cabinets Aseptic filling - Grade B, C, D -ISO 5 (at rest), ISO 7, ISO 8 BSL 3 / 4 Focus on exhaust filtration Protect environment against process High care / Risk processing Life science (GMP) Bio safety Food UDF -whole room : only applicable for Flow cabinets, RABS and Isolators. Typical grade A in B: aseptic filling Biosafety cabinets Aseptic filling - Grade B, C, D -ISO 5 (at rest), ISO 7, ISO 8 BSL 3 / 4 Focus on exhaust filtration Protect environment against process High care / Risk processing 3

table method to select ACR value: Current table B.

equations air supply rate are: Q = S / ε.

particle concentration (no./m 3 ) Discussions are the values of S and ε and their accuracy. Alternative removal efficiency can be used instead of ε.

4 table method to select ACR value: Current table B.2 Examples for microelectronic cleanrooms Use CFD to calculate ACR scientifically based estimation methods Calculating air supply rate in non-udaf cleanrooms Basic equations air supply rate are: Q = S / ε.c Q = air supply volume rate (m 3 /s), S = total particle dispersion rate from personnel and machinery/s, ε = air change effectiveness index, and C= required airborne particle concentration (no./m 3 ) Discussions are the values of S and ε and their accuracy. Alternative removal efficiency can be used instead of ε. How good should C be within limit Calculating air supply rate in non-udaf cleanrooms ACR = S/ ε.c.v ACR = air change rate per hour, and V= cleanroom volume (m 3 ) Air change effectiveness t all of the air supplied to a cleanroom will mix well with cleanroom air, and there are likely to be locations where the airborne concentration of contamination will be higher than average. The air change effectiveness (ε) is the effectiveness of the cleanroom s air supply in diluting contamination at a location compared to the overall average in the cleanroom. In case air diffusers are fitted to the air supply terminals: ε =0,7. Diffusers are very efficient in mixing the supply and room air, and their air supply rate, matched to that recommended for the diffuser may be set at a higher level. 4

Dispersion rate of particles in cleanroom The rate of particle dispersion depends on the person, the design of the cleanroom garments, the occlusive nature of the fabrics used to manufacture

Gowns (smocks) give a poorer performance than coveralls as the particles dispersed from personnel are able to pass under the garment.

5 Dispersion rate of particles in cleanroom The rate of particle dispersion depends on the person, the design of the cleanroom garments, the occlusive nature of the fabrics used to manufacture garments, and the activity of personnel. The best garments are those that fully cover the personnel, and use fabrics that disperse the minimum of particles. Gowns (smocks) give a poorer performance than coveralls as the particles dispersed from personnel are able to pass under the garment. Dispersion rate of particles in cleanroom Typical dispersion rate of particles/s for two type of cleanroom garments: Gowns Coveralls over normal indoor clothing ,5 μm Particles/s μm Particles/s High activity of personnel will give much higher dispersion than from lower activity. 1 person with coverall ~ particles 5 μm /min Personnel and PDR Dispersion rate of particles in cleanroom Dispersion rates of particles from machinery and other equipment will vary according to type. These rates vary, and it is best to obtain information of the dispersion rate from the manufacturer of the machinery or equipment. Alternatively, the total emission rate can be obtained experimentally using the method outlined in ISO Garment data from: Reinmuller B and Ljungqvist B, Predicted Contamination Levels in Cleanrooms When Cleanroom- Dressed People Are the Contamination Source. Pharmaceutical Technology, May MCP s 25 µm 29 Particle dispersion from machinery Type of machine /equipment Dispersion rate (particles 0.5 μm/sec) Vial filling machine A 3.3 x10 4 Vial filling machine B 5 x10 2 Blow-fill-seal (BFS) machines depending on type of BFS machinery Six-axis robot (unmodified) 4 x10 3 (particles 0.5 μm) Six-axis robot (modified) 0,3 Check ISO for measurement S of equipment. Unidirectional airflow In the case of personnel, the following variables should be taken into account when seeking a lower velocity: 1) Minimise the number of personnel present. 2) Minimise the proportion of their bodies under the unidirectional airflow 3) Minimise the proportion of time they are within the unidirectional airflow. 4) Increase personnel distance from the exposed product. Conclusion calculation should be simple. Correction models should be noted. Examples should be worked out. Sources strengthes should be determined but bandwidth could be given as example. ISO and 15 could be used for equipment and materials. 5

6 Questions 6

Calculation of air supply rates and concentrations of airborne contamination in non- UDAF cleanrooms

European Journal of Parenteral & Pharmaceutical Sciences 2017; 22(4): 126-138 2017 Pharmaceutical and Healthcare Sciences Society Calculation of air supply rates and concentrations of airborne contamination