This Presentation gives an Idea about what "Clean Rooms" are, their significance, types and examples from pharmaceutical industry.

1. CLEAN ROOMS &
CLASSIFICATION OF CLEAN ROOMS
by: Amna Saeed
Pharm.D(2009-2014) (L.C.W.U)

2. CLEAN ROOM
A clean room (or cleanroom) is an
enclosed space in which airborne
particulates, contaminants, and pollutants
are kept within strict limits.

3. WHY WE
NEED
CLEAN
ROOM???

4. TO AVOID
“CONTAMINATION”

5. CONTAMINATION
Contamination is a process or act that causes
materials or surfaces to be soiled with
contaminating substances.
Sources of Contamination:
1:Facilities
2:People
3:Tool generated
4: Fluids
5: Product generated

6. 1. Facilities
Walls, floors and ceilings
Paint and coatings
Construction material (sheet rock, saw dust etc.)
Air conditioning debris
Room air and vapors
Spills and leaks
2. People
Skin flakes and oil
Cosmetics and perfume
Clothing debris (lint, fibers etc.)
Hair

7. 3. Tool Generated
Friction and wear particles
Lubricants and emissions
Vibrations
mops and dusters
4. Fluids
Particulates floating in air
Bacteria, organics and moisture
Floor finishes or coatings
Cleaning chemicals
Deionized water

8. 5. Product generated
Silicon chips
Quartz flakes
Cleanroom debris
Aluminum particles

9. HOW TO CONTROL
CONTAMINATION???

11. Key Elements of Contamination Control
•HVAC system
•HEPA
•CLEANROOM ARCHITECTURE
•LAMINAR FLOW CABINET
•FILTERATION
•CLEANING
•CLEANROOM GARMENTS
•HUMANS IN CLEANROOM
•COMODITIES
•COSMETICS
•MEASUREMENTS & INSTRUMENTATION
•ELECTROSTATIC DISCHARGE(ESD)

12. HVAC SYSTEM (heating,
ventilation & air-conditioning)
What can HVAC do?
HVAC system performs four basic functions:
1. Control airborne particles, dust and micro-organisms
– Thru air filtration using high efficiency particulate
air (HEPA) filters.
They filter particles as small as 0.3
microns with a 99.97% minimum
particle-collective efficiency

13. 2. Maintain room pressure (delta P) –
Areas that must remain “cleaner” than
surrounding areas must be kept under a
“positive” pressurization,
This is achieved by the HVAC system providing
more air into the “cleaner” space than is
mechanically removed from that same space.

14. 3: Maintain space moisture (Relative
Humidity)
 Humidity is controlled by cooling air to dew
point temperatures or by using desiccant
dehumidifiers.

15. 4. Maintain space temperature –
Temperature can affect production directly or
indirectly by fostering the growth of microbial
contaminants on workers.

16. CLEANROOM ARCHITECTURE
This air flow is called laminar flow.
The more restriction of air flow the
more turbulence. Turbulence can
cause particle movement.

17. Laminar flow cabinet
•Laminar flow principle involves double
filteration of air through coarse Pre-filters
(upto 5 microns) and HEPA filters
(down to 0.3 microns) for filteration of
Biological & Particulate contaminants.
•A constant uni-directional air flows
either Horizontally or Vertically, is
drawn from atmosphere and passed
through pre and Hepa filters on to the
work surface.

18. COMPONENTS OF LAMINAR
FLOW CABINET
Prefilters : Made of Washable synthetic
material.
Hepa Filters : Made of Microglass fibre with
corrugated aluminium foil separators.
Blower Units : A motor,with dynamically
balanced blowers making the unit least vibrant
with minimum noise level.
Lighting : Fluorescent tube lights.
Sterilization : Germicidal Ultra Violet (UV)
tube.
manometer : Pressure measuring device

19. TYPES OF LAMINAR FLOW
CABINETS

20. CLEANROOM GARMENTS
The requirements for cleanroom garments will
vary from location to location.
Gloves, face masks and head covers are
standard in nearly every cleanroom
environment

22. HUMANS IN CLEANROOMS
People are a major source of contamination in
the cleanroom.
1. Body Regenerative Processes-- Skin flakes,
oils, perspiration and hair.
2. Behavior-- Rate of movement, sneezing and
coughing.
3. Attitude-- Work habits and communciation
between workers.

23. Notice the number of particles produced per
minute during these activities.
PEOPLE ACTIVITY NUMBER OF
PARTICLES/MIN(0.3 micron
and larger)
Motionless (Standing or
Seated)
100,000
Walking about 2 mph 5,000,000
Walking about 3.5 mph 7,000,000
Walking about 5 mph 10,000,000
Horseplay 100,000,000

24. COMMODITIES - Care is taken when
selecting and using commodity items in
cleanrooms. Wipers, cleanroom paper and
pencils and other supplies that service
the cleanroom should be carefully
screened and selected

25. COSMETICS - Many cosmetics contain
sodium, magnesium, silicon, calcium, potassium
or iron.
These chemicals can create damaging particles.
Cleanroom managers may ban or restrict
cosmetics in the cleanroom
A recent mirror on a space telescope was
fogged up from the cologne that was present in
the cleanroom.

26. MEASUREMENT AND INSTRUMENTATION -
Some important measurements related to
contamination control are particle count, air
flow & velocity, humidity, temperature and
surface cleanliness
ELECTROSTATIC DISCHARGE (ESD)
Moving air creates a charge.
People touching surfaces or walking across the
floor can create an electric charge.
Special care is taken to use ESD protective
materials to prevent damage from ESD. Cleaning
managers should work with their personnel to
understand where these conditions may be
present and how to prevent them.

27. CLASSIFICATION OF
CLEAN ROOMS
Clean rooms are classified by the
cleanliness of their air.
•The method most easily understood and
most universally applied is the one
suggested in the earlier versions (A to
D) of Federal Standard 209 of the USA.
•In this old standard the number of
particles equal to and greater than 0.5 m
m is measured in one cubic foot of air
and this count used to classify the room.

28. Federal Standard 209
This standard was first published in 1963 in the
USA and titled "Cleanroom and Work Station
Requirements, Controlled Environments“

29. Pharmaceutical Clean Room
Classification
For the manufacture of sterile medicinal
products four grades are given

30. Grade A: The local zone for high risk
operations, e.g.
filling zone, stopper bowls, open
ampoules and vials, making aseptic
connections.
Normally such conditions are provided
by a laminar air flow work station.
Laminar air flow systems should provide
an homogeneous air speed of 0.45 m/s
+/- 20% at the working position.

31. Grade B: In case of aseptic
preparation and filling, the background
environment for grade A zone.
Grades C and D: Clean areas
for carrying out less critical
stages in the manufacture of
sterile products.

32. Examples of operations to be
carried out in the various grades
are given in the table below

33. Additional microbiological
monitoring is also required
outside production operations, e.g.
after validation of systems,
cleaning and sanitization.
(NOTES: a) These are average values.
(b) Individual settle plates may be exposed for less than 4 hours.
(c) Appropriate alert and action limits should be set for the results of
particulate and microbiological monitoring. If these limits are
exceeded operating procedures should prescribe corrective action.

34. REFERENCES:
1:http://www.mssl.ucl.ac.uk/www_cleanro
om/cleanroom/cr_standards.html#pcc
2:http://whatis.techtarget.com/definition
/clean-room
3:http://www.coastwidelabs.com/Technical
%20Articles/Cleaning%20the%20Cleanroom
.htm
4:http://www.fda.gov/downloads/Drugs/..
./Guidances/ucm070342.pdf