Fundamental of CGMP For Pharmaceutical Hvac System

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Fundamental of cGMP for Pharmaceutical HVAC System
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Part#1
Section1: GMP Fundamentals of

Pharmaceutical HVAC System
MAJDI AYOUB
HVAC Qualification 2018
cGMP guidelines/trends in HVAC Qualification/Validation for Pharmaceutical Sterile and non-Sterile Facilities 1
Views and Opinions
The views and opinions expressed in this
presentation are those of the author and are
not necessarily representative of the views,
opinions or policies Firm.
2018 Majdi Ayoub
cGMP-HVAC 2018-Eng.Majdi Ayoub

2
Presentation Scope
• The scope of this training will
focus primarily with current
good manufacturing practices
(cGMP) design requirements for
HVAC systems serving
Pharmaceutical manufacturing
Sterile and non sterile facility.

3
Presentation Out-of-Scope
• This training program is
intended as a basic guide for
use by GMP inspectors. They
are not intended to be
prescriptive in specifying
requirements and design
requirements for the
ducting/loads nor design
calculations.

4
Presentation Overview
A. What are Factors contributing to quality products?
B. What do HVAC abbreviation mean ?
C. Why do we require air Conditioning
D. What Can not HVAC system do?
E. Where contaminants are come from ?
F. What are contaminants cause?
G. What is the Cross contamination?
H. What is the relation between HVAC & cGMP
Environmental Conditions.

5
A. What are Factors contributing to quality
products (1/1)
Inadequacies in the above factors will lead

to sub-standard products .
Environment=HVAC systemm and more……

6
B. What does HVAC abbreviations mean? (1/7)
Heating
Ventilation
Air Conditioning

7
HVAC
Heating The temperature out side is less than inside
Conduction: The heat transfer due to

conduction takes place if the
two bodies at different
temperatures are in contact
with each other. It is also true
if a substance is heated from
one end. heat transfer takes
place to the other end by
conduction.
Video1
Heat_Conduction_Trick 8
HVAC
1.Conduction: ….
2.Convection: When liquid or gas is heated, expansion takes place. Due to this it
becomes lighter and rises up. Its place is taken by colder or dense
fluid. This is a continuous process and thus heat transfer takes place
due to these currents and heat is distributed through the mass.
Video2
Hot_and_Cold_Water_Science_Experiment cGMP-HVAC 2018-Eng.Majdi Ayoub 9
HVAC
1.Conduction: ….
2.Convection……
3.Radiation: The heat transfer due to radiation
takes place from one body to
another without effecting the
medium through which heat
travels. Heat flow from sun to
earth takes place in this fashion.
Video3
04:55
Methods_of_Heatr_Transfer after 04 and 55 10
HVAC
1.Conduction:
2.Convection:
`
3. Radiation:
-All three methods normally are used at the same time.

- One method may do more and the other may do less.
- All three methods give excess heat depending on the surrounding conditions

11
HVAC
Ventilation Sending the air out from the space and/or
supplying the fresh air into the space.

12
HV AC
Air Conditioning It means a process by which the temperature,
humidity, flow and purity of the air is controlled
simultaneously – to get the required conditions.
- Temperature Air Conditioning
Video4
Indoor_Air_Quality_IAQ_HVAC particle prevention
- Air Flow Conditioning
Video5
- Purity Air Conditioning
Ventilation_Example (air change diagram)
- Humidity Air Conditioning

13
C. Why do we require Air Conditioning? (1/13)
To maintain
Human
comfort.
To improve
or control an
Industrial
process.

14
To maintain
Human comfort.
To improve or control
an Industrial process.
Maintaining Human
comfort.
Increasing the
Working in Good Reduce the exposure humane comfort will
Environment to materials Reduce the humane
contaminant
Major factor to achieve proper Humane Comfort
To be continued….
15
To maintain Human comfort.
To improve or control
an Industrial process.
To improve or control an Industrial process.
Maintain space Control airborne

Maintain room Control of Air
Maintain space mois ture (Relative
Humidity)
particles, dust and
micro-organisms
pressure (delta P) movement
temperature
(1 / 1 ) Air Temperature at the critical location may

Comfort temperature in affect product or product contact surface,
winter/summer and/or affected by room equipments
Video6
Air_Flow_Simulation_by_Flow Designer_-Utility_Space 16
To improve or control an
Industrial process.
To improve or control an Industrial

process.
Control airborne
Maintain space
temperature Maintain space particles, dust and
micro-organisms
Maintain room
pressure (delta P)
Control of Air
movement
moisture (Relative
Humidity)
(1 / 1 ) Air Relative Humidity at the critical location

may affect product moisture content or cause
Comfort Relative Humidity in
material corrosion
winter/summer

17
Industrial process.

Maintain space mois
Maintain space
temperature
ture (Relative
Humidity)
Control airborne Maintain room
pressure (delta P)
Control of Air
movement
particles, dust and
micro-organisms
(1 / 6 )
Comfort working atmospheric Airborne contamination at critical
conditions location may affect product purity
To be continued….
18
Industrial process.

Maintain space mois
Maintain space
temperature
ture (Relative
Humidity)
pressure (delta P)
Control of Air
movement
particles, dust and
micro-organisms
(2/6)
Non- Viable
Viable Counts
Counts
X-product
Substances
Particle contaminants
To be continued….

19
Industrial process.

Non-Viable Viable
Maintain space mois Counts Counts
Maintain space
temperature
ture (Relative
Humidity)
pressure (delta P)
Control of Air
movement X-
particles, dust and product
Substanc
micro-organisms es
(3/6)
particle contaminants
- Typical comfortable person - Non-comfortable person
Gives 100,000 particle /min (for Gives millions particle /min

>0.3 micron, 100 micron from (different particle sizes and more
-Viable count hair) bacteria)
-Non viable Counts
To be continued….

20
Industrial process.
To improve or control an Industrial process. Non-Viable Viable

Counts Counts
Maintain space mois X-
Maintain space
temperature
ture (Relative
Humidity)
pressure (delta P)
Control of Air
movement product
particles, dust and Substanc
es
micro-organisms
(4/6) particle contaminants
Even seemingly
- X-product Substances smooth surfaces
can harbor
bacteria !
Scanning electron micrograph of Listeria

monocytogenes forming a biofilm in soy on a
stainless steel chip. Courtesy of Professor
Amy Wong.
To be continued….

21

Industrial process.

Counts Counts
Maintain space
temperature
ture (Relative
Humidity)
pressure (delta P)
Control of Air
movement product
es
micro-organisms
- 90% of airborne particles in out door air are <

0.5 Micron (1% of the mass)
- 2% of airborne particles in out door air are > 1
Micron (97% of the mass)
- Virus (0.002-0.05 Mcron ),Bacteria (0.4-20
microns), spores ( 10-40 microns), smoke(
0.01 – 1 micron),DOP (0.1 to 0.7 micron),dust
and ash( 0.5 to 1000 microns)
- Pre-filter do must of mass removal
To be continued….

22
Industrial process.

Counts Counts
Maintain space
temperature
ture (Relative
Humidity)
pressure (delta P)
Control of Air
movement product
es
micro-organisms
Displacement
Particle
Removal
Dilution
Video 8
Air_Flow_Simul
ation_by_Flow
Designer_-
Utility_Space
23
C. Why do we require Air Conditioning?(11/13)
Industrial process.

Control airborne
Maintain space Maintain space mois Control of Air
particles, dust and
temperature ture (Relative Humidity)
micro-organisms Maintain room movement
pressure (delta P)
(1 / 1 )
Outside room boundaries contamination may affect
product purity , maintain room pressure is needed
to reduce the chance of airborne contamination

24
Industrial process.

process.
Maintain space mois ture Control airborne particles, Maintain room pressure
Maintain space temperature (Relative Humidity) dust and micro-organisms (delta P) Control of Air
Movement
(1 / 1 )
Air movement is critical for

proper air change/ and air
mixing and to minimize
contamination
To be continued….

25
Industrial process.

process.
Maintain space mois ture Control airborne particles, Maintain room pressure
Maintain space temperature (Relative Humidity) dust and micro-organisms (delta P) Control of Air
Movement
(2/2)
1st :Air Velocity 2nd: Air Volume

26
D. What Can not HVAC system do? (1/1)

27
E. Where contaminants are come from ? (1/5)
Sources of
Contamination
External Internal
sources sources

28
Sources of
Contamination
E… Where contaminants are come from ? (2/5)
Internal
External sources sources
1st :Makeup air from AHU 2nd: Building door/ windows seal 3rd: Wall penetration pipes/
cable/ ducts
Action taken:
Action taken:
High Efficiency Filtration
Space Pressurization
Sealing of space Penetration

Sources of
Contamination
External
sources Internal sources
1st :People in the room 2nd: Process Equipment 3rd:manufacturing process
- Skin/Hair Flakes
- Body cosmetics
-Respiratory
emissions
Action taken: Action taken:
Follow personnel GMP practices (hygien ) Proper Cleaning procedure

Proper HVAC Supply/ return
configuration
To be continued….
30
The primary factor that separates pharmaceutical HVAC from comfort HVAC is the need to control
contamination to assure “….purity , identity and quality of the product “ (21 CFR 211)

31
Classification of Clean Room

Contaminants
Physical Chemical Biologic Energy
Dust Organic Compounds Bacteria Thermal
Dirt Inorganic Salts Fungus Light
Grit Vapour Spore Electromagnetic (EMI)
Fibre Mist Pollen Electrostatic(ESD)
Lint Fume Virus Radiation
Fly ash Smoke Human Skin Electrical
- - Cells -

32
F. What are contaminants cause? (1/5)
Illness (eyes,
respiratory organs
cancer, heart, lung
diseases)
Contaminants
Risk

33
Illness (eyes, Common Dirty,

respiratory organs indoor damage if air
cancer, heart, lung cleaning is
diseases)
insufficient
Contaminants
Risk

34
Illness (eyes, Common Dirty, indoor

respiratory organs
cancer, heart, lung damage if air cleaning is
diseases) insufficient
Contaminants
Risk
Corrosion

35
Illness (eyes,
Common Dirty, indoor
respiratory organs
damage if air cleaning is
cancer, heart, lung
insufficient
diseases)
Contaminants
Risk
Damage to the
Corrosion
environment

36
G. What is the Cross contamination? (1/3)
Definition of Cross-Contamination (WHO) :

Contamination of a starting material, intermediate product, or
finished product with another starting material or product during
production .

37
From where does Cross-Contamination originate?
Poorly operated
Poorly designed and maintained
air handling and air handling
dust extraction systems and dust
systems extraction
systems
Inadequate
Insufficiently
procedures for
cleaned
personnel and
equipment
equipment

38
What is the difference between contamination and cross contamination?
Contaminant
Contaminant
from
Contamination from
Environment
Equipment
Operators
Product
Product
from Cross
from
Environment Contamination
Equipment
Operators

39
H. What is the relation between HVAC & cGMP
View publication stats
Environment Conditions (1/1),
Ref.: WHO TRS 962,2011, Annex5 cGMP-HVAC 2018-Eng.Majdi Ayoub

40

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See discussions, stats, and author profiles for this publication at: https://www.researchgate.

Section1: GMP Fundamentals of

2018 Majdi Ayoub

cGMP-HVAC 2018-Eng.Majdi Ayoub

cGMP-HVAC 2018-Eng.Majdi Ayoub

cGMP-HVAC 2018-Eng.Majdi Ayoub

cGMP-HVAC 2018-Eng.Majdi Ayoub

Inadequacies in the above factors will lead

Environment=HVAC systemm and more……

cGMP-HVAC 2018-Eng.Majdi Ayoub

cGMP-HVAC 2018-Eng.Majdi Ayoub

Conduction: The heat transfer due to

-All three methods normally are used at the same time.

cGMP-HVAC 2018-Eng.Majdi Ayoub

cGMP-HVAC 2018-Eng.Majdi Ayoub

- Humidity Air Conditioning

cGMP-HVAC 2018-Eng.Majdi Ayoub

cGMP-HVAC 2018-Eng.Majdi Ayoub

Major factor to achieve proper Humane Comfort

To improve or control an Industrial process.

Maintain space Control airborne

(1 / 1 ) Air Temperature at the critical location may

To improve or control an Industrial

(1 / 1 ) Air Relative Humidity at the critical location

cGMP-HVAC 2018-Eng.Majdi Ayoub

To improve or control an Industrial process.

To improve or control an Industrial process.

cGMP-HVAC 2018-Eng.Majdi Ayoub

To improve or control an Industrial process.

- Typical comfortable person - Non-comfortable person

Gives 100,000 particle /min (for Gives millions particle /min

-Non viable Counts

cGMP-HVAC 2018-Eng.Majdi Ayoub

To improve or control an Industrial process. Non-Viable Viable

(4/6) particle contaminants

Scanning electron micrograph of Listeria

cGMP-HVAC 2018-Eng.Majdi Ayoub

C. Why do we require Air Conditioning? (9/13)

To improve or control an Industrial process. Non-Viable Viable

(5/6) particle contaminants

- 90% of airborne particles in out door air are <

- Pre-filter do must of mass removal

cGMP-HVAC 2018-Eng.Majdi Ayoub

To improve or control an Industrial process. Non-Viable Viable

To improve or control an Industrial process.

cGMP-HVAC 2018-Eng.Majdi Ayoub

To improve or control an Industrial

Air movement is critical for

cGMP-HVAC 2018-Eng.Majdi Ayoub

To improve or control an Industrial

1st :Air Velocity 2nd: Air Volume

cGMP-HVAC 2018-Eng.Majdi Ayoub

cGMP-HVAC 2018-Eng.Majdi Ayoub

cGMP-HVAC 2018-Eng.Majdi Ayoub

cGMP-HVAC 2018-Eng.Majdi Ayoub

1st :People in the room 2nd: Process Equipment 3rd:manufacturing process

Action taken: Action taken:

Follow personnel GMP practices (hygien ) Proper Cleaning procedure