ƒ Cleanrooms provide product protection

together with great flexibility in material

handling, personnel movement and
process staging.
ƒ Cleanrooms are defined as any controlled
entry room with a HEPA (High Efficiency
Particulate Air) filtered air handling system
operating under positive pressure.
 Types of cleanrooms
ƒ There are five main fabrication styles for cleanrooms
(although custom styles are available).
ƒ conventional,
ƒ modular hardwall,
ƒ modular softwall,
ƒ mini environment,
ƒ micro environment.

ƒ Conventional construction is the most common type, and

these are generally permanent structures.
ƒ Cleanrooms are contamination-free
environments where high-tech manufacturing
and assembly take place.
ƒ Cleanrooms range from very small chambers,
called microenvironments, to large-scale rooms,
called ballrooms.
ƒ Cleanroom technology is used in a wide range
of industries including semiconductor assembly,
biotechnology, pharmaceutical, aerospace, food,
medical devices and hospitals.
ƒ There are a number of important aspects
to consider while determining which
cleanroom type fits the needed
application. This includes the
ƒ cleanliness class,
ƒ fabrication type, and
ƒ special features such as ESD control, pass
throughs, and a gowning area.
Fabrication Types
 Who determines what is a
cleanroom?
ƒ Cleanliness class is a standard determined by
the contamination control industry. They
currently use a government specification known
as Federal Standard 209D to provide a qualified
and standardized method for measuring how
clean the air is in a cleanroom.
ƒ Six classes have been established to designate
cleanroom cleanliness.
 Cleanroom Classification
ƒ In Class 100, particle count is not to exceed a total of
100 particles per cubic foot of a size 0.5 micron and
larger.
In Class 10,000, particle count not to exceed a total of
10,000 particles per cubic foot of a size 0.5 micron and
larger, or 65 particles per cubic foot of a size 5.0 micron
and larger.
In Class 100,000, particle count not to exceed a total of
100,000 particles per cubic foot of a size 0.5 micron and
larger, or 700 particles per cubic foot of a size 5.0 micron
and larger.
ƒ The class number refers to the maximum number of
particles bigger than one-half of a micron (0.5 micron)
that would be allowed in one cubic foot of cleanroom air.

ƒ A Class 100 cleanroom, for example, would not contain

more than 100 particles bigger than half a micron in a
cubic foot of air.

ƒ The six classes are

ƒ Class 1 (ISO 3),
ƒ Class 10 (ISO4),
ƒ Class 100 (ISO 5),
ƒ Class 1,000 (ISO 6),
ƒ Class 10,000 (ISO 7), and
ƒ Class 100,000 (ISO 8)
 Air Pressure

p CONTROLS p

CLEANLINESS
Lower P
Higher P

Class 100,000 Class 100

FERMENTATION,
FILL AND FINISH
RECOVERY
EARLY LATE
 Clean Room Qualification
ƒ Installation IQ
ƒ Operation OQ
ƒ Performance PQ
 Installation Qualification
ƒ Documentation that cleanroom was
installed according to plans and designs
ƒ Verify that ducts were cleaned
ƒ System components conform to as specified
ƒ HEPA filter integrity testing
ƒ Initial room sanitization
 Operational Qualification
ƒ Documentation that equipment can
operate as designed and is capable of
repeatable operation over the entire range
of process variables
ƒ Ex: Airborne particulates under static
conditions - daily for 10 days
ƒ Microbial testing not more than 25% of the
proposed microbial levels for each
environment
 Performance Qualifications
ƒ DOCUMENTATION that the systems
operate consistently and reliably
ƒ Ex: air flow patterns, pressure differentials
Hoods in the cleanroom

Clean benches

Class II (types A and B) are Laminar Flow Biological Safety Cabinets that
protect personnel, product and environment. They provide inward airflow to
protect personnel, downflow HEPA filtered air to the work area to protect the
product and exhaust HEPA filtered air to protect the environment from
particulate and aerosol hazards.

Class III cabinet is defined as ventilated Glovebox. This is a gas-tight

chamber operated through sealed gloves which provide a complete barrier
between the worker and hazardous material. The Glovebox is maintained
under negative pressure with HEPA filtered supply air and double HEPA
filtered exhaust air.
ƒ A common component in clean benches is the HEPA
(high efficiency particulate air) filter. The HEPA filter
removes particulates, generally called aerosols, such as
microorganisms, from the air. However, the HEPA filter
does not remove vapors or gases.

ƒ HEPA filters are made of boron silicate microfibers

formed into a flat sheet by a process similar to making
paper. Depending on its quality, a HEPA filter can trap
from 9,997 to 9,999 of every 10,000 particulates of a
diameter greater than 0.3 microns. For most industrial
use, the 99.97% performance is acceptable. Pharmacy
and laboratory applications, however, require a 99.99%
filtration performance level.
It’s a cleaner room in a cleanroom
 Laminar Flow Workstations
Laminar Flow Workstations provide a high degree of
localized control for critical processes. The Laminar Flow
Workstations operate by drawing ambient air, under
negative pressure, into the top of the unit. This air first
passes through a prefilter which traps the larger dust and
dirt particles. The blower then directs this prefiltered air,
now under positive pressure, through the 99.99%
efficient HEPA filter engulfing the entire work area with
sterile, unidirectional ultra-clean air. This air travels at a
velocity calculated to prevent the intrusion of unfiltered
room air into the work area. It also washes away
particles that may be generated by manipulations within
the Workstations.
Airflow Pattern of Horizontal Laminar Flow Workstation

Filtered Air
1. Easy to Change Prefilter.
2. High Capacity Multy-Blower System Greatly
Reduces Noise Level and Increases Air
Movement Efficiency.
3. Dual Fluorescent Lights.
4. Probed 99.99% Efficient HEPA Filter.
5. Metal Diffuser to Protect HEPA Filter.
6. Spill-Guard in Rear and Sides of Work Area
7. Protects HEPA Filter from Spills.
8. Curve-FLEX Forearm Support Promotes
9. Operator Comfort.
 Horizontal Laminar Flow
Workstations
ƒ The Horizontal Laminar Flow Workstations is designed
for the handling of materials wherever a sterile, particle-
free work environment is required.
ƒ The work area of the Horizontal Laminar Flow units is
continuously bathed with positive pressure, horizontal
laminar flow air that has passed through a HEPA filter
(High Efficiency Particulate Air).
ƒ ideal for such diverse functions as electronic assembly,
sterile packaging and I.V. pharmacy preparations.
The Vertical Laminar Flow Benches meet the same high standards for ultra-
clean, particulate-free air as our Horizontal Laminar Flow Benches Series.
The work area is bathed with filtered air directed downward by the low
profile HEPA fan filter module at the top of the unit. These free-standing
units are used primarily for parts assembly and/or to house process
equipment which, due to its configuration, is best protected by vertical
laminar airflow.
Standard free-
standing
Modular
Cleanroom with
ceiling grid
system, Fan
Filter Units, solid
vinyl softwalls
and strip curtain
door.
What is the difference between a fume
hood, a biosafety cabinet, and a clean
bench?
Although they can look similar, they are used for
very different purposes.
ƒ A chemical fume hood is designed to contain hazardous
vapors and gases and exhaust them outside the
building.
ƒ A biosafety cabinet provides biological protection for
both specimen and user. Particulate free air is passed
down from the top of the hood and across the work
surfaces, and is captured before entering a worker’s
breathing zone. The air is then re-filtered before being
exhausted, back into the laboratory. Because all clean
benches and most biological safety cabinets exhaust air
back into the work area, they cannot safely be used with
hazardous gases and vapors.
 Clean Bench
ƒ A clean bench is designed
to protect biological
specimens by bathing the
work area with air free of
particulate contamination.
Because a clean bench
forces air out from the back
of the hood, across the
work area and toward the
worker, it protects only the
specimen, not the user.
 Laminar Flow Hoods
ƒ Horizontal Flow Hood
ƒ Used for non-
infectious sterile
manipulations
ƒ Ex. making buffers or
media
 Biosafety Cabinet –used for
biologically hazardous work
ƒ A biosafety cabinet
provides biological
protection for both
specimen and user.
Particulate free air is
passed down from the top
of the hood and across
the work surfaces, and is
captured before entering
a worker’s breathing
zone. The air is then re-
filtered before being
exhausted, back into the
laboratory.
Because all clean benches and most biological safety cabinets exhaust air back
into the work area, they cannot safely be used with hazardous gases and
vapors.
Biological Safety Cabinet -BSL
ƒ The airborne particle concentration in a
cleanroom is highly dependent on the
occupancy of the room because occupants are
major particle sources.
ƒ So the classification of the cleanroom must be
defined at one or more of the room’s occupancy
states,
ƒ “as-built”,
ƒ “at rest”, or
ƒ “operational”.
ƒ For example, a cleanroom may be class 10,000
in the “operational” state and class 100 in the “at
rest” state.
Ways to keep a cleanroom clean
Gloves
Hand Cleaning/Drying Systems

Cleaning Solutions/Chemicals Laundry Services

Microbial Samplers

Cleanroom Supplies Mops/Squeeges

Particle Counters
Critical Cleaning Pressure Monitors/Detectors

Flooring/Floor Mats Wipers/Swabs

Furniture
Doors

Garments
 FLOORING

ƒ Various types of flooring are used in clean

rooms, depending upon cleanliness levels,
ƒ Contamination control flooring may have a tacky
finish to trap dust and other debris from wheels and
shoes.
ƒ Access flooring consists of solid or perforated panels
or raised pedestals. Air can flow through perforated
panels and can be exhausted in a sub-floor area.
ƒ Vinyl flooring features sealed seams to prevent
accumulation of contamination.
ƒ Static Dissipative flooring prevents static buildup and
electrostatic discharge
 Lighting
ƒ Room lighting is supplied by ceiling
modules, often incorporated into ceiling
HEPA filter modules. Work area lighting
may be supplied by illuminations
(concentrated light sources that are placed
next to the work area which can be
adjusted to focus light on a desired area.
Fixtures are sealed to prevent
contamination.
GOWNING

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