QUALITY NEXGEN PHARMACEUTICAL

Page 1 of 4
PVT. LTD.
STANDARD OPERATING PROCEDURE SOP No.
QN/CAP/OP-03
PROCEDURE FOR OPERATION OF Revision No 002
Title SEMI AUTOMATIC CAPSULE FILLING
Issue Date 01.03.2016
MACHINE
Department Production Effective Date 01.04.2016
Area Capsule Department Review on or before 01.04.2018
QA & Copy Made: 2 QN/CAP/OP-03
Distribution Supersedes
PRODUCTION
1. OBJECTIVE:
To provide guidelines for operation of Semi Automatic Capsule filling machine.

2. SCOPE :
Applicable for filling of empty hard gelatin capsules.

3. MAKE AND CAPACITY:

Cap-Tech Engineers.
Pacific Technologies.

4. RESPONSIBILITY
Production Chemist/Production Manager..& Operator

5. PROCEDURE
5.1 ASSEMBLING
Assemble the cleaned and dried accessories in the following order:
5.1.1 Capsule loading assembly consisting of magazine, slide (Pusher Plate),rectifying block
and right hand side loading turn table.
5.1.2 Left hand side loading turn table with appropriate spares below.
5.1.3 Modified auger and stirrer if required, to the shaft of the filling side.
5.1.4 Hopper shoe to the blend hopper and fit the hopper to the hopper holder.
5.1.5 Base late.

PREPARED BY CHECKED BY APPROVED BY AUTHORISED BY

SIGNATURE
DATE
DESIGNATION PROD. CHEMIST PROD. MANAGER QA MANAGER PLANT MANAGER
 QUALITY NEXGEN PHARMACEUTICAL
Page 2 of 4
PVT. LTD.
STANDARD OPERATING PROCEDURE SOP No.
QN/CAP/OP-03
PROCEDURE FOR OPERATION OF Revision No 002
Title SEMI AUTOMATIC CAPSULE FILLING
Issue Date 01.03.2016
MACHINE
Department Production Effective Date 01.04.2016
Area Capsule Department Review on or before 01.04.2018
QA & Copy Made: 2 QN/CAP/OP-03
Distribution Supersedes
PRODUCTION
5.1.6 Pin plate in locking unit.
5.2 OPERATION
5.2.1 Load the empty capsules in the empty capsule hopper. Load the blend into the blend
hopper.
5.2.2 a) Switch ON the vacuum pump.
b) Start the compressed air supply by opening the compressed air.
c) Switch ON the electrical supply.
d) Switch ON the mains of the machine (Lever situated behind the machine)
e) Switch ON the motor of the machine by pressing CONTROL START push button
(situated on control panel in front of the machine)
5.2.3 Place the loading ring on loading turn table (i.e. right hand side turn table for loading
empty capsules. Start loading by pressing the RECTIFIER START push button for
loading empty capsules. Stop loading of empty capsules, if necessary , by pressing the
RECTIFIER STOP push button.
5.2.4 Ensure that all parts of the M/C are cleaned as per S.O.P. QN/CAP/CL-03.
5.2.5 Load the empty capsules in hopper. Load the bled into power hopper.
5.2.6 Start the vacuum & compressed air. Switch on the power supply & switch on the mains
of the m/c.
5.2.7 Fit the capsule ring on loading turn table for loading empty capsules. Start loading by
pushing ON the start button for loading empty capsules.
5.2.8 On the completion of one revolution of capsule ring the loading stops automatically. Turn
the ring 2-.3 complete rotations to separate cap & body.

PREPARED BY CHECKED BY APPROVED BY AUTHORISED BY

SIGNATURE
DATE
DESIGNATION PROD. CHEMIST PROD. MANAGER QA MANAGER PLANT MANAGER
 QUALITY NEXGEN PHARMACEUTICAL
Page 3 of 4
PVT. LTD.
STANDARD OPERATING PROCEDURE SOP No.
QN/CAP/OP-03
PROCEDURE FOR OPERATION OF Revision No 002
Title SEMI AUTOMATIC CAPSULE FILLING
Issue Date 01.03.2016
MACHINE
Department Production Effective Date 01.04.2016
Area Capsule Department Review on or before 01.04.2018
QA & Copy Made: 2 QN/CAP/OP-03
Distribution Supersedes
PRODUCTION
5.2.9 Separate the cap & body rings. Place the lock partial fill attachment on the ring. Keep the
body ring on the turntable. Pull the handle of the powder hopper over the body ring to
start powder filling. After one complete revolution of the ring push the hopper back to
it’s original position scrape the excess powder from the die plate with the help of a Teflon
or nylon brush.
5.2.10 Place cap ring on the body partially filled with the blend. The joined loading ring is
placed on vertical closing unit & closing unit is pushed manually into the closing
structure, where capsule get locked. Apply compressed air by pressing the foot lever to
ensure uniform locking. Release the air pressure and manually press the pin assembly to
eject the capsules into the IPC.
5.2.11 After completion of operation switch OFF the M/C by pressing the switch marked
emergency lever power mains vacuum & compressed air supply.

6. PRECAUTION
6.1 Ensure correct assembling by moving the hand wheel manually to check free movement of all
loading parts and then switch ON
6.2 In case of any abnormal sound from machine during its operation stop the machine and report to
Engg. Dept.
6.3 Vacuum supply be adjusted to (limit 15”- 20” of Hg) separate cap & body of the capsules.
6.4 Compressed air required to operate the M/C & for closing unit should be (limit 70-100 psi)
6.5 Adjust the locked length of the capsule by adjusting the closing length adjustment nut.

PREPARED BY CHECKED BY APPROVED BY AUTHORISED BY

SIGNATURE
DATE
DESIGNATION PROD. CHEMIST PROD. MANAGER QA MANAGER PLANT MANAGER
 QUALITY NEXGEN PHARMACEUTICAL
Page 4 of 4
PVT. LTD.
STANDARD OPERATING PROCEDURE SOP No.
QN/CAP/OP-03
PROCEDURE FOR OPERATION OF Revision No 002
Title SEMI AUTOMATIC CAPSULE FILLING
Issue Date 01.03.2016
MACHINE
Department Production Effective Date 01.04.2016
Area Capsule Department Review on or before 01.04.2018
QA & Copy Made: 2 QN/CAP/OP-03
Distribution Supersedes
PRODUCTION

7. REVISION HISTORY
7.1 Revision History Table

SOP Number Effective Date Supersedes Brief description of change

QN/CAP/OP-03 01.04.2016 QN/CAP/OP-03 1] Change in Format.
2] Added History, Precaution
and Revision History table
in SOP.

PREPARED BY CHECKED BY APPROVED BY AUTHORISED BY

SIGNATURE
DATE
DESIGNATION PROD. CHEMIST PROD. MANAGER QA MANAGER PLANT MANAGER