1.0 OBJECTIVE:
To
lay down the operating procedure of Semi-automatic capsule filling machine.
2.0 SCOPE:
This
shall be applicable to the Semi-automatic
capsule filling machine of Capsule filling area of Production.
3.0 RESPONSIBILITY:
3.1
Supervisor/
Machine Operator.
3.2
Production
Pharmacist.
4.0 ACCOUNTABILITY:
4.1
Manager-Production
department.
5.0 MATERIAL AND
EQUIPMENT:
5.1
Semi-automatic capsule filling machine.
6.0 PROCEDURE:
6.1
Preliminary
operations:
6.1.1
The RH in the room
or area should be checked and recorded on manufacturing sheet. Filling should
not be started if humidity is more than 35%.
6.1.2
The compressed air
supply should be turned on and regulator set at about 5psi.
6.1.3
The vacuum pump should
be turned on with vacuum hole blocked and the vacuum adjusted to NLT 600mmHg.
6.1.4
At a time on one
container each of the blended product to be filled and of the empty hard
gelatin capsule should be brought into the room and placed on either side of
filling machine.
6.2
Loading
and Rectification:
6.2.1
The setting of the
loader and rectifier is checked by rotating the machine manually with the
clutch in the ON position and the adjustment should be made.
6.2.2
The bag of empty
capsule shells should be opened and with a clean scoop, capsules should be loaded
into the hopper of the rectification assembly.
6.2.3
The capsule
holding ring should be placed on the turntable and turned clockwise until it
stops firmly against the drive pin.
6.2.4
The machine should
be run manually to check if the capsules enter the ring correctly. If not, the
necessary adjustments should be made.
6.2.5
The main switch of
the machine should be switched on and the vacuum pump started. The vacuum
should not be less than 600mmHg.
6.2.6
The machine should
be started and clutch lever moved to the right to bring the capsule loader into
action. It should be checked whether the capsules are loaded properly. If the
loading is satisfactory, the loading of the disc should be completed.
6.2.7
As the last row of
empty capsules is deposited into the ring, on the turntable should be stopped
by moving the clutch lever to the left.
6.2.8
The ring assembly
should be subjected to two or three revolutions on the turntable in an
anti-clockwise direction to provide the capsules additional exposure to vacuum
for effective separation of the bodies from the caps.
6.2.9
The ring assembly
should be removed from the table slowly taking care to avoid spilling the
capsule; if then be placed on the ring of the machine.
6.2.10
The top half of
the ring should be separated vertically and held-chest high to see whether all
the capsules have been separated, defective ones should be rectified the hand
and the bodies of such capsules should be positioned inside the bottom hold of
the ring if too many capsules bodies are found un-separated, the vacuum should
be increased.
6.2.11
If the loading and
rectification of the capsules are satisfactory the process should be repeated
with another ring assembly.
6.3
Filling
of powder:
6.3.1
The bottom half of
the ring assembly should be placed on the left turntable near the drug hopper
and positioned.
6.3.2
The operator
should run his hand lightly over the ring to ensure that all the capsules are
below the ring surface.
6.3.3
The speed of the
turntable should be adjusted to the pre-determined rate. This should not be adjusted
while the machine is running on power.
6.3.4
The drug hopper
should be filled with the powder up to the stirring arm.
6.3.5
The machine should
be switched on the and the drug hopper pulled over the face of the moving ring
until the stirrer start moving and the powder fills the capsule bodies.
6.3.6
At the end of one
revolution of the ring should be pushed back smartly in order to avoid double
feeding of powder.
6.3.7
Excess powder from
the surface of the ring should be scrapped off with a small PVX sheet or Teflon
scraper and the powder should be collected in the dust tray.
6.3.8
The body ring with
the capsules filled with powder should be removed and the cap ring placed on it
and positioned so that the two rings are joined.
6.4
Sealing
of capsules:
6.4.1
The pressure of
the compressed air supply should be checked and adjusted if necessary to
between 5.5kg/sq.cm to 6.5kg/sq.cm. The air supply valve should be opened.
6.4.2
The sealing
position should be adjusted by means of a venire so that the sealed capsules
comply with the limits specified.
6.4.3
The complete ring
assembly containing the filled capsules should be lifted and held in a slightly
inclined position with the cap half facing the operator, and then positioned on
the joiner or sealing device.
6.4.4
The joiner plate should
be swung downwards into position and the ring assembly should be pulled snugly
against it.
6.4.5
The peg ring
assembly should be pulled, rotating if necessary to align the pins with the
holes the peg pins should be eased into the ring assembly until the capsule
have started to join.
6.5
Note:
6.5.1
The ring assembly
must be kept firmly against the joiner plate to prevent the capsules from being
pushed before joining.
6.5.2
The ring assembly
along with the joiner plate should be held firmly and the air control foot
pedal pressed in order to seal the capsules with air pressure.
6.5.3
The ring assembly
should be turned along with the joiner plate by approximately 180o
and the pedal pressed again to repeat the sealing process.
6.5.4
The ring assembly
should be pushed back completely on to the peg ring in order to eject the
capsules.
6.5.5
The capsules
should be collected in a container placed below the joiner.
6.5.6
The joiner plate
should be swung upwards and the ring assembly should be removed.
6.5.7
The ring should be
removed and knocked against the rubber bumper to remove excess powder.
6.5.8
The drug hopper
rotary table should be cleaned before repeating the filling cycle.
6.5.9
The weight of the
filled capsules should be determined and the weight of contents should be
adjusted, if necessary, by altering the speed of the machine.
6.5.10
The capsule should
be checked for proper sealing and the necessary adjustments to the joiner
plate, made if required.
6.5.11
Machine
adjustments should be made until the weighs are found to be within specified
limits.
6.5.12
Capsules produced
until these limits are reached should be segregated and stored separately until
they are taken up for reprocessing.
7.0 REVISION LOG:
|
Revision No.
|
Effective Date
|
Reason
|
|
00
|
|
New
SOP
|
8.0 REFERENCES:
8.1
Not Applicable.
9.0 ANNEXURES:
9.1
Not Applicable.
10.0
ABBREVIATIONS:
|
Abbreviation
|
Expanded Form
|
|
SOP
|
Standard operating
procedure
|
|
&
|
And
|
|
No.
|
Number
|
|
Ltd.
|
Limited
|
|
PM
|
Production machinery
|
|
PMO
|
Production machinery
operation
|
|
F
|
Format
|
|
RH
|
Relative humidity
|
|
%
|
Percentage
|
|
psi
|
Per square inches
|
|
mmHg
|
Millimeter mercury
|
|
NLT
|
Not less than
|
|
Kg/sq.cm
|
Kilogram per square
centimeter
|