FILTER ENGINEERING VERY HIGH EFFICIENCY FILTERS CLEAN ROOMS

Standards, Regulations, Standards Classification of different air qualities required for

manufacture of sterile products
Recommendations Year Reference Type of test Classification
Maximum number of particles per m3 of a size greater than or equal to Max. nbr: of
1956 MIL STD 282 DOP 0.3 µm -
µorganisms
0.5 µm 5 µm 0.5 µm 5 µm
AFNOR per m
VENTILATION FILTERS 1972 Uranine 0.15 µm - inactive (b) active (active)
NFX 44.011
1976 EUROVENT 4/4 NaCl 0.65 µm EU10 to EU14 A 3.500 0 3.500 0 <1
Standards B 3.500 0 350,000 2.000 10
HEPA: H10 to H14
1995 CENE N1 822 MPPS 0.1 to 0.2 µm
Year Reference Type of test Classification ULPA: U15 to U17 C 350,000 2.000 3.500,000 20,000 100
1968 ASHRAE ARRESTANCE / EFFICIENCY D 3.500,000 20,000 not defined (c) not defined (c) 200
1980 EUROVENT 4/5 ARRESTANCE / EFFICIENCY EU1 to EU4 - EU5 to EU9 EN 1822 Classification
Rules and Guidance for Pharmaceutical Manufacturers and Distributors (2002)
1982 AFNOR NFX 44.012 ARRESTANCE / EFFICIENCY MPPSin tegral values MPPSlo cal values (b) Corresponds approximately to the US Federal Standard 209 E and ISO as follows: classes A and B to class
Minimum Maximum Minimum Maximum 100. M3 .5. ISO 5; class C to class 10,000. M5 .5. ISO 7; class D to class 100.000. M6 .5 ISO 8.
1993 CENE N7 79 ARRESTANCE / EFFICIENCY G1 to G4 - F5 to F9 Filter Filter
efficiency penetration Minimum D.C. efficiency penetration Minimum D.C.
group class
(%) (%) (%) (%) Comparison of international classification standards
EN 779 Classification H10 85 15 6.7 - - -
Nbr of part US ENI SO France AFNOR European Union Pharma Nbr of part
Average arrestance Average efficiency EUROVENT4 /5 H11 95 5 20 - - - 0.5 µm/ m Fed. Std 209 E 14644-1 NF X 44.101 industry Guide GMP 0.1 µm/ m
EN7 79 standard HEPA
Am (%) Em (%) equivalent (approx.) 1992 1996 1981 1989 (approx.)
H12 99.5 0.5 200 - - -
(H)
Filter Filter - - - ISO 1 - - 10
Filter class limits Filter class H13 99.95 0.05 2.000 99.75 0.25 400
group class
1 - - - - - 35
H14 99.995 0.005 20,000 99.975 0.025 4.000
G1 Am < 65 - EU 1 4 - - ISO 2 - - 100
U15 99.9995 0.0005 200,000 99.9975 0.0025 40,000
G2 65 Am< 80 - EU 2 ULPA 10 M1 - - - - 350
Coarse (G)* U16 99.99995 0.00005 2.000,000 99.99975 0.00025 400,000
G3 80 Am< 90 - EU 3 (U)
35 M1 .5 1 ISO 3 - - 1.000
U17 99.999995 0.000005 20,000,000 99.9999 0.0001 1.000,000
G4 90 Am - EU 4 100 M2 - - - - 3 500
HEPA : High Efficiency Particulate Air (filter)
F5 - 40 Em < 60 EU 5 ULPA : Ultra Low Penetration Air (filter) 353 M2 .5 10 ISO 4 - - 10,000
F6 - 60 Em < 80 EU 6 D.C. : Decontamination Coefficient 1.000 M3 - - - - 35.000
Fine 3.530 M3 .5 100 ISO 5 4.000 A and B 100,000
F7 - 80 Em < 90 EU 7
(F) ** Classification as per Eurovent 4/4 recommendation, NaCI 10,000 M4 - - - - 350,000
F8 - 90 Em < 95 EU 8
method 35.300 M4 .5 1.000 ISO 6 - - 1.000,000
F9 - 95 Em EU 9
Initial efficiency (Ea) : * Ea < 20% ; ** Ea 20% EUROVENT4 /4 Inicial efficiency Ei (%) Penetration Pi (%) 100,000 M5 - - - - -
Final pressure drop: * 250 Pa ; ** 450 Pa Filter class Limits of filter classes 353.000 M5 .5 10,000 ISO 7 400,000 C -

EU 10 95 Ei < 99.9 5 Pi < 0.1 1.000,000 M6 - - - - -

Fed Std 209D - ISO 14644-1 guide EU 11 99.9 Ei < 99.97 0.1 Pi < 0.03 3.530,000 M6 .5 100,000 ISO 8 4.000,000 D -
10,000,000 M7 - - - - -
209D ISO 14644-1 (@0.5µm,unmanned) EU 12 99.97 Ei < 99.99 0.03 Pi < 0.01
35.000,000 - - ISO 9 - - -
EU 13 99.99 Ei < 99.999 0.01 Pi < 0.001
1 ISO 3 EU 14 99.999 Ei 0.001 Pi
10 ISO 4
100 ISO 5
1 000 ISO 6
10 000 ISO 7
100 000 ISO 8

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