SOP Title: Operation And Cleaning of Polishing Machine for Capsules
- Objective:
To define a procedure for the Operation, Cleaning and Preventive Maintenance of Dedusting and Polishing Machine for Capsules.
- Scope:
This Procedure is applicable to Dedusting and Polishing machine used for the dedusting and polishing of filled Hard Gelatin Capsules located in Capsule section of Production Department.
- Responsibility:
- Production Department: To prepare and review the SOP. To follow the procedures laid down for the operation and cleaning and to support for Preventive Maintenance of Dedusting and Polishing Machine for capsules.
- Engineering Department: To perform the preventive maintenance of Dedusting and Polishing Machine.
- Quality Control Department: To analyse and report the Swab / Rinse samples.
- Quality Assurance Department: To provide line clearance prior to operation. To collect the swab/rinse samples. To approve the 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.
- Type A Cleaning: Dry cleaning with clean lint free cloth / Vacuum 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 soap 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
- 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
- Monthly if the cleaned machine is not used for production activity.
- 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.
- 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.
- Procedure
- Definition:
| Precautions | ||
| 5.2.1 | Do not stop the vacuum cleaner and the polishing machine simultaneously after the end of production run. | |
| 5.2.2 | Run the polishing machine for 2 – 3 min after the stoppage of capsule in feed to ensure that all the capsules in polishing chamber will come out. | |
| 5.2.3 | After switching of the polishing machine let the vacuum cleaner run for 3 – 5 minutes and then switch it off . | |
| 5.2.4 | Drain the filter regulator at regular intervals. | |
| 5.3 | Setting of Brush Assembly | |
| 5.3.1 | Mount the in feed end locks on the brush shaft and tighten the grub screw. | |
| 5.3.2 | Position the lock such that the grub screw is tighten on the notch provided on the shaft. | |
| 5.3.3 | Slide the brush on the brush shaft gently to the in feed end and lock it in the in feed end lock. | |
| 5.3.4 | Ensure that the end of the brush has properly entered the groove of the lock. | |
| 5.3.5 | Put them in feed end Baffle cover from the delivery end. | |
| 5.3.6 | Ensure that the bristles of the brush are completely out of the baffle cover. | |
| 5.3.7 | Mount the delivery end lock on the shaft. | |
| 5.3.8 | Insert the open end of the brush in the grove of the lock properly. | |
| 5.3.9 | Press the lock in, to compress the brush and holding the in feed end of the brush. | |
| 5.3.10 | Turn the delivery end lock clockwise to bring the grub screw position over the notch provided on the shaft. | |
| 5.3.11 | Tighten the grub screw, this will keep the brush in position and avoid possible slipping of the brush during running. | |
| 5.3.12 | Mount the delivery end nylon spacer on the shaft by tightening the grub screw in position. | |
| 5.4 | Setting of Net Assembly | |
| 5.4.1 | The net is provided with a Velcro arrangement and a hinge pin. | |
| 5.4.2 | Form a cylindrical shape of the net by joining the Velcro. | |
| 5.4.3 | Insert the hinge pin in the eyelet provided in the net. | |
| 5.4.4 | Slide the net into the perforated tube with the hinge pin properly positioned in the channel of the perforated tube. | |
| 5.4.5 | Match the openings provided in the net with that of the perforated tube. | |
| 5.4.6 | Ensure that the net has a snug fit with the perforated tube. | |
| 5.4.7 | If the net sit loose in the perforated tube, asjust the diameter of the net by shifting the Velcro position to get a snug fit. | |
| 5.4.8 | Insert the spring slowly by rotating it into the net care should be taken to ensure that the spring does not cross the in feed opening of the perforated tube. | |
| 5.5 | Setting of Perforated Tube and Brush assembly | |
| 5.5.1 | Holding the shaft vertical, slide the perforated tube and net assembly over the shaft. | |
| 5.5.2 | Locate the in feed end baffle cover in the perforated tube. | |
| 5.5.3 | Assemble the delivery and baffle cover on the brush shaft locating it in the perforated tube. | |
| 5.5.4 | Assemble the timer pulley on to the brush shaft and fix it with grub screw over the notch provided on the shaft. | |
| 5.5.5 | Place the assembly in the trough locating the in feed and bearing in the split bearing block. | |
| 5.5.6 | Mount the delivery and bearing on the hexagonal bush, and the bush on to the shaft. | |
| 5.5.7 | Locate the delivery and bearing in the split bearing block. | |
| 5.5.8 | Place the cover on the trough and fix it with the locks. | |
| 5.5.9 | Connect the rotary Gland to the brush Shaft and the Air pipe to the coupling. | |
| 5.5.10 | Mount the infeed chute. | |
| 5.5.11 | Rotate the spiral brush by rotating the belt by hand in the anti clockwise direction (looking from motor end) and ensure that the movement is free. | |
| 5.5.12 | Fit the drive cover and clamp with the locks. | |
| 5.6 | Operation | |
| 5.6.1 | Before starting the machine make sure that the line clearance is taken and recorded in the BMR.
Record the activity in the equipment log book. |
|
| 5.6.2 | Before starting the operation ensure the temperature and relative humidity of the area is within the limit specified in the BMR. | |
| 5.6.3 | Set the angle of polishing chamber at intermediate position. | |
| 5.6.4 | Set the height of the machine as required. | |
| 5.6.5 | If the machine is in the bottom most position, unlock the locking stud from the guide tube and raise the machine holding the main frame. | |
| 5.6.6 | Tighten the locking stud, ensure that the stud is in the slot of the shaft. | |
| 5.6.7 | To lower the machine, loosen the locking stud and gently press the machine from the top and then tighten the locking stud. | |
| 5.6.8 | Keep the potentiometer knob of the thyristor drive at zero position. | |
| 5.6.9 | Connect the machine to a vacuum cleaner with a hose pipe. | |
| 5.6.10 | First start the vacuum cleaner and ensure correct direction of rotation of the motor by checking the direction of air flow. | |
| 5.6.11 | Switch on the Mains of the machine by the toggle switch. The mains ON (red) LED will glow indicating the main supply. | |
| 5.6.12 | Then Press the push button (RED) to start the motor. The motor ON (Green) LED will glow indicating the supply to the motor. | |
| 5.6.13 | Slowly turn the potentiometer knob clockwise and set it at the middle speed. | |
| 5.6.14 | Start compressed air supply and set the pressure regulator at about 5Kg/cm2 pressure. | |
| 5.6.15 | Start the feeding of Capsules from sorting machine to inlet chute of the polishing machine at a uniform rate. | |
| 5.6.16 | Check the polishing quality of the polished Capsules. If the quality is not satisfactory then vary the polishing chamber inclination and the speed of the brush. | |
| 5.6.17 | For Hygroscopic powders a steeper angle is recommended. | |
| 5.6.18 | The motor can be stopped by switching “OFF” the main supply with the help of toggle switch. | |
| 5.6.19 | Record the activity in equipment log book as per Annexure. | |
| 5.7 | Type A Cleaning | |
| 5.7.1 | Mention on the area status board as “Under Cleaning” prior to initiation of cleaning process. | |
| 5.7.2 | Ensure that capsule inspection cum polishing machine main switch is “OFF” and affix “To Be Cleaned” status label. | |
| 5.7.3 | Remove the in feed chute by gently lifting it from the machine. | |
| 5.7.4 | Remove the drive cover and cover of the polishing cover by unlocking the mechanical locks (just pull the cap of the lock upwards and guide it through the slot). | |
| 5.7.5 | Disconnect the air pipe connected to the rotary gland by pushing in the collet and pulling out the pipe. | |
| 5.7.6 | With the help of hexagonal spanner disconnect the rotary gland from the brush shaft. | |
| 5.7.7 | Lift the brush shaft by holding it at the delivery end and remove the timer belt. | |
| 5.7.8 | Take the perforated tube assembly out of the trough and holding it vertically, in pulley down position, remove the bearing from the delivery end and remove the delivery end baffle cover. | |
| 5.7.9 | Remove the perforated tube from the top, holding the brush shaft down vertically, in pulley down position. | |
| 5.7.10 | Then remove the nylon spacer and deliver end lock from the haft, that are fitted with grub screws. | |
| 5.7.11 | Turn the brush anti clockwise to disengage the brush from the in feed end lock removing the grub screw and slide it off gently from the brush shaft. | |
| 5.7.12 | Holding the shaft upside down, remove the bearing and timer pulley by unscrewing the grub screw of the pulley. | |
| 5.7.13 | Take out the spring from the perforated tube assembly by slowly rotating and pulling it. | |
| 5.7.14 | Remove the nylon net from the perforated tube. | |
| 5.7.15 | Lift the trough from the trough support and take out the delivery chute by unscrewing from the main frame. | |
| 5.7.16 | Clean all the dismantled parts with dry clean lint free cloth or by vacuum cleaner. | |
| 5.7.17 | De-dust external surfaces of machine with vacuum cleaner. | |
| 5.7.18 | De-dust the conveyor belt with vacuum cleaner. | |
| 5.7.19 | Ensure the cleanliness by checking visually for the presence of any powder or particles, then affix “Type A Cleaned” label. | |
| 5.7.20 | Record the activity in equipment log book as per Annexure. | |
| 5.8 | Type B Cleaning | |
| 5.8.1 | Mention on the area status board as “Under Cleaning” prior to initiation of cleaning process. | |
| 5.8.2 | Follow step 5.7.2 to 5.7.18 for dismantling of the polishing machine. | |
| 5.8.3 | 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. Finally rinse with Purified water. | |
| 5.8.4 | Fill the Swab / Rinse Sample Intimation Slip and submit to QA Department for collection of samples. | |
| 5.8.5 | Record the activity in equipment log book. | |
| 5.8.6 | 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 5.8.3 to 5.8.5. | |
| 5.8.7 | Dry the cleaned parts with clean, dry duster/tray dryer. | |
| 5.8.8 | After successful completion of cleaning process, mention on the area status board as “Type B Cleaned”. | |
| 5.8.9 | Dry the cleaned parts with clean, dry duster/tray dryer. | |
| 5.9 | Breakdown | |
| 5.9.1 | If breakdown occurs during operation, hold the polishing activity. Inform to the Head Production. | |
| 5.9.2 | Fill the “Complaint Note” and submit to Engineering Department. | |
| 5.9.3 | Fill the “Incident Report” and submit to Quality Assurance Department. | |
| 5.9.4 | Unload the Capsules only, if required for breakdown rectification. | |
| 5.9.5 | Store the unloaded capsules in suitable SS closed container. | |
| 5.9.6 | If breakdown occurs prior to start of operation, follow step 5.9.2. | |
| 5.9.7 | Record the breakdown activity in Equipment Log Book. | |
| 5.9.8 | After completion of repairs, the operations can be resumed. Perform “Type A or Type B” cleaning if the capsules has been unloaded from the machine. | |
| 5.9.9 | Collect and file a copy of the “Complaint Note” certifying that the repair works have been successfully completed. | |
| 5.9.10 | Record the repair completion activity in Equipment Log Book. | |
| 5.9.11 | Describe the breakdown activity in the respective product BMR. | |
| 5.10 | Preventive Maintenance | |
| 5.10.1 | Perform the preventive maintenance as per Annexure. | |
| 5.10.2 | If preventive maintenance activity is outsourced, the values are to be transcribed in the Annexure, and external party certificate to be attached. |
- Abbreviation:
| Abbreviation | Expansion |
| CAP | Capsule |
| SS | Stainless Steel |
| % | Percent |
| v/v | Volume By Volume |
| ml | Millilitre |
| BMR | Batch Manufacturing Record |
| QA | Quality Assurance |
*Note – Ready to use SOP available in “DOWNLOAD” Section.