UNICURE INDIA LTD (Unit-III)

Plot No.112-113, Ecotech No.12 Greater Noida (West), U.P

USER REQUIREMENT SPECIFICATION

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 UNICURE INDIA LTD (Unit-III)
Plot No.112-113, Ecotech No.12 Greater Noida (West), U.P

USER REQUIREMENT SPECIFICATION

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CONTENTS

S. NO. TITLE PAGE NO.

1.0 URS Approval 3

2.0 Objective 4

3.0 Scope 4

4.0 Scope of Services 4-5

5.0 Technical Requirements 5-7

6.0 Salient Features 7

7.0 Safety Features 8

8.0 Technical Specification 9

9.0 Total AHU supply in Rooms 10

10.0 Deviation 10

11.0 Delivery 10

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 UNICURE INDIA LTD (Unit-III)
Plot No.112-113, Ecotech No.12 Greater Noida (West), U.P

USER REQUIREMENT SPECIFICATION

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1.0 URS APPROVAL:

PROTOCOL PREPARED BY:

Department Name Signature Date

Engineering
(Executive/Manager)

PROTOCOL REVIEWED BY:

Quality Control
(Executive/Manager)

Production
(Executive/Manager)

Engineering
(Executive/Manager)

Quality Assurance
(Executive/Manager)

PROTOCOL APPROVED BY:

Managing Director

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 UNICURE INDIA LTD (Unit-III)
Plot No.112-113, Ecotech No.12 Greater Noida (West), U.P

USER REQUIREMENT SPECIFICATION

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2.0 OBJECTIVE:
The purpose of this document is to detail the basic guidelines to the vendor for the purpose of
fabricating the Purified Water Distribution System as per the defined specifications. It is the
foremost and the basic requirement of the process and system as envisaged by the project team and
management.
3.0 SCOPE:
Scope of URS cover finalization of equipment and its major components design specifications and
also comprising of the following main equipments:
3.1 AHU units
3.2 Process motor
3.3 Reactivate motor
3.4 Supply air Terminal HEPA Filter
3.5 Return air Riser
3.6 Gear motor
3.7 Instrumentation and Controls
3.8 Electrical
3.9 Ducting, Terminal HEPA, R.A Riser, Damper
3.10 Insulation
3.11 Condensing unit for cooling
3.12 Heater for RH maintain
3.13 The responsibility and authority to ensure that this policy is observed and acted upon is vested in
UNICURE INDIA LTD (Unit-III), Plot No.112-113, Ecotech No.1 Greater Noida, U.P Project team.
They will ensure that procedures are written to address the issues raised below.

Note: Scope of URS cover finalization of equipment and its major components and design
specifications and also comprising after finalization the URS

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 UNICURE INDIA LTD (Unit-III)
Plot No.112-113, Ecotech No.12 Greater Noida (West), U.P

USER REQUIREMENT SPECIFICATION

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4.0 SCOPE OF SERVICES:

4.1 To design a Purified Water Distribution system shall meet with, WHO, EUGMP guide lines, which
controls Temperature, Relative Humidity, Differential Pressure and Air-Borne Particle
Contamination (Viable and Non-viable) to meet the specific class in the area.
4.2 The system should have unique features & high tech, with simplicity in operation and reliable. The
system design should facilitate minimum time with easy accessibility for servicing and maintenance.
4.3 Commissioning include supervision and erection of system and their alignments. Trial run of system
is to be taken with and without dummy materials as per specified capacities at shop and after
installation.
4.4 Our offer shall be complete with literature and catalogue of all the items offered, process flow
diagrams, equipment and piping ducting layout (with dimensions), the information required on the
equipment specs such as dimensions, electrical details, utility requirement, utility hook- up details,
installation drawings, P & Ids, etc.
4.5 The installation shall meet with the highest standards of cGMP and international standards of
construction.
4.6 Exclusion from Scope of Supply.
4.6.1 All Civil Work
4.6.2 Utility
4.6.3 Electric supply, wherever required.

4.7 The AHU system should be able to control the following parameter:
4.7.1 Temperature (°C).
4.7.2 Relative Humidity (%).
4.7.3 No. of ACPH (Air Changes per Hour) in Cubicle.
4.7.4 Particulate count (Non-viable and Viable) of the area.
4.7.5 Fresh Air Qty. / Supply and Return Air Qty.

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 UNICURE INDIA LTD (Unit-III)
Plot No.112-113, Ecotech No.12 Greater Noida (West), U.P

USER REQUIREMENT SPECIFICATION

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5.0 TECHNICAL REQUIREMENTS:

5.1 Documentations:
5.1.1 Relevant catalogues and technical details in duplicate to be given with DQ.
5.1.2 Layout showing overall dimensions for each item of AHU and dimensions of base to be submitted at
the earliest for approval.
5.1.3 Power and services requirements for each item of AHU including utility characteristics required.
5.1.4 Certification for Filters, Coils, Fans and Motor, Insulation, Ducts etc.
5.1.5 Shipping weight and crate dimensions.
5.1.6 Safety features.
5.1.7 Change parts requirement, if any.
5.1.8 Complete technical specifications.
5.1.9 All instruments/ gauges/controls including electronic controls should be calibrated and calibration
certificates along with calibration procedure followed to be provided (traceability to National
Standards to be informed by vendor). Vendor should recommend frequency for calibration of
instrument/ gauges/controls.
5.1.10 Certificates for the following should be provided wherever applicable. MOC, Pressure Test,
Performance Test. Design Qualification (DQ) and General assembly Drawings shall be submitted to
Unicure India Limited within two weeks after issuance of Purchase Order. Installation Qualification
(IQ), Operational Qualification (OQ) and Performance Qualification (PQ) shall be done at the
installation site as per the approved Protocol by UNICURE INDIA LTD (Unit-III) Plot No.112-113,
Ecotech No.1 Greater Noida, U.P
5.1.11 Operation and maintenance manuals shall be submitted prior to AHU delivery in triplicate, as early
as possible.
5.1.12 All AHU drawings as built to be submitted for records in triplicate.
5.1.13 The service requirement AHU shall be clearly indicated. The service hook-up details to be provided.
5.1.14 Commissioning methods and commissioning tests/Qualification/Acceptance criteria shall be
specified either in operational manual or in commissioning document to be submitted prior to
delivery of AHU at the earliest.
5.1.15 Construction certificate shall be provided with the AHU.
5.1.16 Training to operators to be carried out and documented evidence to be submitted.

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 UNICURE INDIA LTD (Unit-III)
Plot No.112-113, Ecotech No.12 Greater Noida (West), U.P

USER REQUIREMENT SPECIFICATION

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5.1.17 Details and frequency of Preventive maintenance is to be provided.

5.1.18 Draft SOP for the operation is to be provided before any Qualification activity is under taken.
5.1.19 Recommended cleaning procedure is to be given in the manual. A declaration of hard to clean area is
to be given in the manual.
6.0 Finishing And Line Balancing:(has to be check)
6.1.1 The system comprises of Air Handling unit which is a single tier unit with a ZIEHL- ABECG fan.
The AHU shall be double skin construction with thermal break profile made of Aluminum Alloy
with 43 mm thick PUF insulation of density 38±2 Kg/ m3. The AHU shall be having outer skin of 0.8
mm thick pre coated GI Sheet and inner skin of 0.8 mm thick plain GI sheet.
6.1.2 In Air Handling Unit air passes through a series of filters before entering into clean rooms. The
ambient air is first filtered through a Pre filters EU -5(F-5 grade) efficiency 99% to 5 micron), &Fine
Filter EU -7 (F-7 grade) efficiency 99% to 3 micron) before entering into the ducting system. The air
in the ducts is ultimately filtered in terminal HEPA filters of Grade EU -13 (H-13 grade) (0.3 micron)
and ultimately introduced into the room through HEPA Filters at terminals. Similarly return air shall
be picked up from low level return air risers which shall be having pre filter of EU – 4 (G-4 grade) (10
micron) grades for preventing any carryover to AHU.
6.1.3 The AHU shall have cooling section with coil and hot water coil section to maintain the humidity
and temperature in the air.
6.1.4 The AHU shall have a mixing box wherein the fresh air shall be mixed with room return air. This
mixed air shall be treated in/passed through chilled water & Hot Water coils for maintaining room
temperature as described. The AHU also has an exhaust air cutout through which air is exhausted
through EU - 4 pre-filter.
6.1.5 AHU placement, Terminal HEPA & R.A Riser location, etc, with layout of rooms are enclose.
(Drawing and AHU placement, Terminal HEPA & R.A Riser location, has to be enclose).
6.2 Electrical:
6.2.1 All drive motors to be flameproof suitable for 415 V ± 10%, 3 Phase, 50 ±5% Hz.
6.2.2 All AHU offered should be guaranteed for workmanship and quality of materials for a minimum
period of one year from the date of commissioning.
6.2.3 All system to be provided with overhead relay for protection against single phasing and low voltage.

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Plot No.112-113, Ecotech No.12 Greater Noida (West), U.P

USER REQUIREMENT SPECIFICATION

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6.2.4 All bought out items / Motors /Sub Module should be of reputed make meeting International
Standards.
6.2.5 All system accessories offered should be guaranteed for workmanship and quality of materials for a
minimum period of one year from the date of commissioning.
7.0 SALIENT FEATURES:
5.0.1 Humidity Sensor with controller for control the RH.
5.0.2 Temperature indicator – digital or analogue display.
5.0.3 Magnahelic gauges for measuring differential pressure.
5.0.4 Efficiency of HEPA Filter should be 99.97 %. Acceptance criteria for filter leakage should be 0.01
%.
5.0.5 All the critical test parameters should be as per ISO 8 criteria.
Note: ISO Class can be varying based on the classified and un-classified areas and the places.
8.0 SAFTY FEATURES:
AHU should have the following features:
i) Fire Dampers with actuators in SA. Fire Dampers shall be interlocked with AHU motor to switch
off the respective AHU in case of fire.
ii) The limit switch shall be provided in AHU door which shall be interlocked with AHU motor. As
soon as door is opened AHU motor- blower shall turn “OFF”.
iii) Wire guard shall be provided at AHU fan section for protecting the operator from any injury.

Note: The detailed layout will be displayed on the drawings, which gives clear idea about the
duct running in the Ecotech facility is required.

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 UNICURE INDIA LTD (Unit-III)
Plot No.112-113, Ecotech No.12 Greater Noida (West), U.P

USER REQUIREMENT SPECIFICATION

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9.0 TECHNICAL SPECIFICATION:

S. No. EQUIPMENTS Details
 Air Handling Units (AHU), ducting for Air distribution Grills and filters.
 Supply, installation & commissioning of Air handling Units as specified
here-under, filters, coil and plenums etc. as per various air flow diagrams,
coil selection and AC requirements indicated in Air flow drawings, all as per
technical specifications.
 Mixing plenums with Return air & fresh air dampers (Extruded All Volume
Control damper with opposed blade) as required with access panel for 5.0
micron filters.
 Cooling Coil section with attached with condensing unit, fresh air vent on
header and drain pan insulated as per specification, drift eliminator if
System
01. required.
(AHU)
 Electronic heater section with access plenum.
 Fan section with backward / forward curved fans mounted inside the AHU
casing with separate enclosure for motor, belts, access doors etc.
 Exhaust Air opening for AIR BLEED with volume control damper.
 Filter section with 7.0 micron panel filters and HEPA filters (wherever
specified) complete with provision for measuring pressure across filter banks
and fans.
 Discharge plenum with discharge air volume control damper (s).
 Filter configuration for all AHU’s and Ventilation units are 10µ, 5µ and
0.3µ filters and in return air riser of 10 µ filters.

Note: Filter size has to be check and Specification has to be verify

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 UNICURE INDIA LTD (Unit-III)
Plot No.112-113, Ecotech No.12 Greater Noida (West), U.P

USER REQUIREMENT SPECIFICATION

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10.0 TOTAL CFM OF AHU SUPPLY IN ROOMS ( From the Plant layout no has to be taken)
AHU TOTAL
SR. NO. ROOM NAME TEMP. R.H. ∆P
CFM
01 L-005 23±2 NMT 55%
2158
02 L-010 23±2 NMT 55%

11.0 DEVIATION:
Any Deviation or Modification to the User requirement specification shall be highlighted.

S. No. Specification Deviation Checked by Verified by

12.0 DELIVERY:
a. As per purchase order.
b. To be delivered at company address.

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