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APPLICATION NOTE

Cleanroom Standards and Classifications

APPLICATION NOTE Cleanroom Standards and Classifications PO Box 531, Cambridge, NZ Telephone + 64 7 827

PO Box 531, Cambridge, NZ Telephone + 64 7 827 4142 Facsimile + 64 7 827 8435 www.aircaretechnology.co.nz Ph 0800 774 100 Fax 0800 774 101

Cleanroom technology has developed into a specialist field with its own technical journals, its own conferences and exhibitions, and its own language of technical terms and classifications. This application note covers relevant standards and attempts to clarify the myriad classification systems.

Cleanroom Standards

The main cleanroom standards of interest in New Zealand are as follows:

AS 1386:1989 This standard in seven parts has been widely used in New Zealand as a reference for design, operation and validation of cleanrooms.

FED-STD-209E:1992

Until recently, this standard was used throughout the US and by auditors from the US. It was cancelled in November 2001 in favour of ISO 14644, but its classification system will undoubtedly be used for years to come. ISO 14644 Cleanrooms and associated controlled environments (8 parts) ISO 14698 Biocontamination control (3 parts) These 11 documents will make up a set of global cleanroom standards. They are still being developed, with some already released and most of the others available in draft form.

Ref

Title

Status

ISO 14644-1

Classification of Air Cleanliness

Released May 1999

ISO 14644-2

Specifications for testing and monitoring to prove continued compliance with ISO 14644-1

Released Apr 2000

ISO 14644-3

Metrology and test methods

Draft under

discussion

ISO 14644-4

Design, construction and start-up

Released Apr 2001

ISO 14644-5

Operations

Draft Available

ISO 14644-6

Vocabulary

 

ISO 14644-7

Separative devices (clean air hoods, glove boxes, isolators, mini-environments)

Draft Available

ISO 14644-8

Classification of airborne molecular contamination

 

ISO 14698-1

General principles

Draft Available

ISO 14698-2

Evaluation and interpretation of biocontamination data

Draft Available

ISO 14698-3

Measurement of the efficiency of cleaning processes

Draft Available

May 2003

© Air Care Technology Ltd

Cleanroom Classifications

Cleanrooms are classified according to the concentration of airborne particles. The following table shows the ISO 14644-1 classification for the main particle sizes of interest together with comparable AS1386 and FED-STD-209E classifications.

ISO

Max concentration (particles/m 3 of air) for particles equal to or greater than size shown

FED-STD-209E

AS1386

Class

Class

Class

 

0.1mm

0.3mm

0.5mm

5mm

   

1

10

         

2

100

10

4

     

3

1000

102

35

 

1

0.035

4

10000

1020

352

 

10

0.35

5

100000

10200

3520

29

100

3.5

6

1000000

102000

35200

293

1000

35

7

   

352000

2930

10000

350

8

   

3520000

29300

100000

3500

9

   

35200000

293000

   

ISO classes 1-4 are mainly applicable to the semi-conductor industry and we are not aware of any such cleanrooms in New Zealand. Classes 5, 7 and 8 are most common.

The airborne particle concentration in a cleanroom is highly dependent on the occupancy of the room because occupants are major particle sources. So the classification of the cleanroom must be defined at one or more of the room’s occupancy states, viz. “as-built”, “at rest”, or “operational”. For example, a cleanroom may be class 7 (= class 10000 = class 350) in the “operational” state and class 5 (= class 100 = class 3.5) in the “at rest” state.

Good Manufacturing Practice (GMP)

There are two methods by which cleanrooms and semi-clean rooms have been specified in New Zealand.

For the Food Industry, MAF have traditionally specified the air filters required. For example air filtration of EU5 or better for processing areas is specified in the Meat Industry Agreed Standard 2 – Design and Construction (1) . This may be appropriate for low-level clean spaces, but is not ideal. The filtration efficiency is only one factor determining the cleanliness of the space – the airflow, the room construction, the room pressurisation and the operations in the room are also important factors. Furthermore, unless the air filters are well manufactured and properly installed, a significant proportion of air can bypass the installed filters.

The other method is to specify the air quality using a cleanroom classification system as

described above.

classification. For example, in the code of GMP for medicinal products (2) , the general requirement is “Class 7000” which is extrapolated from AS1386. This requirement is

commonly used in New Zealand for food processing areas.

New Zealand is the UK (European) “Orange Guide” (3) which defines 4 grades of cleanrooms for manufacture of sterile medicinal products according to air quality in both the “at rest” and “in operation” states.

The Australian Therapeutic Goods Association use the AS1386

Also commonly used in

May 2003

© Air Care Technology Ltd

Orange

 

At rest

In operation

Max permitted viable micro- organisms /m 3

Guide

Max permitted particles /m 3 equal to or larger than

Grade

0.5mm

5mm

0.5mm

5mm

A

3

500

0

3 500

0

<1

B

3

500

0

350 000

2 000

10

C

350 000

2 000

3 500 000

20 000

100

D

3 500 000

20 000

Not defined

200

Beware of using grades for cleanrooms! Although the definitions above are commonly used, other codes for GMP such as TGA (4) and MAF – ACVM (5) define grades A to D slightly differently.

References

(1)

Industry Agreed Standard 2 – Design and Construction, Animal Products Group, New Zealand Food Safety Authority. Section 5.3

(

available on-line at http://www.nzfsa.govt.nz/meatdoc/meatman/manual-2v )

(2)

Australian Code of Good Manufacturing Practice For Therapeutic Goods – Medicinal Products, Therapeutic Goods Association, 1990. Page 11.

(3)

Rules and Guidance for Pharmaceutical Manufacturers and Distributors, (known as “The Orange Guide”) Medicines Control Agency, The Stationery Office, London, 1997. Annex 1.

(4)

Australian Code of Good Manufacturing Practice For Therapeutic Goods – Medicinal Products, Therapeutic Goods Association, 1990. Page 56.

(5)

ACVM (Agricultural Compounds & Veterinary Medicines) – Guideline for Good

Manufacturing Practice, Ministry of Agriculture and Forestry, Wellington, NZ, 1999, Annex 1.

( available on-line at http://www.nzfsa.govt.nz/acvm/publications/standards- guidelines )

May 2003

© Air Care Technology Ltd

ISO cleanroom classifications Ultra-clean environments for the biopharma industry
ISO cleanroom
classifications
Ultra-clean environments for the
biopharma industry

ISO standards for controlled environments Adoption of ISO standards makes national standards such as AS 1386 redundant. The ISO standards shown below are complemented by ISO-14698, dealing with bio-contamination control and monitoring.

ISO-14644-1 Classification by Airborne Particles ISO-14644-3 Measurement & Testing ISO-14644-5 Cleanroom Operations ISO-14644-7 Separative Enclosures

ISO-14644-2 Monitoring for Compliance ISO-14644-4 Design, Construction and Start-up ISO-14644-6 Terms, Definitions & Units ISO-14644-8 Molecular Contamination

ISO air cleanliness classifications – Class limits (particles/m 3 )

Classification

Maximum concentration limits (particles/m 3 ) for particles particle sizes shown

number

(N)

0.1 µm

0.2 µm

0.3 µm

0.5 µm

1 µm

5 µm

ISO Class 1

10

2

       

ISO Class 2

100

24

10

4

   

ISO Class 3

1000

237

102

35

8

 

ISO Class 4

10000

2370

1020

352

83

 

ISO Class 5

100000

23700

10200

3520

832

29

ISO Class 6

1000000

237000

102000

35200

8320

293

ISO Class 7

     

352000

83200

2930

ISO Class 8

     

3520000

832000

29300

ISO Class 9

     

35200000

8320000

293000

Note: Uncertainties related to the measurement process require that data with no more than three (3) significant figures be used in determining the classification level.

EU CGMP classifications

 

Maximum concentration limits (particles/m 3 ) for particles sizes shown

Grade

At rest (b)

In operation

0.5µm

5.0µm

0.5µm

5.0 µm

A

3500

0

3500

0

B

(a)

3500

0

350000

2000

C

(a)

350000

2000

3500000

20000

D

(a)

3500000

20000

not defined (c)

not defined (c)

Notes:

(a) For B, C and D, the number of air changes should be related to the size of the room and the equipment and

personnel present. The HVAC system should be provided with appropriate filters, e.g. HEPA for Grades A, B and C. (b)The maximum permitted number of particles in the "at rest" condition correspond approximately to the US Federal

Standard 209E & the ISO classifications as follows: Grades A and B Class 100, M 3.5, ISO 5; grade C Class 10 000, M 5.5, ISO 7 and Grade D Class 100 000, M 6.5, ISO 8.

(c) The requirement and classification limit for the area will depend on the nature of the operations carried out.

Cross-reference to AS 1386 and other standards

Standard

 

Classification

 

ISO 14644-1

3

4

5

6

7

8

AS 1386

0.035

0.35

3.5

35

350

3,500

BS 5295

C

D

E/F

G/H

J

K

Federal Standard 209E

1

10

100

1,000

10,000

100,000

EU CGMP

-

-

A/B

-

C

D

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CLASSIFICATION OF CLEANROOMS Cleanrooms are classified by the cleanliness of their air. The method most

CLASSIFICATION OF CLEANROOMS

Cleanrooms 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 is measured in one cubic foot of air and this count used to classify the room. The most recent 209E version has also accepted a metric nomenclature.

In the UK the British Standard 5295, published in 1989, is also used to classify cleanrooms. This standard is about to be superseded by BS EN ISO 14644-1.

Federal Standard 209

This standard was first published in 1963 in the USA and titled "Cleanroom and Work Station Requirements, Controlled Environments". It was revised in 1966 (209A), 1973 (209B), 1987 (C), 1988 (D) and 1992 (E). It is available from:

Institute of Environmental Sciences and Technology 940 East Northwest Highway Mount Prospect Illinois, 60056 USA

Tel: 0101 708 255 1561

Fax: 0101 708 255 1699

e-mail: iest@iest.org:

The cleanroom classifications given in the earlier 209 A to D versions are shown in Table 1.

Table 1: Federal Standard 209D Class Limits

   

MEASURED PARTICLE SIZE (MICROMETERS)

CLASS

0.1

0.2

0.3

0.5

5.0

1

35

7.5

3

1

NA

10

350

75

30

10

NA

100

NA

750

300

100

NA

1,000

NA

NA

NA

1,000

7

10,000

NA

NA

NA

10,000

70

100,000

NA

NA

NA

100,000

700

In the new 209E published in 1992 the airborne concentrations in the room are given in metric units, i.e per m 3 and the classifications of the room defined as the logarithm of the airborne concentration of particles ? 0.5 ? m e.g. a Class M3 room has a particle limit for particles ?0.5 ? m of 1000/m 3 . This is shown in Table 2.

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Cleanroom Standards

Table 2: Federal Standard 209E Airborne Particulate Cleanliness Classes

Standard 209E Airborne Particulate Cleanliness Classes     Class Limits     Class Name
   

Class Limits

 
 

Class Name

 

0.1? m

 

0.2? m

 

0.3? m

 

0.5? m

 

5? m

   

Volume Units

Volume Units

 

Volume Units

 

Volume Units

Volume Units

 

SI

English

(m

3 )

(ft 3 )

3 )

(m

(ft 3 )

(m

3 )

(ft 3 )

 

(m

3 )

(ft 3 )

3 )

(m

(ft 3 )

M

1

   

350

9.91

 

75.7

2.14

 

30.9

0.875

 

10.0

0.283

 

--

--

M

1.5

1

 

1

240

35.0

265

7.50

106

3.00

35.3

1.00

--

--

M

2

3

500

99.1

757

21.4

309

8.75

100

2.83

--

--

M

2.5

10

12

400

350

2

650

75.0

 

1

060

30.0

353

10.0

--

--

M

3

35

000

991

7

570

214

3

090

87.5

 

1

000

28.3

--

--

M

3.5

100

--

--

26

500

750

10

600

300

3

530

100

--

--

M

4

--

--

75

700

2 140

30

900

875

 

10

000

283

--

--

M

4.5

1 000

--

--

--

--

--

--

35

300

1 000

247

7.00

M

5

--

--

--

--

--

--

100

000

2 830

618

17.5

M

5.5

10 000

--

--

--

--

--

--

353

000

10 000

2

470

70.0

M

6

--

--

--

--

--

--

1

000 000

28 300

6

180

175

M

6.5

100 000

--

--

--

--

--

--

3

350 000

100 000

24

700

700

M

7

--

--

--

--

--

--

10 000 000

283 000

61

800

1 750

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British Standard 5295:1989

This standard is available from:

B S I Standards 389 Chiswick High Road London W44 AL Tel 0181 996 9000

Fax 0181 996 7400

High Road London W44 AL Tel 0181 996 9000 Fax 0181 996 7400 e-mail: info@bsi.org.uk Because

e-mail: info@bsi.org.uk

Because of the imminent publication of EN ISO 14644-1 parts of this British Standard have a limited life. Parts will be superseded by the ISO standards as they app ear as an EN standard.

The British Standard is in five parts. These are:

Part 0 -

Part 1 -

Part 2 -

devices. (14 pages) Part 3 - Guide to operational procedures and disciplines applicable to cleanrooms and clean air

General introduction and terms and definitions for cleanrooms and clean air devices. (4 pages) Specification for cleanrooms and clean air devices. (14 pages) Method for specifying the design, construction and commissioning of cleanroom and clean air

Part 4 -

devices. (6 pages) Specification for monitoring cleanrooms and clean air devices to prove continued compliance with BS 5295. (10 pages)

Part 1 of the standard contains ten classes of environmental cleanliness. Shown in Table 3 are the classes given in the standard. All classes have particle counts specified for at least two particle size ranges to provide adequate confidence over the range of particle size relevant to each class.

Table 3 BS 5295 Environmental cleanliness classes

 

Maximum permitted number of particles per m 3 (equal to, or greater than, stated size)

Maximum

Minimum pressure

floor area

difference*

Class of

0.3 ? m

0.5 ? m

5 ?m

10 ? m

25 ? m

per

Between

Between classified area and adjacent areas of lower

environ-

sampling

classified

mental

position for

areas and

cleanliness

cleanrooms

unclassified

(m

2 )

areas

classification (Pa)

 

(Pa)

C

100

 

35

0

NS

NS

10

15

10

D

1 000

350

0

NS

NS

10

15

10

E

10 000

3

500

0

NS

NS

10

15

10

F

NS

3

500

0

NS

NS

25

15

10

G

100 000

35

000

200

0

NS

25

15

10

H

NS

35

000

200

0

NS

25

15

10

J

NS

350 000

2 000

450

0

25

15

10

K

NS

3 500 000

20 000

4 500

500

50

15

10

L

NS

NS

200 000

45 000

5 000

50

10

10

M

NS

NS

NS

450 000

50 000

50

10

NA

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BS EN ISO Standard Because of the large number of cleanroom standards produced by individual

BS EN ISO Standard

Because of the large number of cleanroom standards produced by individual countries it is very desirable that one world-wide standard of cleanroom classification is produced. The first ISO standard on cleanrooms has been published (June 1999) as 14644-1 ‘Classification of Air Cleanliness’. It is about to be adopted as a European standard and hence a standard for all countries in the EU. This standard is available from standard organisations throughout the world and in the UK is available from the BSI. Shown in Table 4 is the classification that has been adopted.

Table 4. Selected ISO 209 airborne particulate cleanliness classes for cleanrooms and clean zones.

Classification

Maximum concentration limits (particles/m 3 of air) for particles equal to and larger than the considered sizes shown below

numbers

numbers (N)

 

0.1? m

0.2? m

0.3? m

0.5? m

1? m

5.0? m

ISO 1

10

2

       

ISO 2

100

24

10

4

ISO 3

1 000

237

102

35

8

ISO 4

10 000

2 370

1 020

352

83

ISO 5

100 000

23 700

10 200

3 520

832

29

ISO 6

1 000 000

237 000

102 000

35 200

8 320

293

ISO 7

352 000

83 200

2 930

ISO 8

3 520 000

832 000

29 300

ISO 9

35 200 000

8 320 000

293 000

The table is derived from the following formula:

where:

Cn

=

10 N ?

0.1

?

? D ?

?

?

?

2.08

Cn represents the maximum permitted concentration ( in particles/m 3 of air ) of airborne

particles that are equal to or larger than the considered particle size. Cn is rounded to the

nearest whole number.

N is the ISO classification number, which shall not exceed the value of 9. Intermediate ISO

classification numbers may be specified, with 0.1 the smallest permitted increment of N.

D

is the considered particle size in ? m.

0.1

is a constant with a dimension of ? m.

Table 4 shows a crossover to the old FS 209 classes e.g. ISO 5 is equivalent to the old FS 209 Class

100.

The occupancy state is defined in this standard as follows:

As built: the condition where the installation is complete with all services connected and functioning but with no production equipment, materials, or personnel present.

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At-rest : The condition where the installation is complete with equipment installed and operating in

At-rest: The condition where the installation is complete with equipment installed and operating in a manner agreed between the customer and supplier, but with no personnel present.

Operational: The condition where the installation is functioning in the specified manner, with

the specified number of personnel present and working in the manner agreed upon.

The standard also gives a method by which the performance of a cleanroom may be verified i.e. sampling locations, sample volume etc. These are similar to FS 209. It also includes a method for specifying a room using particles outside the size range given in the table 4. Smaller particles (ultrafine) will be of particular use to the semiconductor industry and the large (?5? m macroparticles) will be of use in industries such as parts of the medical device industry, where small particles are of no practical importance. Fibres can also be used. The method employed with macroparticles is to use the format:

‘M(a; b);c’

where

a

is the maximum permitted concentration/m 3

b

is the equivalent diameter.

c is the specified measurement method. An example would be:

‘M(1 000; 10? m to 20? m); cascade impactor followed by microscopic sizing and counting’.

Pharmaceutical Cleanroom Classification

EU GGMP

The most recent set of standards for use in Europe came into operation on the 1 st of January 1997. This is contained in a ‘Revision of the Annexe to the EU Guide to Good Manufacturing Practice- Manufacture of Sterile Medicinal Products’. The following is an extract of the information in the standard that is relevant to the design of cle anrooms :

For the manufacture of sterile medicinal products four grades are given. The airborne particulate classification for these grades is given in the following table.

   

maximum permitted number of particles/m3 equal to or above

   

Grade

at rest (b)

in operation

 

0,5? m

5? m

0,5? m

5,0? m

A

3

500

0

3 500

0

B(a)

3

500

0

350 000

2 000

C(a)

350 000

2 000

3 500 000

20000

D(a)

3 500 000

20 000

not defined (c)

not defined (c)

Notes:

 

(a)

In order to reach the B, C and D air grades, the number of air changes should be related to the

size of the room and the equipment and personnel present in the room. The air system should be provided with appropriate filters such as HEPA for grades A, B and C.

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(b) The guidance given for the maximum permitted number of particles in the “at rest”

(b) The guidance given for the maximum permitted number of particles in the “at rest” condition

corresponds approximately to the US Federal Standard 209E and the ISO classifications as follows:

grades A and B correspond with class 100, M 3.5, ISO 5; grade C with class 10 000, M 5.5, ISO 7 and grade D with class 100 000, M 6.5, ISO 8.

(c) The requirement and limit for this area will depend on the nature of the operations carried out.

The particulate conditions given in the table for the “at rest” state should be achieved in the unmanned state after a short “clean up” period of 15-20 minutes (guidance value), after completion of operations. The particulate conditions for grade A in operation given in the table should be maintained in the zone immediately surrounding the product whenever the product or open container is exp osed to the environment. It is accepted that it may not always be possible to demonstrate conformity with particulate standards at the point of fill when filling is in progress, due to the generation of particles or droplets from the product itself.

Examp les of operations to be carried out in the various grades are given in the table below. (see also par. 11 and 12).

Grade

Examples of operations for terminally sterilised products. (see par. 11)

A

Filling of products, when unusually at risk.

C

Preparation of solutions, when unusually at risk. Filling of products.

D

Preparation of solutions and components for subsequent filling.

Grade

Examples of operations for aseptic preparations. (see par. 12)

A

Aseptic preparation and filling.

C

Preparation of solutions to be filtered

D

Handling of components after washing.

Additional microbiological monitoring is also required outside production operations, e.g. after validation of systems, cleaning and sanitisation.

 

Recommended limits for microbial contamination (a)

 
 

air sample

settle plates (diam. 90

contact plates

glove print. 5 fingers.cfu/glove

GRADE

cfu/m3

mm), cfu/4 hours(b)

(diam.55 mm),

cfu/plate

 

A

?

1

?

1

?

1

?

1

B

10

5

 

5

5

C

100

50

 

25

-

D

200

100

 

50

-

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.

Isolator and Blow Fill Technology (extract only) The air classification required for the background environment depends on the design of the isolator and its application. It should be controlled and for aseptic processing be at least grade D.

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Blow/fill/seal equipment used for aseptic production which is fitted with an effective grade A air

Blow/fill/seal equipment used for aseptic production which is fitted with an effective grade A air shower may be installed in at least a grade C environment, provided that grade A/B clothing is used. The environment should comply with the viable and non viable limits at rest and the viable limit only when in operation. Blow/fill/seal equipment used for the production of products for terminal sterilisation should be installed in at least a grade D environment.

Guideline on Sterile Drug Products Produced by Aseptic Processing.

This document is produced by the FDA in the USA and published in 1987. Two areas are defined. The ‘critical area’ is where the sterilized dosage form, containers, and closures are exposed to the environment. The ‘controlled area’ is where unsterilized product, in-process materials, and container/closures are prepared. The environmental requirements for these two areas given in the Guide are as follows:

Critical areas ‘Air in the immediate proximity of exposed sterilized containers/closures and filling/closing operations is of acceptable particulate quality when it has a per-cubic -foot particle count of no more than 100 in a size range of 0.5 micron and larger (Class 100) when measured not more than one foot away from the work site, and upstream of the air flow, during filling/closing operations. The agency recognizes that some powder filling operations may generate high levels of powder particulates which, by their nature, do not pose a risk of product contamination. It may not, in these cases, be feasible to measure air quality within the one foot distance and still differentiate "background noise" levels of powder particles from air contaminants which can impeach product quality. In these instances,

it is nonetheless important to sample the air in a manner which, to the extent possible, characterizes the

true level of extrinsic particulate contamination to which the product is exposed. Air in critical areas should be supplied at the point of use as HEPA filtered laminar flow air, having a velocity sufficient to sweep particulate matter away from the filling/closing area. Normally, a

velocity of 90 feet per minute, plus or minus 20%, is adequate, although higher velocities may be needed where the operations generate high levels of particulates or where equipment configuration disrupts laminar flow. Air should also be of a high microbial quality. An incidence of no more than one colony forming unit per 10 cubic feet is considered as attainable and desirable. Critical areas should have a positive pressure differential relative to adjacent less clean areas;

a pressure differential of 0.05 inch of water is acceptable’.

Controlled areas ‘Air in controlled areas is generally of acceptable particulate quality if it has a per- cubic-foot particle count of not more than 100,000 in a size range of 0.5 micron and larger (Class 100,000) when measured in the vicinity of the exposed articles during periods of activity. With regard to microbial quality, an incidence of no more than 25 colony forming units per 10 cubic feet is acceptable. In order to maintain air quality in controlled areas, it is important to achieve a sufficient air flow and a positive pressure differential relative to adjacent uncontrolled areas. In this regard, an air flow sufficient to achieve at least 20 air changes per hour and, in general, a pressure differential of at least 0.05 inch of water (with all doors closed), are acceptable. When doors are open, outward airflow should be sufficient to minimize ingress of contamination’.

Moorfield Associates

Moorfield House

Plumley Moor Road Plumley; Cheshire United Kingdom; WA16 9RS

Tel: +44 (0) 1565 722609

www.moorfield.co.uk

sales@moorfield.co.uk

Fax: +44 (0) 1565 722758

© Moorfield 2001

Comparison of Various Standards Shown in Table 5 is a comparison of the classes given

Comparison of Various Standards

Shown in Table 5 is a comparison of the classes given in the standards discussed above.

Table 5: A comparison of international standards.

Country

U.S.A.

U.S.A.

Britain

Australia

France

Germany

ISO

and

209D

209E

BS 5295

AS 1386

AFNOR

VD

standard

standard

X44101

I.2083

Date of

1988

1992

1989

1989

1972

1990

1997

current

onwards

issue

         

-

0

 
 

1

M1.5

C

0.035

-

1

3

 

10

M2.5

D

0.35

-

2

4

 

100

M3.5

E

or F

3.5

4 000

3

5

 

1 000

M4.5

G

or H

35

-

4

6

 

10 000

M5.5

J

350

400 000

5

7

 

100 000

M6.5

K

3500

4 000 000

6

8

The above information has been extracted from the handbook ‘Cleanroom Technology’ written by Bill Whyte.

Moorfield Associates

Moorfield House

Plumley Moor Road Plumley; Cheshire United Kingdom; WA16 9RS

Tel: +44 (0) 1565 722609

www.moorfield.co.uk

sales@moorfield.co.uk

Fax: +44 (0) 1565 722758

© Moorfield 2001

CLASIFICACIONDELAIRE­ESTANDARES­CLASES­SALASLIMPIAS­TESTS

◊LimitesdelasClasesdelFederalStandard209D

 
 

Clase

 

Particulas/pié 3

   

Tamaño

>= 0.1 µm

>= 0.2 µm

>= 0.3 µm

>= 0.5 µm

>= 5.0 µm

 

1

35

7.5

3

1

NA

 

10

350

75

30

10

NA

 

100

NA

750

300

100

NA

 

1.000

NA

NA

NA

1.000

7

 

10.000

NA

NA

NA

10.000

70

 

100.000

NA

NA

NA

100.000

700

◊LímitesdelasClasesdelFederalStandard209E

 
 

LimitesdelaClase

 

NombredelaClase

 

>= 0.1µm

 

>=0.2µm

 

>= 0.3µm

 

>=0,5µm

>=5.0

 

VolumeUnits

 

SI

English

m

3

pié 3

m

3

pié 3

m

3

pié 3

m

3

pié 3

m

3

M1

   

350

9.91

 

75.7

2.14

 

30.9

0.875

 

10.0

0.283

 

­­

M

1.5

1

 

1.240

35

 

265

7.50

 

106

3.00

 

35.3

1.00

 

­­

M2

   

3.500

99.1

 

757

21.4

 

309

8.75

 

100

2.83

 

­­

M

2.5

10

 

12.400

350

 

2.650

75.0

 

1.060

30.0

 

353

10.0

 

­­

M3

   

35.000

991

 

7.570

214

 

3.090

87.5

 

1.000

28.3

 

­­

M

3.5

100

 

­­

­­

 

26.500

750

 

10.600

300

 

3.530

100

 

­­

M4

   

­­

­­

 

75.700

2140

 

30.900

875

10.000

283

 

­­

M

4.5

1.000

 

­­

­­

 

­­

­­

 

­­

­­

35.300

1.000

 

247

M5

   

­­

­­

 

­­

­­

 

­­

­­

100.000

2.830

 

618

M

5.5

10.000

 

­­

­­

 

­­

­­

 

­­

­­

353.000

10.000

2.470

M6

   

­­

­­

 

­­

­­

 

­­

­­

1.000.000

28.300

6.180

M

6.5

100000

 

­­

­­

 

­­

­­

 

­­

­­

3.350.000

100.000

24.700

M7

   

­­

­­

 

­­

­­

 

­­

­­

10.000.000

283.000

61.800

◊ Límites de las Clases del Estándar I SO 14644­1

 

Númerodela

Límitesmáximosdeconcentración(Particulas/m 3 deaire)departiculas"iguales

ClasificaciónISO

a"y"mayoresque"lostamañosmostradosabajo

 
 

>= 0.1µm

>= 0.2m

>= 0.3µm

>= 0.5µm

>=1µm

>= 5.0µm

ISO Clase 1

10

2

       

ISO Clase 2

100

24

10

4

   

ISO Clase 3

1.000

237

102

35

8

 

ISO Clase 4

10.000

2.370

1.020

352

83

 

ISO Clase 5

100.000

23.700

10.200

3.520

832

29

ISO Clase 6

1.000.000

237.000

102.000

35.200

8.320

293

ISO Clase 7

     

352.000

83.200

2.930

ISO Clase 8

     

3.520.000

832.000

29.300

ISO Clase 9

     

35.200.000

8.320.000

293.000

◊ Comparación entre las clases equivalentes del Federal Standard 209 y de la I SO 14644­1

 

Clase I SO 14644­1

Clase 3

Clase 4

Clase 5

Clase 6

Clase 7

Clase 8

FederalStandard

Clase 1

Clase 10

Clase 100

Clase 1.000

Clase 10.000

Clase 100.000

◊ClasificacióndelAireenlaUniónEuropea,guíaparaBuenasPrácticasdeFabricación

N umero m áximo de partículas permitidas x m 3 igualesaosobre

 

Grado

endescanso

enoperación

 

>= 0.5µm

>= 5.0µm

>= 0.5µm

>= 5.0 µm

A

350

0

3.500

0

B

3.500

0

350.000

2.000

C

350.000

2.000

3.500.000

20.000

D

3.500.000

20.000

not defined

not defined

Note Grado A y B corresponde a clase 100, M 3.5, ISO 5 Grado C corresponde a clase 10000, M 5.5, ISO 7 Grado D corresponde a clase 100000, M 6.5, ISO 8

 

◊ClasificacióndecontaminacióndeSalasLimpias

 
 

Sustancia

Energía

Física

Química

Biológica

 

Polvo

Compuestos orgánicos

Bacteria

Térmica

Suciedad

Sales inorgánicas

Hongos

Luz

Arenilla

Vapor

Esporas

Electromagnetica (EMI)

Fibra

Mist

Polen

Electrostática (ESD)

Lint

Fume

Virus

Radiación

Ceniza volatil

Humo

Celulas de piel humana

Electrica

◊Particulasenelaireexterior

 

NumerodeParticulas/m 3 enelaireexterior

Tamaño en Micrones

Sucio

Normal

Limpio

>0.1

10.000.000.000

3.000.000.000

500.000.000

>0.3

300.000.000

90.000.000

20.000.000

>0.5

30.000.000

7.000.000

1.000.000

◊CalendariodetestsOBLIGATORIOSparademostrarelcumplimientocontinuodesalaslimpias

Parámetro

Clase

MáximoIntervalodeTiempo

 

Conteo de Partículas

<= ISO 5

6Meses

>ISO 5

12

Meses

Diferencia presión aire

Todas las Clases

12

Meses

Flujo de Aire

Todas las Clases

12

Meses

◊CalendariodetestsOPCIONALESparademostrarelcumplimientocontinuodesalaslimpias

Parámetro

Clase

MáximoIntervalodeTiempo

Installed Filter Leakage Fugas

Todas

 

24

Meses

 

Containment Leakage

Todas

 

24

Meses

Recovery

Todas

 

24

Meses

Airflow Visualization

Todas

 

24

Meses

◊ComparacióndeestándaresInternacionales

 
 

PaísyEstándar

 

USA 209D

 

USA 209E

Inglaterra BS

Australia AS

 

Francia

Alemania

ISO

   

5295

1386

AFNOR NFX

VDI 2083

   

44­101

 

Fechadeemisión

 

1988

 

1992

 

1989

1989

 

1981

1990

1999

1

M

1.5

C

0,035

­

 

1 3

10

M

2.5

D

0,35

­

 

2 4

100

M

3.5

E

or F

3,5

 

4000

 

3 5

1000

M

4.5

G

or H

35

­

 

4 6

10000

M

5.5

J

350

 

400000

 

5 7

100000

M

6.5

K

3500

 

4000000

 

6 8

◊EUGGMP2002LímitesrecomendadosdeContaminaciónMicrobiana

     

contact

 

Settle Plates Diam 90 mm cfu/m 3

Plates Diam

Glove Print

Air Sample

55 mm

5 fingers

Grade

cfu/m 3

cfu/m 3

cfu/glove

A

<1

<1

<1

<1

B

10

5

5

5

C

100

50

25

­

D

200

100

50

­

Note Grado A y B corresponde a clase 100, M 3.5, ISO 5 Grado C corresponde a clase 10000, M 5.5, ISO 7 Grado D corresponde a clase 100000, M 6.5, ISO 8

 

◊ClasificacióndelAireporlaOrganizaciónMundialdelaSalud(WHO)2002

NúmeroMáximoPermitido/m 3

   

Grado

Partículas

Micro

0.5µm

5.0µm

organismos

A(LAF)

350

0

<1

 

B 3.500

0

5

 

C 350.000

2

100

 

D 3.500.000

20

500

Note Grado A y B corresponde a clase 100, M 3.5, ISO 5 Grado C corresponde a clase 10000, M 5.5, ISO 7 Grado D corresponde a clase 100000, M 6.5, ISO 8

 

◊ClasificacióndelAireporel"ScheduleM"

 

NúmeroMáximoPermitidodepartículas/m 3 igualomayor

Grado

endescanso

enoperación

0.5µm

5.0µm

0.5µm

5.0µm

A

352

29

3.520

293

B

3.520

293

352.000

2.930

C

352.000

2.930

3.520.000

29.300

D

3.520.000

29.300

not defined

not defined

Note Grado A y B corresponde a clase 100, M 3.5, ISO 5 Grado C corresponde a clase 10000, M 5.5, ISO 7 Grado D corresponde a clase 100000, M 6.5, ISO 8

 

◊TiposdeOperacionesparapreparacionesasépticas.

Grade

TypesofOpeartionsforAsepticPreparations

A

Preparación aséptica y relleno

B

Background room conditions for activities requiring Grade A

C

Preparacion de Soluciones para ser filtradas

D

Manipuleo de componentes después del lavado

Note Grado A y B corresponde a clase 100, M 3.5, ISO 5 Grado C corresponde a clase 10000, M 5.5, ISO 7 Grado D corresponde a clase 100000, M 6.5, ISO 8

◊TiposdeOperacionesparaproductosesterilizadosterminales

Grade

TypesofOpeartionsforTerminallySterilisedProducts

A

Relleno de productos, no usualmente riesgosos

C

Placement of filling and sealing machines, preparation of solutions, when unusually at risk. Filling of products when unusually at risk

D

moulding, blowing (pre­forming) opearions of plastic containers, Preparation of solutions and components for subsequent filling

Note Grado A y B corresponde a clase 100, M 3.5, ISO 5 Grado C corresponde a clase 10000, M 5.5, ISO 7 Grado D corresponde a clase 100000, M 6.5, ISO 8

◊MonitoreoambientaldeSalasLimpias

 

Sl.N o

Test

Frecuencia

1

Monitoreo de partículas en suspensión

6