INTRODUCTION

INTRODUCTION TO
TO
PHARMACEUTICAL
PHARMACEUTICAL CLEAN
CLEAN
ROOM
ROOM
Presented by: Kiran Kumar
M. Pharm First Sem.(Q.A.T.)
Roll no. 634
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Padm . Dr. D. Y. Patil Institute Of

Pharmaceutical Sciences And
Research Pimpri , Pune-18

CONTENTS
CONTENTS
Purpose of clean protocol
Introduction
Classification
Types of contamination
Contamination sources
Contamination control
Clean room enviroment monitoring
Conclusion
Refrences

PURPOSE
PURPOSE OF
OF CLEAN
CLEAN PROTOCOL
PROTOCOL
Promote Successful Cleanroom Operations
Ensure Safety in the Clean Environment
Provide Operational Conditions that Meet Process
& User Needs

WHAT
WHAT IS
IS A
A CLEAN
CLEAN ROOM?
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.

PRINCIPLES
PRINCIPLES OF
OF THE
THE CLEAN
CLEAN
ENVIRONMENT
ENVIRONMENT
Air is highly (HEPA) filtered (99.97% @ 0.3m)
Layout should minimize particle sources in filtered
air stream
Air flow should remove most particles generated by
process

Clean room
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CLASSIFICATION
CLASSIFICATION OF
OF CLEAN
CLEAN
ROOM
ROOM

ISO
ISO STANDARDS
STANDARDS

CLASSIFICATION
CLASSIFICATION OF
OF AIR
AIR &
& MICROMICROORGANISM
ORGANISM AS
AS PER
PER WHO
WHO GUIDELINES
GUIDELINES

CLASSIFICATION
CLASSIFICATION AS
AS PER
PER EU
EU CGMP
CGMP

SCHEDULE
SCHEDULE M
M

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Comparison
Comparison of
of various
various grades
grades
described
described in
in various
various guidelines
guidelines
Sr. no

U.S.
Federal 209
E

MHRA/TGA

ISO
Standards

Class 100

A&B

Class 10,000

Class
1,00,000

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TYPES
TYPES OF
OF CONTAMINATION
CONTAMINATION
Particulate
Dust, skin, hair, makeup
Chemical
Oil, grease, metal ions, perfume
Biological
Bacteria, fungi, rodents???
Radiation
Ultraviolet light

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CONTAMINATION
CONTAMINATION SOURCES
SOURCES
People ~75%
Ventilation ~15%
Room Structure ~5%
Equipment ~5%

CONTAMINATION
CONTAMINATION CONTROL
CONTROL
Personnel Control
Dress code
Personal Hygiene
Gowning

Environmental Control
Entrance and exit
Materials and supplies
Cleaning and maintenance
Atmospheric (HVAC &
Microbial monitoring)

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PERSONAL
PERSONAL HYGIENE
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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GOWNING
GOWNING
Proper gowning order
Hair cover
Hood
Shoe covers
Coverall
Gloves
Face mask
Safety Glasses
Cotton garments shed
fibers. Hence, not used

Decron (polyster)

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HVAC
HVAC SYSTEM
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 0.050.1 inch water guage.

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HEPA
HEPA &
& UEPA
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 m
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.

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AIRFLOW
AIRFLOW DISTRIBUTION
DISTRIBUTION AND
AND
CONTROL
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.

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ENTRY
ENTRY &
& EXIT
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.

Some
Some specific
specific requirements
requirements
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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CLEAN
CLEAN ROOM
ROOM ENVIRONMENT
ENVIRONMENT MONITORING
MONITORING
Test
I.
II.
III.
IV.
V.

VI.

Frequency

Particle Monitoring in air--------------6 monthly

HEPA Filter Integrity Testing---------Yearly
Air Changes Rate Calculation-------6 Monthly
Air Pressure Differentials--------------Daily
Temperature and Humidity------------Daily
Microbiological monitoring by---------Daily, and at
decreased
settle plates and / or swabs in
frequency in other
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aseptic areas areas

CONCLUSION
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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REFERENCES
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

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