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HVAC SYSTEM

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

 Differential Air Pressures

 Monitoring & Data Logging

 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

 Air filtration systems, including


prefilters and particulate matter air
filters, shall be used when appropriate
on air supplies to production areas.
 If air is circulated to production areas,
measures shall be taken to control
recirculation of dust from production.
 In areas where air contamination
occurs during production, there shall
be adequate exhaust systems or other
systems adequate to control
contaminants
6
Factors Affecting The HVAC system
Design
 Critical parameters
 Required Level of Protection
 Reliability
 Economic Analysis Criteria
 Future Growth/Flexibility Needs
 Budget
 Government Regulations

7
Critical Parameters

 Temperature
 Humidity

 Air borne particulates

 Air flow pattern


 Air changes
 Room pressure
 Microbial contamination
Temperature Control
 Heating / Cooling systems
 Heating (Electrical, Gas, Steam, Hot water,
Thermal oil)
 Cooling (Chilled water, DX coil)
 Critical when quality, efficacy or stability of the
products or processes affected by temperature
variation.
Cont’d
 Exposure time is important for temperature sensitive
products.
 The storage temperature should be maintained for raw

& Packaging materials according to QA documents.


 The storage temperature should be maintained for

semi finished & finished products according to QA


documents & label claim.
Relative Humidity
Control
 Humidification & Dehumidification
 Types of equipment for dehumidification
 Refrigerant type
 Desiccant type
 Solid Desiccant
 Liquid Desiccant
 Humidity (moisture content) affects the
products or materials sensitive to air moisture
…..Cont’d

 Dehumidification system should


not adversely contaminate the
products.

 The carry over of the desiccant


into the supply air system should
be protected.
Air Cleanliness Classes

 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

 Through Air Filtration


 Types of Filters & Filter Classes
 Through Air Washing
 Through Other means
 The filtration system should be
evaluated for capturing possible
contamination particulates
…..Cont’d
 In multi-product facility where
product has no tolerance for cross
contamination, air should not be
returned (even if HEPA filtered) for
re-circulation
 When air re-circulation is feasible and
economically justifiable, the return
air should be filtered to prevent
potential for cross-contamination
 For multiple product facility dedicated
AHU’s and ductwork are more
practical and cheaper than filtration
of return air or use of once through
air
Weight Arrestance

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

%5. 9>9 21 H %79. >9


9 21 UE
MIL STD 282

(++)

%59. 9>9 31 H%9999. >9


9 41 UE
EN 1822

%599. 9>9 41 H%9999. >9


9 41 UE
EUROVENT 4/4

%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

 Importance of Air Changes to Area


Classification
 Calculation of Air Changes Rates
 Recovery Periods
…..Cont’d

 Air cleanliness classes 1000 and


10,000
≥ 30 air changes/h
 Air cleanliness classes 100,000
≥ 20 air changes/h
 Pharmaceutically clean room
(Secondary rooms - ISO class 9)

≥ 10 air changes/h
Room Pressure Control

 It is important to cleanliness cascade.


 The velocity and direction of airflow should
be adequate to reduce contamination
 Air locks must be used to separate areas
from different cleanliness class.
 The door interlocks must be provided to
separate area of two different class.
 Air locks may be “positive” or “negative”
…..Cont’d
 Critical areas against less clean
areas ≥ 12.5 Pascal
 Controlled areas against
uncontrolled areas - with closed
doors ≥ 12.5 Pascal
 Adjacent rooms of different
grades should have a pressure
differential of 10 - 15 Pascal
Microbial Contamination
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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