®

High Efficiency Filter Standards

USA EUROPE
YEAR Eurovent Italy Germany Great Britain France

NBS 1950
1952
1953
1954
1955
AFI 1956
1957 BS 2831
1958
1959
1960
1961
1962
1963
1964
1965
1966
1967
ASHRAE 52/68 1968
1969
1970
1971
1972
1973
1974
1975
ASHRAE 52/76 1976
1977
1978 UNI 7832
1979 EUROVENT 4/5
1980 DIN 24185
1981
1982 AFNOR X44-011
1983
1984
1985 BS 6540
1986
1987
1988
1989
1990
ASHRAE 52.1-91 1991
1992 EUROVENT 4/9
1993
1994 CEN EN 779
1995
ASHRAE 52.2 P 1996 EUROVENT 4/10
1997
1998
1999
2000
2001 pr EN 779

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Absolute Filter Standards

USA EUROPE
YEAR Eurovent Italy Germany Great Britain France
1950
1952
1953
1954
1955
Mil.Std 282 1956
1957
1958
1959
1960
1961
1962
1963
1964
1965
1966
1967
1968
1969 BS 3928
1970
1971
1972 AFNOR X44-011
1973
1974 DIN 24184
1975
1976 EUROVENT 4/4
1977
1978 UNI 7833
1979
1980
1981
1982
IEST-RP-CC-001-83-T 1983
1984
1985
1986
1987
1988
1989
1990
1991
IEST-RP-CC-007.1 1992
IEST-RP-CC-001.3 1993
1994
1995 UNI 10339
1996 DIN 24183
1997
1998
IEST-RP-CC-0034.1 1999
2000 CEN EN 1822

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Air filter testing

methods

Classification of air filters As we have said, the test includes

Air filter classification is regulated
by a series of very strict standards that
specifically define the features of the filters
according to the relevant efficiency class
and use.
The designer and the installation technician
must know all these standards to be able
to propose the filter that best meets the
project requirements.
Below, are the main standards used today
with a series of tables that indicate
the efficiency class of each filter.
Before starting, we want to remind you that
the air filters considered by the standards
belong to three main groups:
• coarse
• fine
• absolute: these are then divided into
two different classes:
HEPA (High Efficiency Particulate Air filters)
ULPA (Ultra Low Penetration Air filters).
Industrial dust exhaust systems and other
similar products are not contemplated by
these standards. Specific tables have been
created for these products based on the
experience of the industry and can be
found at the end of this section.
two methods: a gravimetric one, used for
coarse filters, and the opacimetric one for
filters with medium-high efficiency rates.
The gravimetric method uses standard
synthetic dust whereas the opacimetric
one is carried out by using the natural
dust in the air.
The first is more suitable, within certain
limits, to study the performances
of filters that will be used mainly to treat
re-circulating air, generally richer
in fibrous dusts.
The tests are used to establish the
arrestance of coarse filters and
the efficiency of medium and fine filters;
furthermore, they also allow us
to determine:
• the pressure drop trend in clean filters
• the pressure drop trend according
to the dust build-up
The arrestance or the separation efficiency
does not remain constant with
the progressive build-up of dusts
on the filter: it can increase or decrease
according to its characteristics.
Tab. 2 indicates the equivalence
between CEN EN 779 classes
and UNI 10339 classes.

Tab. 2 Equivalence between CEN EN 779

CEN EN 779 Standard and UNI 10339
This standard is based on the Filter Filter
Eurovent 4/5 Standard and class class Filtration
on the ASHRAE 52-76 Standard. CEN EN 779 UNI 10339 efficiency
It aims at determining: the efficiency
of medium and fine filters with atmospheric G1 1 M
coarse

dust by using an opacimetric system G2 2 M

and the arrestance of coarse filters with G3 3 M
synthetic dust by using a gravimetric G4 4 M
method. The CEN standard has a double
classification system that uses letters F5 5 A
and numbers: G and F, respectively, F6 6 A
fine

for coarse and fine filters, followed F7 7 A

by numbers, from 1 to 9. See tab. 1. F8 8 A
It recalls the division of the filters in different F9 9 A
classes from EU1 to EU9, according to the
arrestance and efficiency from the previous
and now obsolete Eurovent 4/5 Standard.

Tab. 1 Classification of coarse and fine filters according to CEN EN 779 and EU 4/5
Average Average Final Class*
arrestance opacimetric pressure
with synthetic efficiency drop
dusts
Type of filter CEN EN 779 Am% Em% Pa Eurovent 4/5
G1 Am < 65 250 EU 1
coarse G2 65 < Am < 80 250 EU 2
G3 80 < Am < 90 250 EU 3 LEGEND
G4 90 < Am 250 EU 4 Am = Average arrestance referred
F5 40 < Em < 60 to the Weight /Gravimetric method
450 EU 5 Em = Average efficiency referred
F6 60 < Em < 80 450 EU 6 to the Colorimetric /Opacimetric method
fine F7 80 < Em < 90 450 EU 7
F8 90 < Em < 95 EU 8 * According to the EUROVENT 4/5
450 classification that does not specify
F9 95 < Em 450 EU 9 the final pressure drop

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Air filter testing

methods

ANSI / ASHRAE 52.2P Standard
This standard determines the fractional
efficiency of all types of filters and
the arrestance for coarse filters.
Besides the standard, there is also
a classification that is not part of
the standard itself but it can be used
at discretion. The main difference compared
to the Eurovent 4/9 standard is:
• the size range of the particles
• the type of areosol
• the classification system.
For coarse filters the test is carried
out using synthetic particles to determine
the arrestance and with aerosol
to determine the efficiency. For medium
and fine filters the test is solely carried out
through aerosol to establish the fractional
efficiency. The size range of the particles
generated by the aerosol goes from
0.3 to 10 micron.
Up to 10 micron, which is the top limit,
the particles are considered breathable.
The aerosol, for the fractional efficiency
tests, is made of potassium chloride
(KCI), which produces solid particles
used to measure the bounce effect, i.e.
the breakaway of the particles from the filter
and the following passage.
This is a common phenomenon for coarse
filters and big diameter particles.
Tab. 3 Classification of filters according to the ANSI / ASHRAE 52.2P Standard
Minimum efficiency % in the size range Arrestance Final
of micron particles std. 52.1 pressure
µm µm µm drop
Categ. Class 0,30 - 1,14 1,14 - 3,46 3,46 - 10,0 % Pa
C1 - - Emin.< 20 Aavg < 65 150
coarse
The testing bench of the ANSI / ASHRAE
52.2P Standard is mainly made of a:
fan, two series of filters positioned upstream
and downstream of the filter being tested,
an aerosol generator, an aerosol sampling
system with opacimetric measuring device
and a calibrated nozzle.
During the test the filter must be filled with
synthetic particles made of:
• 93.5% of SAEJ-726 Fine
(equivalent to Arizona road dust)
• and 6.5% of cotton fibers.
The carbon black, used in the 52-76
standard, was eliminated because
it is a conductor of electricity
in the electrostatically charged filter tests.
Fiber filters are loaded with synthetic dust
until they loose the final recommended
pressure drop, whereas the electrostatically
charged filters are loaded with a pre-set
amount of particles.
The criteria for the classification of the filters
are those of lower efficiency during the test.
For coarse filters and electrostatically
charged filters, the efficiency can decrease
during the test. According to the results,
the filters are divided in 4 categories:
• coarse C
• low efficiency L
• average efficiency M
• high efficiency H
Each group contains 4 sub-groups,
identified by numbers, for a total of 16
different classes of filters.
While coarse filters are only tested with
synthetic dust according to the previous
52.1 standard, L, M and H filters are
tested in a particle size range
from 0.3 to 10 micron divided into three
groups with diameters:
• 0,30 - 1,14 micron
• 1,14 - 3,46 micron

C2 - - Emin.< 20 65 < Aavg < 70 150 • e 3,46 - 10,0 micron.

C3 - - Emin.< 20 70 < Aavg < 75 150
Tab. 3 represents the classification
C4 - - Emin.< 20 75 < Aavg 150 of the filters obtained in the appendix
L5 - - 20 < Emin.< 30 - 150 of standard 52.2P.
efficiency

L6 - - 30 < Emin.< 45 - 150 The final pressure drop of the filters

low

L7 - - 45 < Emin.< 65 - 150 is double compared to the initial one or

at least equal to the value in the table.
L8 - - 65 < Emin.< 80 - 150
The features of the filter are expressed
M 9 - Emin.< 30 80 < Emin. - 250 through an indicator.
efficiency
average

M 10 - 30 < Emin.< 45 80 < Emin. - 250

M 11 - 45 < Emin.< 65 80 < Emin. - 250 EXAMPLE
M 12 - 65 < Emin.< 90 80 < Emin. - 250 M10/93/0.94
H 13 Emin.< 65 90 < Emin. 90 < Emin. - 350 means the filter belongs to class:
efficiency

H 14 65 < Emin.< 85 90 < Emin. 90 < Emin. - 350 M10

high

90 < Emin. and it has a filtration efficiency equal to:

H 15 85 < Emin.< 95 90 < Emin. - 350
93% (for particles between 3,46 ÷ 10,0µm)
H 16 95 < Emin. 90 < Emin. 90 < Emin. - 350 at 0,94 m3/s.

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Air filter testing
methods
DOP MIL. STD 282
This photometric method was studied
to test filters with high performance levels
belonging to the HEPA (High Efficiency
Particulate Air Filters) and ULPA class (Ultra
Low Penetration Air Filter).
The DOP Penetration Test is the most
important method used in the US and in the
countries under their sphere of influence.
The test aims at determining the filtration
performance of the filter and
the penetration percentage of the tracer
particulates used in the test through
the filter.
The test is generally carried out for two
air flow rates: the nominal one, declared
by the manufacturer, and for a value equal
to 20% of the nominal value.
The “tracer” substance used is dioctylptha-
late an oil with high boiling levels.
Its most important feature, in relation
to this test, is the uniformity of the diameter
of the drops that are obtained after
the evaporation and subsequent
condensation of steam.
The drops produced have a uniform
diameter of 0.3 micron.
Concentration is kept at around 80 mg/m3.
The cloud of drops is dragged to the filter
being tested. The air upstream and then
downstream of the filter is tested.
The last test is carried out in a point where
the air is mixed, so the particulates that
have passed through the filter are uniformly
distributed.
The air taken upstream and downstream
of the filter passes through a light diffuser
photometer, which determines
the concentration of the drops.
From the ratio between the concentration
upstream and downstream of the filter,
the penetration percentage
can be determined:
P = N x 100
M demand for absolute filters many countries
where: P = penetration percentage;
N = concentration of drops
downstream of the filter;
M = concentration of drops
upstream of the filter.
From the calculated penetration value,
you can find the corresponding filtration
performance value:
E = (1 - P) x 100
where: E = filtration performance;
P = filter penetration.
By way of an example, we wish to indicate
the correspondence between some
penetration percentage values
and the performance values
Penetration Performance
5% 95 %
0,05 % 99,95 %
0,01 % 99,99 %
0,003 % 99,997 %
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For performance values very close
to 100%, the relevant figures are not
significant. Instead the penetration
percentage allows for a wider extension
of the size.
A particular application of the DOP method
is that related to the determination of any
“leakage” due to pinholes in the filtering
media or to tightness defects between
the media and the frame.
This test is called “Leakage (Scan) Test”
and it is carried out using more or less
the same technique used for the DOP test.
The diversity lies in the fact that the test
probe, downstream of the filter, is right
by the filter and it is moved slowly around
the media/frame contact areas and through
the entire surface of the filter itself.
The identification of a leakage point allows
you to repair the problem by closing
the relevant area with special resins.
This test can be carried out also
on the system, after installing the filter.
In this case you use a dioctylpthalate intake
mobile generator instead of the heavy
thermal generator.
The only difference is the fact that the
drops forming the cloud do not have
a uniform diameter, and their average
size is 0.45 –0.6 micron.
However, to find “leakages” the size
of the particulates is less critical than
what is required to find the penetration
value of the filter.
In the same way you can determine
tightness defects between the filter
and the relevant housing system,
which has to have the same qualities
of the installed filter (see EUROVENT 4/8).
EUROVENT 4/4 Standard
As a result of the growing market
felt the need to establish a standardization
of the efficiency test.
In 1974 the European EUROVENT
Committee adopted the (English sodium
flame test – NaCI) depicted in the (British
Standards 3928) and called it Eurovent 4/4.
According to these standards the air filters
are divided into 5 classes and can reach
the maximum efficiency of E ≥ 99,999 %
Sodium Flame Test.
See tab. 5
Other testing methods, based on different
principles, have been developed in various
Countries and are usually accepted.
They are shown in tab. 6.
The equivalence with the UNI 10339
Standard is shown in tab. 7.

EUROVENT 4/9 method
For medium and high efficiency filters,
normally used in conditioning systems,
the Eurovent 4/9 testing method, similar
to the ANSI / ASHRAE 52.2P Standard, is
used to determine fractional efficiency, i.e.
the efficiency for particles with different
size ranges.
Hence, it generates a series of efficiency
values according to the diameter
of the particles as well as the final pressure
drop. This method replaces the standard
opacimetric method and measures
the efficiency of the filter for particles
with a 0.4 micron diameter (particle test).
Fractional efficiency (fractional test)
is measured for particles with a diameter
ranging from 0.2 to 5 micron, through
a laser counter.
Another difference compared to
the opacimetric test is that two different
aerosols can be used for this test:
Latex or DEHS.
The first, a polymeric vinyl acetate, is made
of plastic spherical particles; the second,
diethylhexyl sebacate, is equivalent to the
well known dioctylpthalate used in the DOP
method. The efficiency testing bench of
the EUROVENT 4/9 method is similar
to the one used for the ASHRAE tests.
The air is filtered through a HEPA filter;
downstream of the filter, a Latex or DEHS
particle generator produces the necessary
quantity of aerosol.
Two air samples are taken, both upstream
and downstream of the filter, which feed the
particle counter connected to a computer.
This computer checks the sampling both
upstream and downstream of the filter
controlling a solenoid valve.
The laser particle counter allows
to measure diameters up to 0.1 micron.
The behavior of the filter is determined
first when the filter is clean and then
after loading it with dust, when it reaches
a pressure drop level of 200 or 300 Pa.
This method uses a filter classification
system similar to the one used in
the CEN EN 779 (which is appendix D of
EUROVENT 4/9). According to this
classification the filters are grouped in two
classes from EU1 to EU9.
The average arrestance values with
synthetic dust is indicated for coarse
filters from EU1 to EU4.
For fine filters from EU5 to EU9 only the
percentage efficiency referred to particles
with a diameter of 0.4 micron is indicated.
The final pressure drop is 250 Pa for coarse
filters and 450 Pa for fine filters.
The air flow rate is 0.944 m3/s (3400 m3/h)
when not specifically indicated
by the manufacturer.
®
CEN EN 1822 Standard it was then established that each filter
certification ought to be based on this
For many years now filter manufacturers MPPS point (Most Penetrating Particle Size)
have been producing and marketing filters which is the most critical.
with efficiencies exceeding the limits The new standards classify the HEPA
set forth for class EU 14 (Eurovent 4/4), (High Efficiency Particulate Air Filters) and
certifying the design performance ULPA (Ultra Low Penetration Air Filters)
on the basis of different innovative control filters separately: the first from H10 to H14,
systems. and the second from class U15 to U17
On the other hand, several customers included, see tab. 4, determining
especially the producers of integrated specifically, the activities for
circuits, were demanding more and more the implementation of control systems,
sophisticated products capable to perform for the verification of the filtering media,
very high efficiencies. for the test of the finished filter elements,
etc.
As a response to this situation the
European Committee of Normalization Basically the test consists of a double
control: the first is carried out on the media
set up a research group with the aim
of drawing up a standard discipline ruling and measures the size of the most
penetrating particle (MPPS), verifying that
the matter.
The new standards, EN 1822 (based on the speed across the media is the same
as during the actual operation.
DIN 24183), are composed of 5 parts, each
dealing with one specific subject which is The second control is carried out on the
finished product and determines the global
described in detail. It was stated that any
single filtering media has a point of: MPPS efficiency.
• maximum penetration (or of lowest Filters with global efficiency over 99,95 %
efficiency) according to a specific are to undergo an additional test on each
particle size point of their filtration surface with the aim
• variable according to: of finding out a possible leakage (pinholes)
- air flow velocity whose local penetration value should
- media density no higher than 5 times (classes H13 - U16)
- the diameter of the media fiber and 20 times (class U17) the global one.
Tab. 4 Classification of high and very high efficiency filters
according to EN 1822 (and DIN 24183
Class global punctual efficiency
CEN EN MPPS efficiency Localized drop
1822 % % DIN 24183
H 10 85 - EU 10
H 11 95 - EU 11
H 12 99,5 - EU 12
H 13 99,95 99,75 EU 13
H 14 99,995 99,975 EU 14
U 15 99,9995 99,9975 EU 15
U 16 99,99995 99,99975 EU 16
U 17 99,999995 99,9999 EU 17
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Tab. 5 Classification of very high efficiency filters according to EUROVENT 4/4

Filter Initial efficiency Penetration Decontamination factor
class EI P DF
EU 10 95 < EI < 99,9 5 < P < 0,1 20 < DF < 1000
EU 11 99,9 < EI < 99,97 0,1 < P < 0,03 1000 < DF < 3000
EU 12 99,97 < EI < 99,99 0,03 < P < 0,01 3000 < DF < 10000
EU 13 99,99 < EI < 99,999 0,01 < P < 0,001 10000 < DF < 100000
EU 14 99,999 < EI 0,001 < P 100000 < DF
NOTE
The filter class must also indicate air flow rate (m3/h).

Tab. 6 Main testing methods for absolute filters

Testing method Aerosol Particle size µm Country
DOP MIL Std 282 DOP monodisperse 0,3 U.S.A.
UNI 7833 DOP / DEHS polidisperse 0,45 Italy
BS 3928 NaCl 0,65 Great Britain
EUROVENT 4/4 NaCl 0,65 Europe
AFNOR X44-011 Uranine 0,17 France
DIN 24 184 .1 Liquid paraffin 0,45 Germany
DIN 24 183 DEHS MPPS Germany
CEN EN 1822 DEHS MPPS Europe
IES-RP-CC 001.3 DOP 0,45 U.S.A.
IES-RP-CC 007.1 Various 0,1-0,2 U.S.A.

Tab. 7 Equivalence between EUROVENT 4/4 and UNI 10339

Filter class Filter class Filtration
EUROVENT 4/4 UNI 10339 efficieny
EU 10 10 AS
EU 11 11 AS
EU 12 12 AS
EU 13 13 AS
EU 14 14 AS

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Application of
air filters

For a correct application of air filters you

need to know the type of dust and polluting
Tab. 8 Concentration of dust in outdoor air in different areas substances, and their concentration,
Average Most Maximum in outdoor and room air.
concentration frequent particle size For example, tab. 8 shows the average
particle size concentration and the typical sizes of the
Area mg/m3 micron micron dust particles in outdoor air, according
to the areas and the weather conditions.
humid weather 0,01 0,8 4 Special calculation procedures are used
Rural areas
dry weather 0,15 2,0 25 to select the right filter, especially
residential areas 0,4 7,0 60 for industrial use. In civil applications,
Urban areas more simply, yet with a good safety margin,
industrial areas 0,75 20,0 100
refer to tab. 9, of the UNI 10339 standard,
Distretti industriali e autostrade 3 60 1000 shown below.
ad alto scorrimento and over Use this table to choose the most suitable
air filters for most of the applications
in the civil sector.

Tab. 9 Filter classes and filtration efficiency for various categories of buildings
Classification of buildings per category Filter classification Filtration efficiency
minimum maximum
Residential and - Houses 4 7 M*, M + A
similar buildings - Colleges, homes, penitentiaries, police stations, convents 4 7 M*, M + A
- Hotels 5 7 M+A

Office and similar - Offices in general 5 7 M+A

buildings - Meeting rooms 5 7 M+A
- Data processing offices 6 9 M+A

Hospitals, clinics, - Rooms (2-3 beds) 6 8 M+A

nursing homes and - Wards 6 8 M+A
similar - Sterile and infective rooms 10 11 M + A + AS
- Maternity, anesthesia, radiation 10 11 M + A + AS
- Premature, operating rooms 11 12 M + A + AS
- Medical examination rooms 6 8 M+A
- Treatments, physical therapies 6 8 M+A

Recreational - Cinemas, theaters, congress halls 5 6 M+A

buildings - Museums, libraries 7 9 M+A
and churches - Churches 4 6 M*, M + A
- Bars, restaurants, dancing rooms
• bars in general 3 5 M*, M + A
• dining rooms, restaurants 5 6 M+A
• dancing rooms 3 5 M*, M + A
• kitchens 2 4 M

Commercial - Department stores 4 6 M*, M + A

and similar - Shops in general 4 6 M*, M + A
buildings - Special shops
• food 5 6 M+A
• photographers 5 6 M+A
• pharmacies 5 6 M+A
- Public areas, banks 4 6 M*, M + A
- Trade fair areas 2 3 M

Sport buildings - Swimming pools, saunas and similar 4 6 M*, M + A

- Gyms and similar areas 2 4 M

Scholastic buildings - Nursery schools and elementary schools 7 9 M+A

- Classrooms in general 5 6 M+A
- Other rooms
• music and language rooms 6 7 M+A
• laboratories 6 7 M+A
From UNI 10339* = To adopt for efficiencies up to 4

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Classification
of rooms

Federal Standard 209 E This classification is used to count The standard also indicates the conditions
0.5 micron particles but it can be used to in accordance to which the controls must
The best known classification of air in count different size particles, for example: be carried out:
“clean rooms” or rooms with controlled • Class M3 (0,5 µm) • as built:
contamination levels is undoubtedly Class providing no more than 1.000 Clean rooms or clean zones ready
Federal Standard 209. particles of 0.5 µm in a m3 to start operating, but without production
It was issued in the United States in 1963 • Class M2 (0,3 e 0,5 µm) equipment and personnel.
for the first time and it was revised different Class providing no more than 309 • at rest:
times until the last version of 1992, particles of 0.3 µ in a m3 and no more Clean rooms or clean zones fitted
Fed. Std. 209 E presently in use, than 100 particles of 0.5 µm in a m3. with the relevant processing machines,
was reached. but without personnel.
The updated version of this classification An implementation of the expression
is based on the S.I. (International System) of class can be given by the introduction • operational:
providing the metric system, but also of the “U” indicator shown in the Clean rooms or clean zones in ordinary
the Anglo-Saxon system is allowable. Fed. Std. 209 E. working activities with personnel
The classifications of air cleanness are This indicator represents the number of and running processing machines.
thirteen, as shown in tab. 10 and are ultra-fine particles, from 0,02 up to 0,1 µm
counted in a surface of 1 m3 in this case This standard also determines
given as a power of 10 from the characteristics of the flow,
class 1 to class 10,000,000. the relevant class will be shown as follows:
distinguishing between unidirectional
For the intermediate classes the formula • U (20) (instead of linear) and non unidirectional
shown below provides a good degree Class with no more that 20 ultra-fine flow (instead of turbulent).
of approximation: particles in a m3. It establishes the conditions for
• M 1,5 (0,3 µm) e U (2000) the measurement of particles
Particles / m3 = 10M (0,5/d)2.2 Class with no more than and the instruments to use. There are two
where: M = class to be analyzed 106 particles/m3 ≥ 0,3 µm and no more different methodologies according to
d = particles size in µm than 2000 ultra-fine particles in a m3. whether there is a unidirectional flow or not.
In the case of unidirectional flow the clean
area is identified on a perpendicular level
to the air flow upstream of the work area.
The number of samples must be
Tab. 10 Maximum concentration of particles per class according determined according to the comparison
to the Federal Standard 209 E between two rates that take into account
Class 209E Max. number of particles per m3 the surface of the level intercepted by the
air flow and by the contamination class.
S.I. English 0,1 µm 0,2 µm 0,3 µm 0,5 µm 5,0 µm
In the case of non unidirectional flow the
M 1 350 75,7 30,9 10,0 - sampling points should be uniformly
M 1.5 1 1240 265 106 35,3 - spaced on the horizontal level through
M 2 3500 757 309 100 - the clean area.
M 2.5 10 12.400 2650 1060 353 -
M 3 35.000 7570 3090 1000 -
M 3,5 100 - 26.500 10.600 3530 - ISO 14644.1
M 4 - 75.700 30.900 10.000 - (International Standards Organisation)
M 4.5 1000 - - - 35.300 247
M 5 - - - 100.000 618 In 1996 ISO issued a new standard
M 5.5 10000 - - - 353.000 2470 aimed at setting the acceptability limits
M 6 - - - 1.000.000 6180 for airborne particles in clean rooms
(ISO 14644.1). The particulate reference
M 6.5 100000 - - - 3.530.000 24.700 numbers in the ISO 14644.1 see tab. 11
M 7 - - - 10.000.000 61.800 are similar to table FS 209 E,
the only difference is a new field for 1 µm
particulate, thus making the classification
of clean rooms more complete.
Tab. 11 Classification according to ISO 14644.1 Interesting differences between the two
Classification Max. n. part./ m3 of air or same size or larger than shown standards are found regarding control
and monitoring activities: in fact,
ISO 14644.1 0,1 µm 0,2 µm 0,3 µm 0,5 µm 1 µm 5 µm the quantity of checking points is higher
ISO Class 1 10 2 - - - - or lower according to the standard used
according to the considered room size
ISO Class 2 100 24 10 4 - - or to the controlled contamination area.
ISO Class 3 1.000 237 102 35 8 - Other concept differences distinguish
ISO Class 4 10.000 2.370 1.020 352 83 - the two standards; and for this reason it is
ISO Class 5 100.000 23.700 10.200 3,520 832 29 essential to identify the reference standards
ISO Class 6 1.000.000 237.000 102.000 35.200 8.320 293 and parameters in the filter design phase
ISO Class 7 - - - 352.000 83.200 2.930 to be able to control the results obtained.
ISO Class 8 - - - 3.520.000 832.000 29.300
ISO Class 9 - - - 35.200.000 8.320.000 293.000

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filtration

Type of controlled
contamination
rooms
There are two main types of systems
for controlled contamination rooms with
reference to the position of the air filters:
horizontal ceiling filters or vertical wall
filters. In the first case the filters can cover
the entire ceiling or only parts
of it according to the requirements of use.
As regards the functional aspect,
air distribution can be of two types: non
unidirectional flow or unidirectional flow.
The non unidirectional flow diffusion
allows to reach a cleanness level
up to 1.000 (= M 4,5).
Unidirectional flow diffusion allows
to reach cleanness class 1,
the maximum available today.
Rooms with non
unidirectional flow (turbulent)
HEPA or ULPA filters are installed on the
ceiling, in appropriate diffusers distributed
above the occupied space right by the work
areas. Sometimes wall supply systems
are used, and even in this case the diffuser
directly faces the room.
In both applications, a non unidirectional
air flow is produced in the room, which,
even though filtered, is not able to uniformly
clean the room.
Air exhaust systems are usually positioned
at the bottom of walls. Rooms with
non unidirectional flows allow to reach
cleanness levels up to 1.000 (= M 4,5).
Rooms with unidirectional flow
(laminar)
Entire filtering ceilings or walls with
a vertical or horizontal air flow respectively
are created in these rooms.
New ISPESL
Guidelines
for operating
From a general point of view, and leaving
rooms. aside safety requirements, the new ISPESL
guidelines can be summarized as follows:
• General architecture of the operating
rooms designed in order to assure
a control hierarchy, i.e. the use of inner
doors dedicated to the personnel,
patients, materials, i.e. an architecture
that complies with the technical
requirements of controlled
contaminations rooms.
More specifically, the department
architecture must be structured so that
is it impossible to pass from a room with
lower cleanness level to one with higher
cleanness levels and that the doors
of inner communication doors
do not open simultaneously.
• Creation of appropriate secondary areas,
both technical and service areas, external
to the departments themselves, such as
locker rooms, restrooms, inspection
areas, emergency exit areas.
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With a vertical flow, air exhaust systems are
made of wall grilles or through raised floors.
With a horizontal flow, the exhaust system
is made through a false wall opposite
the filtering one.
Panel-type HEPA or ULPA filters are used,
they are assembled on special frames
able to assure air tightness and prevent
any minimum air by-pass.
Certain filter models are designed to be fed
individually through a flexible duct from
a collecting duct, fitted with a connection
tube on the upper plenum.
The unidirectional flow obtained through
these technologies is made of a series
of very fine parallel air flows that can
uniformly and completely clean the entire
room.
Air speed is kept at around 0,45 m/s.
The vertical air flow that completely cleans
the entire room, offers cleanness conditions
over the entire work area of the room.
On the other hand, in the case of large
surfaces, the starting up and operating
costs are considerable.
The horizontal air flow keeps the desired
conditions on a vertical level corresponding
with the work surface.
Whatever is downstream of this level
will be affected by the pollution produced
by the operator, the materials being
machined etc. You can take this into
consideration by positioning in the right
order, processes that require progressively
lower cleanness conditions.
The cost of this solution, both start-up
and operating costs, is usually lower
than the previous one.
In rooms with unidirectional flows,
vertical or horizontal, you can reach
cleanness level 1 (M = 1,5).
• The design of the rooms must assure
that they can be cleaned, i.e. the use
of round corners, smooth surfaces,
washable, resistant against chemical
and physical agents and anti-skid floors.
• The obligation to organize programmed
cleaning schedules both for the rooms
and the equipment.
• Obligation to organize programmed
maintenance schedules for all systems.
As regards contamination control,
the guidelines recall all the design
and control requirements set forth
by the European G.M.P. for rooms used
for the preparation of pharmaceutical
products.
A paragraph is dedicated to ventilation
and conditioning systems. The indications
supplied use the minimum requirements
set forth in the President’s Ordnance
of January 14 1997 as starting base with
all the essential modifications required
by the pharmaceutical industry.

Minimum system requirements
The HVAC system must guarantee
adequate hygienic-environmental conditions
in the operating room and more specifically:
• Maintain “adequate” room ventilation
able to limit the room concentration
of anesthetic gasses and/or other gas
pollutants, even in the case of unusual
emissions.
• Maintain correct thermal hygrometric
conditions for the user and the personnel.
• Maintain the concentration of total
airborne particulate under the limits set
for the rooms, through adequate inlet air
filtration, through constant
and measurable overpressures,
established so that the air moves
from cleaner rooms to less cleaner
rooms. The minimum pressure difference
between the two communicating rooms
must be at least 5 Pa.
The minimum functional specifications that
the system must guarantee in the various
rooms are shown in table 12.
The geometry of the ventilation and filtration
systems must be such as to assure
the performance levels in time through
planned management and maintenance
interventions.
Particularly:
• Easily controllable systems, foreseeing
suitable measurement sections of critical
parameters that allow for the use
of auxiliary equipment to control
performances, the fixed instrumentation
or for certification.
• Ducts made of anti-corrosive material,
fitted with external insulations and with
air drop lower than 5% when tested
at 1,5 times nominal operating pressure.
• Acoustic/optical alarm devices that
immediately warn the operator when the
critical parameters are below safety limits.
(For example: manometers with alarms,
pressure switches for room pressures,
measurement devices for inlet flow rates
with alarms for minimum rates etc.)
• Very high efficiency filters as last element
of air distribution systems and installed
directly in the ceilings or false ceilings
of ventilated rooms. For high efficiency
filters (HEPA) we mean filters with
an average efficiency higher than 99,97%
in relation to the DOP test method
or comparable to other systems:
DIN 24183, BS 5296, EUROVENT 4/4 or,
according to the most recent standards
updating UNI EN 1822.
• A planned management and maintenance
procedure to check the functionality and
the performances of the systems and
assure functionality in time.
• The possibility of isolating every single
operating room for room sanitization
cycles.
• To limit energy consumption,
it is necessary to reduce the quantity
of circulating air, in operating conditions,
providing room pressure remains
constant, a guarantee against the inlet
of non-filtered air.
• The geometry of air supplies
and exhausts from the rooms must
be optimized to minimize the harmful
effects such as short circuits between
inlet and exhaust, the creation
of non-ventilated bags,
local under-cooling caused by a very high
residual speed of the inlet air.
Air supply systems must be chosen
according to the use of the each room
of the ward. For pre/post-operating rooms,
washing, surgeon preparation
and sub-sterilization, the most suitable
systems could be terminal hoods with high
efficiency filters (HEPA) fitted with Coanda
effect or high induction diffusers,
for a turbulent air distribution system.
For operating rooms used for general
surgery or similar practices, suitable
diffusion systems could be vertical/horizon-
tal unidirectional flow systems partially
on the operating field (mixed flow system).
For operating used for orthopedic, heart
surgery, arthroprosthesis, neurosurgery,
vascular surgery, etc. operations, suitable
distribution systems could be vertical/hori-
zontal unidirectional flow systems,
on the entire operating room
(unidirectional flow system).
In this case you should remember that:
• The quantity of air needed is higher
than 15 changes/h
• Residual air speed on surgeons/patients
is higher than an induction diffusion
system, so it requires a very low
under-cooling level of the inlet air
(2-3 °K).
• The high quantities of air used could
require the use of local recycling
ventilation devices, room per room,
to limit energy consumption.
Suggested control parameters for
the management of the system
The periodical assessment of the
performances of the system is a way to
control its functionality even to assure the
compliance with the minimum requirements
foreseen for environmental parameters.
The critical parameters to consider and
check periodically according
to a management program are:
• The positive pressure of the rooms,
measured and recorded with an
appropriate manometer,
placed in a visible area, at least once
a day.
• Inlet air flow rate measured and recorded
at least every six months.
This value can be measured directly
on terminal filters or in the ducts
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in accordance with the UNI,
IES RPCC-006, ISO 14644/3, BS 5276
standards. If the system is an all external
air system (typical of turbulent distribu-
tion
systems) the number of room changes
can be calculated with the following
formula:
N = Inlet air flow rate / Room volume
In the case of unidirectional flow
distributions, a part of the air
can be locally re-circulated. In this case
the relation Inlet air flow rate / Room
volume does not produce the number
of changes but the number of re-cycles.
Of course, even in this case the changes
must be higher than the minimum
requirements.
• Pressure drop of filtration systems,
measured and registered at least
once a month.
• Total microbic load, of opportunistic
microorganisms and air pathogens after
each sterilization, measured averagely
for each room and directly on the supply
grilles.
• Verification of the efficiency of terminal
filtration systems that should be carried
out at least during the system
acceptance phase (DOP Leak Test,
IES RPCC-006, ISO 14644/3,
EUROVENT 4/8 or similar), and every
time the filter is replaced.
You should also check the following
additional features for operating rooms:
• Daily thermal hygrometric check
• Environmental contamination class
referred to the total airborne particulate,
to be carried out at least every 6 months
and when the system is accepted.
For mixed flow or unidirectional systems
the value of the class in idle conditions
must be at least M 3,5 Federal Standard
209 E or ISO 5.
This means that the maximum quantity
of particles contained in a cubic meter
of air with a diameter higher than or equal
to 0,5 micron is 3520.
Please remember that the filtered air room
recycling levels with HEPA filters must
exceed 30 Volumes/h.
For rooms with turbulent flows, the class
in idle conditions must at least be equal
to M 5,5 Federal Standard 209 E or ISO 7.
In this case, the maximum number
of particles contained in a cubic meter
of air with a diameter higher than or equal
to 0,5 micron is 352.000.
The concentrations of airborne particulate,
both microbic and inert, in a room with
controlled contamination, depend on the air
supply and exhaust geometries, besides
on the air flow rates, filtration efficiency,
overpressure, architecture of the ward,
hence they depend on the path that
air follows in a room.
 ®

Tab. 12 Minimal functional specifications the system must assure for each room
I In the operating room
Minimum filtration efficiency: > 99,97% DOP Test
Total microbic volume of inlet air: < 1 CFU**/m3
Overpressure compared to the outside of the ward: positive
n° external air changes: 15 Volumes/h
Summer/ winter temperature between: 20-24 °C
Summer/winter relative humidity: 40-60 %

II Pre/post, surgeon washing-preparation

n° external air changes : 6 Volumes/h
Temperature/humidity: comfortable
Overpressure compared to the outside of the ward: positive
Overpressure compared to operating room: negative

III Surgical instruments washing, sub-sterilization

n° external air changes : 15 Volumes/h
Temperature/humidity: comfortable
Overpressure compared to the outside of the ward: positive
Overpressure compared to operating room: negative

IV In remaining rooms of surgery ward

n° external air changes : 2 Volumi/h
Temperature/humidity: comfortable
Overpressure compared to the outside of the ward: positive
Overpressure compared to operating room: negative

Tab. 13 Division of operating ward

Operating rooms with total laminar flow class A
Rooms with mixed flow critical areas (operating field) in class A,
surrounding areas in class B
Rooms with turbulent flow class B
Surgical team locker rooms first stage in class C,
second stage in class B
Patient preparation/wake-up class C/B
Instrument washing class D
Sub - sterilization generally class C
Ward halways class D
Deposit of sterile material class B
Waiting room outside of ward
Inner ward access door not classified
General access locker room not classified
Restrooms dedicated but outside of ward

ECC GMP Annex 1
From a general point of view the prescrip-
tions of the guide are contained in the more
general European GMP dedicated to the
preparation of pharmaceutical products.
For a more accurate definition of the
environmental parameters you can,
undoubtedly, refer to this guide to act
in compliance with the spirit used to
draw up the guide, providing the minimum
requirements set forth by the law,
if in contrast with the GMP prescriptions,
are observed.
We can divide the operating ward
in classes, A,B,C,D.
See the indications in tab. 13.
The requirements for the various classes
identified above and the bacteriologic
contamination values are shown in tab. 14
and refer to room air samples.

Tab. 13 Requirements of the various rooms

idle idle in operation in operation in operation
Level Pt* / m3 > 0,5 µm Pt */ m3 > 5 µm Pt */ m3 > 0,5 µm Pt* / m3 > 5 µm CFU** / m3
A 3500 0 3500 0 <1
B 3500 0 350000 2000 10
C 350000 2000 3500000 20000 100
D 3500000 20000 N.C. N.C. 200

* Pt = Particles
** CFU = Colony Forming Units, i.e. all those particles in the air that deposited on an adequate
layer of bacterial culture can develop colonies.

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Industrial filters
and dust exhaust
systems
The field of industrial dust exhaust systems
and gas emission controls, is very broad
and divided into various specialized
branches. In this case we particularly refer
to the main exhaust control systems
for dust coming from processing plants
or working cycles. In reality, the need
to control industrial emissions often
includes other things, such as:
• compliance with the laws in force against
environmental pollution;
• controlling product quality, avoiding
product contamination from agents
or substances produced during working
cycles;
• keeping the initial cost and the
maintenance cost of the dust exhaust
system within a certain limit so not to
increase the unitary cost of the product;
• prevent damages or disturbing conditions
for the people or things in the area
of installation of the system or in external
areas;
• prevent the distribution of polluting
substances in the work place;
• allow for the recycling of materials,
energy, heat, from the treated aeriform
particles;
• allow the recycling of filtered air
in the work place;
• reduce fire, explosion, etc, risks.
After setting the primary needs,
the specifications of the process or the
system must be evaluated along with the
possible interventions. In fact frequently,
you can reach substantial savings
on filtration or dust exhaust systems by
intervening at the source, i.e. the process
which produces the polluting substances
themselves.
For a preliminary exam of the problem
you need to have two types of information:
• specifications of the system that
produces the pollutants
• nature of the pollutants and their
specifications.
Tab. 14 Typical performances of dust extraction systems
Ponderal separation Minimum Admitted dust
efficiency dust diameter volume
Type % µm mg/m3
Cartidge 100 0,5 5.000
Cyclone 85 10 2.000
Scrubber 90 5 2.000
(wet washer)
Sleeve separators 99 1 500
Electrostatic 95 2 200
precipitators
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The first group includes all the information
related to the climate of the site, presence
of dominating winds, pressure, temperature,
relative humidity, etc.
Hence, information on the use of energy
and the materials or substances used
in the process which generates
the pollutants. And finally, the assessment
of the personal and environmental
protection standards in force.
As regards gas pollutants, you need
to know the nature and concentration
of the substances. For dusts, it is important
to know the distribution of the sizes,
their concentration with average and
extreme values, and their possible features
in terms of erosion capacity, abrasion,
adhesion, etc., alongside the electric
properties (resistivity) as well as possible
solubility features.
It is important to know the concentration
value per volume units, for recovery
evaluations. Toxicity, inflammability,
inclination towards explosion are further
features to take into account.
When choosing a dust extraction system
it is very important to know the distribution
of the size of the dusts.
In fact, the efficiency of these systems
is strongly affected by the diameter
of the particles.
If you don’t have precise figures, you need
to take samples using methods that can
produce significant results.
The concentration, in weight, of the dusts
produced by industrial systems has a very
broad spectrum of values.
It goes from 20 mg/m3 up to 40,000 mg/m3
and more.
The available dust extraction systems
are limited to just about 5 different
configurations according to the basic
interception principle or mechanism:
• centrifugal separators
(cyclone, inertial, gravity)
• sleeve / bag filters
• electrostatic precipitators
• wet separators
(wet towers, scrubbers, wet cyclones)
• cartridge filters
Especially experience has allowed us to
determine for the various industrial sectors
which types of dust extraction system
better meets their needs.
The performances related to the various
dust extraction systems are shown
in tab. 14.
Tab 15 summarizes the most common
industrial situations.
 ®

Industrial filters and dust

extraction systems

Legend:
O Optimal use (suggested)
B Good use
D Fair use
S Poor use

Tab. 15 Mosto common use of industrial dust extraction systems

Sector Particle Dust Centrifugal Electrostatic Wet separators Sleeve / bag Cartidge
and processes Ø concentration or inertial precipitators scrubbers water filters filters
separator mist application
µm mg/m3 booths
Pharmaceutical
• Granulation 10 ÷ 50 200 ÷ 1000
• Coating 5 ÷ 10 50 ÷ 500 S S D S O
Pharmaceutical / Food
• Packaging 20 ÷ 50 200 ÷ 1000
• Grinding 2 ÷ 50 300 ÷ 1000 S S S B O
• Weighing 2 ÷ 20 100 ÷ 200

Chemical
• Mixing 10 ÷ 100 100 ÷ 500
• Grinding 5 ÷ 20 300 ÷ 1000 S S S B O
• Packaging 20 ÷ 100 200 ÷ 1000

Plastic machining
• Mixing 2 ÷ 20 100 ÷ 500
• Hot processing 0,5 ÷ 20 50 ÷ 200 D S S B B
• Cold processing 10 ÷ 100 200 ÷ 1000

Agriculture
• Cereal processing 10 ÷ 500 500 ÷ 2000
• Drying 10 ÷ 100 100 ÷ 500 B S S B D
• Packaging 50 ÷ 500 500 ÷ 2000

Metalworking
• Electric furnace 10 ÷ 50 500 ÷ 5000
• Blast furnace 20 ÷ 200 300 ÷ 2000 B B D D O
• Mineral transport 50 ÷ 500 500 ÷ 5000

Mechanical machining
• Laser / Plasma 0,5 ÷ 10 10 ÷ 50
• Welding 0,5 ÷ 5 50 ÷ 20 S D D S O
• Varnishing 2 ÷ 30 100 ÷ 500

Wood machining
• Cutting 50 ÷ 1000 200 ÷ 2000
• Finishing 20 ÷ 500 50 ÷ 1000 B S B D/B S
• Painting 2 ÷ 30 100 ÷ 500

Ceramic
• Atomization 2 ÷ 20 200 ÷ 2000
• Packaging 5 ÷ 100 50 ÷ 1000 S S D S O
• Painting 2 ÷ 30 100 ÷ 500

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