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A Tool To Maintain
Environment
In Pharmaceutical Plant.
by:
Ali Raza
Microbiologist
Fassgen Pharma, Pakistan 1
Heating
Ventilation
Air -
Conditioning
HVAC
Environmental
Requirements
In Pharmaceuticals
Temperature
Relative Humidity
Air Cleanliness Classes
Air Distribution
Air Motion
Air Filtration
Air Changes
……Cont’d
Maintenance
Heating, Ventilation,
Air-Conditioning
CFR-211.46 (a,b)
Adequate ventilation shall be provided.
Equipment for adequate control over air
pressure , microorganisms, dust,
humidity, and temperature shall be
provided when appropriate for the
manufacture, processing, packaging, or
holding of a drug product.
5
……Cont’d
7
Critical Parameters
Temperature
Humidity
Α ir Cleanliness classes
For FS209 cleanliness classes 100,
1000 & 10000 terminally installed
HEPA filters are required.
For cleanliness class 100,000
centrally installed filter bank of
99.97% may be installed although
terminal filteration is preferred.
Airborne Particulate
Control
2 G %5>6 2 UE
3 G %0>8 3 UE
EN 779
EUROVENT 4/5
COARSE FILTERS
4 G %>9
0 4 UE
(--)
Dust Spot
5 F %0>4 5 UE
6 F %0>6 6 UE
EN 779
7 F %0>8 7 UE
EUROVENT 4/5
FINE FILTERS
8 F %>9
0 8 UE
Efficiency
9 F %5>9 9 UE
MPPS DOP
Most Penetrating Particle Size 0.3µm
%5>8 01 H %>9
5 11 UE
%5>9 11 H %9. >9
9 11 UE
(++)
%5999. 9>9 51 U
“ABSOLUTE” FILTERS
%59999. 9>9 61 U
%599999. 9>9 71 U
Air Flow Patterns
Turbulent Flow
Laminar Flow
Dilution Versus Displacement
Air Changes
≥ 10 air changes/h
Room Pressure Control
Through filtration.
Through fumigation.
Through irradiation.
Monitoring & Data
Logging
Manual
Semi Automatic
Automatic
All critical parameters should be monitored
regularly and non-compliances should be
indicated
Alert limit alarms may be utilized to
indicate when a critical parameter goes out
of the set limit
…..Cont’d
The sensors, alarms, and
recording systems for
critical parameters should
carefully be selected and
installed
Maintenance
Break down
Preventive
Predictive
Thank You !
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