100% found this document useful (1 vote)
1K views4 pages

URS-oct Blender

The document is a user requirement specification for an octagonal blender to be installed at a pharmaceutical plant in Saudi Arabia. It specifies the need for a 300 liter stainless steel blender with a speed range of 5-40 RPM and 6 inch discharge valve. The blender must mix powders and granules efficiently and be easy to operate, clean and validate according to cGMP standards. Safety features like guards and emergency stops are required. Documentation including manuals, diagrams and test certificates must also be provided.

Uploaded by

QA
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
100% found this document useful (1 vote)
1K views4 pages

URS-oct Blender

The document is a user requirement specification for an octagonal blender to be installed at a pharmaceutical plant in Saudi Arabia. It specifies the need for a 300 liter stainless steel blender with a speed range of 5-40 RPM and 6 inch discharge valve. The blender must mix powders and granules efficiently and be easy to operate, clean and validate according to cGMP standards. Safety features like guards and emergency stops are required. Documentation including manuals, diagrams and test certificates must also be provided.

Uploaded by

QA
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 4

SAUDI PHARMACEUTICAL INDUSTRIES - RIYADH

USER REQUIREMENT

SPECIFICATION (URS)

NAME : OCTAGONAL BLENDER


USER DEPARTMENT : PRODUCTION (SUDAIR PLANT )
URS REFERENCE No. :

APPROVAL OF URS
In-Charge Name & Title Signature Date

Prepared By
Production Department Head

Reviewed By
Maintenance Department Head

Reviewed By
Validation Department Head

Reviewed By
Quality Assurance Department
Head

Approved By
Head – Quality & Technical Affairs

CONFIDENTIAL INFORMATION SAUDI PHARMACEUTICAL INDUSTRIES - RIYADH


NOT TO BE REPRODUCED / DISCLOSED WITHOUT PRIOR WRITTEN APPROVAL
Page 1 of 4
SAUDI PHARMACEUTICAL INDUSTRIES - RIYADH

USER REQUIREMENT SPECIFICATION


EQUIPMENT NAME OCTOGONAL BLENDER
URS REFERENCE No.

S.NO PARAMETER DETAILED DESCRIPTION OF THE SPECIFICATION


EQUIPMENT /
1 OCTAGONAL BLENDER
MACHINE NAME
A octagonal blender should be designed for blending of dry granules
or powder.
The blender features an octagon shaped body with rectangular
central portion and top & bottom polygonal frustum.
This should be provided with baffles for fast and efficient mixing,
charging port and outlet with butterfly valve.
PURPOSE & Capacity : 300 liters gross ( 140 kg working capacity )
2 GENERAL Speed in RPM : 5-40 RPM
DESCRIPTION
Discharge Valve Size in inches: 6 inches
Dimensions : as per manufacturer recommendation

It should be cGMP model, Complying to industrial standard and easy


to operate , clean
Octagonal blender shall be installed at sudair plant of Production
INSTALLATION
3 section of Saudi Pharmaceutical Industries. Sudair site , Kingdom of
LOCATION
Saudi Arabia
octagonal blender should be made-up SS316L construction,
MATERIAL OF
4 All surfaces shall be smooth, crevice free and corrosive resistance.
CONSTRUCTION
All other accessories shall be industrial standards

The octagonal blender shall be designed with following features


The entire unit is mounted on a sturdy stand, complete with electric
motor and gear box
Machine is provided with control panel board and safety railing
Simple operation and easy to cleaning
SPECIFIC
5 Contact parts in stainless steel 316
REQUIREMENTS
Octagonal shaped with rectangular center, conical discharge frustum
and rectangular top frustum

Baffles provided in the shell

Manhole with gasket is provided to fix baffles and for ease of cleaning
the shell

CONFIDENTIAL INFORMATION SAUDI PHARMACEUTICAL INDUSTRIES - RIYADH


NOT TO BE REPRODUCED / DISCLOSED WITHOUT PRIOR WRITTEN APPROVAL
Page 2 of 4
SAUDI PHARMACEUTICAL INDUSTRIES - RIYADH

USER REQUIREMENT SPECIFICATION


EQUIPMENT NAME OCTOGONAL BLENDER
URS REFERENCE No.

Charging and discharging is through a butterfly valve. A conical


adaptor can be provided for fixing charging drum after butterfly valve

Unit can be provided with bin charging arrangement

All moving parts are enclosed in guards

A safety railing with a limit switch is provided for operator safety ꞏ


Manual Inching arrangement can be provided

Flame - proof motors with flame - proof push button stations can be
provided.

A complete unit is supplied with suitable electrical motors, gear box,


control panel shall be provided.

Audiovisual alarms shall be provide for malfunction of critical


operation / critical utilities (optional)

The blender features an octagon shaped body with rectangular


central portion and top & bottom polygonal frustum.
This should be provided with baffles for fast and efficient mixing,
charging port and outlet with butterfly valve.

Blender shall have following features


OPERATING The entire unit is mounted on a sturdy stand, complete with electric
6
PRINCIPLE motor and gear box
The machine is provided with control panel board and safety railing
It is a slow speed blender and has a removable baffle mounted
through a rectangular lid

Flame- proof motors with flame proof push button stations can be
provided (optional)
SAFETY Emergency bottom shall be provided on the panel
7
FEATURES Other features shall comply with industrial requirements

DATA & HMI screen shall be displayed all function like RPM , date and time
8
RPORTS option shall be provided (optional)
TEST Test certificates of the different Materials used in the construction of
9 CERTIFICATES the machine (MOC certificates).
(Hard Copies) Calibration certificates of the all the instruments

CONFIDENTIAL INFORMATION SAUDI PHARMACEUTICAL INDUSTRIES - RIYADH


NOT TO BE REPRODUCED / DISCLOSED WITHOUT PRIOR WRITTEN APPROVAL
Page 3 of 4
SAUDI PHARMACEUTICAL INDUSTRIES - RIYADH

USER REQUIREMENT SPECIFICATION


EQUIPMENT NAME OCTOGONAL BLENDER
URS REFERENCE No.

Data sheets of all major parts


One copy of operational , maintenance manuals in English
One copy of Functional specification in English
One copy of design specification created by vendor ( English )
One copy of validation document (DQ, IQ,OQ And PQ ) (optional)
DOCUMENTATI Data sheet for the all installed instruments
10
ON Machine mechanical , electrical diagrams
Change parts shall be provided
Spare part for first one year
P&ID , electrical drawing to be provided
Four levels ( operator , supervisor , Maintenance , admin) multi user
11 Passwords
password access to the HMI shall be provided (optional)
Required Start up & technical support on the user site during final
Start up & installation and qualification time.
12
Technical support Installation will be done at site by our Maintenance team.

Type of current –single phase , 220 Voltage and Frequency : 60 Hz


Energy / Utility or
13
Resources 3 phase supply,380 Voltage and Frequency :60 Hz

CONFIDENTIAL INFORMATION SAUDI PHARMACEUTICAL INDUSTRIES - RIYADH


NOT TO BE REPRODUCED / DISCLOSED WITHOUT PRIOR WRITTEN APPROVAL
Page 4 of 4

You might also like