USER REQUIREMENT SPECIFICATION

(URS)

URS No.: URS/O-PJ003-03

Effective Date:13/08/2014
Page No.: 1 of 8

Filling ,Stoppering and capping machine with aseptic positive

isolator

1.0

Name of Equipment / system

2.0

Equipments Make / Model

3.0

Purpose of equipment

To fill the vials with liquid &do the partial or full stoppering and
capping(for oncological products) OEL - 5

4.0

Capacity / Output / speed

100 vials /minute of 10ml.vial size.

Room Height

FCH: 2.8, Slab bottom: 6.0 Meters

PREPARED BY
User Department

(Sign and Date)

QA000/F00-00

REVIEWED BY
Head of The Department
Head Engineering / Projects

(Sign and Date)

(Sign and Date)

APPROVED BY
User Department

(Sign and Date)

USER REQUIREMENT SPECIFICATION

(URS)
c5.0 Process Requirement (s)

PREPARED BY
User Department

(Sign and Date)

QA000/F00-00

URS No.: URS/O-PJ003-03

Effective Date:13/08/2014
Page No.: 2 of 8

CGMP model, monoblock filling, stoppering and capping

machine with positive isolator consists of
1.0 Volumetric, rotary piston pumps driven by servomotors.
2.0 Class 100 under laminar flow with illumination > 350lux.
3.0 All Fluid contact parts should be SS316L with finish <0.5
RA and sterilizable.
4.0 Non-contact parts above worktable should be SS316 with
finish <1 RA.
5.0 Isolation of mechanical area with production area should
be 100% sealed.
6.0 Machine with wall installation required.
7.0 Machine should be suitable for 2 to 8o C products also
(Product manifold buffer tank need to be insulated, Temp
& RH Need to be controlled inside of the machine),filling
at isolator temperature.
8.0 No lubrication in the working zone.
9.0 Vials feeding & transport system to be derlin material &
cleanable with IPA & should not generate particles during
transport.
10.0 Pre and post inert gas provision & accessories should be
sterilizable.
11.0 SS316L,0.5 RA , Buffer tank with sterile vent filter and
fill level controller along with minimum level monitoring
system in the buffer tank.
12.0 All gassing stations are to be provided with sterile filter
along with flow control.
13.0 All needles used for gassing are to be SS316L and
sterilizable.
14.0 All stoppers and seals contact parts to be SS316L with
<0.5Ra and sterilizable.
15.0 Stoppers placement (13mm & 20mm liquid as well as Lyo
stoppers) mechanism to be Pick and Place driven by servo
motors.
16.0 Vials transport system controlled by servo drive and
product splashing should be nil.
17.0 Contained charging of seals, stoppers into the machine.
18.0 DOP ports and Differential pressure monitoring required
across HEPA.
19.0 Jog button required with flexible cord for temporary stop
and during machine setting.
20.0 End of batch mode to maximize the use of left over
product at the end of the shift.
21.0 During LYO product filling, capping mode should be off.
22.0 Electrical control panel with IP54 protection, placement in

REVIEWED BY
Head of The Department
Head Engineering / Projects

(Sign and Date)

(Sign and Date)

APPROVED BY
User Department

(Sign and Date)

USER REQUIREMENT SPECIFICATION

(URS)

URS No.: URS/O-PJ003-03

Effective Date:13/08/2014
Page No.: 3 of 8

25.0 Supply chute for stoppers and caps are with aseptic
version and electro polished down to < 0.5Ra
26.0
Stoppering and capping zone should be separated
by polycarbonate enclosure with adjustable mouse hole
& DP Monitoring.
27.0
Fillings pumps, stoppering, capping are driven by
servo motors.
28.0
Exhaust requires from the crimping operation.
29.0
The sorting device for Filling, Stoppers, and Seals
is accessible by a glove port.
30.0
Positioning of Microbiological plate (petri dish) &
Air sampling heads.
31.0
Solution shall be transferred through closed
system (SART system) from sterile filtration isolator to
filling M/c.
32.0
Dosing of filling pumps shall be 1ml to 25ml.
33.0
Vial diameter ranges from 16-55mm, height 32 to
100mm.
34.0
Max. Accumulation sensor for the control of one
upstream sterilizing tunnel.
35.0
Supplier should provide two set of change parts,
one for 10ml tubular vial ,another to be determined.
36.0
Isolator requirements:
36.1 Isolator leak tightness classification should be
Class 3 as per ISO 10648-2
36.2 Chamber leak test can be performed by pressure
decay method and leak rate should meet ISO
10648-2, class 3.
36.3 Isolator should be able to perform leak test before
and after of each process.
36.4 Working area should be grade A with UDAF
Membrane to get unidirectional airflow
Vendor to specify what are the systems available
with description to get laminar air flow
36.5 OEL validation to be done at site.
36.6 Surrounding environment will be Grade B.
36.7 Isolator should have VHP Provision.
36.8 Isokinetic probes required for online particle
monitoring.
36.9 Provision to connect the SART system to transfer
solution from mobile filtration isolator to dosing
system.
36.10 Temp, RH & DP Monitoring system inside the
isolator.
36.11 Catch pot for used accessories collection.

PREPARED BY
User Department

(Sign and Date)

QA000/F00-00

REVIEWED BY
Head of The Department
Head Engineering / Projects

(Sign and Date)

(Sign and Date)

APPROVED BY
User Department

(Sign and Date)

URS No.: URS/O-PJ003-03

USER REQUIREMENT SPECIFICATION

(URS)

Effective Date:13/08/2014
Page No.: 4 of 8

36.15 Clean room grade compact fluorescent lamp with

ballast to isolator with flush fittings to illuminate
the work space with greater than 350 Lux.
36.16 Provision for SVP Lamp for light sensitive products.
36.17 Digital display type differential pressure
monitoring system for.

Chamber
36.18 Zero leak dampers with actuators to facilitate VHP
sanitization and to perform leak testing

6.0 Components Details:

Sr. No.
6.1
6.2
6.3
6.4
6.5
6.6
6.7
6.8
6.9
6.10
6.11
6.12
6.13

Description of Component
Contact parts
Non contact parts
Hose pipes
Buffer tank
Vent filter
Hinges for polycarbonate
panes
Bio seal flange
Gassing stations (needles)
Bowl
Chute
Gloves
Glove ports
Manifold

MOC / Surface
finish
SS316L 0.5 Ra
SS316 1 Ra
Silicone
SS316L 0.5 Ra
PTFE

With test certificates

SS316
SS316L
SS316L
SS316L
Hypalon Clear
POM
SS316L

With test certificates

With test certificates
With test certificates
With test certificates
With test certificates
With test certificates
With test certificates
Applicable / Not Applicable

Component(s) / Feature(s)

PREPARED BY
User Department

(Sign and Date)

QA000/F00-00

With test certificates

With test certificates
With test certificates
With test certificates
With test certificates

SS304

7.0 Control Systems:

Sr.
No.

Features

Required
(Yes / No)

Description (as applicable)

REVIEWED BY
Head of The Department
Head Engineering / Projects

(Sign and Date)

(Sign and Date)

APPROVED BY
User Department

(Sign and Date)

URS No.: URS/O-PJ003-03

USER REQUIREMENT SPECIFICATION

(URS)

7.1

HMI and PLC Details

Yes

7.2

Alarms and Warnings

Yes

7.3
7.4

Data storage and security

Others

Yes
Yes

Effective Date:13/08/2014
Page No.: 5 of 8
The indications on HMI as follows
1. Batch code
2. Date
3. Starting time
4. Set parameters
5. Actual weights
6. Machine speed
7. Out put
In case of power failure, operational
status (parameters) changes like
No bottle/no fill/no stoppering
Machine Over load
Gassing fluid indication
Stoppers and seals level in chutes
Seals and stoppers level in bowl
No vials in conveyor
Utilities flow
Serial fault stop
When doors open
Required

8.0 Safety features:

Sr. No.
8.1
8.2
8.3

Applicable / Not Applicable

Safety Feature(s)
Emergency Stop
Power Failure / Recovery
Electrical Protection (Flame Proof / Non
Flame Proof)

Required
(Yes / No)
Yes
Yes

Alarms & warnings

Yes

8.5
8.6

Earthing
Noise level

Yes
Less

8.7

Interlocks

Yes

(Sign and Date)

QA000/F00-00

Applicable
Applicable

NA

8.4

PREPARED BY
User Department

Description (as applicable)

380volts,50hz,3phase
System to provide for operators
view, acknowledge and take
corrective action in the event of
system alarms
Applicable
Below 90db in the operating area
Machine should stop while guards
open

REVIEWED BY
Head of The Department
Head Engineering / Projects

(Sign and Date)

(Sign and Date)

APPROVED BY
User Department

(Sign and Date)

URS No.: URS/O-PJ003-03

USER REQUIREMENT SPECIFICATION

(URS)
8.8
8.9

Emergency switch
Protection Class

Effective Date:13/08/2014
Page No.: 6 of 8
Yes
Yes

9.0 Documentation:
Sr.
No.
9.1
9.2
9.3
9.4
9.5
9.6
9.6.1
9.6.2
9.6.3
9.6.4

Required for emergency stop

IP54
Applicable / Not Applicable

Title
Material of construction Certificate
(MOC) of Contact Parts / Non contact
parts
Calibration Certificates traceable to
NIST standard
Performance Test Certificates
Qualification Documents (DQ/IQ&OQ
document )
Operation and Maintenance Manual
Drawings
GA Drawing
P& ID Drawings
Electrical
Ladder Diagram

9.6.5 Process flow

Required
(Yes / No)

Description (as applicable)

Yes

Applicable

Yes

Applicable

Yes

Applicable

Yes

Soft and hard copy

Yes

3 sets required, Soft and hard copy

Yes
Yes
Yes
Yes

Authorized
Authorized
Authorized
Required
3 D Animation for entire process flow(as
built)

Yes

Back up of software / PLC based

system
9.8 Others
9.8.1 Ethernet
9.7

Yes

Required

Yes
Yes

Equipment specifications
Required

10.0 Others
10.1
10.2
10.3

Training
Inspection at Vendors end
Technical support

PREPARED BY
User Department

(Sign and Date)

QA000/F00-00

Yes
Yes
Yes

Operational and performance

FAT
As and when required

REVIEWED BY
Head of The Department
Head Engineering / Projects

(Sign and Date)

(Sign and Date)

APPROVED BY
User Department

(Sign and Date)

URS No.: URS/O-PJ003-03

USER REQUIREMENT SPECIFICATION

(URS)

10.4

11.0

Others

Effective Date:13/08/2014
Page No.: 7 of 8

---

Any proposals from the vendors are

encouraged which are superior and
more desirable to maintain the system
in controlled state. Based on the
outcome on discussion with vendors
regarding the proposals, URS /
features in the equipment or system
can be changed. The same shall be
summarized and approved before
release of purchase order.

URS Acceptance by the vendor:

Comments by vendor (if any):

Conclusion by vendor:
The User requirement specification has been discussed and agreed upon. We hereby declare that we will
supply the equipment / system as per above laid down specification.
Name of the Vendor

PREPARED BY
User Department

(Sign and Date)

QA000/F00-00

Signature / Date

REVIEWED BY
Head of The Department
Head Engineering / Projects

(Sign and Date)

(Sign and Date)

APPROVED BY
User Department

(Sign and Date)

USER REQUIREMENT SPECIFICATION

(URS)

PREPARED BY
User Department

(Sign and Date)

QA000/F00-00

URS No.: URS/O-PJ003-03

Effective Date:13/08/2014
Page No.: 8 of 8

REVIEWED BY
Head of The Department
Head Engineering / Projects

(Sign and Date)

(Sign and Date)

APPROVED BY
User Department

(Sign and Date)