Environmental Monitoring - CERHB
Environmental Monitoring
? UF
Purpose of Environmental Monitoring
? Critical process within the pharmaceutical and biotechnology industries.
? Determines the microbial and particulate content of cleanroom air and surfaces.
? Highlights conditions contributing to excessive microbial & particulate levels due to ineffective cleaning, or personnel/equipment issues (Trending).
? Alerts to conditions exceeding classifications ? Pro-active tool for Quality Assurance
? UF
Who Does It?
? Quality Control
? Demonstrate product safety ? Environmental Monitoring ? Testing
? Quality Assurance
? Oversight responsibilities ? ensure compliance with GMPs
? Review and Approve all Records, Reports, written procedures, specifications
? Audit methods, results, systems and processes
? UF
Classifications
Critical Environment Classification
FS 209E N/A N/A 1 10 100
ISO 14644-1 1 2 3 4 5
1,000
6
10,000
7
100,000
8
Concentration (particles/meter?) > or = Size Shown
0.1 ?m
0.2 ?m 0.3 ?m
10
2
100
24
10
1,000
237
102
10,000
2,370
1,020
100,000 23,700 10,200
0.5 ?m
1.0 ?m
5.0 ?m
4 35 352 3,520
8
83
832
29
1,000,000 237,000 102,000
35,200 352,000
8,320 83,200
293 2,930
3,520,000 832,000 29,300
N/A
9
? UF
35,200,000 8,320,000 293,000
To be monitored
? Non-viable airborne particulates ? Viable airborn particulates ? Viable surface bound particulates on cleanroom
surfaces and personnel
Contamination Sources: ? People ~75% ? Ventilation ~15% ? Room Structure ~5% ? Equipment ~5%
? UF
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