pharmaceutical engineering company
pharmaceutical and biotechnological plants
turnkey GMP solutions for Russia and CIS

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Pharmtech Expo 2011, Moscow. Big success for FAVEA

ABOUT US

- history
- news
- specialization
- reference: pharmacy, healthcare
- certificates
- FAVEA Group structure
- career

PHARMACEUTICAL PLANTS

- turnkey GMP solutions for Russia and CIS

CLEANROOMS

- cleanrooms
- HVAC for cleanroom

HEALTHCARE ENGINEERING

- healthcare enginneering
- reference

EXPORT FINANCING

- export financing

CONTACTS

Moscow: moscow@favea.org
Prague: prague@favea.org
Kiev: kiev@favea.org
- contacts




EXPORT FINANCING
экспортное финансирование FAVEA

- export financing




HEALTHCARE ENGINEERING
операционные блоки FAVEA

- healthcare enginneering

- reference


HVAC for cleanroom

Air Con

FAVEA builds HVAC systems for cleanrooms in accordance with GMP standards.

Cleanrooms maintain particulate-free air through the use of either HEPA or ULPA filters employing laminar or turbulent air flow principles. Laminar, or unidirectional, air flow systems direct filtered air downward in a constant stream towards filters located on walls near the cleanroom floor or through raised perforated floor panels to be recirculated. Laminar air flow systems are typically employed across 80 percent of a cleanroom ceiling to maintain constant air processing. Stainless steel or other non-shed materials are used to construct laminar air flow filters and hoods to prevent excess particles entering the air. Turbulent, or non-unidirectional, air flow uses both laminar air flow hoods and non-specific velocity filters to keep air in a cleanroom in constant motion, although not all in the same direction. The rough air seeks to trap particles that may be in the air and drive them towards the floor, where they enter filters and leave the cleanroom environment.

Selected ISO 209 airborne particulate cleanliness classes for cleanrooms

 

numbers (N) Maximum concentration limits (particles/m3 of air) for particles equal to and larger than the considered sizes shown below
 

0.1mm

0.2mm

0.3mm

0.5mm

1mm

5.0mm

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:

Cn = 10N x (10/D)2.08

where:

Cn represents the maximum permitted concentration ( in particles/m3 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 mm.

0.1 is a constant with a dimension of mm.

The table shows a crossover to the old FS 209 classes e.g. ISO 5 is equivalent to the old FS 209 Class 100.

The standard also gives a method by which the performance of a cleanroommay 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 5. Smaller particles (ultra fine) will be of particular use to the semiconductor industry and the large (³ 5mm macro particles) 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 macro particles is to use the format:

'M(a; b);c'

where

a is the maximum permitted concentration/m3

b is the equivalent diameter.

c is the specified measurement method.

An example would be

'M(1 000; 10mm to 20mm); cascade impactor followed by microscopic sizing and counting'.


© FAVEA.org, 2011