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Environmental Monitoring in Sterile Area
Environmental Monitoring in Sterile Area
1. Particulate Matter
Particle Counter
2. Differential Pressure
Positive pressure differential of 10-15 Pascal should
be maintained between adjacent rooms of different
classification (with door closed).
Most critical area should have the highest pressure
3. Air Changes and Air flow patterns
Air flow over critical areas should be uni-directional
4. Temperature and Relative Humidity
Ambient Temperature and RH.
5. Microbiological Testing of Air
Two types of Microbiological Air testing Methods
A. Sedimentation method
B. Impaction method
Microbiological Testing of Air
1. Sedimentation method
The principle involved is Gravitational fallout in a
given time on a given area.
Irregularities in counts due to wild air currents,
physical movement of personnel etc.
2. Impaction Method
Different types of air samplers use this principle
The particles in air Impact onto the medium plates
by the application of Electrical or mechanical forces.
Slit Samplers
Sieve Samplers
Centrifugal Samplers
Microbiological Testing of Water