Alu-Alu Blister packing machine operation SOP

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 160^oC, upper heating at about 100^oC, lower heating temperature at about 100^oC. (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