USER REQUIREMENT SPECIFICATION

Pulse Pharmaceuticals Pvt.Ltd.

USER REQUIREMENT SPECIFICATION

OF
1000 L WORKING CAPACITY (WC) LIQUID MANUFACTURING TANK
 USER REQUIREMENT SPECIFICATION
Pulse Pharmaceuticals Pvt.Ltd.

TABLE OF CONTENTS

1. GENERAL REQUIREMENTS:.............................................................................................................3

1. EQUIPMENT / SYSTEM REQUIREMENTS:......................................................................................3

1. OPERATIONAL & FUNCTIONAL REQUIREMENTS:.....................................................................4

2. GMP REQUIREMENTS:.......................................................................................................................5

1. SAFETY REQUIREMENTS:.................................................................................................................5

1. SUPPORT REQUIRED FROM SUPPLIER:.........................................................................................5

7. DOCUMENTATION REQUIREMENTS:............................................................................................6

1. VALIDATION REQUIREMENT WITH SCOPE:.................................................................................6

1. REVIEW AND COMMENTS:...............................................................................................................6

2. APPROVAL SIGNATURE:...................................................................................................................7
 USER REQUIREMENT SPECIFICATION
Pulse Pharmaceuticals Pvt.Ltd.

1. GENERAL REQUIREMENTS:
The Manufacturing Tank shall be capable of performing as per the supplier’s operational manual. All
equipment specifications reflects the approach of M/s Pulse Pharmaceuticals Pvt.Ltd. to comply with
International GMP requirements, Health regulatory norms and Schedule M of Drugs and Cosmetics
Act 1940 (India).

General GMP compliance requirements:

 The Manufacturing Tank design and utility points should comply with the national and international
Good Manufacturing Practices (GMP) or better.
 The liquid filling machine design shall consider the safety of the process, environment and operator.
 Material Contact Parts shall of 316 L grade SS & the non-contact parts of SS316 and/or SS 304.
 Design Code: ASME/cGMP
 Operation and cleaning shall be user friendly.
 There shall be no dust-accumulating locations like crevices.
 Maximum care shall be taken to ensure safe operation of the equipment.
 The equipment shall have low power consumption
 The equipment shall be PLC based for manual-free setting.

2. EQUIPMENT / SYSTEM REQUIREMENTS:

Name of the Equipment /
2.1 1000 L Working Capacity (WC) Manufacturing Tank
System
Purpose of the Equipment /
2.2 Manufacturing of Plain Liquids/ Emulsion/ Suspension
System
Number of equipments
2.3 1
required
2.4 Required Working Capacity 1000 L
Accuracy of the equipment /
2.5 100 %
system
2.6 Required utilities Utilities Required Capacities
Plant Steam for jacket and SIP

Potable water qs

Purified water. As per IP

Electricity qs

Compressed air filtered

Nitrogen Filtered and dried

cooling Required. Upto 22 degree Celsius

from RT( depend on PW temp in
loop) in 30 min.
 USER REQUIREMENT SPECIFICATION
Pulse Pharmaceuticals Pvt.Ltd.

Change parts and spare parts

2.7 As needed for the equipment
requirement
Attachment / connectivity with
2.8 Transfer pump.
other equipment
Specification of the room for
Drawing No.: As per layout
equipment / system installation
2.9 Room volume: L x W x H
(Specify such as layout,
Classification : Grade D
available volume, class etc.)
Specification for Material of Construction
Product contact parts SS316L
2.10 Non-contact parts SS316 and /or SS304
Product contact gaskets etc. FDA approved Food grade
Others Suggest if any.

3. OPERATIONAL & FUNCTIONAL REQUIREMENTS

Language requirements
3.1 English
(Specify such as English, Bilingual / Others)
Data Acquisition Yes
b) Batch Recording No
3.2
c) Trend and saving No
d) Upload to company network No
3.3 Language requirement in the system English
Data and security
Operator level Password protected
3.4
Supervisor level Password protected
Manager level Password protected
 USER REQUIREMENT SPECIFICATION
Pulse Pharmaceuticals Pvt.Ltd.

Process Requirements
Stirrer type Bottom entry with removable stirring element.
Scale Required
Load cells Required ( with weight prints)
Jacket Steam jacketed
Spray Ball Required
Light Required
Sight Glass with wiper Required
Vacuum Required
Nitrogen Required (Covered in Utility)
Safety valve Required for steam jacket
Temperature Sensor Required
Required and should be able to set and display all
HMI parameters
RPM of stirrer To be decided by supplier with VFD to control speed.
Temperature Upto 100˚C
Minimum mixing volume 60L
Baffels Removable

Other Requirements:
 Equipment shall be easy to access manual loading points.
3.5  All the service lines to the equipment should come from the rear.
 The height of the base of the tank shall be atleast 900 mm to facilitate easy access to
the unloading port at the bottom.
 The motors used on the tank must be of standard quality and make.
 The operation of motors/gearbox must not cause vibration of the tank or wobbling of
the stirrer.
 The maximum viscosity of the liquid will be NMT 150 cps and the complete mixing
must be demonstrated during FAT.
 The maximum speed of the stirrer will be decided by the manufacturer and must be
controlled by VFD to regulate the speed.
 Should have provision of CIP system with as many spray balls as needed (to clean
the entire surface of the tank including the top dish) with access to potable water,
purified water.
 The insulation of the tanks shall be in such a way that there will not be any
significant heat transfer to the outer surface of the tank.
 Provision for cooling of the tanks to RT using chilled water.
 It will be the responsibility of the vendor to suggest and also approve the flooring
foundation and finish for perfect leveling which will not affect the function of the
load cell during operation.
 The unloading port at the bottom should have a pneumatic operated valve with zero
material hold up for viscous material.
 The transfer pump should be of suitable capacity to transfer the product to the.
 SS long and wide Funnel for dry material transfer ( Design to be informed to vendor
 USER REQUIREMENT SPECIFICATION
Pulse Pharmaceuticals Pvt.Ltd.

Sensors/Gauges
Temperature To measure the product temperature.
Load cell To measure the load or weights.
3.6 Pressure gauge
Vacuum gauge
Include a list of all gauges
Safety pressure valve

4. GMP REQUIREMENTS:
Sufficient space for man and material movement.
Room Temp. : 25 ± 2ºC
Working area environmental Relative Humidity : NMT 65%RH
4.1
requirement Room pressure : 20 Pa
Air Changes : 30
Lighting : NLT 300 Lux
Desired means for avoiding
4.2 contamination & cross AHU with terminal filters.
contamination of the Product (s)
Power failure and recovery The system will stop automatically upon loss of
4.3 (Specify the requirements in electricity and will recover soon after starting the DG
case of power failure) set.

5. SAFETY REQUIREMENTS:
Desired Product / Process Safety systems
Inter locking system and all operational safety
5.1 (Specify the systems interlocks, security
required
password, Alarm, event-logging system etc.)
Desired Personnel Safety systems Emergency stop switch to be provided.
(Specify the requirements for an emergency All electrical wiring should be properly
stop switch / alarm) concealed.
5.2
Noise Level < 85 db
Safety valves Safety valves required where needed
5.3 Electrical Earthing Required
5.4 Flameproof electrical connection Not required
5.5 Other (if any) Suggest if any
Equipment/ Systems safety requirement
5.6 Suggest if any
Inter Locks
 USER REQUIREMENT SPECIFICATION
Pulse Pharmaceuticals Pvt.Ltd.

6. SUPPORT REQUIRED FROM SUPPLIER:

Supplier shall send one copy of equipment drawings (P&ID and GA),
Pre-installation
6.1 operational manual and Factory acceptance test protocol and
support
specification.
➢ Technical staff of supplier shall come to install the equipment and
shall be present up to first three successful performance qualification
runs
➢ Technical staff of supplier shall train the applicable equipment
6.2 Start-up support operators of M/s Pulse Pharmaceuticals Pvt. Ltd. before operation
qualification.
➢ Technical staff of Supplier shall help M/s Pulse Pharmaceuticals Pvt.
Ltd. to prepare the SOP of operation, cleaning, calibration and
Preventive maintenance of the equipment.

7. DOCUMENTATION REQUIREMENTS:

Required
S.No Document Name
(Yes/ No/NA)
1 Operating manual and maintenance Instruction manual Yes
2 Replacement parts availability list Yes
3 Calibration certificates of all instruments Yes
4 Material of Construction test certificates Yes
5 Food grade certificates of silicone gaskets Yes
6 Test Certificates for bought out items and their calibration certificates Yes
7 Radiography/Boroscope test for weld joints Yes
8 Factory Acceptance Test specification and test report Yes
9 Design, Installation and Operation Qualification protocols Yes
10 Set and Reset point of all Field Instrument Yes
11 As-built and As installed drawing Yes
12 Wiring diagram of control panel, P&Id’s and GA drawing Yes
13 Cable Termination details of all field instruments Yes
14 Surface area calculation sheet Yes
Following documents are required for PLC validation:
Back up of Software/PLC based system Yes
15
PLC Calibration certificates Yes
PLC Documents (Circuit Drawings/Ladder drawings/Manuals etc.) Yes
 USER REQUIREMENT SPECIFICATION
Pulse Pharmaceuticals Pvt.Ltd.

8. VALIDATION REQUIREMENT WITH SCOPE:

Required
S.No Validation topic Scope
(Yes/ No)
1 Design Qualification Yes User and Supplier
2 Installation Qualification Yes User and Supplier
3 Operational Qualification Yes User and Supplier
4 Performance Qualification Yes User
5 PLC validation Yes User and supplier

9. REVIEW AND COMMENTS:

The user requirements shall be reviewed and purchase order shall be released for the procurement of the
equipment.

10. APPROVAL SIGNATURE:

Signatures in this page indicate the agreement with the User Requirement Specification of the
equipment described in this document. If any changes are needed, the document should be revised and
approved.

Department Name Designation Signature & Date

Prepared by

Engineering/
Projects

Reviewed by

Research &
Development

Approved by

Quality Assurance

END OF DOCUMENT