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 ✅