STEDAM PHARMA MANUFACTURING LIMITED
INSTALLATION QUALIFICATION PROTOCOL $ REPORT FOR HVAC SYSYEM
INSTALLATION QUALIFICATION
OF HVAC SYSYEM
APPROVAL
Installation Qualification Preparation, Review, Approval
Function Department Name Sign & date
Prepared by Initiating department
Production / QC
Reviewed by Department
Engineering
Approved by Quality Assurance
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STEDAM PHARMA MANUFACTURING LIMITED
INSTALLATION QUALIFICATION PROTOCOL $ REPORT FOR HVAC SYSYEM
Table of Contents
1.0 PURPOSE.........................................................................................................................................
2.0 SCOPE..............................................................................................................................................
3.0 RESPONSIBILITY.............................................................................................................................
4.0 PROCEDURE …………………………………………………………………………………...3
5.0 EQUIPMENT DETAILS.....................................................................................................................
6.0 GENERAL REQUIREMENTS ...........................................................................................................
7.0 QUALIFICATION PROCEDURE.......................................................................................................
8.0 INSTALLATION CHECKLIST ...........................................................................................................
9.0 CHANGE CONTROL ........................................................................................................................
10.0 DEVIATION REPORT ......................................................................................................................
11.0 IMPACT ON THE PROCESS ...........................................................................................................
12.0 JUSTIFICATION FOR ACCEPTANCE .............................................................................................
13.0 FINAL REPORT ...............................................................................................................................
14.0 CONCLUSION .................................................................................................................................
15.0 ABBREVIATIONS .............................................................................................................................
1.0 PURPOSE
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STEDAM PHARMA MANUFACTURING LIMITED
INSTALLATION QUALIFICATION PROTOCOL $ REPORT FOR HVAC SYSYEM
The objectives of the Installation Qualification for the HVAC system are as follows:
To provide the guideline for installation qualification of the HVAC system.
To verify and document that the HVAC system has been installed in accordance with the
design specification & manufacturer’s recommendations.
To ensure that the measuring & monitoring instruments of the HVAC system that require
calibration have been identified and included in the calibration program.
To verify and document that operating personnel training requirements on the scope of
operation, maintenance and cleaning of the HVAC system have been identified and
implemented as per specifications.
2.0 SCOPE
The Installation Qualification protocol will be applicable under installation of the new HVAC
system
3.0 RESPONSIBILITY
S No. Department Responsibility
- Preparation of IQ protocol
Engineering
1 - Execution of IQ protocol
- Compilation and review of IQ protocol
- Review of IQ with respect to DQ, cGMP and regulatory
2 Production / QC
requirements
- Review of IQ with respect to Stedam pharma
requirements,
5 Quality Assurance - Regulatory requirement and cGMP requirements,
- Review & Approval, Authorization of IQ and clearance
for proceeding to next stage
4.0 PROCEDURE:
For each component of the equipment, fill in the details as per the provided checklist.
All information, data & deviations should be filled in the checklist.
5.0 EQUIPMENTS DETAILS
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STEDAM PHARMA MANUFACTURING LIMITED
INSTALLATION QUALIFICATION PROTOCOL $ REPORT FOR HVAC SYSYEM
The HVAC system to be qualified supplies & extracts processes air to/from all rooms in
production department.
Presented below are the User Requirement Specifications for the HVAC system:
Temperature: 21 ± 3°C
Relative Humidity: 45 ± 5%
Air Changes Per Hour (ACPH): NLT 30
Pressure differential: 10 - 35 Psa
Particle count: Class D
HEPA filter position: Terminal position
Particle count limits:
Non-Viable count limits:
Grade At Rest (Per M3) In Operation (Per M3)
> 0.5µ > 5µ > 0.5µ > 5µ
A 3520 20 3520 20
B 3520 29 352000 2900
C 352000 2900 3520000 29000
D 3520000 29000 Not defined Not defined
Viable count limits:
-Air sample Cfu/m³ - 200 Cfu/m³
-Settle plate (diameter 90 mm) Cfu/4hrs – 100 Cfu/4hrs.
-Contact plate (diameter 5 mm) Cfu/plate – 50 Cfu/plate
The HVAC system comprises of the Air processing unit, extraction system, air supply,
extraction & recirculation duct work. The duct work is made of galvanized sheet for
circulation & extraction of air to & from the rooms. A system of controls has been
incorporated in the design of the HVAC system to control the operation of the unit.
The HVAC system comprises of the following components:
Compressor
Cold condenser
Evaporator
Humidifier
Heater
Filters (Prefilter, intermediate filters & terminal filters)
Galvanized air supply duct work
Galvanized air extraction duct work
Air supply to the various rooms will be from the centrally placed terminal HEPA filter & extraction
from the lower sides of the walls. This will facilitate a unidirectional air flow in the respective
areas. Particulate air count in the rooms will be maintained within the Class C limits.
Refer to the non-viable particulate count limits above.
6.0 GENERAL REQUIREMENTS:
Verify the availability of the following documents:
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STEDAM PHARMA MANUFACTURING LIMITED
INSTALLATION QUALIFICATION PROTOCOL $ REPORT FOR HVAC SYSYEM
S.NO Document Available Not Available
1 Manufacturer user manual of (HVAC) √
2 General Arrangement drawing (HVAC) √
3 General Electrical wiring diagram √
7.0 QUALIFICATION PROCEDURE:
S.NO. Checkpoint Requirement Observation Checked by Date
1. Verify the HVAC – Electric power supply should Complies
Electric power supply match the requirement of the
Air system.
2. Verify required electric Electric connections already Complies
connections are tight properly installed, take the
weather proof and necessary measures to
grounded. ensure the electric
connections are tight
weather proof and grounded
3. Verify the equipment Equipment accessories and Complies
details. related documents are
complete.
4. Verify that there is no Equipment without physical Complies
observable physical damage.
damage.
5. Verify the dimension of The dimension and design Complies
the equipment against specification details of the
the G.A drawing of the equipment are correct.
equipment and the
design specification
details.
6. Confirm that there is Enough space provided for Complies
sufficient space for servicing, operation and
servicing provided. maintenance
7. Check that all electrical All the electrical connections Complies
connections have been are correct.
done according to the
drawings
8. Availability of schematic The schematic diagram Complies
diagram correct and availability.
9. Verify that major Major components are Complies
components are securely securely anchored and
anchored and protected protected from shock.
from shock.
10. External surface finishing The surface of equipment Complies
of equipment. treated and meets the
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STEDAM PHARMA MANUFACTURING LIMITED
INSTALLATION QUALIFICATION PROTOCOL $ REPORT FOR HVAC SYSYEM
requirements.
11. Check whether the filters The filters are installed in Complies
are installed in proper air proper air flow direction.
flow direction
Comments:
The above indicated checklist indicates that all the major components of the HVAC system have
been installed in accordance with the design & user requirement specification
8.0 INSTALLATION CHECKLIST
Design Requirement Observation Checked by Date
AHU cabinet:
Air volume 6, 000 m³/hr Complies
Surface panel 50 mm Complies
Inside bottom panel 50 mm Complies
Machine inside top 50 mm Complies
Thickness 50 mm Complies
Base plate height 50 mm Complies
Air inlet:
Type M/S damper Complies
Size 410 mm x 600 mm Complies
Position Side Complies
Control mode Manual Complies
Supply air filter:
Pre filters:
Installation Frame Complies
Filter type Plate type Complies
Filter grade G4 (90%) Complies
Support material Galvanized steel Complies
Filter brand Mayair Complies
Intermediate filter:
Installation Frame Complies
Filter type Bag Complies
Filter grade F7 Complies
Support material Galvanized steel Complies
Filter brand Mayair Complies
HEPA filter:
Type H13/H14 Complies
Material PTFE filter paper Complies
Size 630mm x 630mm x Complies
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STEDAM PHARMA MANUFACTURING LIMITED
INSTALLATION QUALIFICATION PROTOCOL $ REPORT FOR HVAC SYSYEM
220mm
Air volume 6, 000 m³/hr Complies
Filtration efficiency ≥99.99% Complies
Design Requirement Observation Checked by Date
Cooling part:
Model JHF 26 Complies
Manufacturer # 1405 B02 Complies
MOC Copper Complies
Fin material Copper Complies
Frame material Galvanized steel Complies
Air volume 6, 000 m³/hr. Complies
Heating part:
Capacity 14.4 KW Complies
Wiring direction Left Complies
Humidifying unit:
Manufacturer # 1405 B 02 Complies
Model JHF 26 Complies
Humidifying capacity 5 kg/hr Complies
Refrigerant R 22 Complies
Air volume 6, 000 m³/hr Complies
Control MMI Complies
Drainage direction Left Complies
Air supply fan:
Capacity 6, 000 m³/hr Complies
Blade type Backward Complies
Air outlet:
Type M/S damper Complies
Size 410 mm x 600 mm Complies
Position Side Complies
Control mode Manual Complies
Comments:
The above checklist indicates that all critical components for the HVAC system conform to the design
recommendations.
9.0 CHANGE CONTROL:
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STEDAM PHARMA MANUFACTURING LIMITED
INSTALLATION QUALIFICATION PROTOCOL $ REPORT FOR HVAC SYSYEM
Any changes regarding to the installation of the HVAC system will be carried out in accordance with the
change control procedure (SOP No.QA/10)
10.0 DEVIATION REPORT:
No deviation has been observed on the installation of the HVAC system in production area
11.0 IMPACT ON THE PROCESS:
The installation, mounting & support of the HVAC system and the support utilities have no impact
(negative or otherwise) on the process parameters.
The installation has no impact on the functionality, operation and overall performance of the HVAC
system
12.0 JUSTIFICATION FOR ACCEPTANCE:
Acceptance of the Installation of the HVAC system is justifiable on basis of the following:
Design of the main components of the HVAC system in conformity with c GMP recommendations.
Compliance of the provided support utilities in accordance with the User Requirement Specification
Installation of the HVAC system as per layout diagram.
13.0 FINAL REPORT:
The Installation Qualification report indicates that the HVAC system has been installed in accordance
with the design specifications, manufacturers recommendations and user specifications
The Installation Qualification demonstrates the following:
Assembly & connection of the subcomponents of the HVAC system in accordance with
the design & manufacturers recommendations.
Installation of the HVAC system has been performed in accordance with the proposed
layout configuration.
Required support utilities, mechanisms have been provided & connected as per the
design specification.
Safety requirements for the operating personnel, machine & environment have been for
as per the specification.
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STEDAM PHARMA MANUFACTURING LIMITED
INSTALLATION QUALIFICATION PROTOCOL $ REPORT FOR HVAC SYSYEM
All maintenance & calibration requirements of the HVAC system have been identified &
implemented as per specification.
The relevant signatories have verified, reviewed and approved the installation Qualification report
following the installation of the HVAC system, and found it to comply with the protocol requirements.
14.0 CONCLUSION:
In view of these, the HVAC system stands qualified as Installed in accordance with the design
specifications
Name Designation Signature Date
Checked by
Reviewed by
15.0 ABBREVIATIONS:
Short Full Form
Form
IQ Installation Qualification
Temp. Temperature
RH Relative Humidity
Doc. Document reference
Ref.
OQ Operational Qualification
URS User Requirement Specification
HEPA High Efficiency Particulate Air
mm³ Cubic millimeters
p. d Pressure Differential
c - GMP Current good manufacturing practices
PTFE Polytetrafluoroethylene
RPM Revolutions per minute
ID. NO Identification Number
GA General Arrangement
QA Quality Assurance
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STEDAM PHARMA MANUFACTURING LIMITED
INSTALLATION QUALIFICATION PROTOCOL $ REPORT FOR HVAC SYSYEM
APU Air Processing Unit
KW Kilowatts
m³/hr. Cubic meters per hour
Psa Pascal
HEPA High Efficiency Air Particulate
m/s Meters per second
HVAC Heating Ventilation and Air Conditioning
Qty. Quantity
MOC Material Of Construction
R.M Raw Material
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