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Precautions |
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5.2.1 |
Ensure that machine is cleaned and line clearance is taken. |
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5.2.2 |
Ensure that all parts are properly fitted by rotating the hand wheel. Ensure that the vacuum pressure is within the limit of 500 – 600 mm of Hg. |
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5.2.3 |
Do not touch the moving parts or put hand during the running of the machine. |
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5.2.4 |
During cleaning/dismantling of machine switch ‘OFF’ the mains of the machine. |
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5.2.5 |
Ensure that the limit switches are working properly. Use Hand wheel during setting/cleaning. |
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5.2.6 |
Before starting the Operation make sure that the line clearance is taken and recorded in the BMR and Record the activity in the equipment log book. |
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5.2.7 |
Before starting the operation ensure the temperature and relative humidity of the area is within the limit specified in the BMR. |
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5.2.8 |
Place a clean container lined with double poly bag below the Capsule ejection ports of the machine before start of the operation. |
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5.3 |
Setting of Loading Station |
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5.3.1 |
Issue the change parts of the machine as per respective product BMR. Record the Issuance details in Annexure. |
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5.3.2 |
Rotate the hand wheel and bring the magazine to the bottom most position over the rectifier raceway. |
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5.3.3 |
At this moment, one capsule from each slot of magazine is released. |
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5.3.4 |
The capsule releasing pin can be pushed in and pulled out. |
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5.3.5 |
To facilitate the release of capsules from the magazine the pin should be pushed in |
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5.3.6 |
Continue the Hand wheel rotation and the slide will start moving back. |
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5.3.7 |
Simultaneously the vertical blades will start moving down. |
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5.3.8 |
The tips of the blades will touch the capsules at its cap edge and capsules starts tilting in the cap up and body down position. This is called rectification. |
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5.3.9 |
Ensure that the required vacuum is available at the vacuum slot. |
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5.3.10 |
Now place the loading ring on the loading table. |
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5.3.11 |
When the hand wheel is rotated the loading table also indexes anti-clock wise and stops before the capsules are loaded. |
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5.3.12 |
At this moment, one row of holes on loading rings is totally aligned with the vacuum slot. |
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5.4 |
Setting for Proper Rectification |
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5.4.1 |
Once the capsules are released from the magazine in to the rectifier raceway slot, they are pushed forward by the slide. |
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5.4.2 |
The setting of the slide determines the position of the capsule over the slot. |
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5.4.3 |
The correct position of the capsule is ensured when the tip of the blade touched the body just near the cut edge of the capsule. |
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5.4.4 |
For proper loading of the capsules the alignment of the loading ring holes with the vacuum slot is important. |
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5.4.5 |
In case the alignment is disturbed, this can be set right using the centring gauge. |
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5.4.6 |
Remove the rectifier block assembly fitted on the front face of the magazine. |
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5.4.7 |
Fix the centring block at the same location with the screws |
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5.4.8 |
Insert the centring pins in to the holes of the centring block and align the block with the slots of the rectifier raceway. |
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5.4.9 |
Turn the hand wheel and check that the open end of both the pins enter into the holes of the loading ring |
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5.4.10 |
Care should be taken to remove the pins from the block before forward indexing of the loading ring. Failing to do so the pins will get struck and bent. |
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5.4.11 |
In case the pins do not enter the loading ring re align the loading table. |
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5.4.12 |
To facilitate loading table realignment adjust kidney slot position on loading table with respect to fixing screws. |
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5.5 |
Operation of Loading Station |
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5.5.1 |
Put the machine in Auto mode and load the loading ring with capsules. |
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5.5.2 |
Press the rest (yellow) button first and then rectifier start (Green) button. The loading cycle will start. |
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5.5.3 |
The cycle will stop after completing one rotation of the loading ring consisting of 60 indexings. |
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5.5.4 |
During the loading cycle press the Rectifier Stop (Red) button to stop the loading cycle midway. |
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5.5.5 |
Again press the Rectifier start (Green) button to start the loading cycle. The loading cycle will restart and continue till completion of remaining strokes. |
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5.5.6 |
Once the cycle is completed, rotate the loading ring manually for 2 turns before lifting to ensure complete separation of capsules. |
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5.6 |
Operation of Filling Station |
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5.6.1 |
Place the body of the loading ring on the filling table and check the gap between the proximity switch and body ring is around 1 to 2 mm. |
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5.6.2 |
As soon as the body ring is placed, LED of proximity switch will glow. |
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5.6.3 |
Ensure that all the body ring holes are filled with bodies of the empty capsule and their top edges are below the top surface of the body ring. |
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5.6.4 |
Fill the drug hopper with the powder to be filled. |
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5.6.5 |
Select one Medium speed (say 8.1 RPM) for the filling table. Select the minimum speed (310/288) for the auger. |
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5.6.6 |
Press the powder table start (Green) Button, the Hopper will swing over the body ring placed on the filling table. |
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5.6.7 |
The Auger will start rotating in clockwise direction and will push the powder into the body of the capsule. |
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5.6.8 |
When the filling table completes one rotation the hopper returns to its initial position and the Auger rotation stops. |
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5.6.9 |
Scrape off the extra powder from the surface of the body ring with Teflon dispenser. |
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5.7 |
Operation of Closing Station |
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5.7.1 |
Place the Cap ring on the body ring matching the respective lugs and place it on the locating table of the closing unit. |
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5.7.2 |
Gently push in the unit by the handle. |
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5.7.3 |
The capsules will get locked by pin plate assembly operated by the pneumatic cylinder. |
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5.7.4 |
The closing length of the capsules can be set by adjusting the position of the nut on the threaded shaft. |
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5.7.5 |
Pull out the closing unit and place the stopper on the lugs of the loading ring. |
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5.7.6 |
Turn the trolley anti clockwise to eject the locked capsules into the chute from where the capsule rolls down into the collection box. |
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5.7.7 |
The loose powder is collected in the powder tray provided below the exit chute. |
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5.8 |
Fill Weight Control |
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5.8. |
The fill weight can be controlled by the speed of rotation of the Auger present in the hopper. |
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5.8.1 |
If the fill weight of the capsule is marginally less then shift to the next lower speed of the gerar box. |
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5.8.2 |
If the fill weight of the capsule is more than the theoretical fill weight then shift to the next higher speed of the gear box. |
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5.8.3 |
Check for all the In-Process parameters as per product BMR. If all the parameters comply as per the limit mentioned in the BMR then continue the capsule filling activity. |
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5.8.4 |
Collect all the Capsules from the ejection station of the machine in clean containers lined with double poly bag. |
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5.8.5 |
After the completion of filling cycle, remove any un-filled blend from the hopper and turn-table. Label them as ‘Non Recoverable Rejects’. |
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5.8.6 |
Weigh the filled capsules and rejected Capsules and Blend for yield reconciliation. Record the respective weight in the BMR. |
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5.8.7 |
After completion of Capsule Filling activity, label the equipment as “To be Type A cleaned” or “To be Type B Cleaned”. |
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5.8.8 |
Record the activity in the equipment log book. |
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5.9 |
Type A Cleaning |
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5.9. |
Mention on the area status board as “Under Cleaning” prior to initiation of cleaning process. |
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5.9.1 |
Remove empty capsules and powder from hopper and Dismantle the machine as follows |
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5.9.2 |
Turn the hand wheel and bring the magazine to the uppermost position |
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5.9.3 |
Remove the rectifier raceway with allen key (two screws) |
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5.9.4 |
Remove the slide using allen key (two screws) |
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5.9.5 |
Then turn the hand wheel and bring the magazine to the bottommost position |
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5.9.6 |
Remove the whole magazine assembly with a 6mm allen key (Two screws from front and one from side) |
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5.9.7 |
Clean all the dismantle parts with clean dry lint free cloth or vacuum cleaner. |
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5.9.8 |
Align all the parts again in the reverse order of dismantling. |
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5.9.9 |
Ensure the cleanliness by checking visually for the presence of any granules or particles, then affix “Type A Cleaned” label. Refer |
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5.9.10 |
Record the activity in equipment log book. |
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5.10 |
Type B Cleaning |
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5.10. |
Mention on the area status board as “Under Cleaning” prior to initiation of cleaning process. |
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5.10.1 |
Remove empty capsules and powder from hopper. |
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5.10.2 |
Follow step no 5.9.2 to 5.9.7 for the dismantling of the machine. |
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5.10.3 |
Wash the dismantled parts with 30-40 litres of potable water then clean with 0.1% soap (teepol) solution then wash the parts with 30-40 litres of potable water to remove the traces of soap solution |
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5.10.4 |
Finally rinse the cleaned parts with purified water. |
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5.10.5 |
Remove any spilled powder over the machine by vacuum cleaner or lint free cloth. |
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5.10.6 |
Wipe the entire outer surface with wet lint free cloth soaked in purified water. |
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5.10.7 |
Fill the Swab / Rinse Sample Intimation Slip and submit to QA department for collection of samples. |
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5.10.8 |
Record the activity in equipment log book as per Annexure. |
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5.10.9 |
Collect the Swab/Rinse sample result from Quality Assurance department. If the result is complying, label the equipment as “Type B Cleaned”. If the result is not complying repeat the steps 5.10.3 to 5.10.6. |
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5.10.10 |
After successful completion of cleaning process, mention on the area status board as “Type B Cleaned”. |
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5.11 |
Breakdown |
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5.11.1 |
If breakdown occurs during operation, hold the capsules in closed condition. Inform to the Head Production. |
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5.11.2 |
Fill the “Complaint Note” and submit to Engineering Department. |
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5.11.3 |
Fill the “Incident Report” and submit to Quality Assurance Department. |
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5.11.4 |
Unload the powder, empty capsules from hopper only if required for breakdown rectification. |
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5.11.5 |
Store the unloaded Blend/Capsules separately in closed container separately with proper status label. |
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5.11.6 |
If breakdown occurs prior to start of operation, follow step 5.11.2. |
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5.11.7 |
Record the breakdown activity in Equipment Log Book. |
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5.11.8 |
After completion of repairs, the operations can be resumed. Perform ‘Type A” or “Type B” cleaning if the tablets have been unloaded from the hopper. |
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5.11.9 |
Collect and file a copy of the “Complaint Note” certifying that the repair works have been successfully completed. |
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5.11.10 |
Describe the breakdown activity in the respective product BMR. |
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5.11.11 |
Inform to department head, QA and Engineering Department. |
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5.11.12 |
Dry clean the machine after rectified the problem. |
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5.11.13 |
After completion of repairs, the operations can be resumed. Perform “Type A or Type B” cleaning if the material has been unloaded from the machine. |
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5.11.14 |
Collect and file a copy of the “Complaint Note” certifying that the repair works have been successfully completed. |
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5.11.15 |
Record the repair completion activity in Equipment Log Book. |
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5.11.16 |
Describe the breakdown activity in the respective product BMR. |
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5.12 |
Preventive Maintenance |
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5.12.1 |
Perform the preventive maintenance as per Annexure. |
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5.12.2 |
If preventive maintenance activity is outsourced, the values are to be transcribed in the Annexure, and external party certificate to be attached. |
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5.12.3 |
Attach the preventive maintenance label on the equipment. |
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5.13 |
Calibration |
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5.13.1 |
Perform the calibration as per Annexure. |
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5.13.2 |
If calibration activity is outsourced, the values are to be transcribed in the Annexure, and external party certificate to be attached. |
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5.13.3 |
Attach the calibration label on the equipment. |
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