VALIDATION AND QUALIFICATION OF HEATING, VENTILATION, AIR

CONDITIONING SYSTEM & PHARMACEUTICAL EQUIPMENTS

DISSERTATION PROTOCOL
SUBMITTED TO

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

BANGALORE, KARNATAKA.

BY
PATEL DHRUMIL DILIPKUMAR
B.PHARM,
UNDER THE GUIDANCE OF,
DR. SURESH D.
HEAD OF DEPARTMENT,
DEPARTMENT OF QUALITY ASSURANCE
SHREE DEVI COLLEGE OF PHARMACY
MANGALORE-574 142
(2011-2013).

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,

BANGALORE, KARNATAKA.
ANNEXURE-II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
1.

NAME OF THE CANDIDATE

PATEL DHRUMIL DILIPKUMAR.

AND ADDRESS (IN BLOCK

HOUSE NO-:856,

LETTERS)

THIRD STREET,
NARANPURA VILLAGE,
NARANPURA,
AHMEDABAD -: 380013

2.

NAME OF THE INSTITUTION

GUJARAT.
SHREE DEVI COLLEGE OF PHARMACY,
AIRPORT ROAD, KENJAR VILLAGE,
MALAVOOR PANCHAYAT,
MANGALORE-574 142,
KARNATAKA.

3.

4.

COURSE OF STUDY AND

MASTER OF PHARMACY IN

SUBJECT

QUALITY ASSURANCE

DATE OF ADMISSION OF
COURSE

5.

JULY-2011

TITLE OF TOPIC: VALIDATION AND QUALIFICATION OF HEATING, VENTILATION, AIR

CONDITIONING SYSTEM & PHARMACEUTICAL EQUIPMENTS

6.

BRIEF RESUME OF THE INTENDED WORK:

6.1

NEED FOR THE STUDY:

WHAT IS VALIDATION?
Definition
Food and Drug Administration of United State defines the validation as
Validation is defined as a documented program that provides a high degree of
assurance that a specific process, method or system will consistently produce a
result meeting its predetermined acceptance criteria.
Definition
The Commission of European communities defines validation as
Action of proving, in accordance with the principles of Good manufacturing
Practice, that any procedure, process, equipment, material, activity or system
actually leads to the expected results.
Definition
The World health organization (WHO) define the validation in the same way but
elaborates considerably on the concept
Validation studies are essential part of Good manufacturing practice and
should be conducted in according with predefined protocols. A written report
summarizing results and conclusions should be recorded, prepared and stored.
Processes and procedures should be established based upon the validation study
and undergo periodic revalidation to ensure that they remain capable of achieve
the intended results. Particular attention should be accorded to the validation of
processing, testing and cleaning procedures. Critical processes should be
validated, prospectively or retrospectively. When any new master formula or
method of preparation is adopted, steps should be taken to demonstrate its
stability for routine processing. The defined process , using the materials and
equipment specified, should be shown to yield a product consistently of the
required quality. Significant amendments to the manufacturing process,
including any change in equipment or materials, which may affect product
quality and/or the reproducibility of the process, should be validated.
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 Types of validation
Validation can be divided into four types
1
2
3

Prospective validation,
Rtrospective validation
Concurrent validation

Revalidation

Computerized validation

(1) Prospective Validation

In prospective validation, an experimental plan called the Validation Protocol
is executed (following completion of the qualification of the qualification trials)
before the process is put into commercial use.
(2) Retrospective Validation
The retrospective validation option is chosen for established products whose
manufacturing processes are considered stable (e.g. long History State of control
operation) and when, on the basis of economic considerations alone and
validation experimentation cannot be justified
(3) Concurrent Validation
In-process monitoring of critical processing steps and end product, the testing of
current production can provide documented evidence to show that the
manufacturing process is in state of control.
(4) Revalidation
Conditions requiring revalidation study and documentation are

Change in a critical component ( usually refers to raw materials )

Change or replacement in a critical piece of modular (capital ) equipment
Change in a facility and /or plant (usually location or site )
Significant (usually order of magnitude ) increase or decrease in batch size .
Sequential batches that fail to meet product and process specifications

(5) Computer Validation

Documented evidence which provides a high degree of assurances that a
computerized system analyses, controls and records data correctly and that data
processing complies with predetermined specifications

HVAC SYSTEM VALIDATION

4

The HVAC System is designed to serve the laboratory suite of the biotechnology plant
including cell culture rooms, aseptic rooms, preparation rooms, and air locks.
The laboratory rooms are designed for Class 10,000 and the air locks for Class 100,000.
Corridors are controlled but unclassified areas. Clean benches in the Class 10,000
laboratory rooms are designed for Class 100.
The outside air, combined with the return air, is treated by AHU and supplied to the
laboratory area. A part of the air exiting from the laboratory rooms is directly exhausted
into the atmosphere by an exhaust fan, while the remaining air is re-circulated to the
AHU as return air by a return fan.
The air entering into the AHU is filtered by pre-filters and medium filters and then air
conditioned for humidity and temperature control, and is supplied to the laboratory area
by a supply fan at desired pressure.
The supply air is terminal filtered by HEPA filers at the entrance to the cleanrooms. The
system is designed to satisfy all cGMP requirements.
Three Functions of HVAC
Heating is significant in maintaining adequate room temperature especially during
colder weather conditions. There are two classifications of heating: local and central.
The latter is more commonly used because it is more economical. Furnace or boiler,
heat pump, and radiator make up the heating system2.
Ventilation, on the other hand, is associated with air movement. There are many types
of ventilation, but they all function similarly. Ventilation is necessary to allow carbon
dioxide to go out and oxygen to get in, making sure that people are inhaling fresh air.
Stagnant air causes the spreading of sickness, usually airborne, and allergies. But it is
also essential to maintain an efficient ventilation system, especially in the attics.
Insufficient ventilation usually promotes the growth of bacteria and fungi such as molds
because of high humidity. It will also decrease the effectiveness of rafter and roof
sheathing insulation because of water vapor condensation.
The air-conditioning system controls the heat as well as ventilation. They often come in
different sizes. Most air conditioners have large air ducts, so it is better to check out the
5

building first to see if they can be installed. Or else, you can use the split system or
remote coils. It is necessary, though, that air ducts are properly cleaned. Pathogens
thrive in dirty air ducts. Return-air grills are also vulnerable to chemical,
microbiological, and radiological elements. Thus, HVAC return-air grill height should
be that it is not accessible but visible for any observation.

6.2

10

6.3

7.0

11

7.1

12

7.2

13

7.3

7.4

14

8.

15

AHU - 9

Droplet
Eliminator

AHU Air
Return Air
Fresh Air through 10

Exhaust Air through 10

(During Fumigation)

Pre filter 10+5

Access door panel
Cooling coil
for Filter
RAR
Fire Damper
Leakage
(1 filter 5)

VCD : Vacuum Control Damper

K
: Chilled water inlet
E
RAFC : Return Air Flange Connection
: Chilled water outlet
SAFC : Supply Air Flange Connection
Y
RAR : Return Air Riser
SAF : Supply Air Filter

Access Door Pan

SAF
(1 filter 3)

Ampoule filling Room LIine -1

Category 0.3

VCD

RAFC

16

17

9.

Signature of the candidate

(PATEL DHRUMIL D)
10.

Remarks of the Guide:

VALIDATION AND QUALIFICATION OF HEATING, VENTILATION, AIR
CONDITIONING SYSTEM & PHARMACEUTICAL EQUIPMENTS
to be carried out by Mr. Patel Dhrumil D. of M.Pharm has been discussed and worked
out under my direction and supervision as an official guide. The project work envisaged
is of great importance in the field of analytical research. The work can be carried out in
Quality Assurance Laboratory of Shree Devi College Of Pharmacy for which facilities
are available. Hence the project is viable and is recommended for clearance and

11.

approval.
Name & Designation of
(in block letters)
1
Guide

DR. SURESH D.
Department of Quality Assurance.
Shree Devi College Of Pharmacy,
Airport Road, Kenjar Village,
Malavoor Panchayat,
Mangalore, 574 142
Karnataka.

11.2 Signature
11.3 Head of the department

DR. SURESH D.
Department of Quality Assurance.
Shree Devi College Of Pharmacy,
Airport Road, Kenjar Village,
Malavoor Panchayat,
Mangalore, 574 142
Karnataka.

11.4 Signature

18

12.

12.1 Remarks of Principal:

The Program and the Research that is undertaken by Mr. Patel Dhrumil D. has the
potential implication in the field of Quality Assurance. The work can be carried in the
Research Laboratories of Quality Assurance Department at Shree Devi College Of
Pharmacy. Hence the project is recommended and requested for clearance and
approval.
12.2 Signature

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