USER REQUIREMENT SPECIFICATION

Equipment Name
User Department
Document No.
Supercede No. --
Effective Date

This specification is issued by Purchase Department to Manufacturer/Vendor

Name & Address of
Manufacturer/Vendor
Contact Person Name
& Contact No.
Mode
Date
Copy No.
Issued By (Name & Date)
 USER REQUIREMENT SPECIFICATION
Equipment Name:
Document No.: Page No.: 2 of 7
1.0 PROTOCOL APPROVAL:
1.1 This protocol is prepared by validation task force

Department Utility
Signature

Name
Designation
Date

1.2 This protocol is reviewed by validation core committee

Department Quality Assurance Quality Control Production Engineering

Signature

Name
Designation
Date

1.3 This protocol is approved by validation task force leader (Head QA)

Signature

Name
Designation
Date

1.4 This protocol is authorized for implementation by Plant Head

Signature

Name
Designation
Date
 USER REQUIREMENT SPECIFICATION
Equipment Name:
Document No.: Page No.: 3 of 7

2.0 TABLE OF CONTENT:

SR. NO. CONTENT PAGE NO.

1.0 APPROVAL 02

2.0 TABLE OF CONTENT 03-04

3.0 OBJECTIVE 05

4.0 SCOPE 05

5.0 REQUIRED SPECIFICATION 05-07

5.1 Intended use
5.2 Location/Area
5.3 Description of equipment / system
5.4 Intended type of material(s) to be handled
5.5 Construction requirement
5.6 Capacity requirement
5.7 Electrical construction
5.8 Control parameter requirement
5.9 Parameters to be indicated by control systems
5.10 Available utilities
5.11 Limitations / constraints
5.12 Regulatory requirements
5.13 Safety requirement

6.0 DELIVERY NORMS & ADDRESS 07

7.0 VENDOR SCOPE 08

7.1 Spare Parts
7.2 Support

8.0 DOCUMENTATION REQUIREMENT 08

9.0 REFERENCES 08

10.0 LIST OF ANNEXES 08

 USER REQUIREMENT SPECIFICATION
Equipment Name:
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SR. NO. CONTENT PAGE NO.

11.0 REVISION HISTORY 08

 USER REQUIREMENT SPECIFICATION
Equipment Name:
Document No.: Page No.: 5 of 7

3.0 OBJECTIVE:
Objective of user requirement of Installation of filter in supply line (before dryer and after dryer) is:
3.1 To continuously filtration of compressed air (before dryer and after dryer) .

4.0 SCOPE:

5.0 REQUIRED SPECIFICATION:

5.1 Intended use
5.1.1
5.2 Location/Area
Utility Block.
5.3 Description/feature requirement of this equipment / system

Sr. Description Model No. Filtration Oil Aerosol Free Air

No. Delivery
1 General Purpose Filter FA400IG 1 micron 005 PPM 235 CFM
2 High Efficiency Filter FA400IH 001 Micron 0.01 PPM 235 CFM

5.4 Intended type of material(s) to be handled

Air Filter (Before and after dryer).
5.5 Construction requirement
Sr. No. Name of part Specification / Material of construction
1.0 Compressor Air compressor
2.0 Motor of Compressor 37 kw
3.0 Air Dryer Refrigerant gas
Voltage:230
Phase:1phase
Frequency:50Hz
4.0 Control Panel Control Panel should have switches for ON & OFF
5.0 Microprocessor with all units:
Microprocessor Power unit
Processor module

5.6 Capacity requirement

Specification required as per ISO 8573.
Electrical construction
NA.
 USER REQUIREMENT SPECIFICATION
Equipment Name:
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Control parameter requirement
Sr. No. Parameter Requirement
1.0 Main on/off
Required
switch
2.0 Electric Control PLC or Controller

5.7 Available utilities

Total Power (KW/HP): 16.5 HP
Main motor :11 KW/15HP,415+10% V,50+5%
Feeder Motor: 0.18 KW/0.25HP,415+10% V,50+5%
5.8 Limitations / constraints
NA
5.9 Regulatory requirements
As per 21CFR part 11

5.10 Safety requirement

As per manufacturer specification, if any.

6.0 DELIVERY NORMS & ADDRESS:

Address: As mentioned on first page.

7.0 VENDOR SCOPE:

7.1 Spare Parts
Provide the list.

7.2 Support
Installation and Training for operation.

8.0 DOCUMENTATION REQUIREMENT:

Sr. No. Document name Document type* Required quantity

1.0 Operating and Maintenance Manual Hard copy as
01
well as soft copy
 USER REQUIREMENT SPECIFICATION
Equipment Name:
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2.0 Certificate of Material of Construction of Hard copy
01
SS304
3.0 Diagram Hard copy 01
4.0 General Assembly (GA) drawings Hard copy 01
5.0 DQ, IQ, OQ Protocol Hard copy 01
6.0 Calibration certificate of Pressure gauge Hard copy 01
* = Hard copy / Soft copy (Specify soft coy extension type)

9.0 REFERENCES:
ISO 8573

10.0 LIST OF ANNEXES:

Following annexes are attached with this specification
Annex Name of annex

11.0 REVISION HISTORY:

Revision Change control Reason for Changes incorporated

No. No. revision

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