This document provides an overview of cleanrooms, including: what a cleanroom is, how particle size is measured, how cleanrooms are classified by particle counts, sources of contamination and how particles are controlled through isolation, dilution and filtration. It discusses cleanroom design considerations such as layout, HVAC, filtration and certification. Cleanrooms aim to control airborne particle concentrations to appropriate cleanliness levels through regulated air supply, distribution, filtration and operating procedures. Particle testing and ISO 14644-1 standards are used to certify cleanroom classifications.
This document provides an overview of cleanrooms, including: what a cleanroom is, how particle size is measured, how cleanrooms are classified by particle counts, sources of contamination and how particles are controlled through isolation, dilution and filtration. It discusses cleanroom design considerations such as layout, HVAC, filtration and certification. Cleanrooms aim to control airborne particle concentrations to appropriate cleanliness levels through regulated air supply, distribution, filtration and operating procedures. Particle testing and ISO 14644-1 standards are used to certify cleanroom classifications.
This document provides an overview of cleanrooms, including: what a cleanroom is, how particle size is measured, how cleanrooms are classified by particle counts, sources of contamination and how particles are controlled through isolation, dilution and filtration. It discusses cleanroom design considerations such as layout, HVAC, filtration and certification. Cleanrooms aim to control airborne particle concentrations to appropriate cleanliness levels through regulated air supply, distribution, filtration and operating procedures. Particle testing and ISO 14644-1 standards are used to certify cleanroom classifications.
This document provides an overview of cleanrooms, including: what a cleanroom is, how particle size is measured, how cleanrooms are classified by particle counts, sources of contamination and how particles are controlled through isolation, dilution and filtration. It discusses cleanroom design considerations such as layout, HVAC, filtration and certification. Cleanrooms aim to control airborne particle concentrations to appropriate cleanliness levels through regulated air supply, distribution, filtration and operating procedures. Particle testing and ISO 14644-1 standards are used to certify cleanroom classifications.
What is a Cleanroom? A specially designed & constructed room in which; the air supply, air distribution,, filtration of air supply, pp y, materials of construction, and operating procedures, are regulated to control airborne particle concentrations to meet appropriate cleanliness levels.
Particle Size Comparison
An ISO Class 8 Cleanroom will have a maximum of 70 particles @ 5.0 Micron and a maximum of 100,000 @ 0.5 Microns / Cubic Foot (Actually measured in Cubic Metres in ISO)
Learn - What is a Cleanroom
Understand how we achieve the Level of Cleanliness Cleanliness. Discuss Cleanroom Design. Discuss the Certification Process.
What is a Particle?
A Particle is a very small discrete mass
of solid or liquid matter, usually measured in microns. A micron is 1/1,000,000 of a metre. A human hair is 60 - 90 Microns.
Cleanroom Classification Particles per Cubic Metre ISO 14644 3
209E
0.5 Micron
5 Micron
35
N/A N/A
10
352
100
3,520
29
1,000
35,200
293
10,000
352,000
2,930
100,000
3,520,000
29,300
Sources of Contamination
Smoking Particle Generation
30,000
Subject stopped smoking
Smoker 20,000
10,000
5,000
Ambient Equipment People
2,000
Non - Smoker 1,000
500
A typical smoker is expelling 10,000 to 20,000 0.03 M particles l 10 minutes after stopping. A non smoker generates less than 1,000.
200 100 1
10
11
12
Elapsed Time (Minutes)
How are Particles Controlled?
How do we Control Particles
Isolation - Particles may be isolated by
containing them at the source of generation. This is difficult as the Processes and Associates in the Cleanroom are the Largest Source of Contamination
How do we Control Particles?
Negative Pressure Plenum
Cooled / Heated / Humidified &/or Dehumidified Secondary Air
Fan Powered H.E.P.A. Filter which removes 99.99% of all Particles 0.3 Micron
Clean Filtered & Conditioned "Primary Air"
"Dirty" Air Leaving
Cleanroom
Dilution - Particles are captured by filtration, and the totall space volume l is diluted by clean air
HEPA / ULPA Filters
This is a Ceiling Mounted HEPA Filter. High Efficiency Particulate Air Filters, range from 99.97% to 99.995% Efficient
ULPA Filters
Return Air Filter Grilles
These are Ceiling
Mounted ULPA Filters. These High Efficiency Particulate Air Filters are 99.9995% Efficient
Typical Air Change Rates
ISO Class
Health Canada
US Fed Std. 209E
10
720+
100
500-720 60-100
4 5
Air Changes Per
Hour
1,000
10,000
30-50
100,000
20-30
Where does Contamination Come From?
Equipment, Material & Processes in the
Cleanroom produce contamination. The largest single controllable source of contamination enters the Cleanroom with the Associates that work there.
This is the method of Returning Air to the h Negative Pressure Plenum
equipment requirements and use that information to produce an equipment matrix
Design Considerations ISO Class
Health Canada
US Fed Std. 209E 10
720+
100
500-720 500 720 60-100
4 5
A Processing or Manufacturing Environment A Marketing Tool Design with both in mind
Layout for process flow
Can any of our equipment be installed outside the Cleanroom, with just the face in the Cleanroom Reduction in space saves cost.
Design Considerations - Layout
Air Changes Per Hour
1,000
10,000
30-50
100,000
20-30
Airflow rates are the way we maintain the
required levels of particle control, the air changes come at a cost.
Design Considerations
Temperature / Humidity Ranges have a large impact on the HVAC systems required to maintain the conditions required
Design Considerations Room or Zone Classifications Typically in Pharmaceutical we look for an Ante Room between zones with a differential of 12.5 PA (0.05 WC) between different classifications, and 7.5 PA (0.03 WC) for the same classification
Design Considerations
Design Considerations
Dont Skimp on the
size of the Gowning Room You will require Storage for garments, gloves, etc. Where will you store cleaning equipment & supplies
Design Consideration - Ceiling
Design Consideration - Walls
Drywall Epoxy Painted
Modular Progressive Modular Non Progressive
Ceiling height, can be
as low as 8, however unless there process equipment requirements for more height, 9 is the normal.
in your HVAC, Air Handling, Exhaust & Make U Air Up Ai Systems S t Component Selection is crucial as there are many factors to a complete system. Consider all component factors. Pressure Drop drives fan horsepower.
Design Consideration Air Handling
Exhaust is the largest driver of energy cost,
with our fluctuations in outdoor temperature we have large winter heating costs, and Summer conditions that rival the highest in North America.
With large amounts of air required for
recirculation, this can be handled by dedicated air handling systems, systems or by the use of Fan Filter Units.
Design Consideration Make Up Air
Design Consideration - Exhaust
HEPA / ULPA / SULPA
Terminal Room Side Replaceable Bubble Tight Dampers Duct / AHU Mounted Bag In / Bag Out Fan Filter Units
Make Up Air required for pressurization or to make
up exhaust is a large component in the system energy cost. To maintain humidity levels within the controlled space cooling systems are sized for full system capacity that may only be a few hours per year.
Design Consideration - Electrical
Design Consideration Process
Design Consideration - Ancillaries
Design Consideration - Portable
Air Showers Cleaning Materials Communication Systems Containment Gowning Pass Throughs
Cleanroom: Testing and Certification
HEPA Filter: High Efficiency Particulate Air Filter
Rated at 99.97% efficiency minimum
@.3 micron Scanned d tested d HEPA filter fl is 99.99% efficiency Gasket seal vs. Gel Seal Terminal HEPA vs. Ducted HEPA Fan Filter Modules
High Efficiency Particulate Air Filter
HEPA Housings: Gel Seal vs. Gasket
Airflow Volume / Velocity Readings
Primary Tests performed :
Airflow Volume / Velocity Readings
HEPA Filter Integrity g y Test Room pressure differential readings Particle Counts per ISO 14644-1
Velocity Profiles:
For non-unidirectional room readings
are taken 6 inches from the supply source at center of source For unidirectional rooms readings are taken 12 inches from the supply source. Divide the plane into equal sections and take multiple readings. Standard IES-RP-CC-006.3
Air Volume Readings:
Air volume readings taken to calculate air
changes per hour
Calculation : Total Diffused Air Supply x 60 Divide by Room Volume (Cubic Feet) = ACPH
Installation tips:
Ensure ductwork is clean of debris
Important p to not touch HEPA filter media Do not over tighten clamping system (gel seal) Ensure filter is 99.99% eff. (99.97%) Record model, and serial numbers
HEPA Integrity Test
HEPA Filter Integrity Testing
IES-RP-CC034.2 HEPA Integrity Test
Introduce aerosol into air system
Measure upstream concentration to ensure g/ minimum 10ug/L. Target upstream is > 20-40ug/L. Set photometer for determined upstream concentration Perform scan of filter face with probe at a scanning rate of 3m/min (10ft per min) Maximum repair 5% of area of filter
Room Pressure Differential Readings.
Correlation between room pressure and
ACPH Differential between classes, 0.05 WC Magnahelic Gauge & Photohelic packages and configurations
Particle Counts per ISO-14644-1
ISO Class
Class 1
Sample Locations
0.1 um 10
0.2 um
0.3 um
0.5 um
1 um
5 um
Class 2
100
24
10
Class 3
1,000
237
102
35
Class 4
10,000
2370
1020
352
83
Class 5
100,000
23700
10200
3520
832
29
Class 6
1,000,000
237,000
102,000
35,200
8320
293
Class 7
352,000
83,200
2930
Class 8
3,520,000
832,000
29,300
Class 9
35,200,000
8,320,000
293,000
Particle Counts per ISO 14644-1
Determining the number of locations.
Measure the area under consideration in square meters. meters Calculate the square root of that area. Ensure locations are distributed evenly throughout the area of the Cleanroom and positioned at the height of the work activity
Duct Layout Drawings
Additional Systems
10
Resources
Cleanroom Standards:
IEST-RP-CC034.2 HEPA and ULPA Leak Tests
IEST-RP-CC006.3 Testing Cleanrooms ISO 14644-1 14644 1 Classification of air cleanliness
Institute of Environmental Sciences and Technology
2340 S. Arlington Heights Road, Suite 100 Arlington Heights, IL 60005-4516 Phone 847-981-0100 Fax 847-981-4130 Email [email protected]
IEST - Recommended Practices & ISO
Documents www.iest.org ISPE - Baseline Guides Communities of Practice & So much More www.ispe.org ASHRAE Handbooks www.ashrae.org
For More Information Contact:
Environmental Systems Corporation
122 Commerce Park Drive, Unit F Barrie, Ontario, L4N 8W8, Canada 705 722 3220 / 1 866 565 7055 Vernon Solomon 705 720 0030 [email protected] David Hislop 416 953 8691 [email protected]
H.E.P.A. FILTER SERVICES INC.
# 4 124 Connie Crescent Concord, ON, L4K 1L7 905 669 1991 / 1 800 669 0037 Bruce Peat [email protected] Danny Yee Montreal - 514 871 9990 [email protected] Ottawa & Vancouver
