NDB HEALTHCARE

User Requirement Specifications (URS)

Equipment
Vial Filling Linear Closing Machine
Name
Revision No.:
URS NO. NDB/URS/001 Page No.: 1 of 22
00

USER
REQUIREMENT SPECIFICATIONS (URS)
FOR
VIAL FILLING LINEAR CLOSING MACHINE

Name of Equipment: : Vial Filling Linear Closing Machine.

URS Number :
NDB/URS/001

Department : Production Injection

URS Effective Date :

Total No of pages : 21

Client Address : NDB HEALTHCARE

 NDB HEALTHCARE
User Requirement Specifications (URS)
Equipment
Vial Filling Linear Closing Machine
Name
Revision No.:
URS NO. NDB/URS/001 Page No.: 2 of 22
00

Revision index

Revisio Date Reason for Revision

n
00 New Documents
 NDB HEALTHCARE
User Requirement Specifications (URS)
Equipment
Vial Filling Linear Closing Machine
Name
Revision No.:
URS NO. NDB/URS/001 Page No.: 3 of 22
00

Table of Contents
Sr. No. Content Page No.
1.0 Approval Signatures 4
2.0 Overview 5
2.1 Project Introduction 5
2.2 Project Standard 5
2.3 Equipment Description 5-6
2.4 Reference Standard/Guideline for Equipment 7
3.0 Process Description 8
3.1 Input & Charging Method 8
3.2 Brief Process Steps 8
3.3 Output & Discharging Method 8
4.0 Productivity Requirement 9
4.1 Desired/ Suggested Capacity 9
4.2 Standard Batch Size 9
4.3 Change Over Time (as Applicable) 9
4.4 Cleaning/sanitization /sterilization time (as applicable) 9
4.5 Other Productivity Requirement 9
5.0 Safety Requirement 10
5.1 General 10
5.2 Power Failure And Recovery 10
5.3 Containment 10
6.0 GMP Requirements 11
6.1 Process Control 11-12
6.2 Failure Mode Detection 12
6.3 Level Of Instrumentation 13
6.4 Qualification Requirement 13
6.5 Material Of Construction 14
6.6 Use Of Lubricants 15
6.7 21 CFR Part 11 Compliance 15
6.8 Data Integrity 15
6.9 Batch Data Display And Record Printing 15-16
6.10 Desired Documents 16
6.11 Training 16-17
7.0 Technical Requirement 17
7.1 Basic Technical Requirement 17
7.2 Level Of Automation 17
7.3 Specific Requirements 17-18
7.4 Inspection Testing 18
8.0 Constraints 18
8.1 Equipment Location And Available Space 18
8.2 Available Utility 18
9.0 Timelines 18
10.0 Abbreviation 19
11.0 URS Acceptance By The Vendor 20
12.0 Final Evaluation By User On Vendor Acceptance 21
 NDB HEALTHCARE
User Requirement Specifications (URS)
Equipment
Vial Filling Linear Closing Machine
Name
Revision No.:
URS NO. NDB/URS/001 Page No.: 4 of 22
00

1.0 Approval signatures:

This document is prepared by the production (user); engineering and validation team at
NDB HEALTHCAREfacility and this document before being effective shall be approved by
the QA Head and authorized by the Plant Head/Project Authority.

Prepared by

Name/ Designation Signature Date

Checked by

Name/ Designation Signature Date

Approved by

Name/ Designation Signature Date

Authorized by
Name/ Designation Signature Date
 NDB HEALTHCARE
User Requirement Specifications (URS)
Equipment
Vial Filling Linear Closing Machine
Name
Revision No.:
URS NO. NDB/URS/001 Page No.: 5 of 22
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2.0 Overview
2.1 Project Introduction
NDB HEALTHCAREis amongst the most progressive companies in India as
well as abroad. Company has set the highest of standards for
pharmaceuticals manufacturing.
NDB HEALTHCAREis one of the largest manufacturers of antibacterial
products. The company has a state of art of antibacterial manufacturing
facility at Baddi, Himachal Pradesh.
Company wants to install Vial Filling Linear Closing machine in new
production line BAL2 to enhance the productivity for business and to full fill
market requirements as well as to meets the domestic and international
markets.
Note: This URS has been prepared based on our in-house knowledge &
understanding for this equipment. It is possible that certain points
might have been overlooked. As a vendor we expect you to go
through the document with the keen eye and give your suggestions
separately as an option. However, the base offer shall be as per this
URS. All suggestions shall be highlighted and summarized separately.
2.2 Project Standard
Equipment shall be in compliance with the Schedule-M, WHO guidelines, EU-
GMP and 21CFR Part 211.
2.3 Equipment Description
 NDB HEALTHCARE
User Requirement Specifications (URS)
Equipment
Vial Filling Linear Closing Machine
Name
Revision No.:
URS NO. NDB/URS/001 Page No.: 6 of 22
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Operating Sequence:
 The vial line shall be scalable and capable of handling the following vials with an
average production throughput of 120 vials/min based on the different fill
volume with 8 head filling piston:
 The vial filling machine shall be scalable and capable of handling the following
vials with various change parts;
 The system shall be equipped with sensors and controls to fully integrate the
line operation through each unit function. Controls shall include protection
against line jams.
 Vials will be filled and stoppered in one vial size at a time at a set production
rate.
 All equipment shall be capable of achieving the stated speeds without
scratching, breaking, or otherwise causing damage to the vials and vial
components or causing the partially inserted stoppers to become dislodged or
pushed in too far.
 Vials will be manually loaded from trays onto an accumulation table in an
upright manner. From the accumulation table vials shall be fed into the washer.
 Vials will exit the washer machine and be conveyed directly into the vial
sterilization/depyrogenation tunnel. An acrylic barrier will direct HEPA filtered air
coming out of the in-feed zone of the sterilization/depyrogenation tunnel. Vials
are sterilized / depyrogenated at more than 300C and cooled to ambient
temperature.
 Vials will exit the sterilization tunnel and be conveyed to an turn table then to
filling machine. The environment over this filling machine will be ISO Class 5
Vials are then filled with sterile liquid solution of product. Filled vials are then
stoppered. The vial filling machine is under an ISO Class 5 environment.
 Filled and stoppered vials exit the filling machine and are conveyed further in
turn table. These vials are conveyed for sealing machine for sealing with 13 mm
f/o aluminum seals through a conveyor belt directly then this vials are take for
visual inspection for further processing
Vial Filling/Stoppering Chamber:
 An intermittent / continuous motion Vial Filling linear closing Machine capable of
processing up to 400 vial/min. configurations with 8 head filling piston. Motion
of the vial filling niddle shall include the pushing out the solution out of the
position in the vials.
 The Vial Filling linear closing Machine to be designed for installation in an ISO
Class 6 environment
 The Vial Filling linear closing Machine shall be equipped with automatic control
the fill volume with different fill volume size recipe to eliminate wastage of filled
solution through PLC.
 The Vial Filling linear closing Machine shall be equipped with a vibratory
stainless steel stopper bowl.
 The Vial Filling linear closing Machine control system shall have a no vial / no
fill / no stopper algorithm
 A recipe storage system capable of storing machine set-up information
 The Vial Filling linear closing Machine shall perform 100% in-process checks with
a 100% filling accuracy of the fill volume. Provision for monitoring of filled
volume data shall be included with the Vial Filling linear closing Machine Control
System.
 The Vial Filling linear closing Machine shall be capable of fully stoppering filled
vials
 NDB HEALTHCARE
User Requirement Specifications (URS)
Equipment
Vial Filling Linear Closing Machine
Name
Revision No.:
URS NO. NDB/URS/001 Page No.: 7 of 22
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2.4 Reference standard/Guideline for equipment

The equipment should comply with the following guidelines/standard:
GMP-Regulations
 Schedule-M of Indian Drugs and Cosmetics Act
 WHO guideline.
 EU-GMP Guideline
 21CFR Part 211: Current Good Manufacturing Practice for finished
Pharmaceuticals
 Pharmacopoeia.
 NDB HEALTHCARE
User Requirement Specifications (URS)
Equipment
Vial Filling Linear Closing Machine
Name
Revision No.:
URS NO. NDB/URS/001 Page No.: 8 of 22
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Vendor shall provide response as “Yes” or “No” against each specification for the compliance of their offered
equipment in the remarks column.
Specifications Remarks
3.0 Process Description:
3.1 Input & Charging method:
a) DHS: The depyrogenated vials after cooling zone in the tunnel shall
enter into filling LAFs. The vial shall be collected in a turntable. From  Yes 
the turn table vials should be singled on a conveyor and reach filling No
station.
b) Sterilized rubber stopper bag, which shall be opened in hopper that  Yes 
shall be provided within LAFs. No
c) Product Liquid: The product is aqueous based. The product viscosity  Yes 
can be as high as 500 cps. The product liquid shall be hold in sterile No
pressure vessel under nitrogen overpressure before filling. During
filling the product liquid shall be transferred by filtered (0.2 micron)
nitrogen pressure or by peristaltic pump from the pressure vessel to
the buffer tank (approx. 5L) of the filling machine through a sterilizing
grade filter (0.2 micron).
d) Buffer tank shall be provided with minimum and maximum level
sensor to control automatic transfer of product solution into buffer
tank from the product tank/vessel.
e) Vendor shall consider the connection of cartridge filter (0.2 micron)
and recommend the size of housing. The user shall provide the filter.
f) Pressure vessel shall be placed under a LAF and connection to be
made under aseptic condition. This LAF should be included in the offer.
g) Filtered Nitrogen Air: Filtered (0.2 micron) nitrogen air shall be used
for pre and post gassing/purging of vials. Nitrogen pressure and flow  Yes 
rate should be regulated to have consistent removal of oxygen from No
the vial. Vendor shall quote for filter housing as optional.
3.2 Brief Process Steps
a) Transportation of depyrogenated vials singlized on a conveyor belt up  Yes 
to filling station. No
 Yes 
b) Pre and post gassing by nitrogen purging within vials.
No
c) Dosing of product liquid within vial from 2.0 ml to 10 ml based on the  Yes 
vial sizes. No
d) Transportation of vial to rubber stoppering station without falling on  Yes 
conveyor belt. No
 Yes 
e) Inspection for the presence of vial and stopper placement/positioning.
No
f) The machine shall install under Grade A environment and vials  Yes 
transported through conveyor belt and bulk liquid filled at filling No
station with pre and post purging of nitrogen gas and then filled vials
shall be with 13mm rubber stoppered properly.
3.3 Output & Discharging method
a) Filled rubber stoppered vials shall be transported at sealing machine  Yes 
for sealing with 13 mm flip off aluminium seals through a conveyor No
 NDB HEALTHCARE
User Requirement Specifications (URS)
Equipment
Vial Filling Linear Closing Machine
Name
Revision No.:
URS NO. NDB/URS/001 Page No.: 9 of 22
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Specifications Remarks
belt directly then this vials are taken for visual inspection for further
processing.
4.0 Productivity Requirement
4.1 Desired/ Suggested capacity
a) The filling line shall be suitable to produce filled and stoppered
vials of different vial sizes.
 Yes 
For 3.5ml glass tubular vials USP type-I : 400 vials/min.
No
For 5.0 ml, 7.5ml and 10ml (provison for future use-vendor shall be
specified)
4.2 Standard Batch Size
For
a) Standard batch size : 95,238 vials (200 ltrs) informatio
n
4.3 Change Over Time (if applicable)
a) Vendor shall ensure minimum time for change over parts for
assembling and disassembling (i.e. less than 30 minutes) with  Yes 
minimum usage of tools and also inform the exact time for change no
over.
A. The fix the number at each filling piston head, so that find out any
 Yes 
filled volume variation at time of filling of solution in vials which is
no
not erasable.
4.4 Cleaning /sanitization/sterilization time (if applicable)
a) Manual cleaning of the equipment is proposed.
 Yes 
Vendor to suggest the solvent/cleaning agent to be used for the
no
cleaning of the equipment.
b) Machine shall be easy to clean and sanitize. Shall be free from
cavities to avoid the product and dirt entrapment.
 Yes 
Vendor to suggest solvent to be used for cleaning of the
no
equipment.
Filling change parts easily dismantle & sterilization is requirement.
a) Machine part shall be compatible with wide variety of disinfectants  Yes 
used in Pharma industries. no
b) Design of the machine should enhance cleaning feasibility by
 Yes 
providing of the minimum sharp corners, crevices and smooth
no
finished weld joints.
c) Parts which require cleaning during product change over should be  Yes 
provided with quick fixing arrangement. no
d) All moving parts shall be accessible for application of the
equipment.  Yes 
Vendor to suggest lubricant to be used with catalogues and detail no
of supplier.
e) All bolts, nuts on the exterior part of the equipment will be with cap  Yes 
head or nut cap. Nut and cup free design preferable. no
f) Machine should be suitably designed for easy clearance, in case of  Yes 
breakage of product during packing. no
 NDB HEALTHCARE
User Requirement Specifications (URS)
Equipment
Vial Filling Linear Closing Machine
Name
Revision No.:
URS NO. NDB/URS/001 Page No.: 10 of 22
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Specifications Remarks
4.5 Other Productivity Requirement
a) Provision of SS 316L table/case under LAF near to hopper is  Yes 
required for keeping/holding of RFU bags (If needed). no
b) The filling machine shall have average working hours per day: 18-  Yes 
20 considering three shifts (If needed). no
c) To minimize the amount of product to be rejected after machine  Yes 
stop and at the end of filling. no
5.0 Safety requirement
5.1 General
Following facilities must be provided to protect personnel, product and
equipment:
a) In the event of equipment malfunction or loss of utilities, the
 Yes 
machine must contain all necessary protection devices to ensure
no
that the equipment and the article remain in a safe condition.
b) Noise level should not be more than 70 db at a distance of 1 m  Yes 
from the machine. no
 Yes 
c) Emergency stop buttons shall be accessible to the operator.
no
d) Provision of audible alarms & warnings shall be provided.  Yes 
no
e) Integration of filling line/machine with de-pyrogenating tunnel.  Yes 
no
f) Warning stickers on all hot surfaces and sharp surface.  Yes 
no 
 Yes
g) Appropriate failure detection and alarm notification
no
h) Control wiring shall be labelled and identified; machine name plate
 Yes 
with requisite details shall be affixed on an easy accessible
no
location.
i) All machine doors/guards, which are closed during operation,
according to operator safety, have to be supervised by security  Yes 
switches. In case of opening the machine must stop immediately no
(as applicable).
5.2 Power failure and recovery
a) On power failure, on line filling machine must come to rest (safe
 Yes 
state) and power restart must not be automatic and human
no
intervention must be required.
 Yes 
b) All motion stopped on the machine.
no
c) A “Safe State” shall be defined as:  Yes 
All motion stopped on the machine. no
No damage to machine will occur as a result of going to the safe
state.
All devices go to safe state-the safe state to be defined by the
vendor.
Batch printing can be restarted without loss of printing details.
In the event of a power failure, the system shall protect in the
following priority:
 NDB HEALTHCARE
User Requirement Specifications (URS)
Equipment
Vial Filling Linear Closing Machine
Name
Revision No.:
URS NO. NDB/URS/001 Page No.: 11 of 22
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Specifications Remarks
Personnel Equipment Product.
On the restoration of power ,the system shall behave as follows:
Manually re-start based on operator inputs.
If there is an automatic batch reporting system, the information
shall be retained in the event of a power failure.
d) Emergency stop button shall be provided at easy assessable area  Yes 
in case of emergency. no
 Yes 
e) UPS supply shall be provided to PLC to prevent any loss of data.
no
f) “Critical alarms” shall be action automatically to shut the  Yes 
equipment down and notify the operator. The operator shall be no
required to acknowledge the alarm before the alarm can be reset
and the system restarted. Once the alarm is reset, the operator
may restart the system.
g) “Non-Critical warnings” shall notify the operator and take no
further action. Non-Critical warnings and shall sound the alarm
horn, illuminate the alarm indicator but allow the system to
 Yes 
continue to operate. The operator shall be required to
no
acknowledge the warning in order to silence the alarm horn, and
the alarm indicator shall be extinguished when the warning
condition disappears.
h) Power Failure/Recovery, Electrical Protection Alarms and warnings  Yes 
(Flame Proof), Earthling. no
 Yes 
i) Electrical Protection ( Flame Proof /Non Flame Proof ) NFLP
no
j) Necessary interlocks shall be provided for operating with tunnel  Yes 
and sealing machine. no
k) The process should not start unless all the doors of closed
 Yes 
chamber are closed. Door closure indicator status shall be
no
displayed. Which door open which closed shall also be displayed?
l) Provision of electronic back-up/data storage.  Yes 
no
5.3 Containment
a) A separate bin shall be provided for collection of un stoppered &  Yes 
broken vials. no
6.0 GMP requirements
6.1 Process control
a) Filling machine should consistently and reproducibly meet the
 Yes 
following filling accuracy at operating ranges of filling speed:
no
Filling accuracy for fill volume more than 1.0 ml should be ± 0.5 %.
b) The equipment control system should be suitable to adjust and maintain  Yes 
the rate of filling (number of vials/ minute) no
c) The equipment should control and monitor the pressure/flow rate of  Yes 
sterile nitrogen supply to be used for pre and post-purging of nitrogen air. no
 Yes 
d) Auto rejection mechanism, reject verification and reject counter
no
e) The utilities supply lines should be provided with the equipment.  Yes 
 NDB HEALTHCARE
User Requirement Specifications (URS)
Equipment
Vial Filling Linear Closing Machine
Name
Revision No.:
URS NO. NDB/URS/001 Page No.: 12 of 22
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Specifications Remarks
no
a) Lamps shall be provided having green light for machine ok for  Yes 
running, red-light for any malfunction and yellow light for inching no
(vendor specified accordingly).
 Yes 
b) Batch details must be clearly readable.
no
c) Noise level should not be more than 70 db at a distance of 1 m  Yes 
from the equipment. no
d) Emergency stop buttons shall be accessible to the Operator. The E-  Yes 
stop will be hardwired into the emergency stop circuits of all of no
rotating machinery
e) Power failure/recovery, electrical protection alarms and warnings  Yes 
flame proof and earthling. Machine shall trip on power failure and no
after resumption shall restart without damage of machine and
loss of data (as applicable).
f) UPS supply provision shall be provided to PLC to prevent any loss  Yes 
of data. no
g) Checks for pre-operational performance/verification of printing  Yes 
detail of the batch on PLC and their speed. no
h) Pressure gauge for utilities shall provide or better design as vendor  Yes 
specify. no
i) Necessary shafts/guards and moving parts have to be tightly  Yes 
sealed. no
 Yes 
j) Vendor to give code numbers for each component
no
k) The transport of the vials from machine in-feed and out-feed  Yes 
turntable under LAF through conveyor belt. no
f) Control Panel - Control panels furnished with equipment shall be SS  Yes 
304. no
g) A clear separation between clean and technical area must be  Yes 
realized in equipment. no
h) Moving parts between the technical and the clean areas are not  Yes 
permitted. Necessary shafts and moving parts have to be tightly no
sealed.
6.2 Failure mode detection:
Equipment shall be capable to detect the following minimum failure
and notify the operator with audio visual alarm, shutdown the process
and batch printing (as applicable) the details:
a) Emergency stop activated  Yes 
no 
 Yes
b) In-feed empty
no
 Yes 
c) Overload for all pumps, drives and conveyor belts
no
 Yes 
d) Maximum out feed condition reached
no
 Yes 
e) Continuous detection (max 3) of missing vial on filling station
no
 NDB HEALTHCARE
User Requirement Specifications (URS)
Equipment
Vial Filling Linear Closing Machine
Name
Revision No.:
URS NO. NDB/URS/001 Page No.: 13 of 22
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Specifications Remarks
 Yes 
f) Continuous detection (max 3) of missing stopper on stoppering station
no
 Yes 
g) Reaching very low level in buffer container
no
h) Malfunction of machine i.e. low differential pressure with respect to room  Yes 
(optional) no
i) Particle count results out of limit (optional)  Yes 
no
j) Low utility supply pressure of nitrogen gas, vacuum & low label qty.  Yes 
of filling solution etc. no
k) Machine stop while safety guard is open.  Yes 
no
l) Filling machine should be provided with auto in-process check
 Yes 
weighing system at 100% level without affecting the machine
no
efficiency
m) Continuous monitoring of air particulate is required in different  Yes 
locations to demonstrate grade A condition (users scope). no
n) Machine should have sensors/probes provision for on line particle
monitoring (vendor scope).
6.3 Level of instrumentation
Sufficient and suitable instrumentation for the process, safety and
 Yes 
productivity control shall be provided as per requirements of the
no
operation like pressure, speed and vacuum etc. .
6.4 Qualification requirement
a) Equipment shall be qualified with life cycle approach: i.e. Design
Qualification (DQ), Installation Qualification (IQ), and Operational
Qualification (OQ).  Yes  no
Vendor shall provide all documentation support including protocol
subject to approval by the user.
b) Vendor shall provide execution support to the user to complete all
 Yes  no
stages of the qualification.
c) Filing & stoppering machine should demonstrate the stated filling
accuracy consistently in the vials, when the equipment is operated at  Yes  no
desired range of filling speed.
d) All digital and analogue Input and output function should be
 Yes  no
verified. Test to be performed by supplier during FAT or SAT
e) Digital instruments should be calibrated full loop during SAT  Yes  no
f) Supplier shall perform software backup and restore test as per
 Yes  no
guideline during qualification
g) Software function including algorithm if involved should be verified
 Yes  no
for accuracy (as applicable)
h) Disaster management should be in built in the system. Data back
 Yes  no
up facility should be verified.
i) Application software should have suitable security and access
 Yes  no
control.
j) The hardware and software of computer system should be tested
 Yes  no
for all parameter of GAMP 5 (as applicable).
 NDB HEALTHCARE
User Requirement Specifications (URS)
Equipment
Vial Filling Linear Closing Machine
Name
Revision No.:
URS NO. NDB/URS/001 Page No.: 14 of 22
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Specifications Remarks
6.5 Material of construction
a) All following metallic critical contact surfaces should be constructed
of 316L grade stainless steel or better with internal mirror surface
finish:
 Yes  no
1) Surfaces coming in direct contact of product.
2) Surface coming in contact of sterile gas i.e. nitrogen used for
gassing of vials
b) All non-product contact metallic surfaces should be constructed of
304 grade stainless steel or better (316 steel for sterile area  Yes  no
equipment), external surface finish.
c) Gaskets, seals and O-rings coming in direct / indirect contact
surfaces should be constructed of food grade polymeric materials  Yes  no
only.
d) All welds should be ground finished and properly passivated.  Yes  no
e) Clean media pipes should be orbital welded and weld inspection
report should be available in the submitted document (if  Yes  no
applicable).
f) Insulation material should be non-fibrous and covered with
 Yes  no
completely welded SS 304 or better cladding.
g) All non-metallic surfaces shall be smooth for easy wiping and should
 Yes  no
not accumulate the dust.
h) All machine part shall be compatible with wide verity of cleaning
 Yes  no
agents.
i) The conveyor belt should be constructed of SS quality.  Yes  no

6.6 Use of lubricants

Any lubricant, if used in the equipment must be food grade and
non toxic. Yes  no
Used lubricants must not come in product contact surface.
6.7 21 CFR Part 11 compliance
Software, if used to generate, process, store the quality data must
 Yes 
be complies with 21 CFR Part 11 requirements.
no
(As applicable vendor shall be provided, if any).
6.8 Data integrity
System security access shall consist of the following minimum 3  Yes 
level security profiles-: no
a) Operator: Shall provide operator access to allow routine operation  Yes 
of equipment features. no
b) Supervisor: Shall provide access to operator level features in  Yes 
addition to critical operating parameter configuration. no
c) System administrator: Shall provide the access to the Operator  Yes 
and Supervisor level features in addition to system security no
parameters.
 NDB HEALTHCARE
User Requirement Specifications (URS)
Equipment
Vial Filling Linear Closing Machine
Name
Revision No.:
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Specifications Remarks
d) Sufficient data storage media shall be provided for data storage  Yes 
and vendor specified retention period (as applicable). no
(System shall be equipped with means for transferring or archiving
data and export data via a suitable system in case required for
future use or reference) or vendor specify.
e) Data shall be collected at specified and configurable interval and  Yes 
shall be printed in hardcopy as well as retained electronically. no
f) The system should generate audit trials and record when the users  Yes 
access the system, when changes occur in the system along with no
the nature of change (As applicable).
g) The information for all system functions requiring written or  Yes 
displayed text shall be in English language only. no
(Others units may be followed for ease of understanding-with the
approval of Aristo).

6.9 Batch data display and record printing

HMI should display the following important parameters but  Yes 
not limited to these (as applicable). no
 Yes 
a) Company name and address
no
 Yes 
b) Equipment identification number
no
 Yes 
c) Product name and Batch No
no
 Yes 
d) Start date and time of operation
no
 Yes 
e) End date and time of operation
no
 Yes 
f) All failures and alarms.
no
 Yes 
g) Operator code and name
no
 Yes 
h) Set and process values of process parameter
no
i) The vendor shall provide suitable printer for batch process data  Yes 
printing as applicable. no
A batch record printing indicating the following important parameters but
not limited to these (as applicable):
Equipment should generate on line printing of independent batch record  Yes 
(if required),which should contain the following: no
 Yes 
a) Company name and address
no
 Yes 
b) Equipment identification number
no
 Yes 
c) Set parameters for product/pack specific recipe (as applicable)
no
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User Requirement Specifications (URS)
Equipment
Vial Filling Linear Closing Machine
Name
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Specifications Remarks
 Yes 
d) Product name and Batch No.
no
e) Batch number (Provision to insert >12 alphabet and numeric  Yes 
characters). no
 Yes 
f) Start date and time
no
 Yes 
g) End date and time
no
 Yes 
h) Speed and output per hour (vials per hour)
no
 Yes 
i) All failures and alarms history.
no
 Yes 
j) Operator details like code and name
no
 Yes 
k) Adequate space for writing remarks/corrective actions if any.
no
 Yes 
l) Identified space to sign/date for operator & supervisor.
no
6.10 Desired documents
Following documents, but not limited to these, are expected from the vendor
as part of the supply package as hard copy (English language):
a) Vendor shall supply the documents package in phases throughout
 Yes  no
the life cycle of the project as follows:
Phase-1: Pre-ordering of the equipment  Yes  no

a) Filled in URS  Yes  no

b) P&ID and /or GA drawing.  Yes  no

c) Detailed technical offer the support the compliance of the URS.  Yes  no

Phase-2: Post-ordering of the equipment

a) Design specification and technical specification, that should
 Yes  no
contain the following:
 System description and its function  Yes  no

 System operation steps.  Yes  no

 List of failure indications,  Yes  no

 List of interlocks (if applicable).  Yes  no

 List of inputs/outputs and functions  Yes  no

 List of major components, devices and instruments with
 Yes  no
their specific functions and specifications.
 GA diagram of the system  Yes  no

Phase-3: Fabrication stages of the equipment

 NDB HEALTHCARE
User Requirement Specifications (URS)
Equipment
Vial Filling Linear Closing Machine
Name
Revision No.:
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Specifications Remarks
a) FAT protocol and report. (If needed)  Yes  no

Phase-4: Fabrication stages of the equipment

Vendor shall provide the following documents in the delivery
package. The delivery package shall reach the site of user  Yes  no
before installation of the system.
a) Operation and maintenance manuals, preventive maintenance
schedule for system component as well as the operating  Yes  no
system.
b) Operations and maintenance manuals for the bought out items
 Yes  no
(if applicable)
c) Installation Instructions.  Yes  no

d) As build drawing for machine.  Yes  no

e) Details drawing marking clearly of the necessary dimensions
and location of utilities along with requirement of utilities on  Yes  no
the drawing along with offer.
f) Other drawing such as P & ID , electrical , instrumentation etc.  Yes  no
g) Spare and/or change parts /bought but item list with ordering
information (ordering reference code, vendor contact address).  Yes  no
parts
h) MOC certificates and surface finish test report.  Yes  no
i) Instruments certificates with respect to the traceable national
reference standard instrument and their calibration procedure.  Yes  no
(If applicable)
j) Recommended SOP’s for operations, Cleaning and
 Yes  no
maintenance of each system (optional)
k) Guarantee/warranty/ certificates for each system and major
 Yes  no
bought out items.
l) Shipping checklist  Yes  no

m) DQ, IQ and OQ documents.  Yes  no

n) Vendor to provide code numbers for each component of the
 Yes  no
equipment. (If applicable)
6.11 Training during Instalation.
a) Online training for operation is to be given during installation.  Yes  no

7.0 Technical Requirements:

7.1 Basic Technical Requirement:
a) A proposal of a possible installation layout should be added to the  Yes 
documentation. no
b) The manufacturer has to give the clear details on the total weight  Yes 
and the capacity/dimensions of the equipment. no
c) The heat given off by the machine must be stated (inside the room)  Yes 
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User Requirement Specifications (URS)
Equipment
Vial Filling Linear Closing Machine
Name
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Specifications Remarks
no
d) The construction/design of equipment shall be described in the  Yes 
documentation in details. no
e) Vendor shall provide tools for assembling, disassembling and  Yes 
maintenance of the machine. no
7.2 Level of automation:
a) The equipment should control automatically all critical parameter  Yes 
and detect failure mode automatically. no
b) Human machine interface (HMI) must be used to enter the process
details, which should appear in the print out. Print out must provide  Yes 
results of all critical process parameter and failure alarms (As no
applicable).
c) The equipment should operate with minimum operator involvement.
The equipment control panel must be provided with a Human
 Yes 
machine interface based on English language with appropriate
no
number (a minimum of 10 programs or Vendor specify) of recipe of
all process parameters.
7.3 Specific requirements
a) In general the equipment has to be designed in a way to get easy
 Yes 
and quick access to all necessary maintenance points e. g. Motors,
no
counter sensor etc.
b) The whole/full load transport of the vials to be smooth to avoid any  Yes 
damages/breakage e.g. scratches on the glasses and breakage. no
 Yes 
c) Vendor shall provide tools for maintenance of the equipment.
no
 Yes 
d) The make of the PLC shall preferably be Siemens/Allen Bradley.
no
e) The HMI/MMI shall be touch screen type.  Yes 
no
f) Arrangement of alternative power supply (UPS) to control and  Yes 
monitoring system. no
g) To facilitate to connect from a site tunnel and other side sealing  Yes 
machine of filling machine is required. no
 Yes 
h) Digital counter for filled & stoppered vials along with reset button.
no
 Yes 
i) The conveyor shall be designed with minimum friction.
no
 Yes 
j) All setting should be user adjustable.
no
k) The LAF unit has to be integrated in the clean room ceiling. The  Yes 
connection to the clean room ceiling will be done on site. no
l) And suitable provision should be made to introduce and withdrawal  Yes 
of microbiology environmental sampling aids e.g. media plates. no
Equipment must be fabricated following all Good
Engineering Practices.
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Equipment
Vial Filling Linear Closing Machine
Name
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Specifications Remarks
m) The vendor’s Quality System must follow applicable national or  Yes 
international standards. no
n) Vendor must generate all applicable documents during all
 Yes 
stages/phases of equipment fabrication i.e. design, fabrication,
no
testing and shipment as per applicable standards e.g. GAMP.
o) All sensors, controllers, PLC, transmitters, indicators and any other
controller or indicators to read, print or control any of the
 Yes 
parameter, will have to be calibrated, traceable to National or
no
international standards. Original calibration certificate along with
traceability to be submitted by vendor in their IQ file.
 Yes 
p) All material of construction should have test certificate.
no
q) Vendor must generate and provide all specifications and test  Yes 
certificates of software used in the equipment control and/or no
monitoring system.
7.4 Inspection Testing
a) Qualification shall be executed in presence of vendor along with  Yes 
Aristo team at customer site. no
8.0 Constraints
8.1 Equipments Location and available space.
For
This equipment will be installed in the Aristo laboratories facility.
informati
Floor: Ground floor in filling room of aseptic area.
on
Room size: Refer attached layout.
only
8.2 Available utility
a) Electricity: ______________
b) Compressed air:______________  Yes 
c) Nitrogen gas: ______________ no
Note: Vendor shall inform/notify any other utility requirement if any.
9.0 Timelines
 Yes 
a) Response to URS: Within 2 weeks of receipt of URS.
no
 Yes 
b) Quotation Submission: Within 3 weeks of receipt of URS
no
c) Submission of detail design specification and schematic  Yes 
drawings: 4 weeks after order finalization no
Submission of Qualification document  Yes 
d) (DQ/FS, FAT, SAT, IQ, OQ) With equipment delivery. no
e) Mechanical and electrical drawings: With equipment  Yes 
delivery. no
f) The Supplier shall notify customer three weeks in advance  Yes 
of the start of the qualification. no

10.0 Abbreviation
 NDB HEALTHCARE
User Requirement Specifications (URS)
Equipment
Vial Filling Linear Closing Machine
Name
Revision No.:
URS NO. NDB/URS/001 Page No.: 20 of 22
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Terms Abbrevations

CFR Code of Federal Regulations

db Decibel

DQ Design Qualification

FAT Factory Acceptance Test

GMP Good Manufacturing Practices

IQ Installation Qualification

MOC Material Of Construction

OQ Operational Qualification

PLC Programmable Logic Controller

QA Quality Assurance

SAT Site Acceptance Test

SOP Standard Operating Procedures

SS Stainless steel

0
C Degree Centigrade

IPC Industrial Personnel Computer

HMI Human machine interface

11.0 URS Acceptance by the vendor:

 NDB HEALTHCARE
User Requirement Specifications (URS)
Equipment
Vial Filling Linear Closing Machine
Name
Revision No.:
URS NO. NDB/URS/001 Page No.: 21 of 22
00

Vendor Name
and Address

Name/Sign/
Date

Comments
(If any)

Note: 1-Vendor shall be endorsed/stamped with signature and date in all the
pages of the URS after comments.
2-Vendor shall also be send the endorsed/stamped acceptance URS to
Aristo representative through mail (scanned copy) and hard copy
through currier (as applicable).

12.0 Final evaluation by user on vendor acceptance:

 NDB HEALTHCARE
User Requirement Specifications (URS)
Equipment
Vial Filling Linear Closing Machine
Name
Revision No.:
URS NO. NDB/URS/001 Page No.: 22 of 22
00

Vendor Name
and Address

Name/Sign/
Date

Comments
(If any)