1.0 OBJECTIVE:
To
lay down the operating procedure for the operation of Blister Packing Machine.
2.0 SCOPE:
This
SOP shall be applicable for Blister Packing Machine in packing area at Production
department.
3.0 RESPONSIBILITY:
3.1
Supervisor/
Machine Operator.
3.2
Production
Pharmacist & above.
4.0 ACCOUNTABILITY:
4.1
Manager-Production
department.
5.0 MATERIAL AND
EQUIPMENT:
5.1
Blister Packing Machine.
6.0 PROCEDURE:
6.1 Start-up and Operation:
6.1.1
Assemble all
dismantle parts, channel, and feeding hopper.
6.1.2
Connect the power
source. Press the power ON/OFF key, then press the inching key of main motor.
Check whether the motor rotates as the arrow shows. Exchange the cables if not.
6.1.3
Connect the inlet
and outlet as shown on the back of frame. Connect the air pipe of air pump to
air inlet and connect the air pump motor to the electric control circuit.
6.1.4
Take out the Batch
No. plate and set the digits according to Batch Manufacturing sheet for
specific batch. Reassemble the plate at its position with loose bolts.
6.1.5
Press the upper
heating key, lower heating key and heat-sealing key to preheat all the heating
area. Adjust each temperature controller to have heat-sealing temperature at
about 160oC, upper heating at about 100oC, lower heating
temperature at about 100oC. (Exact temperature is determined by the
actual requirements during blistering).
6.1.6
Install the PVC
and Aluminium foil rolls on machine. Adjust the bubble positions size etc.
manually. Fix Aluminium foil with PVC and adjust its position manually.
6.1.7
Press the main
motor and drawing ON/OFF key, the heating plate will be lowered down
automatically and the machine will be started. Collect first few empty blisters
strips and check them for Batch No. and Expiry date embossing, shaping, and heat-sealing
and cutting.
6.1.8
After checking of
empty blisters, fill the feeding hopper with capsule and open the channel and
start production.
6.1.9
Collect the
blister strips and wastage in separate containers.
6.1.10 After
completion of Batch/Product repeat the cleaning process.
6.2 After
completion of operation, fill “Equipment
Log Book”.
6.3 Precaution:
6.3.1
Ensure that main
power supply/ switch is in “OFF” position while cleaning, dismantling and
assembling.
6.3.2
The operator
should wear hand gloves, mask while operation.
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
|
|
oC
|
Degree centigrade
|
|
PVC
|
Polyvinyl chloride
|