Skip to content
Pharmainform
MAIN MENUMENU
CLEANROOM CLASSIFICATION IN PHARMACEUTICAL
INDUSTRIES
Leave a Comment / General-Topics / By Sajjad Ahmad
A clean room is a room in which particles and the viable count are kept within
standard and defined ranges. As the name indicates, cleaning is a strict
requirement for these rooms and it is necessary to maintain their defined
cleaning level all the time. Clean rooms play an important role in the
manufacturing of pharmaceutical products.
In pharmaceutical industries, clean rooms are classified based on the size
of particles and the number of particles per cubic meter of air. For each
clean room, there are specific limits for particle count, microbial counts and
air changes.
Classification of clean rooms
Clean rooms are classified according to following standards,
ISO 14644-1
Federal Standards (FS 209)
European standards
According to ISO 14644-1
ISO classify clean rooms into following
ISO 1
ISO 2
ISO 3
ISO 4
1SO5
ISO 6
ISO 7
ISO 8
ISO 9
In ISO there are 9 classes of the clean rooms from ISO 1 to IOS 9.ISO 1 is
cleanest from all classes of ISO and ISO 9 is least clean or dirtiest from all
ISO classes but cleaning level of ISO 9 is superior to a regular room. In
pharmaceutical Industries following ISO, classes are generally required
ISO 5
1SO6
ISO 7
ISO 8
According to FS 209
According to the federal standard, FS 209 Clean rooms are classified as,
Class100
Class1000
Class 10,000
Class100,000
According to the EU GMP
Grade A
Grade B
Grade C
Grade D
FS 209 is replaced by ISO 14644-1 but these terms are still in use. In
ISO particle are taken as particles/m³ (cubic meter)and in FS 209
particles were taken as particles/ft³(cubic feet)
A simple comparison of clean rooms classification for pharmaceutical
industries is as follow,
ISO EU GMP FS
ISO 5 Grade A Class 100
ISO 6 Grade B Class 1000
ISO 7 Grade C Class 10,000
ISO 8 Grade D Class 100,000
Particle Size Range
In pharmaceutical industries, two ranges of particle size are considered for
classification of clean rooms one is ≥0.5 micron (equal to or greater than 0.5
microns) and other is ≥5.0 micron (equal to or greater than 5.0-micron particles).
ISO 5 /Grade A
ISO class 5 is cleanest in pharmaceutical industries and particle count limit
for this class is 3520 particles/m³ for particle size ≥0.5 micron, and particle count
for particles ≥5.0 micron is 29 particles/m³.
Air changes per hour are 240-480.
Microbial count in Grade A according to EU is <1 cfu/m³.
Class A is achieved under laminar airflow hood and critical operations take
place in this class,
Filling
Sealing
Aseptic manufacturing(If sterile filtration is not done)
Handling of sterile starting materials.
Manufacturing and filling of sterile creams, ointments,
emulsions and suspension(when Product is exposed and is not
subsequently filtered)
ISO 6 /Grade B
ISO class 6 is the second number for cleaning standard in pharmaceutical
industries and particle count for particles ≥0.5micron is 35200
particles/m³ and particle count for particles ≥5.0 micron is 293
particles/m³.
Air changes per hour are 150-240.
Microbial count in Grade B according to EU is 10 cfu/m³.
Grade B is the background area of Grade A mean area in which laminar airflow hood is
placed.
ISO 7 /Grade C
ISO class 7 is on the third number in pharmaceutical industries and
particle count for particles ≥0.5 micron is 352000 particles/m³ and particle
count for particles ≥5.0 micron is 2930 particles/m³.
Air changes per hour are 60-90.
Microbial count in Grade C according to EU is 100 cfu/m³.
Grade C is for following operations,
Solution preparation( if sterile filtration is to be done later on)
Manufacturing and filling of creams, ointments,
emulsions and suspension before terminal steralization.
Liquid manufacturing area at rest is Grade C.
ISO 8/Grade D
ISO class 8 is on forth number class in pharmaceutical industries and
particle count for particles ≥0.5 micron is 3520,000 particles/m³ and
particle count for particles ≥5.0 micron is 29300 particles/m³.
Air changes per hour are 05-48.
Microbial count in Grade D according to EU is 200 cfu/m³.
washing of components.
Handling of components after washing
Tablet,Capsule section(OSD) is Grade D at rest.
Liquid manufacturing area in operation is Grade D.
All clean rooms are separated from each other through the Airlock system.
Airlocks maintain the cleaning standard of clean rooms through proper air
changes. Air changes are maintained by the HVAC system.
in clean rooms, the air is filtered through HEPA filters.HEPA filter stands for
High-efficiency particulate air filter.HEPA filters remove particles of 0.3
microns and supply clean air in clean rooms.
At Rest
At rest mean all the equipment are installed in a clean room and HVAC
system is operational but manufacturing activity is stopped.
It means the area is cleaned and no operator is performing manufacturing
activity.
At rest particle count in clean rooms is as follow,
Grade A
≥0.5 micron=3520 particles/Cubic meter
≥5.0 micron=29 particles/Cubic meter
Grade B
≥0.5 microns=35200 particles/Cubic meter
≥5.0 micron=293 particles/Cubic meter
Grade C
≥0.5 microns=352000 particles/Cubic meter
≥5.0 micron=2930 particles/Cubic meter
Grade D
≥0.5 micron=3520000 particles/Cubic meter
≥5.0 micron=29300 particles/Cubic meter
In Operation
In operation means all the equipment are installed in a cleanroom and
HVAC system is operational and manufacturing activity is going on in the
cleanroom.
It means the area is cleaned and operators are performing manufacturing
activity in a cleanroom.
In Operations particle count in clean rooms is as follow,
Grade A
≥0.5 micron=3520 particles/Cubic meter
≥5.0 micron=29 particles/Cubic meter
Grade B
≥0.5 microns=352000 particles/Cubic meter
≥5.0 micron=2930 particles/Cubic meter
Grade C
≥0.5 micron=3520,000 particles/Cubic meter
≥5.0microns=29300 particles/Cubic meter
Grade D
≥0.5 microns=Not Defined.
≥5.0 micron=Not Defined.
Note:
EU volume 4 Annex 1 and WHO Annex 6 describe
5.0 micron=20 particles/Cubic meter both for at rest and operation.
Important topics
Classification of HEPA filters
Pass Box In Pharma
Types of airlocks in pharmaceuticals
HVAC or Heating Ventilation & Airconditioning System.
Loop Circulation system for purified water.
Why we Use only 70% IPA
Reconciliation in pharmaceutical industries.
How to become a skilled pharmacist?
Share To Others
WhatsAppFacebookLinkedInTelegramCopy LinkShare
Post navigation
Previous Post
Next Post
Leave a Comment
Your email address will not be published. Required fields are marked *
Type here..
Name*
Email*
Website
Save my name, email, and website in this browser for the next time I comment.
CATEGORIES
Calculations (9)
Coating (13)
Compression (22)
Equipment (6)
Excipients (24)
General-Topics (20)
Granulation (15)
HVAC (6)
Interview-Questions (13)
Key Differences (1)
MCQs (9)
Packaging (5)
Quality Assurance (4)
SOP (27)
Standards (10)
FacebookLinkedinSubscribe
Copyright © 2023 Pharmainform
Developed & Designed By Sajjad Ahamd
