2. It is a process of
configuration of an
instrument to provide
acceptable range or
results of sample.
CALIBRATION
3. It is a process of
configuration of an
instrument to provide
acceptable range or
results of sample.
CALIBRATION
1. Transducer
Calibration.
2. Data System
Calibration.
3. Physical end-to-end
Calibration.
1. External
2. Internal
3. Standard Addition
Methods
Types
5. CFM
Cooling Capacity
Cooling Coil Type
Condensing Unit Type
Refrigerant
AHU
(Air Handling
Unit)
Temperature
Humidity
Air Change Rates
Air Cleanliness Classes
Area Pressure
Fresh Air Make Up
CRITICAL
PARAMETERS
1. G 3 Filter (45%)
2. G 4 Filter (55%)
3. F 9 Filter (95%)
Pre Filters
10. Calculation of Air Changes in Pharmaceuticals
ACH (Air Changes Per Hour)
CFMĂ—60
Room Volume
11. Procedure
1. Measure the size of Grill or SAD (Supply Air Dust).
2. Measure reading 6 inches away from different locations of SAD.
3. First take reading in FPM (Feet Per Minute), calculate the air quantity in CFM (Cubic
Feet Per Minute) with average air velocity.
4. Repeat same procedure for air supply diffusers available in same room.
5. Calculate the total air in CFM inside the room.
6. Now apply following equation;
CFMĂ—60
Room Volume
12. Example
Room Room
Volume
(cubic ft.)
Inlet Air Velocity
(*FPM)
Supply Air
Dust Area
(Sq. ft.)
No. of
Supply
air Duct
CFM Total CFM of
all inlet
ACH
CFMĂ—60
Room Volume
ACH
SAD-1 SAD-2 2 2 SAD-1 SAD-2
Filling Room 1512 422 431 1688 1724 3412 3412Ă—60/1512 135.3 A/H
SP Area 670 110 108 2 2 440 432 872 872Ă—60/670 78 A/H
Prepared By:
Head of Microbiology/ Validation
Saleem Ullah Sheikh