Concepts on Pure Air & its need in Laboratory P. K. Jain, Managing Director Atlanta Healthcare April 05, 2012 www.atlantahealthcare.in 1st National Conclave for Laboratories, New Delhi
May 30, 2015
Concepts on Pure Air & its need in Laboratory
P. K. Jain, Managing Director Atlanta Healthcare
April 05, 2012
www.atlantahealthcare.in
1st National Conclave for Laboratories, New Delhi
Did you know…
• A human hair is about 75-100 microns in diameter. A particle 200 times smaller (0.5 micron) than the human hair can cause major disaster in a Laboratory
• Contamination can lead to expensive downtime, erroneous readings and increased costs
The billion dollar NASA Hubble Space Telescope was damaged and did not perform as designed because of a particle smaller than 0.5 microns!
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…contaminants everywhere…
Contaminants
Facilities
People
Equipment
generatedFluids
Finished Good
generated
• Paints & coating• Construction material• A/C debris and room air vapors• Spills & leaks
• Skin flakes & oil• Spittle• Hair• Cosmetics • Clothing debris
(fibre)
• Friction & wear particles• Lubricants & emissions • Vibrations• Brooms, mops, dusters etc
• Particulates floating in air• Bacteria, organics &
moisture• Floor finishes or coatings
• Cleaning chemicals• Plasticizers, deionized water
• Silicon chips• Quartz flakes
• Aluminum particles
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Concept of ‘CleanRoom’… …crucial to laboratories• A CleanRoom is really clean!
– Controlled level of contamination specified by number of particles per cubic meter at a specified particle size
Ambient Air
Clean Room
Standard Particles per Cubic Meter
Permissible Particle size
ISO 9
ISO 1
35 mn
12
0.5 Micron & larger
0.3 Micron& smaller
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Features of CleanRooms (1/2)
• Air entering a CleanRoom is filtered to exclude dust, and the air inside is constantly re-circulated through:
– High-efficiency particulate air (HEPA) Filters
– Ultra-low penetration air (ULPA) filters
• Staff enter and leave through airlocks (sometimes including an air shower stage), and wear protective clothing
• CleanRoom furniture is also designed to produce a minimum of particles and to be easy to clean – metal furniture not most appropriate
– Intent of the CleanRoom is to minimize metal-containing dust
– Minimize the creation of metal containing particulates within the CleanRoom
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Features of CleanRooms (2/2)
• CleanRooms are not sterile (i.e. free of uncontrolled microbes) but ensure greater focus on removal of airborne particles
• Higher classification CleanRooms are kept at a positive pressure so that if there is a leak, air leaks out of the chamber instead of unfiltered air entering
• Equipment inside the CleanRoom is designed to generate minimal air contamination specialised mops and buckets exist.
CleanRooms are a must for laboratories, semi conductor manufacturing, bio technology, life sciences and other room facilities that are very sensitive to environmental contamination
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Assessing your Laboratory requirements (1/2)• CleanRooms are classified according to the number and size
of particles permitted per volume of air
• There are two prevalent standards:– Federal Standard 209E (phased out but still referred)
– ISO 14644 (classification of air cleanliness)
• Federal Standard 209E
Large numbers like "class 100" or "class 1000" refer to FED-STD-209E, and denote the number of particles of size 0.5 µm or larger permitted per cubic foot of air
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Assessing your Laboratory requirements (2/2)• ISO 14644
The main differences between Federal Standard 209E and ISO 14644-1 (Testing Standards) are:
ISO Establishes 0.1um as the "Standard" Diameter ISO Creates 3 New Cleanliness Classes-
2 "Cleaner" classes (ISO class 1 and ISO class 2) than Federal Standard 209E 1 "Dirtier" Class (ISO Class 9) which is allows more particulate than Fed Standard 209E
class 100,000
Covers the classification of air cleanliness in CleanRooms and associated controlled environments
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There is more to CleanRooms than just filtering air• Critical to CleanRoom is to tightly control:
– Air flow rates & direction
– Pressure, temperature & humidity and
– Specialized filtration
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CleanRoom Working (1/2)
• Achieving a cleaner class of clean room is all about airflow
• CleanRooms maintain particulate-free air through the use of either HEPA or ULPA filters employing laminar or turbulent air flow principles.
• Laminar, or unidirectional air flow systems:
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– Direct filtered air downward in a constant stream towards filters located on walls near the Clean room floor
– Laminar air flow systems are typically employed across 80 percent of a CleanRoom ceiling to maintain constant air processing
CleanRoom Working (2/2)
• The greater the number of HEPA filters and vents, the greater the rate of air change.
Class Average Airflow Velocity Air changes/hour Recommended
Class 8 Not applicable 10-20 20 to 40
Class 7 Not applicable 30-70 50 to 80
Class 6 Not applicable 70-160 100 to 180
Class 5 .2-.5 m/sec (40-90 ft./min) Not applicable 300-400
Class 4 .3-.5 m/sec (60-90 ft./min) Not applicable
– ISO Class 9 through ISO Class 6 rooms are determined based on air changes per hour
– ISO Class 5 through ISO Class 1 rooms are based on the flow of air through the room in meters per second
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Way forward…
• Evaluate the cost benefits of making an investment in CleanRooms of a particular classification– Higher level of accreditation puts you ahead in the value chain
– Its not only expensive to build CleanRooms but also expensive to operate
• Framework for accreditation of Laboratories for “Air quality” in line with ISO 14644 norms– While agencies like CSE has capability of monitoring air quality,
institutional framework for accreditation is required
• Awareness campaign around CleanRoom concept– Classification of ISO 14644 and its application
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P K JainManaging Director, Atlanta Healthcare
Email | [email protected] | +91 9811233395
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