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DESIGN QUALIFICATION (DQ)

DESIGN QUALIFICATION

FOR

SYS-INJ-03
Vial Wash And Sterilization.

ARISTO PHARMACEUTICALS PVT. LTD., NEAR

BADDI, DISTRICT SOLAN,
HIMACHAL PRADESH-173205, INDIA.

SUPPLIER:

SUVIDHA ENGINEERS INDIA PRIVATE LIMITED

C 37, SECTOR 57,
NOIDA

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DESIGN QUALIFICATION (DQ)

Table of Content

Page No. Description

3 OBJECTIVE
3 SCOPE
4 RESPONSIBILITIES
4 USER REQUIREMENT
4-5 SYSTEM DESCRIPTION
6 ROOM DATA SHEET FOR HVAC SYSTEM
6-8 SELECTION CRITERION FOR MAJOR COMPONENTS
DESIGN / TECHNICAL PARAMETERS FOR MAJOR
9-6
COMPONENTS
17 ABBREVIATIONS
18 ENCLOSURES
19 OBSERVED DEVIATION
19 SUMMARY & CONCLUSIONS
20 APPROVALS

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1.0 OBJECTIVE:
The objective of this document is to provide a detail design & specifications for the SYS-INJ-03.
Design qualification document shall ensure that user requirement specification and functional requirement
specification are considered in the design
 This Design qualification is an essential part of the qualification process and will serve as a basic
document for the further validation activities.
 The HVAC system should comply with the following critical parameters as prescribed in the URS.
1.1 Air Cleanliness levels as per Grade –C.
1.2 Temperature
1.3 Relative Humidity
1.4 Differential pressure to provide assurance against cross contamination from low pressure area to higher
Pressure area if applicable.
1.5 Air changes rates specified for different classified rooms.
1.6 Air flow pattern in case of classified area only.

2.0 SCOPE:

The scope of this document is limited to provide detailed design specifications of SYS-INJ-03 which caters to
Vial Wash and Sterilization at Aristo Pharmaceuticals Pvt. Ltd., Solan.

2.1 SCOPE OF CONTRACTOR:

 Supply, Installation, testing and validation of HVAC system comprising of main equipment’s & their
accessories:
2.1.1 HVAC system with Pre Filter (F7), Fine Filter (F9), Fresh air filter (G4) and Bleed air filter
(H13),Hot water coil, chilled water coil, Plug type blower and motor.
2.1.2 Supply and Return Air Diffusers.
2.1.3 Supply and Return Ducts given in the duct layout with duct insulation.
2.1.4 CD Damper (Combination Damper) in the Supply air duct.
2.1.5 Chilled water manifold.

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2.1.6 3 way valve in chilled water manifold & 2 way valve in Hot water manifold if applicable.
2.1.7 SYS Electrical VFD panel

3.0 RESPONSIBILITIES:

3.1 Client :
 To provide the URS/Tender for the HVAC system.
 To review and approve the DQ of the HVAC system.
3.2 Contractor :
 To provide the complete technical details of the HVAC system pertaining to its design
qualification.
 To prepare and review the DQ of the HVAC system
 To confirm the safe delivery of the HVAC system to the user site.
 To ensure that no un-authorized and / or unrecorded design modifications shall take place. If at
any point in time, any change is desired in the mutually agreed design, Change control procedure
shall be followed and documented.
 To ensure the proper installation and commissioning of the equipment.

4.0 USER REQUIREMENTS:

RH % Min. Air Absolute

Class Temperature
S.No. Area (NMT) Changes Room Temp.
Vial Wash And
1. C 22 + 2˚C 50 60 75 + 5 Pa
Sterilization

5.0 SYSTEM DESCRIPTION (AIR HANDLING UNIT) :

 The SYS-INJ-03 is catering to Vial Wash and Sterilization. The SYS-INJ-03 is designed to maintain
temperature 22 + 2˚C, humidity – NMT 50 & cleanliness class –C.
 The system is comprised of double skinned cabinet, Plug type blower with Energy Efficient (IE2) motor,
Hot water coil, chilled water coil, drain tray & Pre Filters (F7), Fine Filters (F9), Fresh Filter (G4)and
Bleed air filter (H13), volume control dampers, Magnehelic gauge across filters.

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 Plug type fan in the System draws the air stream (7363 CFM) from the served area through return air
ducts and return air Swirl diffusers in the rooms, and then it is mixed with some proportion of fresh air
(177 CFM) inside the mixing chamber of your air handling system. Then after passing through Pre- Filter
(F7) in SYS, it is fed to the chilled water coil and hot water coil after passing through SYS Blower, it is
again fed to Fine filters (F-9) and then the Bleed air filter (H13) in the SYS.
 After getting conditioned through the coil, it is fed to the supply air (7461 CFM) ducts (after filtration by
F9 Fine filter in the SYS) and distributed into the concerned areas after passing through Supply Air
Diffuser.
 The SYS blower will have 7540 operating CFM (refer air flow diagram), however SYS blower has been
selected for 8294 CFM i.e. 10 % higher than operating CFM.

 The CFM details as per air flow Diagram is given below:

1. Vial Wash and Sterilization - Supply 7461 CFM & Return 7363 CFM

 CD (Combination Damper) with actuator is installed in the Supply Air Duct. The smoke detector is
installed in the return air duct which operates the CD damper actuator.
 Various parameters and Safety control will monitor and controlled by a DDC controller and various field
devices installed at appropriate locations.
 The chilled water manifold comprising of ball valves or butterfly valves, Y strainers, 3 Way control valve,
temperature gauges & Pressure gauges, globe valve, drain valve.
 Pipe Insulation: The Armacell Nitrile Rubber insulation (Silver Check) for the chilled water manifold
piping work will be used.
 Air Distribution - In all the rooms catered by SYS-INJ-03, Diffusers in supply air & return air will be
used.
 Duct Insulation – Aluminum foil duct insulation (XLPE – Cross Linked Poly Ethylene) will be used for the
entire ducting. 20 mm thick insulation for supply air & 12 mm thick insulation for return air duct will be
used.
 The Magnehelic gauges will be used for measuring differential pressure across filters in the System.
 T sensor is installed in the return air duct. Temp input will be given to DDC controller which gives output

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signal to DDC for controlling temp in room by means of 3 way control valve.

5.1 SAFETY FEATURES:

 The limit switch, as safety feature, is provided in the blower section in the System. It is interlocked with
the blower motor power supply, as the access door is opened, it will cut off the power supply to the System
motor by means of VFD.
 CD Damper with motorized actuator are provided in the supply , which will operate in case of generation
of smoke in the area & actuator will be off through DDC controller .

5.2 ROOM DATA SHEET FOR SYS-INJ-03 :

Part I
Area(Sq. Suppl Retur Fresh/
M) X Volume Volume Eq. y n Min Bleed
Height (cubic (cubic Occ. Load CFM CFM FA Air
Room Name
(M) M) Ft.) (kw) ACPH (CFM)

Vial Wash
70(Area)X 177
and
3 (H) 211 7461 2 12.49 7461 7363 60
Sterilization

Part II

Dehumidified Infiltration Exfiltratio Light Min

n Load Room TR KW
Room Name (CFM) (CFM) ACPH
(CFM) (w/sqft)
Vial Wash
and 4440 0 98 NA 60 8.6 0
Sterilization

6.0 RATIONALE FOR THE SELECTION OF COMPONENTS :

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Name of the Design criteria/
critical component concept/purpose
Plug type Blower SYS-INJ-03 is designed for
particular CFM & to deliver that
CFM suitable blower is required.
Blower operating RPM should be
lower than the critical RPM.
Fan should be selected for max
efficiency.
Motor SYS-INJ-03 is designed for
particular CFM & to deliver that
CFM against designed static
pressure suitable motor kw is
required to run the blower.
Motor should be High energy Operating/Design
efficient, 3 phase & suitable kw CFM=7540/8294,
should be selected to meet the
CFM requirement.
Chilled water coil Coil is designed to achieve the
required temp (22 + 2°C).
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Rational for Selection Actual component
to be provided
Blower is selected for For technical data of
required CFM based upon blower, Refer
the room CFM requirement, technical specs of
keeping the RPM & components in SYS
efficiency factor in GA Drawing.
consideration.
Operating/Design
CFM=7540/8294,
Static Pressure=150 mm
As per required CFM wrt For technical data of
fan model selection & Motor , Refer
design specification like technical specs of
amperage, rpm, frequency, components ,Fan
phase, voltage & efficiency. selection curve , SYS
GA Drawing
Static Pressure=150 mm
Room load unit is in terms For technical data of
of Tonnage (TR) or British chilled water coils ,
thermal unit (BTU/hr). Refer technical specs
For compensate the room of components
load (8.6 TR), the chilled
water coil is selected.
Coil selection is based upon
required air qty. 7540 CFM
& ( 500 FPM )coil face
velocity to compensate the
room load for maintaining
the temp/RH.
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Hot water coil Coil is designed to achieve the
required temp (22 + 2°C).
Room load unit is in terms
of Tonnage (TR) or British
thermal unit (BTU/hr).
For compensate the room
load (8.6 TR), the chilled
water coil is selected.
For technical data of
hot water coils , Refer
technical specs of
components

Coil selection is based upon

required air qty. 7540 CFM
& ( 500 FPM )coil face
velocity to compensate the
room load for maintaining
the temp/RH.

Name of the Design criteria/ Rational for Selection Actual component to be

critical concept/purpose
component
Temperature T sensor installed in return air
duct for controlling temp in
Sensor
the room through 3 way
controlled valve installed in
chilled water manifold
provided
Temp sensor is installed in For technical data of Temp
return air duct for controlling sensor Refer technical specs
chilled water flow to chilled of components.
water coil with the help of
.Temp input signal is given to
DDC controller which further
gives out put signal to the
actuator of 3 way control valve

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7.0 DESIGN /TECHNICAL SPECIFICATION OF THE MAJOR COMPONENTS:

A. Electric Motor :

Specification for Design Specification

Location AIR HANDLING UNIT
Make CROMPTON GRIEVES/EQUI.
Type IE-2
KW 11.18
Voltage 415 V +/- 10 % ,3 Phase
Motor RPM 1450

B. Fan Unit :

Specification for Design specification

Location AIR HANDLING UNIT
Model No. BDB-500 T
Capacity Operating 7540 CFM , Design 8294 CFM
Fan Design RPM 1904
Static Pressure 150 MM
Name of the mfg. KRUGER

C. SYS Filter Details :

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