TECHNICAL COMMITTEE ON CLEANROOM

AND RELATED ENVIRONMENT

The above committee is responsible for the

standard development of ISO 14644.
Cleanroom Standards for a Global
Market
 Cleanroom Standards for a Global
Market
• In the decade since the International Organization for
Standardization (ISO) responded to the call for global
cleanroom standards, ISO Technical Committee (TC)
209 has brought nine standard documents into active
use for the world’s 80,000 cleanrooms.
• Before ISO/TC 209, “Cleanrooms and associated
controlled environments,” took shape, stan-
dardization was in the hands of national bodies. As a
result, the growing international marketplace found
itself grappling with hundreds of national standards
and guidelines.
Top 10 Purchasers of cleanroom
hardware in 2006:
Origin of a Standard
 ISO-Project Stages and Associated
✓Preliminary Stage
✓Proposal Stage
✓Preparatory Stage
✓Committee Stage
✓Enquiry Stage
✓Approval Stage
✓Publication Stage
.
ISO/TC209 Conference in Milan,
Italy Sept. 2011
ISO/TC209 Conference at Zurich Federal
Institute of Technology, Sept. 2012,
Zurich, CH
 ISO/TC209 CONFERENCE SEOUL,
South Korea – Oct. 20-21, 2014
ISO/TC 209
ANNUAL
CONFERENCE AT DIN
HEADQUARTERS
BERLIN, GERMANY,
OCTOBER 14, 2015
ISO/TC 209 PLENARY CONFERENCE
–SAO PAULO,BRAZIL (SEPTEMBER 17-
18,2016)
TC 209/WORKING GROUP 4 (SAO PAULO)
DESIGN, CONSTRUCTION AND START-UP OF CLEANROOM
(SEPTEMBER 15-16, 2016)
ISO/TC 209 CONFERENCE October 26, 2017
(SYDNEY, AUSTRALIA)
TC 209/WG4 MEETING October
2017 (SYDNEY, AUSTRALIA)
 ISO/TC 209 PLENARY
CONFERENCE
THE HAGUE, NETHERLANDS
OCTOBER 1, 2018
BPS/TC 83
BPS/TC 83
ISO/TC209 WG11 in Makati
March 6-8, 2013
INVISIBLE ENEMIES INSIDE THE
CLEANROOM
IT’S THE 0.5 MICRON PARTICLES
(ORGANIC OR INORGANIC)
 1 meter
1 MICRON = __________________________

1,000,000
WHAT IS THE DIFFERENCE BETWEEN
CLEANROOM AND STERILE ROOM?

CLEANROOM a room in which airborne

particulates (organic or inorganic),
contaminants and pollutants are kept within
strict limits.
STERILE ROOM a room free of live
microorganisms, such as bacteria, virus, etc.
1. CHEMICAL GASSES
a. Hydrogen Peroxide
b. Ammonia
2. STEAM/HEAT
a. Autoclave
3. RADIATION
4. NON-RADIATION
a. Ultra Violet (Short wave)
5. FILTRATION
 What is Ultraviolet?
➢Ultraviolet light is part of the light spectrum, which is classified
into three wavelength ranges:
➢UV-C, from 100 nanometers (nm) to 280 nm
➢UV-B, from 280 nm to 315 nm
➢UV-A, from 315 nm to 400 nm
ULTRA VIOLET LIGHT
STEM CELL LABORATORY
 U.S.Federal Standard 209E ISO-14644

CLASS 1 ISO CLASS 3

CLASS 10 ISO CLASS 4
CLASS 100 ISO CLASS 5
CLASS 1,000 ISO CLASS 6
CLASS 10,000 ISO CLASS 7
CLASS 100,000 ISO CLASS 8

12’’
NUMBER OF 0.5 MICRON PER CU. FT. OF AIR
12’
12’’
SAMPLE AIR
W
 THE TERMINAL FILTERS ARE MOUNTED ON THE CEILING (GRID)
AND ARE CALLED ;

IGH LTRA

FFICIENCY OW

ARTICULATE ARTICULATE

IR IR
HAVE EFFICIENCIES OF 99.97% and 99.99% AT 0.3 MICRON

HAVE EFFICIENCIES OF 99.999% and 99.9999% AT 0.3 MICRON

FAN

HEPA FILTER
STATIC CHARGE EXISTS IN A
CONTROLLED
ENVIRONMENT
1. Equipments and materials are cleaned before
entry.

2. Non-shedding paper and roller pens are used.

Pencils and erasers are not permitted.

3. Work parts are handled with gloved hands, finger

cots, tweezers
and other methods to avoid transfer of skin oils
and particles.
AS-BUILT:
CONDITION WHERE THE INSTALLATION IS COMPLETE WITH ALL
SERVICES CONNECTED AND FUNCTIONING BUT WITH NO PRODUCTION
EQUIPMENT, MATERIALS, OR PERSONNEL PRESENT.

AT REST:
CONDITION WHERE THE INSTALLATION IS COMPLETE WITH EQUIPMENT
INSTALLED AND OPERATING IN A MANNER AGREED UPON BY THE
CUSTOMER AND SUPPLIER, BUT WITH NO PERSONNEL PRESENT.

OPERATIONAL:
CONDITION WHERE THE INSTALLATION IS FUNCTIONING IN THE
SPECIFIED MANNER, EQUIPMENT INSTALLED/OPERATIONAL WITH THE
SPECIFIED NUMBER OF PERSONNEL PRESENT AND WORKING IN THE
MANNER AGREED UPON.
• Raw materials:
– Boxes, plastic bags, wafers, ingredients, garments etc.
• Equipments:
– Wafer saw, Die attached, tableting, powder coating
machines, operating tables etc.
• Processed Gases:
– Nitrogen, Compressed dry air, D.I./distilled water,
anesthesia gas, etc.
• Personnel:
– Production, Q.A., Maintenance, nurses, doctors.