USER REQUIREMENT SPECIFICATION (URS) URS No.: URS/O-PJ003-03 Effective Date:13/08/2014 Page No.: 1 of 11 1.0 Name of Equipment / system Filling ,Stoppering and capping machine with aseptic positive isolator 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 REVIEWED BY APPROVED BY User Department Head of The Department Head Engineering / Projects User Department (Sign and Date) (Sign and Date) (Sign and Date) (Sign and Date) QA000/F00-00
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USER REQUIREMENT SPECIFICATION(URS)
URS No.: URS/O-PJ003-03
Effective Date:13/08/2014
Page No.: 1 of 7
1.0 Name of Equipment / system
Filling ,Stoppering and capping machine with aseptic positive isolator
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
PREPARED BY REVIEWED BY APPROVED BYUser Department Head of The Department Head Engineering / Projects User Department
(Sign and Date) (Sign and Date) (Sign and Date) (Sign and Date)QA000/F00-00
USER REQUIREMENT SPECIFICATION(URS)
URS No.: URS/O-PJ003-03
Effective Date:13/08/2014
Page No.: 2 of 7
c5.0
Process Requirement (s) 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 the service
floor.23.0 Pluggable size parts for fast change over.24.0 100%IPC required with online volume correction having 0.5%
volume accuracyPREPARED BY REVIEWED BY APPROVED BYUser Department Head of The Department Head Engineering / Projects User Department
(Sign and Date) (Sign and Date) (Sign and Date) (Sign and Date)QA000/F00-00
USER REQUIREMENT SPECIFICATION(URS)
URS No.: URS/O-PJ003-03
Effective Date:13/08/2014
Page No.: 3 of 7
25.0 Supply chute for stoppers and caps are with aseptic version and electro polished down to < 0.5Ra
26.0Stoppering and capping zone should be separated by polycarbonate enclosure with adjustable mouse hole & DP Monitoring.
27.0Fillings pumps, stoppering, capping are driven by servo motors. 28.0Exhaust requires from the crimping operation.29.0The sorting device for Filling, Stoppers, and Seals is accessible by a
glove port.30.0Positioning of Microbiological plate (petri dish) & Air sampling heads.31.0Solution shall be transferred through closed system (SART system)
from sterile filtration isolator to filling M/c.32.0Dosing of filling pumps shall be 1ml to 25ml.33.0Vial diameter ranges from 16-55mm, height 32 to 100mm.34.0Max. Accumulation sensor for the control of one upstream sterilizing
tunnel.35.0Supplier should provide two set of change parts, one for 10ml tubular
vial ,another to be determined.36.0Isolator 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.36.12 Sampling to be taken during process, collection should be in
contained manner. (Vendor to specify what are the systems available with description)
36.13 DOP port provision across HEPA filters.36.14 Safe changeable PTFE glove ports
PREPARED BY REVIEWED BY APPROVED BYUser Department Head of The Department Head Engineering / Projects User Department
(Sign and Date) (Sign and Date) (Sign and Date) (Sign and Date)QA000/F00-00
USER REQUIREMENT SPECIFICATION(URS)
URS No.: URS/O-PJ003-03
Effective Date:13/08/2014
Page No.: 4 of 7
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. Description of Component MOC / Surface finish Features
6.1 Contact parts SS316L 0.5 Ra With test certificates6.2 Non contact parts SS316 1 Ra With test certificates6.3 Hose pipes Silicone With test certificates6.4 Buffer tank SS316L 0.5 Ra With test certificates6.5 Vent filter PTFE With test certificates
6.6 Hinges for polycarbonate panes SS304 With test certificates
6.7 Bio seal flange SS316 With test certificates6.8 Gassing stations (needles) SS316L With test certificates6.9 Bowl SS316L With test certificates
6.10 Chute SS316L With test certificates6.11 Gloves Hypalon Clear With test certificates6.12 Glove ports POM With test certificates6.13 Manifold SS316L With test certificates
7.0 Control Systems: Applicable / Not Applicable
Sr. No. Component(s) / Feature(s) Required
(Yes / No) Description (as applicable)
PREPARED BY REVIEWED BY APPROVED BYUser Department Head of The Department Head Engineering / Projects User Department
(Sign and Date) (Sign and Date) (Sign and Date) (Sign and Date)QA000/F00-00
USER REQUIREMENT SPECIFICATION(URS)
URS No.: URS/O-PJ003-03
Effective Date:13/08/2014
Page No.: 5 of 7
7.1 HMI and PLC Details Yes
The indications on HMI as follows1. Batch code2. Date3. Starting time4. Set parameters5. Actual weights6. Machine speed7. Out put
7.2 Alarms and Warnings Yes
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
7.3 Data storage and security Yes Required7.4 Others Yes
10.1 Training Yes Operational and performance10.2 Inspection at Vendor’s end Yes FAT10.3 Technical support Yes As and when required
PREPARED BY REVIEWED BY APPROVED BYUser Department Head of The Department Head Engineering / Projects User Department
(Sign and Date) (Sign and Date) (Sign and Date) (Sign and Date)QA000/F00-00
USER REQUIREMENT SPECIFICATION(URS)
URS No.: URS/O-PJ003-03
Effective Date:13/08/2014
Page No.: 7 of 7
10.4 Others ---
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.
11.0 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 Signature / Date
PREPARED BY REVIEWED BY APPROVED BYUser Department Head of The Department Head Engineering / Projects User Department
(Sign and Date) (Sign and Date) (Sign and Date) (Sign and Date)QA000/F00-00
