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Recommended Practices for Clean Rooms

Procedures To Be Followed To Maintain Cleanliness Level

Areas surrounding the Cleanroom should be less pressured than the Cleanroom
Airlock rooms to be provided before Clean Room to reduce entry of contamination
Separate change rooms to be provided for male and female workers. Change rooms are not only used to change the cloths but they
also acts as a buffer zone between the Cleanroom and the contaminated areas.
Whenever going inside the Cleanroom trough the air lock, ensure that the previous air lock door is closed back before entering the
next air lock. Always “open & close” the doors slowly, as this action will pump a lot of air. At any cost the doors should not be left ope
Air Shower to be used to reduce particles entry during human movement
Existing Windows to be closed permanently to avoid cross contamination
Good smooth and scratch resisting flooring with skirting to be provided
Corners to be provided with coving to avoid dust accumulation and for easy cleaning
The room should be considered a restricted area. Only authorized personnel should be allowed to enter during operation
No paper products / cotton buds should be allowed inside the Clean Room
All personnel entering the room facility should remove their shoes and socks. They shall step on the wet/tacky mat in approved manner
All personnel / visitors should wear Clean Room garments while entering Clean room
Clean Room Garments are to be stored properly in a laminar air flow storage cabinet
Personnel should not carry any personnel items such as pencils, pens, hand kerchiefs etc. into the Clean Room
Persons with skin ailments or coughing etc should not be allowed
Avoid talking inside the Cleanroom
For cleaning the Cleanroom it is always better to use liquid detergents and the cleaning process should be slow and the cleaning
personnel should also wear Cleanroom garments
Do not use any blowing equipment inside or nearby a Cleanroom, instead, it is always recommended to use a vacuuming equipment
for cleaning
Movement of materials from and to the Cleanroom must be as minimum as possible
Avoid touching by hand the material inside the Cleanroom, instead use forceps wherever possible
A sitting person sheds over 100000 particles, a moving person emits over one million particles and walking person emits 5 million
particles of 0.5 micron size

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M1   350 9.91 75.7 2.14 30.9 0.875 10.0 0.283 - -

M1.5 1 1240 35.0 265 7.50 106 3.00 35.3 1.00 - -

M2   3500 99.1 757 21.4 309 8.75 100 2.83 - -

M2.5 10 12400 350 2650 75.0 1060 30.0 353 10.0 - -

M3   35000 991 7570 214 3090 87.5 1000 28.3 - -

M3.5 100 - - 26500 750 10600 300 3530 100 - -

M4   - - 75700 2140 30900 875 10000 283 - -

M4.5 1000 - - - - - - 35300 1000 247 7.00

M5   - - - - - - 100000 2830 618 17.5

M5.5 10000 - - - - - - 353000 10000 2470 70.0

M6   - - - - - - 1000000 28300 6180 175

M6.5 100000 - - - - - - 3350000 100000 24700 700

M7   - - - - - - 10000000 283000 61800 1750

Selection ISO 14644-1 airborne particulate cleanliness classes for cleanrooms and clean zones:

ISO Classification  number Maximum concentration limits (particles/m^3 of air ) for particles equal to
and larger than the considered sizes shown below:

  ≥0.1µm ≥0.2µm ≥0.3µm ≥0.5µm ≥1µm ≥5.0µm

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Class Clean rooms of class 10000 are used for mounting procedures in hydraulic or pneumatic equipment and on some occasions
10000: are also used within the food and beverage industry. Class 10000 cleanrooms are also commonly used within the
pharmaceutical industry.

Class This classroom class is used by many industries, for example when working with optical products, when building large
100000: electronic systems based on smaller components, when building hydraulic and pneumatic systems and also within the food
and beverage industry. The pharmaceutical industry also makes frequent use of this class of cleanrooms.

The Scope of the various currently available standards is presented below:

ISO 14644-1 Classification of air cleanliness:

This standard covers the classification of air cleanliness in cleanrooms and associated controlled environments. This classification is in
accordance with the standard as specified and is only concerned with the concentration of airborne particles. It must be stressed that this
standard cannot be used to characterize the physical, chemical, radiological, or viable nature of airborne particle.

ISO 14644-2 Specification for testing and monitoring to prove continued compliance:
This part of the overall standard specifies requirements for periodic testing of cleanrooms and associated controlled environments to prove their
continued compliance with ISO14644-1, and for the designated class of environmental cleanliness.

ISO 14644-3 Metrology and test methods:

This standard specifies the various methods and techniques which can be used to characterize and monitor various parameters in cleanrooms
and other controlled environments.

ISO 14644-4 Design, Construction, and start-up:

ISO 14644-5 Cleanroom operations
This international standard specifies the basic requirements for operating cleanrooms and other controlled environments. It is primarily intended
for those who are planning to carry out work in a cleanroom or any other controlled environment.
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ISO 14698-1 General principles
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Better Than ISO 3 U 60-100 360-600

Air Changes per hour= Average airflow velocity* x room area x 60 min/hr

Room Volume

N=non unidirectional; M= mixed flow room; U= Unidirectional flow.

Classification of filters according to the EN 1822:

Filter Class Overall Value Overall Value Leak test Efficiency (%) Leak test Penetration (%)
Efficiency (%) Penetration (%)

H 10 85 15    

H 11 95 5    

H 12 99.5 0.5    

H 13 99.95 0.05 99.75 0.25

H 14 99.995 0.005 99.975 0.025

U 15 99.999 5 0.000 5 99.997 5 0.002 5

U 16 99.999 95 0.000 05 99.999 75 0.000 25

U 17 99.999 995 0.000 005 99.999 9 0.000 1

Schedule of tests to demonstrate continuing compliance:

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Test Parameter Class Maximum Time Interval
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Various airborne Airborne Ventilation Air supply rate or velocity

dispersions Counts of airborne particles
Counts of airborne micro-organisms
Control of airflow

Floors, Walls and other Contact Cleaning Surface Counting of Particles, and micro-
Surfaces (and ,where required, organisms
disinfection)

  People Airborne   Contact Cleanroom garments   Surface counts; inspection for tears; particle
Gloves penetration testing Inspection for punctures
Surface contamination counts

  Machines Airborne   Contact Ventilation Design of Air extract rates and airflow patterns   Surface
machine cleaning or contamination
disinfection

  Raw materials   Mainly contact Control of manufacturing Particle and bacterial counts within, or on, 
of raw materials the materials   Filtration systems Sterilisation
Cleaning if solids, or system
filtration if fluids
sterilization

  Containers and   Mainly Contact Control of their Particles and microbial Counts on surface
packaging composition and Sterilisation Systems
manufacturing
environment sterilization

R=recommended NR=not recommended

AS=application specific NR*=not recommended in non directional flow

Garments Systems for different classes of cleanrooms according to IEST-RP-CC-003.2:

Apparel Type
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2 piece suit NR NR NR

Coverall R R R

Shoe Cover NR NR NR

Boot R R R

Special Footwear AS AS AS

Hair Cover(bouffant) R R R

Hood AS R R

Facial Cover R** R** R**

Powered headgear AS AS AS

Woven gloves NR NR NR

Barrier gloves R R R

Inner suit AS AS R

R=recommended NR=not recommended

AS=application specific R**=Surgical mask recommended

Recommended frequency of change of garment according to the IEST RP-CC-003:

Class Of Room ISO 7 & 8 Class ISO 6 ISO 5 ISO 4 ISO 3

1000 &100000 (Class 1000) (Class 100) (Class 10) ( Class1)
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