3  US Navy

ISO
10,000 2,370 1,020 352 83 Class 10
4

ISO We have had 6 FDA audits

100,000 23,7000 102,000 3,520 8,320  293 Class 100
5
this year. Two of them
ISO Class surprise. They always
1,000,000 237,000 102,000 35,200 8,320 2,930
6 1,000 attack the cleanroom but it
always passes with flying
ISO Class
352,000 83,200 2,930 colors. Our cleanrooms are
7 10,000
robust and have worked
ISO Class
3,520,000 832,000 29,300 great since ACS installed
8 100,000
them in 2003.
ISO  Eric, Implantable Medical
35,200,000 8,320,000 293,000 Room Air
9 Product, IS07 600 S.F. T RH
Control, Woburn, MA

Class 10 Class 100 Class 1000 Class 10,000 Class 100,000

Criteria
ISO4 ISO5 ISO6 ISO7 ISO8

Air
changes 500-600 / 300 to 480
180 / 3 60 /1 20 /0.33
per 8 to 10 / 5 to 8
HR/Min

Filter
coverage 90 – 100 60 – 70 20 – 30 7 – 15 4  – 5
%

CFM per 85 – 90 36 – 65 18 – 32 9 – 16 4–8

square