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Cleanrooms - Coggle Diagram
Cleanrooms
Design
HEPA & ULPA filters
Air filtering.. flow is...
Laminar
Turbulent
Clean Benches
HLF
VLF
Biosafety Isolators
glove boxes
Layout
Isolation btw. processes
onion concept
Flow of materials,
product & waste
airlock :!:
Inspection of packaging & mat
keeping it in defined areas
modularized structure
pruducts move in one dir. ONLY
Follow up
Air quality
microbiological
centrifugal sampler
settle plate method
contact plate method
swabbing
alert limit & action limit
colony forming unite
working at cleanroom
slowly moving
+planning ahead
personal hygene :!:
No particle creating
clothes / accesories / behavior
Personal protective
clothing & eqp.
Good Gowning Practibe :check:
Cleanroom Tech.
Construction
Standards
Layout
Construction Mat.
Services
Setting cleanroom
to work
Operation
Monitoring cond.
entry of people,
machine & mat
discipline
garments
equipment
Testing
Does it perform
as designed?
Can it go on
to perform as
designed?
Classification
ISO
Class 5
Class 3
Class 6
Class 2
Class 7
Class 1
least # particle
Class 9
most # particle
Class 4
Class 8
USA
1
10
100
1000
10000
100000
EU
B
C
A
D
Particle Sources
Internal
human
machines & dev
processing
bacteria
chem. & gasses
External
atmospheric contamination
ISO 14644-1 (1999)
A room
Controlled
humidity
temperature
Particule contamination
minimized particle
generation
retention
Introduction