SOP Title: Operation and Cleaning of Tablet De-dusting Machine
- Objective:
To define procedure for Operation, Cleaning and Preventive Maintenance of Tablet Dedusting Machine.
- Scope:
This SOP is applicable to De-dusting Machine used for de-dusting of uncoated tablets in compression section.
- Responsibility:
- Production Department: To prepare and review the SOP. To follow the procedures laid down for the operation cleaning and preventive maintenance of Tablet Dedusting Machine
- Engineering Department: To perform the preventive maintenance and calibration of Tablet Dedusting machine.
- Quality Control Department: To analyse and report the swab samples.
- Quality Assurance Department: To provide line clearance prior to operation. To collect the swab/rinse samples. To approve the preventive maintenance and calibration 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.
- Non Recoverable Rejects: The tablets and powder which cannot be re processed, for example, black spot tablets, broken, and powder collected during the dedusting activity. The Non Recoverable Rejects are to be discarded.
- 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 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 cleaned machine is not used for de-dusting 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 and quarterly.
- Procedure
- Definition:
| Precautions | |||
| 5.2.1 | During operation, adjust the tablet flow shutter in such a way that the tablets should not over flow or tablet should not block the brush unit. | ||
| 5.2.2 | Keep the vibrator speed as per the requirement of the tablet flow. | ||
| 5.2.3
|
Do not rub the tablet on the perforated plate. | ||
| 5.2. 4 | Visually, check the filter bag of the dust extractor for cleanliness and integrity. | ||
| 5.2.5 | Use proper personal protective equipment like Nose Masks, Gloves during dedusting operation. | ||
| 5.2.6 | Fix the suction nozzle of the dust extractor to the de-duster properly. | ||
| 5.3 | Operation | ||
| 5.3.1 | Before operation visually check, De-dusting machine is cleaned and line clearance is taken on specific product BMR. | ||
| 5.3.2 | Ensure that, filter bag of the dust collector is properly fitted. | ||
| 5.3.3 | Check the temperature and humidity of the area is within the limit (25±2oC and 55± %RH) by observing on hygrometer provided in the cubicle. | ||
| 5.3.4 | As per the size of the tablet fix the perforated plate on the vibrator assembly. | ||
| 5.3.5 | Bring the tablet to be de-dusted in the area and check the container . | ||
| 5.3.6 | Switch “ON” the MCB and switch “ON” green press switch to check the rotation of brush. | ||
| 5.3.7 | Switch ‘OFF” the de-duster and fix the brush cover. | ||
| 5.3.8 | Load the tablets manually in to the hopper with the help of scoop. | ||
| 5.3.9 | Place the metal detector at the outlet chute of the de duster to pass the de-dusted tablets through metal detector. | ||
| 5.3.10 | Keep cleaned container lined with poly bag at the outlet chute of the metal detector to collect the de-dusted and metal detected tablets. Switch “ON’ the metal detector and check the sensitivity and operate the metal detector as per the SOP. | ||
| 5.3.11 | Switch “ON” the main MCB followed by the green push button of the starter. | ||
| 5.3.12 | Switch “ON” the toggle switch to up position to start the vibrator. Adjust the vibrator speed so that tablet should be de-dusted properly. | ||
| 5.3.13 | Switch “ON’ the dust extractor by pushing green colour start button provided on the dust extractor. | ||
| 5.3.14 | Slightly open and adjust the shutter of the hopper till the flow of tablets as per requirement. | ||
| 5.3.15 | Set the speed of the vibrator with speed regulator knob (RHS side to increase the speed and LHS to decrease the speed). | ||
| 5.3.16 | The shutter should be adjusted in such a way that the tablet should not block the brush unit. | ||
| 5.3.17 | Check the de-dusted tablets visually for absence of powder / dust. | ||
| 5.3.18 | Remove the defective tablets (broken / black spot) on the perforated plate and should be labelled as ‘Non Recoverable Rejects’. | ||
| 5.3.19 | If dedusting is not proper, check the suction of dust extractor and filter bag for choking. | ||
| 5.3.20 | After completion of dedusting, press the red colour “stop” button of the de-duster then switch “OFF” the vibrator followed by the main MCB. | ||
| 5.3.21 | After completion of dedusting and metal detection check the sensitivity of metal detector as per SOP. | ||
| 5.3.22 | After completion of de-dusting activity, label the equipment as “To be Type A cleaned” or “To be Type B Cleaned”. | ||
| 5.3.23 | Record the activity in Equipment Log Book as per Annexure. | ||
| 5.4 | Cleaning: | ||
| 5.4.1 | Type A Cleaning( Batch to Batch Cleaning) | ||
| 5.4.1.1 | Mention on the area status board as “Under Cleaning” prior to initiation of cleaning process. | ||
| 5.4.1.2 | Switch “OFF” the red colour stop button of the de-duster, Then switch down the toggle switch to stop the vibrator. | ||
| 5.4.1.3 | Switch “OFF” the dust extractor and then switch off the MCB. | ||
| 5.4.1.4 | Remove all tablets container from the area. | ||
| 5.4.1.5 | Remove the powder collection tray from the clamp, dismantle the perforated plate, hopper by loosening the relative bolts. | ||
| 5.4.1.6 | Dry clean the dismantled parts with the help of clean dry duster. | ||
| 5.4.1.7 | Clean the outer surface of the vibrating assembly, table top, and stand with dry clean duster. | ||
| 5.4.1.8 | Remove and clean the powder collection tray of dust extractor with dry duster. | ||
| 5.4.1.9 | Ensure the cleanliness visually and fix all the dismantled parts in proper place. | ||
| 5.4.1.10 | Weigh the collected powder and label as “Rejects” and record the weight in the BMR. | ||
| 5.4.1.11 | Ensure the cleanliness by checking visually for the presence of any granules or particles, then affix “Type A Cleaned” label. | ||
| 5.4.1.12 | Record the activity in Equipment Log Book as per Annexure. | ||
| 5.5 | Type B Cleaning(Product to product Cleaning) | ||
| 5.5.1 | Mention on the area status board as “Under Cleaning” prior to initiation of cleaning process. Refer | ||
| 5.5.2 | Switch “OFF” the main followed by switching “OFF” the machine. | ||
| 5.5.3 | Remove the entire tablet container from the area and dry clean the surface of machine with the help of vacuum cleaner / dry clean duster. | ||
| 5.5.4 | Remove the powder collection tray from the clamp. | ||
| 5.5.5 | Dismantle the perforated plate hopper, brush unit by loosening the relative bolts. Dry clean the dismantled parts with the help of clean dry duster / nylon brush. | ||
| 5.5.6 | Cover the dismantled parts with fresh poly bag and transfer to the wash area with “ To Be Type B Cleaned” status label. | ||
| 5.5.8 | Wash all the parts with 15-20 litres of potable water, and then clean with 0.1% soap (teepol) solution. | ||
| 5.5.9 | Wash the above parts with 15-20 litres of potable water to remove the traces of soap solution. Finally rinse all the parts with 15- 20 Litres of purified water. | ||
| 5.5.10 | Fill the Swab / Rinse Sample Intimation Slip and submit to QA Department for collection of samples. | ||
| 5.5.11 | Record the activity in Equipment Log Book as per Annexure. | ||
| 5.5.12 | Collect the Swab/Rinse sample result from Quality Assurance Department. If the result is complying, label the equipment as “Type B Cleaned”. | ||
| 5.5.13 | If the result is not complying repeat the steps 5.5.8 to 5.5.9. | ||
| 5.5.14 | After successful completion of cleaning process, mention on the area status board as “Type B Cleaned”. | ||
| 5.5.15 | Dry the brushes with the help of compressed air and dry duster. Ensure the drying of brushes before fixing to the machine. | ||
| 5.5.16 | Affix “Cleaned” status label to the parts and transfer to the clean equipment room by covering with clean poly bag. | ||
| 5.5.17 | Clean the vibratory base, mounting stand, table top of the de duster with moist lint free cloth followed by dry lint free cloth. | ||
| 5.5.18 | Record the usage and cleaning activity in Equipment Log Book as per Annexure. | ||
| 5.6 | Breakdown | ||
| 5.6.1 | If breakdown occurs during operation, hold the dedusting activity. Inform the Head Production. | ||
| 5.6.2 | Fill the “Complaint Note” and submit to Engineering Department. | ||
| 5.6.3 | Fill the “Incident Report” and submit to Quality Assurance Department. | ||
| 5.6.4 | If the breakdown is major unload the tablets from the machine only if required for breakdown rectification. | ||
| 5.6.5 | Store the tablets in a closed container with proper status label. | ||
| 5.6.6 | If breakdown occurs prior to start of operation, follow step 5.6.2. | ||
| 5.6.7 | After completion of repairs, the operations can be resumed. Perform Type A or Type B cleaning if the tablet has been unloaded from the machine. | ||
| 5.6.8 | Collect and file a copy of the “Complaint Note” certifying that the repair works have been successfully completed. | ||
| 5.6.9 | Record the repair completion activity in Equipment Log Book. Refer Annexure No.01. | ||
| 5.6.10 | Describe the breakdown activity in the respective product BMR. | ||
| 5.7 | Preventive Maintenance | ||
| 5.7.1 | Perform the preventive maintenance as per Annexure. | ||
| 5.7.2 | If preventive maintenance activity is outsourced, the values are to be transcribed in the Annexure, and external party certificate to be attached. | ||
| 5.7.3 | Attach the preventive maintenance label on the equipment. | ||
- Abbreviation :
| Abbreviation | Expansion |
| LHS | Left Hand Side |
| RHS | Right Hand Side |
| SOP | Standard Operating Procedure |
| % | Percent |
| ± | Plus or Minus |
| BMR | Batch Manufacturing Record |
*Note – Ready to use SOP available in “DOWNLOAD” Section.