SAUDI PHARMACEUTICAL INDUSTRIES - RIYADH

USER REQUIREMENT

SPECIFICATION (URS)

NAME : FLUID BED PROCESSOR

USER DEPARTMENT : PRODUCTION (SUDAIR SITE )
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
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 SAUDI PHARMACEUTICAL INDUSTRIES - RIYADH

USER REQUIREMENT SPECIFICATION

EQUIPMENT NAME FLUID BED PROCESSOR
URS REFERENCE No.

S.NO PARAMETER DETAILED DESCRIPTION OF THE SPECIFICATION

EQUIPMENT /
1 FLUID BED PROCESSOR
MACHINE NAME
A Fluid bed processor is designed to dry products as they float on a
cushion of air or gas at respective temperature.
Fluid bed dryer is made up of SS316 L with GMP standards.
It should be pilot scale.
PURPOSE &
2 GENERAL Capacity : 120 kg
DESCRIPTION Dimensions : as per manufacturer recommendation

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

to operate ,clean
Fluid bed dryer shall be installed at sudair plant of Production section
INSTALLATION of Saudi Pharmaceutical Industries. Sudair site , Kingdom of Saudi
3
LOCATION Arabia

Fluid bed dryer should be made-up SS316L construction for all

contact parts and SS304 for all non contact parts ,
MATERIAL OF
4 All surfaces shall be smooth, crevice free and corrosive resistance.
CONSTRUCTION
All other accessories shall be industrial standards

The Fluid bed dryer shall be designed with following features

A complete unit is supplied with suitable motors, switches, control
panel, heating systems shall be provided. .
Audiovisual alarms shall be provide for malfunction of critical
operation / critical utilities
All contact parts AISI 316 & non contact parts AISI 304.
High Mixing Precision, Short Batch Time, Problem free Cleaning and
SPECIFIC
5
REQUIREMENTS Residue Free Discharge.
Auto temperature controller for steam radiator / electrical coil.
Auto shutoff system for over limit temperature/ heating.
Auto stop when process is completed.
Overload relay controls.
Single piece construction & Integrated retarding chamber cum filter
bag housing

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 FLUID BED PROCESSOR
URS REFERENCE No.

S.NO PARAMETER DETAILED DESCRIPTION OF THE SPECIFICATION

Granulation system with advance PLC controls system with MMI
Touch screen.
Spraying system with atomized spraying gun and high precise flow
peristaltic pump.
Pneumatic Sealing of Filter Bag and Product container by inflatable
silicon rubber tube.
Inlet Air handler with Air Filter- Micro and HEPA and Heat Exchanger.

With the help of spray nozzles granulating liquid or coating solution is

sprayed to produces granules or coating of particles respectively and
then dried with hot air.
The particles are lifted from the bottom and suspended in air stream.
This condition is called fluidized state.
A fluidized bed is a bed of solid particles through which hot air is
passed at high pressure through air distribution plate/bottom of
container.
OPERATING
6 The filtered air is then heated to the required temperature by electric/
PRINCIPLE
steam radiator
Movement of both hot air and product is controlled by the apparatus
to ensure that the heating in the process air is used for vaporization of
the liquid and not undesirable heating of the product.
The hot air passes through the product container and the product is
dried by air fluidization
The air circulation is controlled by damper

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 temperature ,batch no.
8
RPORTS date and time option shall be provided
Test certificates of the different Materials used in the construction of
TEST
the machine (MOC certificates).
9 CERTIFICATES
Calibration certificates of the all the instruments
(Hard Copies)
Data sheets of all major parts
DOCUMENTATI
10 One copy of operational , maintenance manuals in English
ON
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 FLUID BED PROCESSOR
URS REFERENCE No.

S.NO PARAMETER DETAILED DESCRIPTION OF THE SPECIFICATION

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)
Data sheet for the all installed instruments
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

Start up & Required Start up & technical support on the user site during final
12
Technical support installation and qualification time.
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
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