Introduction to Contamination Control and Cleanroom Technology

Introduction
CONTAMINANTS
Cleanliness
Contaminants
Cleanliness demands
The world of microorganisms
Control of microorganisms
MEASURING TECHNIQUES
Analytical methods
The surrounding air
Cleanrooms
General particle analysis
Measurements according to US Federal Standard 209 E
Measurement of hygienic parameters in a cleanroom
Microbiological monitoring of air
Active sampling
Passive sampling
Sampling of surfaces in cleanrooms and clean zones
CLEAN ROOMS AND CLEAN ZONES
Definition of cleanrooms
Cleanroom classes
Occupancy states
The meaning of the cleanroom classification
US Federal Standard 209E
British Standard 5295
ISO "209"
Classification of airborne particles according to ISO 14644 1
Measurement within cleanrooms
Pharmaceutical cleanroom classification
Different types of cleanrooms
Clean rooms and clean zones
Working in clean zones
CLEANING AND DECONTAMINATION
The purpose of cleaning
Standards and practises
Cleaning
Cleaning responsibility
Surface cleanliness classification
Basic cleaning
Cleaning program
Cleaning control
Cleaning techniques
Cleaning methods
Cleaning program
Risk factors involving cleaning of cleanrooms
CLEAN ROOM GARMENTS
Garment systems for cleanroom use
Choice of material
Aspects of comfort
Construction of garment systems
Good Manufacturing Practice and Cleanroom Clothing
IEST-RP-CC-003.2
Using cleanroom garments
Clothing and personal items
Processing of clothing and change frequency
Risk factors associated with cleanroom clothing
PERSONAL HYGIENE AND PERSONAL RESPONSIBILITY
Man as generator of contaminants
Smoking
Good Manufacturing Practice for personnel
Education, training and control
Instructions
Man and the process
Guidelines for work within a cleanroom
Personal hygiene
Risk factor involving personnel
Concluding remarks
Glossary
Further reading