Cleanrooms
ISO 14644-1 (1999)
A room
Controlled
humidity
temperature
minimized particle
Particule contamination
generation
retention
Introduction
Particle Sources
Internal
External
atmospheric contamination
human
machines & dev
processing
bacteria
chem. & gasses
Cleanroom Tech.
Construction
Operation
Testing
Standards
Layout
Construction Mat.
Services
Setting cleanroom
to work
Does it perform
as designed?
Can it go on
to perform as
designed?
Monitoring cond.
entry of people,
machine & mat
discipline
garments
equipment
Classification
ISO
Class 5
Class 3
Class 6
Class 2
Class 7
Class 1
least # particle
Class 9
Class 4
Class 8
most # particle
USA
1
10
100
1000
10000
100000
EU
B
C
A
D
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 ✅