SAUDI PHARMACEUTICAL INDUSTRIES - RIYADH

USER REQUIREMENT

SPECIFICATION (URS)

NAME : CAPSULE FILLING 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 CAPSULE FILLING MACHINE
URS REFERENCE No.

S.NO PARAMETER DETAILED DESCRIPTION OF THE SPECIFICATION

EQUIPMENT /
1 Capsule Filling Machine
MACHINE NAME
Capsule Filling Machine should be designed for high precision
Capsule Filling results in the process.
It should be Designed in compliance with the cGMP standard,

This equipment is design to create a uniform capsule filling process

with powder and granules

PURPOSE & Max output (capsules/hour): 90,000 / hr

2 GENERAL Filling percentage(accuracy ):99.7%
DESCRIPTION Vacuum: as per manufacturer recommendation
No. of die orifice: 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

Capsule filling machine shall be installed at sudair plant of Production

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

Capsule Filling Machine 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 Capsule Filling Machine shall be designed with following features

Programmable control system, touch screen panel, speed-shift and

electronic automatic counter.
SPECIFIC Fully automatic, it can complete the actions of position, separation,
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REQUIREMENTS filling and locking of capsules. It should be advanced high precision
tooling machines that guarantee reliable interchangeability of different
capsule models.
It should be suitable for pharmaceutical products such as powder,
pellets, and granules, even special products with sticky, abrasive,
fibrous or other properties.

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 CAPSULE FILLING MACHINE
URS REFERENCE No.

It should be space-saving machine and should provides a

straightforward operation, format changeover

The housing and surface are covered with stainless steel 304. All
contact parts of medical powders are made from a corrosion resistant
stainless steel 316.
All parts are standardized and easy to substitute.
Capable of filling 6 capsules at a time with operation from 10 stations.
Accurate operation for orientation, opening, filling, joining and ejecting
of the capsules
Compulsory spiral feeding in the powder hopper to ensure powder
feeding and filling.
Dual capsule-opening design to ensure all capsules are opened.
Electrical impact protection device to prevent any further damage.
The machine should stop automatically in the event of collision.
Safety Sensing System to shut the machine down automatically in the
event of problems when no capsules, no powder, door is opened, and
abnormal load for the machine are detected.
Automatic vacuum removal of the air in the dosing tube to give more
accurate weight of the filled capsules.
Exclusive dosing tube system, temperature of the powder will not rise
during the filling process.
Adjustable compression piston in dosing tube to adjust the powder
volume without change parts.
Easy to changeable
Dosage accuracy.
Conforms to cGMP.
Flexible batch operations.
Easy to operate with a PLC system fully integrated with a HMI
Meets high quality testing standards (both EU and cGMP)
High production capacity and change parts for one years
Need capsule polisher
Cost competitive
high filling accuracy to the vertical-movement and the vacuum
assisted vacuum dosators
Quick format changes because only a very few format sets required
Statistical weight control system (CWC) for filled capsules

CONFIDENTIAL INFORMATION SAUDI PHARMACEUTICAL INDUSTRIES - RIYADH

NOT TO BE REPRODUCED / DISCLOSED WITHOUT PRIOR WRITTEN APPROVAL
Page 3 of 5
 SAUDI PHARMACEUTICAL INDUSTRIES - RIYADH

USER REQUIREMENT SPECIFICATION

EQUIPMENT NAME CAPSULE FILLING MACHINE
URS REFERENCE No.

Optional automatic feed units for products and capsules

Automatic drug hopper in-feed mechanism to eliminate variations.
Guarantee high degree of accuracy and precision
Special purpose gauges are provided for quick and easy change over
Faulty capsule and filled capsule ejection stations with individual
air controls.
Adjustable gap between dosing disk and tamping plate ensures
minimum spillage of powder.

Automatic Capsule Filling Machine should be designed and

developed to fill hard / soft gelatin capsules with powder or pellets. It
is an extremely durable and reliable machine that fills dosages to the
highest accuracy. It can be applicable to the widest range of capsules
at all sizes and should guarantee the integrity of all capsules.

the empty capsules are fed from the storage hopper and through
rectifying unit, into the two piece filling ring
As the ring is rotated, a vacuum is applied on the outer side. This
vaccum seats the bodies into the lower half of the ring, while the caps
retained in the upper portion.
OPERATING The two pieces of the ring are separated, and the cap containing
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PRINCIPLE portion is placed aside. The body containing portion of the ring is
placed on a variable speed turntable and is rotated mechanically
rotated under the powder hopper, which contains an auger for the
forced delivery of the powder.
After one complete rotation the powder hopper is removed, and the
two segments of the ring are rejoined.
The intact ring is positioned in front of the peg ring and the closing
plate is pivoted to 180 degrees.
Pneumatic pressure is applied to the peg ring, which forces the
capsules body into the cap and the closing plate.
Ejection of the capsules are collected through a chute

Emergency bottom shall be provided on the panel

Safety Sensing System to shut the machine down automatically in the
SAFETY event of problems when no capsules, no powder, door is opened, and
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FEATURES abnormal load for the machine are detected.
Other features shall comply with industrial requirements

CONFIDENTIAL INFORMATION SAUDI PHARMACEUTICAL INDUSTRIES - RIYADH

NOT TO BE REPRODUCED / DISCLOSED WITHOUT PRIOR WRITTEN APPROVAL
Page 4 of 5
 SAUDI PHARMACEUTICAL INDUSTRIES - RIYADH

USER REQUIREMENT SPECIFICATION

EQUIPMENT NAME CAPSULE FILLING MACHINE
URS REFERENCE No.

DATA & HMI screen shall be displayed all function like fill volume capsule
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RPORTS counter , batch no. 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

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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