NDB HEALTHCARE

User Requirement Specifications (URS)

Equipment
Automatic FOUR Head Vial Sealing Machine
Name
Revision No.:
URS NO. NDB/URS/002 Page No.: 1 of 22
00

USER
REQUIREMENT SPECIFICATIONS (URS)
FOR
AUTOMATIC FOUR HEAD VIAL SEALING MACHINE

AUTOMATIC FOUR HEAD VIAL SEALING

Name of Equipment: :
MACHINE

URS Number/Revision No :
NDB/URS/002

Department : Production Injection

URS Effective Date :

Total No of pages : 20

Client Address : NDB HEALTHCARE

 NDB HEALTHCARE
User Requirement Specifications (URS)
Equipment
Automatic FOUR Head Vial Sealing Machine
Name
Revision No.:
URS NO. NDB/URS/002 Page No.: 2 of 22
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Revision index

Revision Date Reason for Revision

00 New Documents
 NDB HEALTHCARE
User Requirement Specifications (URS)
Equipment
Automatic FOUR Head Vial Sealing Machine
Name
Revision No.:
URS NO. NDB/URS/002 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 6
3.0 Process Description 7
3.1 Input & Charging Method 7
3.2 Brief Process Steps 7
3.3 Output & Discharging Method 7
4.0 Productivity Requirement 8
4.1 Desired/ Suggested Capacity 8
4.2 Standard Batch Size 8
4.3 Change Over Time (as Applicable) 8
4.4 Cleaning/sanitization /sterilization time (as applicable) 8
4.5 Other Productivity Requirement 8
5.0 Safety Requirement 8
5.1 General 8
5.2 Power Failure And Recovery 9
5.3 Containment 9
6.0 GMP Requirements 9
6.1 Process Control 10
6.2 Failure Mode Detection 10-11
6.3 Level Of Instrumentation 11
6.4 Qualification Requirement 11
6.5 Material Of Construction 11-12
6.6 Use Of Lubricants 13
6.7 21 CFR Part 11 Compliance 13
6.8 Data Integrity 13
6.9 Batch Data Display And Record Printing 13
6.10 Desired Documents 14-15
6.11 Training 15
7.0 Technical Requirement 15
7.1 Basic Technical Requirement 15
7.2 Level Of Automation 15
7.3 Specific Requirements 15-16
7.4 Inspection Testing 16
8.0 Constraints 16
8.1 Equipment Location And Available Space 16
8.2 Available Utility 16
9.0 Timelines 17
10.0 Abbreviation 18
11.0 URS Acceptance By The Vendor 19
12.0 Final Evaluation By User On Vendor Acceptance 20
 NDB HEALTHCARE
User Requirement Specifications (URS)
Equipment
Automatic FOUR Head Vial Sealing Machine
Name
Revision No.:
URS NO. NDB/URS/002 Page No.: 4 of 22
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1.0 Approval signatures:
This document is prepared by the production (user); engineering and validation
team at NDB HEALTHACREfacility 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
Automatic FOUR Head Vial Sealing Machine
Name
Revision No.:
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2.0 Overview
2.1 Project Introduction
NDB HEALTHACREis amongst the most progressive companies in India as
well as abroad. Company has set the highest of standards for
pharmaceuticals manufacturing.
NDB HEALTHACREis 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 AUTOMATIC FOUR HEAD VIAL SEALING 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 21 CFR Part 211.
2.3 Equipment Description
2.3.1 Main Body:
Machine frame should be made of M.S (Powder coated) and fully covered
with the S.S. 304 sheet suitable SS guard cover the entire body from the
side. Main motor, main gear box pinion shaft assembly, star wheel
assembly, feeder wheel assembly etc. are mounted over the base frame.
2.3.2 Main drive mechanism:
Main drive gear box assembly should be mounted on the bottom side of
machine
frame.
2.3.3 Conveyor Assembly :
Conveyor belt shall be mounted on the top plate of the machine and main
purpose of the conveyor is to feed the stopper vial to the in feeder wheel
and transfer the duly sealed vials to visual inspection machine.
2.3.4 Turret assembly:
It is a main part of the machine, where actual sealing is done .it is located at
the center of the machine and it is made of solid S.S turret is divided into
two parts i.e. upper turret and lower turret. The main function of the turrets
is to pick up the vial from the in-feed wheel and to place under the sealing
assembly where the sealing will done and then again it delivers the vial to
the exit star wheel.
2.3.5 Star wheel clutch assembly:
The main function of this assembly is to operate the clutch when there is
jamming condition due to the oversize diameter of the vial. The clutch is
interlocked with the help of proximity sensor mounted below the clutch plate
 NDB HEALTHCARE
User Requirement Specifications (URS)
Equipment
Automatic FOUR Head Vial Sealing Machine
Name
Revision No.:
URS NO. NDB/URS/002 Page No.: 6 of 22
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as and when this jamming condition takes place the sensor will sense the
clutch and stops the machine immediately.
2.3.6 Vibrator assembly:
Vibrator assembly is located at the top most position of the machine, it is
having vibrator unit with magnetic coil. The spring steel vibrator strips are
provided to transfer the vibration to the cap bowl. Vibrator bowl will be
made of S.S. 304 material. The main function of the vibrator bowl is to
deliver the aluminum seal to the chute, which deliver the aluminum seal to
the exit end of the chute. Vial will pick up the seal during the rotary
movement with the in feed star wheel.
2.3.7 Lifter Assembly:
Lifter assembly is mounted on the lower turret. This moves on the lifter cam
provided at the top plate and bottom side of the lower turret. It picks up the
vial from the in-feed star wheel and holds between the lifter bowl and chuck
and after sealing operation it delivers the vial to the exit star wheel.
2.3.8 Chuck Assembly:
Chuck assembly is located at the upper turret. It is having a chuck shaft.
Spur gear mounted on the top of the shaft which rotates the shaft for the
sealing operation and the bottom side of the shaft is provided with a sealing
chuck which has a cap groove either for plain seal or for flip-off seals.
2.3.9 Crimping Assembly:
Crimping assembly is mounted with the upper turret. It consists of crimping
cam and sealing roller block with roller.
 When the vial is hold by the chuck, crimping roller moves towards the
neck of vial with the help of crimping cam and gradually the pressure of
the roller increase as it moves on crimping cam.
 All electrical cables are located inside of the machine.
 Control panel: control panel is made from SS 304.
 Emergency switch
 Machine on/off switch.
 HMI/IPC touch screen
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
 NDB HEALTHCARE
User Requirement Specifications (URS)
Equipment
Automatic FOUR Head Vial Sealing Machine
Name
Revision No.:
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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) Vial: 3.5ml tubular filled and plugged vial is directly charged in  Yes 
upright position at the conveyor of sealing machine. No
b) 13 mm Flip-off seals: Sanitize/RFU aluminium flip-off seals shall  Yes 
be fed into the hopper provided in the sealing machine No
c) Compressed Air: Provision of Nitrogen supply for flushing of  Yes 
unwanted materials. No
3.2 Brief Process Steps
a) Transportation of stoppered vials signalized on a conveyor belt up to  Yes 
sealing station. No
b) Transportation of vial to sealing station without falling on conveyor  Yes 
belt.
c) Sanitize/RFU aluminum flip-off seals shall be fed into the sterilized No
hopper, stoppered vial will move from filling through conveyor to
sealing machine then it will come under the sealing head one by one  Yes 
with the help of star plate seal shall place on the stoppered vial and no
crimp on it completely sealed and integral vial shall move for next
step of visual inspection
d) The sealing machine shall install under Grade A environment and  Yes 
stoppers vials transported through conveyor belt from filling machine No
and then rubbers stoppered vials shall be sealed with 13mm flip off
seals properly.
3.3 Output & Discharging method
a) The sixteen head vials sealing machine shall be transported  Yes 
through a conveyor belt for visual inspection for further processing. No
b) The rubbers stoppered vial should be sealed properly i.e. no
 Yes 
seal cut and vial should not fall and easily transported in the conveyor
No
of out feed side of sealing machine for visual inspection
4.0 Productivity Requirement
4.1 Desired/ Suggested capacity
a) The sixteen head vials sealing machine (filling line) shall be
suitable to produce sealed vials of different vial sizes.  Yes 
For 3.5ml glass tubular vials USP Type-I : 500 vials/min. No
For 5.0 ml and 7.5ml (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)
 NDB HEALTHCARE
User Requirement Specifications (URS)
Equipment
Automatic FOUR Head Vial Sealing Machine
Name
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Specifications Remarks
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.
b) The fix the number at each sealing head, so that find out any sealed  Yes 
defect at time of sealing, which is not erasable. No
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.
a) Machine shall be easy to clean and sanitize. Shall be free from cavities  Yes 
to avoid the product and dirt entrapment. No
Vendor to suggest solvent to be used for cleaning of the equipment.
Sealing change parts easily dismantle & sterilization is requirement
(as applicable).
b) Machine parts shall be compatible with wide variety of disinfectants  Yes 
used in Pharma industries. No
c) Design of the equipment should enhance cleaning feasibility by  Yes 
providing of the minimum sharp corners, crevices and smooth finished No
weld joints.
d) Parts which require cleaning during product/batch change over should  Yes 
be provided with quick fixing arrangement. No
e) All moving parts shall be accessible for application of the equipment.  Yes 
Vendor to suggest lubricant to be used with catalogues and detail of No
supplier.
f) 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
g) Machine should be suitably designed for easy clearance, in case of  Yes 
breakage of product during sealing. No
4.5 Other Productivity Requirement
a) Provision of SS 316L table/case under LAF near to seals hopper is  Yes 
required for keeping/holding of RFU bags (If needed). No
b) The filling machine shall have average working hours per day: 18-20  Yes 
considering three shifts (If needed). No
c) To minimize of product rejection after machine stop and at the end of  Yes 
sealing. 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 that No
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
 NDB HEALTHCARE
User Requirement Specifications (URS)
Equipment
Automatic FOUR Head Vial Sealing Machine
Name
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Specifications Remarks
 Yes 
c) Emergency stop buttons shall be accessible to the operator.
No
 Yes 
d) Provision of audible alarms & warnings shall be provided.
No
 Yes 
e) Integration of sealing machine with filling line/machine.
No
 Yes 
f) Warning stickers on all hot surfaces and sharp surface.
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 location. No
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 (as No
applicable).
5.2 Power failure and recovery
a) On power failure, sealing machine must come to rest (safe state)
 Yes 
and power restart must not be automatic and human intervention
No
must be required.
b) All motion stopped on the machine.  Yes 
c) A “Safe State” shall be defined as: No
 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:
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  Yes 
further action. Non-Critical warnings and shall sound the alarm horn, No
illuminate the alarm indicator but allow the system to continue to
operate. The operator shall be required to acknowledge the warning in
 NDB HEALTHCARE
User Requirement Specifications (URS)
Equipment
Automatic FOUR Head Vial Sealing Machine
Name
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Specifications Remarks
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 chamber  Yes 
are closed. Door closure indicator status shall be displayed. Which No
door open which closed shall also be displayed?
 Yes 
l) Provision of electronic back-up/data storage (if applicable).
No
5.3 Containment
a) A separate bin shall be provided for collection of un-sealed, broken  Yes 
and rejected vials. No
6.0 GMP requirements
6.1 Process control
a) Sealing machine should consistently and reproducibly seal vials.  Yes 
Vendor shall provide the actual accuracy at operating ranges of No
sealing speed.
b) The equipment control system should be suitable to adjust and  Yes 
maintain the rate of sealing (number of vials/minute) No
c) The equipment should control and monitor the pressure/flow rate of  Yes 
sterile compressed supply. No
 Yes 
d) Auto rejection mechanism, reject verification and reject counter.
No
 Yes 
e) The utilities supply lines should be provided with the equipment.
No
f) 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 
g) Batch details must be clearly readable (if applicable).
No
h) Noise level should not be more than 70 db at a distance of 1 m from  Yes 
the equipment. No
i) 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
j) Power failure/recovery, electrical protection alarms and warnings  Yes 
flame proof and earthling. Machine shall trip on power failure and after No
resumption shall restart without damage of machine and loss of data
(as applicable).
k) UPS supply provision shall be provided to PLC to prevent any loss of  Yes 
data. No
 NDB HEALTHCARE
User Requirement Specifications (URS)
Equipment
Automatic FOUR Head Vial Sealing Machine
Name
Revision No.:
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Specifications Remarks
l) Checks for pre-operational performance/verification of printing detail
 Yes 
of the batch on PLC and their speed. No
m) Pressure gauge for utilities shall provide or better design as  Yes 
vendor specify. No
 Yes 
n) Necessary shafts/guards and moving parts have to be tightly sealed.
No
 Yes 
o) Vendor to give code numbers for each component.
No
p) The transport of the vials from sealing machine in-feed and out-feed  Yes 
turntable under LAF through conveyor belt. No
 Yes 
q) Control Panel furnished with equipment shall be SS 304.
No
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) details:
 Yes 
a) Emergency stop activated.
No
 Yes 
b) In-feed empty
No
 Yes 
c)Overload on conveyor belts
No
 Yes 
d) Maximum out feed condition reached (if applicable).
No
 Yes 
e) Continuous detection (max 3) of missing vials on sealing station
No
 Yes 
f) Continuous detection (max 3) of missing flip off seals on sealing station
No
 Yes 
g) Reaching very low level of seals in hopper.
No
h) Malfunction of machine i.e. low differential pressure with respect to  Yes 
room (optional) No
i) Particle count results out of limit (optional)  Yes 
No
j) Low utility supply pressure of compressed gas and vacuum etc (as  Yes 
applicable). No
k) Machine stop while safety guard is open.  Yes 
No
l) Provision of continuous monitoring of air particulate is required in  Yes 
different locations to demonstrate Grade A condition (users scope-If No
needed).
m) Machine should have sensors/probes provision for on line particle  Yes 
monitoring (vendor scope). No
6.3 Level of instrumentation
a) Sufficient and suitable instrumentation for the process, safety and  Yes 
productivity control shall be provided as per requirements of the No
 NDB HEALTHCARE
User Requirement Specifications (URS)
Equipment
Automatic FOUR Head Vial Sealing Machine
Name
Revision No.:
URS NO. NDB/URS/002 Page No.: 12 of 22
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Specifications Remarks
operation like pressure, speed and vacuum etc.
6.4 Qualification requirement
a) Equipment shall be qualified with life cycle approach: i.e. Design  Yes 
Qualification (DQ), Installation Qualification (IQ), and Operational No
Qualification (OQ).
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 
stages of the qualification. No
c) All digital and analogue Input and output function should be verified.  Yes 
Test to be performed by supplier during FAT or SAT (if needed). No
d) Digital instruments should be calibrated full loop during SAT (if  Yes 
needed). No
e) Vendor shall perform software backup and restore test as per  Yes 
guideline during qualification (as applicable). No
f) Software function including algorithm if involved should be verified for  Yes 
accuracy (as applicable). No
g) Disaster management should be in built in the system. Data backup  Yes 
facility should be verified (as applicable). No
h) Application software should have suitable security and access control  Yes 
(as applicable). No
i) The hardware and software of computer system should be tested for  Yes 
all parameter of GAMP 5 (as applicable). No
6.5 Material of construction
a) All metallic contact surfaces should be constructed of 316L grade  Yes 
stainless steel or better with internal mirror surface finish. No
b) All non-product contact metallic surfaces should be constructed of 304  Yes 
grade stainless steel or better (316 steel for sterile area equipment), No
external surface finish.
c) Gaskets, seals and O-rings coming in direct/indirect contact surfaces  Yes 
should be constructed of food grade polymeric materials only. No
 Yes 
d) All welds should be ground finished and properly passivated.
No
e) Insulation material should be non-fibrous and covered with completely  Yes 
welded SS 304 or better cladding (if applicable). No
f) All non-metallic surfaces shall be smooth for easy wiping and should  Yes 
not accumulate the dust. No
g) All machine part shall be compatible with wide verity of cleaning  Yes 
agents. No
 Yes 
h) The conveyor belt should be constructed of SS quality.
No
i) Gaskets and seals should be constructed of Food grade polymeric  Yes 
materials only. No
6.6 Use of lubricants
Any lubricant, if used in the equipment must be food grade and  Yes 
 NDB HEALTHCARE
User Requirement Specifications (URS)
Equipment
Automatic FOUR Head Vial Sealing Machine
Name
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Specifications Remarks
non toxic.
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.
d) Sufficient data storage media shall be provided for data storage (as  Yes 
applicable). No
e) (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 (as applicable).
f) Data shall be collected/printed in hardcopy as well as retained  Yes 
electronically (as applicable). No
g) 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).
h) The information for all system functions requiring written or
displayed text shall be in English language only.  Yes 
(Others units may be followed for ease of understanding-with the No
approval of Aristo).
6.9 Batch data display and record printing
HMI should display the following important parameters but not limited
to these (as applicable).
 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
 NDB HEALTHCARE
User Requirement Specifications (URS)
Equipment
Automatic FOUR Head Vial Sealing Machine
Name
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Specifications Remarks
 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
 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 
the life cycle of the project as follows: No
 Yes 
Phase-1: Pre-ordering of the equipment
No
 Yes 
a) Filled in URS
No
 Yes 
b) P&ID and /or GA drawing.
No
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User Requirement Specifications (URS)
Equipment
Automatic FOUR Head Vial Sealing Machine
Name
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Specifications Remarks
 Yes 
c) Detailed technical offer the support the compliance of the URS.
No
Phase-2: Post-ordering of the equipment
a) Design specification and technical specification, that should  Yes 
contain the following: No
 Yes 
 System description and its function
No
 Yes 
 System operation steps.
No
 Yes 
 List of failure indications,
No
 Yes 
 List of interlocks (if applicable).
No
 Yes 
 List of inputs/outputs and functions
No
 List of major components, devices and instruments with  Yes 
their specific functions and specifications. No
 Yes 
 GA diagram of the system
No
Phase-3: Fabrication stages of the equipment
 Yes 
a) FAT protocol and report. (If needed)
No
Phase-4: Fabrication stages of the equipment
Vendor shall provide the following documents in the delivery  Yes 
package. The delivery package shall reach the site of user No
before installation of the system.
a) Operation and maintenance manuals, preventive maintenance  Yes 
schedule for system component as well as the operating No
system.
b) Operations and maintenance manuals for the bought out items  Yes 
(if applicable) No
 Yes 
c) Installation Instructions.
No
 Yes 
d) As build drawing for machine.
No
e) Details drawing marking clearly of the necessary dimensions  Yes 
and location of utilities along with requirement of utilities on No
the drawing along with offer.
 Yes 
f) Other drawing such as P & ID , electrical , instrumentation etc.
No
g) Spare and/or change parts /bought but item list with ordering  Yes 
information (ordering reference code, vendor contact address). No
parts
 Yes 
h) MOC certificates and surface finish test report.
No
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Automatic FOUR Head Vial Sealing Machine
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Specifications Remarks
i) Instruments certificates with respect to the traceable national
 Yes 
reference standard instrument and their calibration procedure.
No
(If applicable)
j) Recommended SOP’s for operations, Cleaning and
 Yes 
maintenance of each system (optional) No
k) Guarantee/warranty/ certificates for each system and major
 Yes 
bought out items. No
 Yes 
l) Shipping checklist
No
 Yes 
m) DQ, IQ and OQ documents.
No
n) Vendor to provide code numbers for each component of the  Yes 
equipment. (If applicable) No
6.11 Training during Instalation.
 Yes 
a) Online training for operation is to be given during installation.
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
 Yes 
c) The heat given off by the machine must be stated (inside the room)
No
d) The construction of the complete system should be described in  Yes 
the 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  Yes 
details, which should appear in the print out. Print out must provide No
results of all critical process parameter and failure alarms (As
applicable).
c) The equipment should operate with minimum operator involvement.  Yes 
The equipment control panel must be provided with a Human No
machine interface based on English language with appropriate
number (a minimum of 05 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  No
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User Requirement Specifications (URS)
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Automatic FOUR Head Vial Sealing Machine
Name
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Specifications Remarks
and quick access to all necessary maintenance points e. g. Motors,
counter sensor etc.
b) The 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
d) The make of the PLC shall preferably be Siemens/Allen Bradley (if  Yes 
applicable). 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 filling to other side of visual inspection  Yes 
machine is required. No
 Yes 
h) Digital counter for sealed 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) Suitable provision should be made to introduce and withdrawal of  Yes 
microbiology environmental sampling aids e.g. media plates. No
Equipment must be fabricated following all Good
Engineering Practices.
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  Yes 
controller or indicators to read, print or control any of the No
parameter, will have to be calibrated, traceable to National or
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 (as applicable).
7.4 Inspection Testing
a) Qualification shall be executed in presence of vendor along with  Yes 
Aristo validation team at customer site. No
8.0 Constraints
8.1 Equipments Location and available space.
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User Requirement Specifications (URS)
Equipment
Automatic FOUR Head Vial Sealing Machine
Name
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Specifications Remarks
This equipment will be installed in the Aristo laboratories facility. For
Floor: Ground floor in sealing room of aseptic area. informatio
Room size: Refer attached layout. n only.
8.2 Available utility
a) Electricity: ______________  Yes 
b) Nitrogen /compressed air:______________ No
Note: Vendor shall inform/notify any other utility requirement if
any.
9.0 Timelines
 Yes 
a) Response to URS: Within 4 weeks of receipt of URS.
No
 Yes 
b) Quotation Submission: Within 4 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 
a) (DQ/FS, FAT, SAT, IQ, OQ) With equipment delivery. No
b) Mechanical and electrical drawings: With equipment  Yes 
delivery. No
c) The Supplier shall notify customer three weeks in advance  Yes 
of the start of the qualification. No
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Equipment
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Name
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10.0 Abbreviation
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
PQ Performance Qualification
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
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Automatic FOUR Head Vial Sealing Machine
Name
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11.0 URS Acceptance by the vendor:

Vendor Name
and Address

Name/Sign/
Date

Comments
(If any)
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Equipment
Automatic FOUR Head Vial Sealing Machine
Name
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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:

Vendor Name
and Address

Name/Sign/
Date
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User Requirement Specifications (URS)
Equipment
Automatic FOUR Head Vial Sealing Machine
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Comments
(If any)