Get ISO 14644 certified Clean Rooms in Research Facilities with Atlanta Healthcare Air Purifiers

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


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


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


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


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


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


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


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:


– 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

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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 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


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


P K JainManaging Director, Atlanta Healthcare

Email | [email protected] | +91 9811233395

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