1) OBJECTIVE | |
| To define procedure and steps to be carried out for the operation of 27 stations double rotary tablet compression machine | |
| 2) SCOPE | |
| This SOP is applicable for the operation of 27 stations double rotary tablet compression machine | |
| 3) RESPONSIBILITY | |
| Operator: To operate the equipment as per the given procedure. | |
| 4) ACCOUNTABILITY | |
| Production Officer: To check and monitor the operating activity and record the same. | |
| 5) REFERENCES | |
| In- House | |
| 6) ATTACHMENTS | |
| Annexure – I ( Machine Log Book ) | |
| 7) COMMENTS | |
| 7.1 SOP reviewed at the end of the Review Period. 7.2 SOP revised due to change in the Review period of SOP from 2 years to 3 years. | |
| 8) PROCEDURE | |
| 8.1 | Ensure that the Equipment and the Area are released by the Quality Assurance Department for production. |
| 8.2 | Ensure that the power mains are switched ‘OFF’. |
| 8.3 | Open the left side SS cover to expose the lower punch loading position. |
| 8.4 | Rotate the machine flywheel ( by hand ) to bring one of the stations in the turret directly above the punch loading position. |
| 8.5 | Clean the holes & insert dies in each of them. Press the same with the help of die rod ( in case of DS shape tooling the upper punches are to be set before fixing the dies aligning with the upper punches ). |
| 8.6 | The dies are tightened with Teflon plugs and align cylindrical bolts. The lower punches are from the bottom. |
| 8.7 | Held the lower punch tightly with anti–turning strips and Teflon plumps. |
| 8.8 | Adjust the lower punch height such that on the ejection at the height point the punch surface flushes with the turret die surface. This will eject the tablet freely. |
| 8.9 | On completion of lower punches fixing, fix the feed frame on both left & right. |
| 8.10 | Fix both the hoppers on the left & right to the spindles provided. |
| 8.11 | Fill the hopper with product granules ( to be compressed ) and rotate the flywheel slowly. This will enable the granules to flow down the hopper and into the die holes, 2nd & 3rd ports of the feed frame. |
| 8.12 | Adjust the hopper in such a way that the granules flow freely down. |
| 8.13 | Adjust the tablet weight ( which is related to the die fill volume ) by adjusting the stop screw with the handle, which in turn alters the travel of the dozer on whose surface the lower punch’s heads travel. In the process, the scraper blade fixed to the feed frame scrapes off the excess granules. |
| 8.14 | Adjust the tablet hardness by pressing the adjusting handwheel, which raises or lowers the lower pressure rolls to increase or decrease the distance between the upper and lower punch faces. Reduction of distance will increase the pressure and vice – versa. |
| 8.15 | After setting and obtaining the desired weight and hardness continue the compression. |
| 8.16 | On completion of the operation, label the equipment suitably for further use/cleaning. Clean the machine as per cleaning SOP. |
| 9) | ABBREVIATIONS: |
| SOP: Standard operating procedure | |
| QA: Quality Assurance | |
| QC: Quality Control | |
| PD: Production Department |
MACHINE LOG BOOK
| MACHINE: | MACHINE NO.: | |||||||||||||||||
| LOCATION: | MAKE: | |||||||||||||||||
| CLEANING SOP NO.: | OPERATION SOP NO.: | |||||||||||||||||
| Date | Product | B.No. | Activity | Time | Done By | Breakdown hrs | Nature of Break down | Checked By | Remarks | |||||||||
| From | To | From | To | |||||||||||||||