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Useful Information in Cleanroom Application

Technology International provides cleanroom design, installation, and consulting services. The document includes 6 tables that summarize key standards for cleanroom particle requirements (Tables 1-2), recommended filtration stages (Table 3), FDA and other standards for cleanroom classifications (Table 4), required particle testing schedules (Tables 5-6).

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AKIN EREN
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20 views2 pages

Useful Information in Cleanroom Application

Technology International provides cleanroom design, installation, and consulting services. The document includes 6 tables that summarize key standards for cleanroom particle requirements (Tables 1-2), recommended filtration stages (Table 3), FDA and other standards for cleanroom classifications (Table 4), required particle testing schedules (Tables 5-6).

Uploaded by

AKIN EREN
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on Scribd
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TECHNOLOGY INTERNATIONAL SDN BHD (534019-T)

No. 10C, Jalan Anggerik Vanilla, Y31/Y Seksyen 31, 40460 Shah Alam, Selangor, Malaysia.
Tel: +603-5124 8319 +603-5124 0312
Email: [email protected] website: www.iaqtechnology.com.my

Useful Information in Cleanroom Application


Table 1: Airborne Particle Requirements for ISO 14644 and Federal Standard 209
Obsolete
Number of particles per m3 by micrometer size
ISO Federal
14644-1 Standard
209 0.1ìm 0.2ìm 0.3ìm 0.5ìm 1ìm 5ìm

1 10 2
2 100 24 10 4
3 1 1,000 237 102 35 8
4 10 10,000 2,370 1,020 352 83
5 100 100,000 23,700 10,200 3,520 832 29
6 1,000 1,000,000 237,000 102,000 35,200 8,320 293
7 10,000 352,000 83,200 2,930
8 100,000 3,520,000 832,000 29,300
9 35,200,000 8,320,000 293,000

Table 2: Recommended Filter Ceiling Table 3: Recommended Filtration Stages


Coverage Guide
ISO 14644 First Second Third Fourth
Cleanroom Equivalent Percentage Cleanliness Filter Filter Filter Filter
Class to Cleanroom Class Ceiling Class Stage Stage Stage Stage
FS209D to ISO 14644 Coverage
2 G4 F7 H12 U17

3 G3 F6 H11 U16
100,000 8 5-10
4 G2 F5 H10 U15

10,000 7 15-20 5 F5 F9 H14

6 F5 F8 H13
1,000 6 30 7 G4 F7 H12

8 G3 F6 H11
1-100 3-5 100 9 G3 F5 H10

Table 4: Comparison of FDA, NASA, EU-GMP Standards

FDA NASA EU-GMP


Cleanliness
Class CFU/m3 CFU/m3 CFU/ At Rest In Operation
(CFU/ft3) (CFU/ft3) m3
0.5ìm/m3 5ìm/m3 0.5ìm/m3 5ìm/m3

A 100 - - <1 3,500 - 3,500 -

3.5 3.5
B 100 10 3,500 - 350,000 2,000
(0.1) (0.1)
18
C 10,000 - 100 350,000 2,000 3,500,000 20,000
(0.5)
88 88
D 100,000 200 3,500,000 20,000 - -
(2.5) (2.5)

Note: The above information is for reference only. Please refer to the respective Standards for exact details.
TECHNOLOGY INTERNATIONAL SDN BHD (534019-T)
No. 10C, Jalan Anggerik Vanilla, Y31/Y Seksyen 31, 40460 Shah Alam, Selangor, Malaysia.
Tel: +603-5124 8319 +603-5124 0312
Email: [email protected] website: www.iaqtechnology.com.my

Table 5: Schedule of testing to demonstrate compliance with particle concentration


limits as per ISO 14644-2

Classification Maximum Time Interval Test Method

ISO Class 5 6 months Annex B in ISO 14644-1:1999

ISO Class 5 12 months Annex B in ISO 14644-1:1999

NOTE: Particle count test will normally be performed in the operational state, but may also be
performed in the at-rest state in accordance with the designated ISO classification

Table 6: Schedule of Additional tests for all classes to demonstrate compliance as per
ISO 14633-2

Test Parameter Maximum Time Interval Test Procedures

Airflow volume a or airflow


12 months ISO 14644-3:-, clause B.4
velocity

Air Pressure difference b 12 months ISO 14644-3:-, clause B.5

NOTE: These tests may normally be performed in the operational or at-rest state, but many also
be performed in the at-rest state in accordance with the designated ISO classification

a
Airflow volume may be determined by either velocity or volume measurement techniques
b
This test will not apply to clean zones which are not totally enclosed

Note: The above information is for reference only. Please refer to the respective Standards for exact details.

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