1. INTRODUCTION TO
PHARMACEUTICAL CLEAN
ROOM
Presented by: Kiran Kumar
M. Pharm First Sem.(Q.A.T.)
Roll no. 634
Padm . Dr. D. Y. Patil Institute Of
Pharmaceutical Sciences And
Research Pimpri , Pune-18
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2. CONTENTS
 Purpose of clean protocol
 Introduction
 Classification
 Types of contamination
 Contamination sources
 Contamination control
 Clean room enviroment monitoring
 Conclusion
 Refrences
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3. PURPOSE OF CLEAN PROTOCOL
 Promote Successful Cleanroom Operations
 Ensure Safety in the Clean Environment
 Provide Operational Conditions that Meet Process
& User Needs
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4. WHAT IS A CLEAN ROOM?
 A clean environment designed to reduce the
contamination of processes and materials. This is
accomplished by removing or reducing contamination
sources.
 “Federal Standard 209E” defines a clean room as a
room in which the concentration of airborne particles
is controlled to specified limits.
 “British Standard” defines a clean room as a room
with control of particulate contamination, constructed
and used in such a way as to minimize the
introduction, generation and retention of particles
inside the room and in which the
temperature, humidity, airflow patterns, air motion
and pressure are controlled.
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5. PRINCIPLES OF THE CLEAN
ENVIRONMENT
 Air is highly (HEPA)
filtered (99.97% @
0.3μm)
 Layout should minimize
particle sources in
filtered air stream
 Air flow should remove
most particles generated
by process
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Clean room

6. CLASSIFICATION OF CLEAN ROOM
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7. ISO STANDARDS
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8. 8
CLASSIFICATION OF AIR & MICRO-
ORGANISM AS PER WHO GUIDELINES

9. CLASSIFICATION AS PER EU CGMP
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10. SCHEDULE M
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11. 11
Sr. no U.S. Federal
209 E
MHRA/TGA ISO
Standards
1 Class 100 A & B 5
2 Class 10,000 C 7
3 Class
1,00,000
D 8
Comparison of various grades described in
various guidelines

12. TYPES OF CONTAMINATION
 Particulate
Dust, skin, hair, makeup…
 Chemical
Oil, grease, metal ions, perfume…
 Biological
Bacteria, fungi, rodents???
 Radiation
Ultraviolet light…
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13. CONTAMINATION SOURCES
 People ~75%
 Ventilation ~15%
 Room Structure ~5%
 Equipment ~5%
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CONTAMINATION CONTROL
•Personnel Control
•Dress code
•Personal Hygiene
•Gowning
•Environmental Control
•Entrance and exit
•Materials and supplies
•Cleaning and maintenance
•Atmospheric (HVAC &
Microbial monitoring)

14. PERSONAL HYGIENE
 Shower each day before entry
 Control Dermatitis & Dandruff
 Do not smoke before or after entry
 No chewing gum or tobacco
 No Cosmetics , Jewellery or wrist watches should be
worn
 Leave all personal items in changing room
(wallets,keys,comb etc.)
 Avoid coughing and sneezing if unavoidable leave the
clean room
 Do not move vigorously(Brisk movements shed large
particles from body movement)
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15. GOWNING
 Proper gowning order
 Hair cover
 Hood
 Shoe covers
 Coverall
 Gloves
 Face mask
 Safety Glasses
 Cotton garments shed
fibers. Hence, not used
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Decron (polyster)

16. HVAC SYSTEM
 AIR HANDLING
SYSTEM:
 Requirements –
 Temp should be 15-25
C.
 Atleast 20 air changes
should be there per hr.
 Cleanliness
requirements i.e. class
100.
 Relative humidity 45-55
%.
 Pressure differential
between 2 area should
be 0.05-0.1 inch water
guage.
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17. HEPA & UEPA
 High efficiency particulate air (HEPA):
 They are box type depth filters used for air filtration.
 These filters are made up of glass fibers.
 Efficiency of HEPA filters are 99.97% against 0.3 μm
particles.
 Testing for HEPA filters:
 Hot DOP test (efficiency testing), Cold DOP test
(integrity testing) , Air flow resistance test
 Ultra low penetration air (ULPA):
 Most ULPA filters are replaceable extended media
dry filters that have a minimum particle collection
efficiency of 99.9997 % efficient for particles greater
than or equal to 0.12-micron in size. 17

18. AIRFLOW DISTRIBUTION AND
CONTROL
 Unidirectional:(sometimes referred as laminar flow)
is an airflow pattern in which essentially the entire
body of air within a confined area moves with uniform
velocity and in single direction with generally parallel
airstreams. Clean rooms; class 100 and below have
unidirectional airflow pattern. Laminar air flow ----120
FPM
 Non-unidirectional: airflow is not unidirectional by
having a varying velocity, multiple pass circulation or
nonparallel flow direction. Conventional flow clean
rooms (class 1000 & 10000) have non-unidirectional
or mixed air flow patterns.
 Mixed patterns : combine some of each flow type. 18

19. 19

20. ENTRY & EXIT
 Enter and exit quickly.
 Only one person may enter at a time.
 Each user must use their own access card.
 Pass from the gowning area to the clean area slowly
to reduce migration of particles between areas.
 Restricted no. of people in aseptic area.
 Drug sensitivity tests should be carried out for
employees working in critical area.
 Medical check-ups of people works in critical area
should be more frequent than other employees.
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Some specific requirements

21. CLEAN ROOM ENVIRONMENT
MONITORING
Test Frequency
I. Particle Monitoring in air--------------6 monthly
II. HEPA Filter Integrity Testing---------Yearly
III. Air Changes Rate Calculation-------6 Monthly
IV. Air Pressure Differentials--------------Daily
V. Temperature and Humidity------------Daily
VI. Microbiological monitoring by---------Daily, and at
decreased
settle plates and / or swabs in frequency in
other
aseptic areas areas
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22. CONCLUSION
 The main purpose of building a cleanroom suite is
to provide a vital element in the assurance of
product quality according to whole concept of good
pharmaceutical manufacturing operation.
 The resultant facility should prevent contamination
of the product, and should be seen to be doing so
by the incorporation of effective monitoring devices.
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23. REFERENCES
 Current Good Manufacturing For pharmaceuticals;
Manohar A. Potdar; Page no:70-73.
 Pharmaceutical Quality Assurance, Manohar A.
Potdar , Nirali Prakashan; Page no:13.1-13.10
 Comparison of Quality Requirements for Sterile
Product Manufacture as Per Indian GMP and USFDA
;Yogita P, N Vishal Gupta, Natasha NS, Ashwini
Nageen L, R Sudeendra Bhat; Research Journal of
Pharmaceutical, Biological and Chemical Sciences;
Jan 2012 volume 3(1): 225-236.
 www.fda.gov
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THANK YOU