Clean Room

Chapter 5

Design

By the end of this chapter, Introduction

you will be able to:
l Explain the terms positive and
negative pressure
l Name and describe two
categories of air flow in a
clean room
l List the main design features
of a clean room
l Explain the different grades
of clean rooms
In this chapter we will look at the specific
design of a clean room including the walls,
ceilings and floors as well as the practical
needs of items such as workbenches, storage
cupboards and chairs.
We will examine how air is filtered to
maintain the air quality and how air pressure
prevents contamination of the cleanroom when
people and equipment move into or out of the
clean room.
We will also take a brief look at the different
types of clean room using particle counts to
grade areas.

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What is a Clean Room?
Cleanrooms are usually self-contained
facilities with their own dedicated ventilation
systems. These control air quality, temperature
and humidity.
Air is filtered through High Efficiency
Particulate Air (HEPA) filters which have a very
small pore size. The filters collect and remove
small particles, before air enters through the
ceiling grilles.
Ceiling HEPA filter
Build up of contaminants in the cleanroom is
prevented by the flow of clean air at a rate of a
minimum of 20 room air changes per hour.
2 Chapter 5: Clean Room Design
Dirty air from the surrounding area is
prevented from entering the cleanroom by
controlling the air pressure in the cleanroom.
l Cleanest room at highest pressure
l Air flows from the cleanest to
dirtiest areas
Operation is at positive pressure, so ensures
any airflow is pushed outwards from the room
and dirty air cannot enter the room by default.
The size of the aseptic suite depends on the
maximum number of people who might use it
at any one time.
A fairly large room is more pleasant to work
in, and the overall level of microbes in the
environment is less affected by local air
disturbances or contamination produced by
individual workers.
Clean Room Design
Clean rooms fall into two categories,
unidirectional and non-unidirectional.
Unidirectional clean rooms normally have
vertical airflow. Air flows downwards through
HEPA filters located in the ceiling. The air is
extracted through perforated flooring or grilles
mounted on the walls at floor level.
Note: airflow in a unidirectional clean room
can also be horizontal.
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Clean Room Design

Non unidirectional clean rooms have air When storage space is required, cupboards
flows from HEPA filters located in various are preferable to drawers because they are
positions and returned through opposite easier to clean. Cupboards should be dust
locations. Filters may be distributed at equal proof and smooth inside. Rounded beading
intervals throughout the room or grouped over may be used to cover dust-retaining angles
critical areas. The distribution and returns in within storage spaces and between fixed
this instance mean that the air flow may be benches and walls. Small units on castors
turbulent in nature. make useful additions to the working surface.
Chairs must be adjustable and comfortable
and covered with an impervious washable
material.
Trolleys should be made from stainless steel
and be easily cleanable.
The floors, walls and ceiling should be made
of a smooth impervious material to ensure no Switches and sockets should be flush fitting
particle shedding and easy cleaning. They and have plastic fingerplates.
should also be chemically resistant. All joins
There should be no
in the covering materials should be welded to
l shelves, window ledges or door frames
ensure that there is no chance of seepage of
where dust might settle.
cleaning fluids under the covering.
l pipes or ductwork. (False ceilings should be
Doors should be easy to open and, where fully sealed with lighting recessed).
necessary, two doors linked together to form
l sinks or drains.
an air lock. This prevents a sudden rush of
air when a door is opened. All doors should
be controlled to prevent unwanted flow of air
from one area to another by opening of doors
simultaneously.
Benches should be made from one complete
sheet of laminate because some liquids attack
the adhesive at the joints and eventually cause
lifting. Where possible made they should be
made from stainless steel, Trespa or Conan
which are impervious. They are usually
wall-mounted to reduce dust collection and
facilitate its detection and removal.

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Hand washing facilities should be available
external to changing rooms. Taps should be
elbow or foot operated so that cleaned hands
are not used to turn the water off. Soap should
be conveniently dispensed from a wall or bench
dispenser. Electric hand dryers or high quality
paper towels should be used to dry hands.
There should be a separate two-way transfer
hatch system for the transfer of goods in and
out of the cleanroom, to prevent contamination
of environments.
There should be a support room from which
materials can be passed into and out of the
cleanroom through hatches.
4 Chapter 5: Clean Room Design
Remember: In summary, there should be:
l smooth impervious surfaces
l no ledges for dust to gather
l surfaces which are easy to clean
l transfer systems/airlocks to prevent
contamination
l no water sources
Other aspects of design
of the Cleanroom
When designing a clean room there are many
considerations to make.
Here are a few but this is not an exhaustive list
of good and bad practice.
Material used in the construction should make
cleaning and disinfection easy. For example
there should be no joins between walls, floors
and ceiling and all surfaces should be smooth
and easy to clean.
Horizontal surfaces can accumulate particles
and should be maintained by regular cleaning
Chapter 5
Clean Room Design
Airlocks should be installed between clean
areas and adjoining dirty areas
Equipment should not reduce the airflow
and should not be placed anywhere it disturbs
the airflow.
This image shows an alcohol extraction
unit situated in the spraying in zones of
the preparation area. It works as a vacuum
extracting the alcohol fumes.
This is a close up of a high quality door and
hinge. Glass is easily cleanable and enables
safe access/egress.
Many of the normal routes out of an aseptic
suite can be difficult to access during a fire
alarm due to the number of corridors out of
the suite.
This is an example of a specially constructed
fire escape to the outside of the building from
an aseptic suite. The outer door is fabricated
as a standard fire escape door, however it is
sealed behind a sheet of breakable glass.
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Remember: Here are some other important considerations about the design and use of clean
rooms.
l The equipment should be arranged to minimise the amount of operator movement while
maximising their comfort.
l The number of staff in an aseptic processing room should be kept to a minimum.
l The flow of personnel should be limited to minimise exit and entry especially in the critical
area.
l The number of transfers to the critical area of the clean room or isolator should be
minimised.
l Excessive movement adjacent to the critical area should be restricted.

Test Yourself
Can you list 10 features to take into consideration when designing/fitting out a cleanroom?

1.

2.

3.

4.

5.

6.

7.

8.

9.

10.

6 Chapter 5: Clean Room Design

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Clean Room Design

Environmental Control
The highest standard of environmental control will be included in the design of the clean room.
Processes should be designed to give optimal personnel and product flow through the unit. We
will look at this in more detail later.
Aseptic processes in the clean room are designed to minimise the exposure of sterile components
to the potential hazards of the manufacturing process.
There are a maximum number of particles of different sizes allowed in the clean room at rest and
during operation.
Grade Particle count (max particle /m3)
Particle size at rest Particle size in operation
0.5 m 5 m 0.5 m 5 m
A 3,500 1 3,500 1
B 3,500 1 350,000 2,000
C 350,000 2,000 3,500,000 20,000
D 3,500,000 20,000 Not defined Not defined

The table shows the values for the maximum particle count for different particle sizes within the
different grades of clean room (Reference: Orange Guide 2007)
Examples of Cleanroom Grade
Grade A Laminar air flow cabinets and isolators, i.e. the point of fill.
Grade B The aseptic room.
Grade C The preparation room
inner support room.
Grade D Support, filling and isolator rooms.
Information: Isolators may be sited in Grade C or D rooms check your local procedures).

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Alarm Systems
Fire and smoke alarms must be fitted in all
areas of the facility. Staff must respond to
alarms by evacuating the area immediately.
An air supply alarm should be fitted which
detects if there is a failure in the air supply to
the facility. If this is triggered, work must cease
immediately.

In this simulated image the red lamps would

indicate a problem with the cabinets.

Malfunctioning and Problems

Work should only restart when the air supply
has been reinstated and been running
constantly for a minimum period. In the
absence of a validation exercise of the clean-
up time, this period should be one hour.
Here is an example of an alarm panel with
lamps showing the working status of the
LAFC and Isolator cabinets.
Problems should be reported immediately so
that appropriate action can be taken. Anything
unusual should be reported even though it
may seem trivial, as it could be a precursor to
a major fault or incident.
You should report any procedural deviations
or difficulties.
Reports may be filed with the Estates
Department at the hospital for any routine
work that may need to be done within the
cleanroom or supporting areas. Specialist
cleanroom companies may be required to
carry out more complicated tasks.

Air pressure
The air pressure in clean rooms is highest
in the aseptic filling room (cleanest) and
drops incrementally to the corridors. The usual
practice is to start at 45 Pascals and come
down in 10 Pascals increments, with the final
differential being at least 15 Pascals. This will
depend on the layout of your clean rooms.
The green lamp indicates that the cabinet
is running correctly in this image.

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Clean Room Design

Clean Room Suite Layout

The following plans are examples of clean room suite layouts for Isolators and LAFCs and show
the flow of work and air.

Airflow direction Step over Bench

Workflow direction Transfer Hatches

Isolator Suite Layout Laminar Air Flow Cabinet (LAFC) Suite Layout

Isolator LAFC
EU grade A EU grade A

Clean Room Clean Room

EU Grade D EU Grade B

2nd Change Room 2nd Change Room

EU Grade D at rest EU Grade B at rest

Inner Support Room

Inner Support
Room EU Grade D
(clean room)
1st Change Room Outer Support Room Outer Support Room

1st Change Room

EU Grade D at rest

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Activity
Make a sketch plan of your unit and mark on it:
l Flow of products
l Flow of people
l Flow of documents
l Air pressures in different parts of the unit.

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Clean Room Design

Questions
What is the maximum allowable number of particles in a Grade A and Grade B clean
Q1 room at rest and in operation? Complete the table below to show your answers.
Grade A At rest In operation
Particle size: 0.5 m 5 m 0.5 m 5 m
Max number of
particles allowed:

Grade B At rest In operation

Particle size: 0.5 m 5 m 0.5 m 5 m
Max number of
particles allowed:

Q2 Why are airlocks installed between clean areas and adjoining less clean areas?

(2)

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Q3 Whats the difference between a unidirectional and a non-unidirectional airflow?

(6)

12 Chapter 5: Clean Room Design