SAUDI PHARMACEUTICAL INDUSTRIES - RIYADH

USER REQUIREMENT

SPECIFICATION (URS)

NAME : FILM COATING MACHINE

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
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 SAUDI PHARMACEUTICAL INDUSTRIES - RIYADH

USER REQUIREMENT SPECIFICATION

EQUIPMENT NAME FILM COATING MACHINE
URS REFERENCE No.

S.NO PARAMETER DETAILED DESCRIPTION OF THE SPECIFICATION

EQUIPMENT /
1 Film Coating Machine
MACHINE NAME
A Film Coating machine should be designed for best coating results in
Tablet process.
It should be Designed in compliance with the CGMP standard,
This equipment is design to create a uniform coating of tablet with an
organic solvent, aqueous or enteric coating

Loading Capacity (kg/batch):120-140 Kg/batch

Coating Pan Rotation (rpm) : 2-30 RPM
PURPOSE & Volume of the Solution Tank :20-90 L
2 GENERAL Number of Spray Gun:2
DESCRIPTION Pan Angle :30°
Pan Size: as per manufacturer recommendation and should be in SS
316 quality.

Dimensions : as per manufacturer recommendation

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

to operate , clean

Coating machine shall be installed at sudair plant of Production

INSTALLATION
3 section of Saudi Pharmaceutical Industries. Sudair site , Kingdom of
LOCATION
Saudi Arabia

Coating Machine should be made-up SS316L construction,

MATERIAL OF All surfaces shall be smooth, crevice free and corrosive resistance.
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CONSTRUCTION All other accessories shall be industrial standards

The Film coating machine shall be designed with following features

Film coating with organic solvent. Film coating with aqueous coating.
Sugar coating.
SPECIFIC
5
REQUIREMENTS Audiovisual alarms shall be provide for malfunction of critical
operation / critical utilities

Automated process

Conforms to cGMP.

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 FILM COATING MACHINE
URS REFERENCE No.

Flexible batch operations.

Product protective handling to prevent chipping of tablets.

Complete separation of production and technical area.

Extremely user friendly software and operation through PLC.

Excellent mixing and tumbling by special design of baffles.

Made up of entirely of S.S.316.

Suitable for cleaning by CIP system (provision shall be provided).

Control and display the negative pressure in coating pan.

Control and display supply air speed.

Control and display the temperature.

Preventing the spray gun from plugging up.

The memory and the print function

Atomized Spraying system with Spray Gun,

The application of the coating material should be done on a

continuously moving bed of tablets. There should be a system that
also ensures rapid removal of the solvent using a hot air current.
Product to be coated are placed in a closed drum, that is in
continuous orbital motion and the coating system sprays the coating
material evenly in rotating motion to avoid excess deposit on the
OPERATING tablets.
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PRINCIPLE
During the motion, coating medium automatically sprays according to
the technological process and rational technological parameters, at
the same time hot air is supplied under a negative pressure.

The hot air penetrates through the tablet core layers and is
discharged from the bottom of the layers, so that the coating medium
sprayed on the surface of tablet cores will dry rapidly and evenly, thus

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 FILM COATING MACHINE
URS REFERENCE No.

forming a solid and smooth surface film.

The exhaust , blower & clean air inlet filters can be custom built to
keep out of the production area with suitable ducting

SAFETY Emergency bottom shall be provided on the panel

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FEATURES Other features shall comply with industrial requirements

HMI screen shall be displayed all function like inlet , outlet hot air
DATA &
8 temperature , pan speed , atomized pressure batch no. date and time
RPORTS
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

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
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ON Machine mechanical , electrical diagrams
Change parts shall be provided as applicable
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
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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
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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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