Title: Operation and Calibration of Capsule Filling Machine
- Objective:
To define a procedure for Operation, Cleaning, Preventive Maintenance and Calibration of Capsule Filling Machine.
- Scope:
This SOP is applicable to Capsule Filling Machine, used for capsule filling and is installed at the Capsule Section of the Production area.
- Responsibility:
- Production Department: To prepare and review the SOP. To follow the procedures laid down for the operation, cleaning and to support for Calibration, Preventive Maintenance of Capsule Filling Machine.
- Engineering Department: To perform the Calibration and Preventive Maintenance of Capsule Filling Machine.
- Quality Control Department: To analyse and report the Rinse / Swab samples.
- Quality Assurance Department: To provide line clearance prior to operation. To collect the Swab / Rinse samples. To approve the Calibration and Preventive Maintenance Reports. To review and approve the SOP and Annexure.
- Accountability:
Head, Production Department, Head, Engineering Department and Head Quality Assurance.
- Procedure:
- Definition:
- Production Associate: Executive or Operator of Production Department or any personnel trained to perform duties as per this SOP.
- Quality Assurance Associate: Executive of Quality Assurance Department or any personnel trained to perform duties as per this SOP.
- Quality Control Associate: Executive of Quality Control Department or any personnel trained to perform duties as per this SOP.
- Engineering Associate: Executive or operator of Engineering Department trained to perform duties as per this SOP.
- In-Process Parameters: As per the Scope of this SOP the In-Process parameters refers to Appearance of Capsules, Weight of the Capsules, and Length of filled Capsules, Disintegration time and likewise parameters.
- Non Recoverable Rejects: The Capsules and Blend which cannot be re processed, for example, Capsules collected during the Capsules filling machine setting, Capsules collected during first rounds of Capsule filling cycle. The Non Recoverable Rejects are to be discarded.
- Recoverable Rejects: The Capsules and Blend which can be re processed or re use.
- Type A Cleaning: Dry cleaning with clean lint free cloth in the following cases,
- Remove the previous batch residue.
- During end of the shift.
- Before starting the next batch of the same product.
- Prior to execution of higher strength batches, after the execution of lower strength batches of the same product.
- Type B Cleaning: Wet cleaning by using cleaning solution in the following cases.
- Removal of traces of the previous product, and is ensured by testing rinse /swab sample of the cleaned equipment.
- Change in product and Colour
- Prior to execution of lower strength batches, after the execution of higher strength batches of the same product.
- After continuous five batches of the same product.
- After seven days of cleaning before use, if equipment is not in use.
- After replacement or repair of any product contact part.
- Cleaning Solution: 1 ml of Teepol (soap solution) in 1000 ml of potable water (0.1% v/v)
- Breakdown: Any activity leading to operation of machine other than the set parameters and / or unusual sound or vibration observed in the machine.
- Calibration: Tests performed to ensure that the equipment is functioning as per set parameters. These tests are performed half yearly, yearly and also after repair or replacement of parts coming in direct contact with product.
- Preventive Maintenance: Maintenance activity performed to ensure that the equipment will function smoothly and to avoid breakdowns. These activities are performed monthly, quarterly and half yearly.
- Definition:
- Procedure
| Precautions | ||
| 5.2.1 | Ensure that machine is cleaned and line clearance is taken. | |
| 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. | |
| 5.2.3 | Do not touch the moving parts or put hand during the running of the machine. | |
| 5.2.4 | During cleaning/dismantling of machine switch ‘OFF’ the mains of the machine. | |
| 5.2.5 | Ensure that the limit switches are working properly. Use Hand wheel during setting/cleaning. | |
| 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. | |
| 5.2.7 | Before starting the operation ensure the temperature and relative humidity of the area is within the limit specified in the BMR. | |
| 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. | |
| 5.3 | Setting of Loading Station | |
| 5.3.1 | Issue the change parts of the machine as per respective product BMR. Record the Issuance details in Annexure. | |
| 5.3.2 | Rotate the hand wheel and bring the magazine to the bottom most position over the rectifier raceway. | |
| 5.3.3 | At this moment, one capsule from each slot of magazine is released. | |
| 5.3.4 | The capsule releasing pin can be pushed in and pulled out. | |
| 5.3.5 | To facilitate the release of capsules from the magazine the pin should be pushed in | |
| 5.3.6 | Continue the Hand wheel rotation and the slide will start moving back. | |
| 5.3.7 | Simultaneously the vertical blades will start moving down. | |
| 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. | |
| 5.3.9 | Ensure that the required vacuum is available at the vacuum slot. | |
| 5.3.10 | Now place the loading ring on the loading table. | |
| 5.3.11 | When the hand wheel is rotated the loading table also indexes anti-clock wise and stops before the capsules are loaded. | |
| 5.3.12 | At this moment, one row of holes on loading rings is totally aligned with the vacuum slot. | |
| 5.4 | Setting for Proper Rectification | |
| 5.4.1 | Once the capsules are released from the magazine in to the rectifier raceway slot, they are pushed forward by the slide. | |
| 5.4.2 | The setting of the slide determines the position of the capsule over the slot. | |
| 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. | |
| 5.4.4 | For proper loading of the capsules the alignment of the loading ring holes with the vacuum slot is important. | |
| 5.4.5 | In case the alignment is disturbed, this can be set right using the centring gauge. | |
| 5.4.6 | Remove the rectifier block assembly fitted on the front face of the magazine. | |
| 5.4.7 | Fix the centring block at the same location with the screws | |
| 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. | |
| 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 | |
| 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. | |
| 5.4.11 | In case the pins do not enter the loading ring re align the loading table. | |
| 5.4.12 | To facilitate loading table realignment adjust kidney slot position on loading table with respect to fixing screws. | |
| 5.5 | Operation of Loading Station | |
| 5.5.1 | Put the machine in Auto mode and load the loading ring with capsules. | |
| 5.5.2 | Press the rest (yellow) button first and then rectifier start (Green) button. The loading cycle will start. | |
| 5.5.3 | The cycle will stop after completing one rotation of the loading ring consisting of 60 indexings. | |
| 5.5.4 | During the loading cycle press the Rectifier Stop (Red) button to stop the loading cycle midway. | |
| 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. | |
| 5.5.6 | Once the cycle is completed, rotate the loading ring manually for 2 turns before lifting to ensure complete separation of capsules. | |
| 5.6 | Operation of Filling Station | |
| 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. | |
| 5.6.2 | As soon as the body ring is placed, LED of proximity switch will glow. | |
| 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. | |
| 5.6.4 | Fill the drug hopper with the powder to be filled. | |
| 5.6.5 | Select one Medium speed (say 8.1 RPM) for the filling table. Select the minimum speed (310/288) for the auger. | |
| 5.6.6 | Press the powder table start (Green) Button, the Hopper will swing over the body ring placed on the filling table. | |
| 5.6.7 | The Auger will start rotating in clockwise direction and will push the powder into the body of the capsule. | |
| 5.6.8 | When the filling table completes one rotation the hopper returns to its initial position and the Auger rotation stops. | |
| 5.6.9 | Scrape off the extra powder from the surface of the body ring with Teflon dispenser. | |
| 5.7 | Operation of Closing Station | |
| 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. | |
| 5.7.2 | Gently push in the unit by the handle. | |
| 5.7.3 | The capsules will get locked by pin plate assembly operated by the pneumatic cylinder. | |
| 5.7.4 | The closing length of the capsules can be set by adjusting the position of the nut on the threaded shaft. | |
| 5.7.5 | Pull out the closing unit and place the stopper on the lugs of the loading ring. | |
| 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. | |
| 5.7.7 | The loose powder is collected in the powder tray provided below the exit chute. | |
| 5.8 | Fill Weight Control | |
| 5.8. | The fill weight can be controlled by the speed of rotation of the Auger present in the hopper. | |
| 5.8.1 | If the fill weight of the capsule is marginally less then shift to the next lower speed of the gerar box. | |
| 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. | |
| 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. | |
| 5.8.4 | Collect all the Capsules from the ejection station of the machine in clean containers lined with double poly bag. | |
| 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’. | |
| 5.8.6 | Weigh the filled capsules and rejected Capsules and Blend for yield reconciliation. Record the respective weight in the BMR. | |
| 5.8.7 | After completion of Capsule Filling activity, label the equipment as “To be Type A cleaned” or “To be Type B Cleaned”. | |
| 5.8.8 | Record the activity in the equipment log book. | |
| 5.9 | Type A Cleaning | |
| 5.9. | Mention on the area status board as “Under Cleaning” prior to initiation of cleaning process. | |
| 5.9.1 | Remove empty capsules and powder from hopper and Dismantle the machine as follows | |
| 5.9.2 | Turn the hand wheel and bring the magazine to the uppermost position | |
| 5.9.3 | Remove the rectifier raceway with allen key (two screws) | |
| 5.9.4 | Remove the slide using allen key (two screws) | |
| 5.9.5 | Then turn the hand wheel and bring the magazine to the bottommost position | |
| 5.9.6 | Remove the whole magazine assembly with a 6mm allen key (Two screws from front and one from side) | |
| 5.9.7 | Clean all the dismantle parts with clean dry lint free cloth or vacuum cleaner. | |
| 5.9.8 | Align all the parts again in the reverse order of dismantling. | |
| 5.9.9 | Ensure the cleanliness by checking visually for the presence of any granules or particles, then affix “Type A Cleaned” label. Refer | |
| 5.9.10 | Record the activity in equipment log book. | |
| 5.10 | Type B Cleaning | |
| 5.10. | Mention on the area status board as “Under Cleaning” prior to initiation of cleaning process. | |
| 5.10.1 | Remove empty capsules and powder from hopper. | |
| 5.10.2 | Follow step no 5.9.2 to 5.9.7 for the dismantling of the machine. | |
| 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 | |
| 5.10.4 | Finally rinse the cleaned parts with purified water. | |
| 5.10.5 | Remove any spilled powder over the machine by vacuum cleaner or lint free cloth. | |
| 5.10.6 | Wipe the entire outer surface with wet lint free cloth soaked in purified water. | |
| 5.10.7 | Fill the Swab / Rinse Sample Intimation Slip and submit to QA department for collection of samples. | |
| 5.10.8 | Record the activity in equipment log book as per Annexure. | |
| 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. | |
| 5.10.10 | After successful completion of cleaning process, mention on the area status board as “Type B Cleaned”. | |
| 5.11 | Breakdown | |
| 5.11.1 | If breakdown occurs during operation, hold the capsules in closed condition. Inform to the Head Production. | |
| 5.11.2 | Fill the “Complaint Note” and submit to Engineering Department. | |
| 5.11.3 | Fill the “Incident Report” and submit to Quality Assurance Department. | |
| 5.11.4 | Unload the powder, empty capsules from hopper only if required for breakdown rectification. | |
| 5.11.5 | Store the unloaded Blend/Capsules separately in closed container separately with proper status label. | |
| 5.11.6 | If breakdown occurs prior to start of operation, follow step 5.11.2. | |
| 5.11.7 | Record the breakdown activity in Equipment Log Book. | |
| 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. | |
| 5.11.9 | Collect and file a copy of the “Complaint Note” certifying that the repair works have been successfully completed. | |
| 5.11.10 | Describe the breakdown activity in the respective product BMR. | |
| 5.11.11 | Inform to department head, QA and Engineering Department. | |
| 5.11.12 | Dry clean the machine after rectified the problem. | |
| 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. | |
| 5.11.14 | Collect and file a copy of the “Complaint Note” certifying that the repair works have been successfully completed. | |
| 5.11.15 | Record the repair completion activity in Equipment Log Book. | |
| 5.11.16 | Describe the breakdown activity in the respective product BMR. | |
| 5.12 | Preventive Maintenance | |
| 5.12.1 | Perform the preventive maintenance as per Annexure. | |
| 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. | |
| 5.12.3 | Attach the preventive maintenance label on the equipment. | |
| 5.13 | Calibration | |
| 5.13.1 | Perform the calibration as per Annexure. | |
| 5.13.2 | If calibration activity is outsourced, the values are to be transcribed in the Annexure, and external party certificate to be attached. | |
| 5.13.3 | Attach the calibration label on the equipment. |
- Abbreviation:
| Abbreviation | Expansion | |||
| % | Percentage. | |||
| RH | Relative Humidity. | |||
| mm | Millimetre. | |||
| CAP | Capsule. | |||
| PD | Production Department. | |||
| QAD | Quality Assurance Department. | |||
CALIBRATION VACUUM GAUGE
OBSERVATIONS
| Sr. No | Standard Reading
(mm Hg) |
Observed Reading
(mm Hg) |
Deviation
(mm Hg) |
| 1 | |||
| 2 | |||
| 3 | |||
| 4 | |||
| 5 | |||
| 6 | |||
| UUC : Unit under calibration | |||
*Note – Ready to use SOP available in “DOWNLOAD” Section.