In this slide contains definition, validation method of HVAC Presented by: V NABI RASOOL (Department of pharmaceutical analysis and quality assurance).RIPER, anantapur.

1. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721
Validation of HVAC
(Heating Ventilation and Air conditioning)
A Seminar as a part of curricular requirement
for M. Pharm I year II semester
Presented by
V.NABI RASOOL. (20L81S0401).
Department of Pharmaceutical Quality Assurance.
1

2. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721
Content Table
S.NO CONTENTS
1 Validation
2 Introduction to HVAC
3 Validation parameters of HVAC
4 References
2

3. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721
Validation :
•Process of establishing documented evidence that
demonstrate, the process/activity/test/procedure in
the production/testing of pharmaceuticals that meet
the desired level of compliance at all the time.
Advantages:
•Decreases OOS/OOT.
•Reduces product Recall.
•Assures the quality of the product.
3

4. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721
Heating, Ventilation, and
Air-conditioning systems (HVAC)
• HVAC include all the air filtration, electrical, and
electronic devices required to create and maintain
specific levels of cleanliness, temperature, humidity,
pressure differentials, and airborne cleanliness in
controlled environments.
JSS College of Pharmacy,

5. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721
Function:
JSS College of Pharmacy,
• To condition(heating & cooling)
• To replace(make up, oxygen replacement)
• To Pressurize
• To clean(filter) the air in the environment

6. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721
What is clean room ?
JSS College of Pharmacy,
A room in which the concentration of airborne
particle is controlled and which is constructed and
used in a manner to minimize the
Introduction,
Generation and
Retention of particles inside the room.
A room in which other relevant parameters. e.g..
Temperature, humidity and pressure, are controlled as
necessary.

7. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 7

8. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721
HVAC consists of :
1. Air conditioner
2. Air Handling unit
3. De-humidifier/heater
4. Filters
5. Dust extractors
6. Ducting (for delivery of controlled air)
7. Supply fans
8. Temperature, Pressure, Humidity sensors
9. Heating and Cooling coils
8

9. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 9

10. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721
Validation of HVAC
JSS College of Pharmacy,
Different tests to be conducted:
1. Air Flow Pattern
2. Air Flow Velocity and Change per Hour
3. Filter Leak Test
4. Particles Count
5. Viable Monitoring
6. Filter Integrity Test.
7. Pressure Difference
8. Recovery (Temperature & Humidity)
9. Temperature and Humidity Uniformity Test
10. Fresh Air Determination

11. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721
Air Flow Pattern
JSS College of Pharmacy,
• Take the titanium tetrachloride stick.
• Burn the stick.
• Place the burning stick in front of running Air
Handling Unit (AHU).
• Observe the flow of air with the help of smoke
distribution in the room.
• The distribution of smoke should be uniform.

12. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 12

13. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721
Filter Leak Test
JSS College of Pharmacy,
• Place the VELOMETER infront of AHU unit.
• Next Check the velocity of air to the all corner of the
AHU. The air velocity should be within the higher
limit of HEPAfilter.
• If there is air velocity is less than higher limit, a gas
cut (Silicon)is used to prevent the air leakage.

14. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 14

15. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721
Particles Count :
JSS College of Pharmacy,
• On the air system before one hour of test operation.
• Take the suitable particle counter and operate it to
check the particles in the room at non working
operation.
• Collect the information from particle counter and fill
them in the format.

16. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 16
• Operate the particle counter when work is on
progress in the area. The particles should be count
when more than one hour work has been
progressed in the area.
• Record the data in the format.
• Operate the particle counter for all the room
maintaining grade A, grade B, grade C & grade D.

17. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 17

18. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 18

19. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721
Pressure drop across the HEPA filters :
•The purpose of this test is to check the clogged or clean
condition of the HEPA filters.
•Here the differential pressure transmitter(manometer) is
connected to before and after the filters.
•Then check the status of the filter whether it is in
cleaned condition or in clogged condition.
•If it is in cleaned condition there will be no pressure
drop.
19

20. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 20

21. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721
Temperature and Relative Humidity test :
•Temperature and RH is checked and recorded in
Static and Dynamic condition.
•Static Condition : All the machines are kept in
switch OFF.
•Dynamic Condition :Machine with load are in run
condition.
•Temperature and RH sensor Display units
(Hygrometer sensor) are used and recorded and
should meet the USER requirement specifications.
21

22. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 22

23. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721
Air Borne viable Particle monitering :
•It determines the air borne microbial contamination
in the area.
•Pre incubated SCDA Media plates shall be exposed
in Locations mentioned for 4 hours and incubated
for 48 hours at 300C to 350C .
•Next 72 hours at 200 C to 250 C and record the
results .
•SCDA plates shall be incubated once in 15 days to
moniter the growth of anaerobic microorganisms .
•All the parameters which are performed in the area
should meet the specifications .
23

24. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721
References:
1. Robert Nash and Alfred Watcher, Marcel Decker, Pharmaceutical
Process Validation, 3rd Ed. Edited by, 2003, pp.507-509.
2. Agalloco James, Carleton J. Fredric ‘’ Validation of Pharmaceutical
Processes’’ 3rd Ed.417-428.
24

25. RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 25