1. OBJECTIVE
To lay down the procedure operation Blister packing machine
2. SCOPE
This procedure is applicable to Production, in the blister area of tablet section
3. RESPONSIBILITY
• Supervisor/ Machine Operator
• Production Pharmacist/ Above
4. SAFETY INSTRUCTIONS
• Normal electrical precautions should be followed.
• Gloves, eye and ear protection are required.
5. PROCEDURE
5.1 Growing procedure is followed as per SOP.
5.2 Production person shall ensure the cleanliness of the machine & area and ‘CLEANED’ label on it.
5.3 Before starting the operation production person get the line clearance from Q.A person and affix the status label with product name, batch details to equipment & area.
5.4 Assemble all dismantle parts, channel, and feeding hopper.
5.5 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.
5.6 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.
5.7 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.
5.8 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).
5.9 Install the PVC and Aluminum foil rolls on machine. Adjust the bubble positions size etc. manually. Fix Aluminum foil with PVC and adjust its position manually.
5.10 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.
5.11 After checking of empty blisters, fill the feeding hopper with capsule and open the channel and start production.
5.12 Collect the blister strips and wastage in separate containers.
5.13 After completion of Batch/Product repeat the cleaning process.
5.14 After completion of operation, fill “Equipment Log Book”.
6. RELATED DOCUMENTS
Machine Usage Log Book- Annex -I
7. DISTRIBUTION INDEX
Original Copy will be retained by Quality Assurance Department.
| DISTRIBUTION INDEX | ||
|---|---|---|
| Distributed To | Copy No. | Received By/Date |
| Production Department | 01 | , |
8. ABBREVIATIONS
SS Stainless Steel
QA Quality assurance
No. Number
PVC Polyvinyl Chloride
9. REVISION HISTORY
| Revision No. | Issue Date | Supersedes | Reason of Change / Description |
| Revision No. Dated | |||
| 00 | 06/09/2022 | 00 N/A | First Version |