Title: Operation and Cleaning of Tablet Inspection Belt
- Objective:
To define procedure for Operation ,Cleaning and Preventive Maintenance of Tablet Inspection Belt.
- Scope:
This SOP is applicable to Tablet Inspection Belt used for inspection of Tablets in Production Department.
- Responsibility:
- Production Department: To prepare and review the SOP. To follow the procedures laid down for the Operation, Cleaning and Preventive Maintenance of Tablet Inspection Belt.
- Engineering Department: To perform the Preventive Maintenance of Tablet Inspection Belt.
- 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.
- Non Recoverable Rejects: The tablets and powder which cannot be re processed, for example, black spot tablets, broken, and powder collected during the inspection 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 validity before use/monthly , if cleaned 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.
- 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 | Start the inspection belt and check the movement of belt, belt should not touch the guards. | |
| 5.2.2 | During operation, do not put the finger inside the belt/chain. | |
| 5.2.3
|
Switch “ON” and check the working of foot break and lamp. | |
| 5.2. 4 | Use hand gloves, nose masks, during inspection. | |
| 5.2.5 | Rotate the checkers after two hours. | |
| 5.3 | Operation | |
| 5.3.1 | Before starting the inspection, take line clearance of the area and equipment from QA on specific product BMR. | |
| 5.3.2 | 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. | |
| 5.3.3 | Switch ‘ON’ the main supply, and then switch “ON” the MCB of machine. | |
| 5.3.4 | Switch ‘ON” the belt and vibrator supply red indicator switches. | |
| 5.3.5 | Start the belt, by turning the knob to clock wise direction to increase the speed anti clockwise to decrease the speed. | |
| 5.3.6 | Start the vibrator by turning vibrator knob to the clockwise to increase the speed of vibrator. | |
| 5.3.7 | Switch “ON” the lamps by pressing the switch provided on the lamp stand. | |
| 5.3.8 | Switch “ON’ the paddle break by pressing red indicator switch provided on the panel. | |
| 5.3.9 | Bring the tablet container to be inspected in the inspection area and get it certified by production officer for correctness of product, batch No/lot No. etc. | |
| 5.3.10 | Load the tablets manually with the help of scoop in the tablet hopper. | |
| 5.3.11 | Start the belt motor and vibrator slowly, by turning the regulator knob to clockwise direction provided on the panel. | |
| 5.3.12 | Adjust the vibrator to get the uniform flow of tablets from bowl dish to chute by rotating the controller knob clockwise to increase the speed and anti clock wise to decrease the speed. | |
| 5.3.13 | Set the height of the lamp by turning the flexible lamp stand to get the clear visibility of defective tablets. | |
| 5.3.14 | Adjust the belt and turning cover gap as per the tablet size, so that, tablet holds and turns, to inspect the tablet on other surfaces. | |
| 5.3.15 | For increasing the gap of turning cover loose the bolt and lock to decrease the gap tight the bolt. | |
| 5.3.16 | To tighten the belt, unlock the locking bolt and pull the roller shaft to RHS and to loosen the belt, pull the roller shaft to LHS and tight the locking bolt. | |
| 5.3.17 | Inspect the tablets visually and remove the broken, chipped, sticking, capping, black spot, color spot etc. from the sorted tablets. | |
| 5.3.18 | Put the defective tablets in rejection tray provided on the side of the belt table. | |
| 5.3.19 | In case of emergency or any defective tablet passes through the inspection zone, press the foot break provided in the bottom of the machine to stop the machine then remove the defective tablets. | |
| 5.3.20 | Collect the inspected tablets in double polythene bags in containers kept at the end of the inspection belt. | |
| 5.3.21 | Weigh the inspected tablets and record the good tablets weights and rejects weight on the BMR .Label the defective tablet as “ Non recoverable rejects”. | |
| 5.3.22 | Dispose the rejects after authorisation of Department head and QA. | |
| 5.3.23 | Affix a proper status label on the container and transfer the inspected tablets to the respective storage area. | |
| 5.3.24 | After completion of activity, label the equipment as “To be Type A cleaned” or “To be Type B Cleaned”. | |
| 5.3.25 | 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 main supply and dry clean the hopper, bowl dish, chute, inside out side of belt, laps magnifying glass, brush and outer surface of machine with dry clean duster. | |
| 5.4.1.3 | Dry clean, the scoops and other accessories used for inspection. | |
| 5.4.1.4 | Ensure the cleanliness visually and affix “Cleaned” label. | |
| 5.4.1.5 | Weigh the collected powder and label as “Non recoverable Rejects” and record the weight in the BMR. | |
| 5.4.1.6 | Ensure the cleanliness by checking visually for the presence of any granules or tablets, then affix “Type A Cleaned” label. | |
| 5.4.1.7 | Record the activity in equipment log book as per attached 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. | |
| 5.5.2 | Dry clean the hopper, bowl dish, chute and powder collection tray. | |
| 5.5.3 | Remove all tablet container from the area and dry clean the surface of machine with the help of vacuum cleaner / dry clean duster. | |
| 5.5.4 | Dismantle the hopper by removing the Ellen bolt provided on the hopper holder arm. | |
| 5.5.5 | Dismantle the bowl dish, chute, belt guard plate, rejection tray and nylon brush by removing the relevant screws and transfer these parts to wash area by covering with poly bag. | |
| 5.5.6 | Wash all the dismantled parts with 25 litres of potable water. | |
| 5.5.7 | Clean the above parts with 0.1% soap (teepol) solution. Again wash with 25 litre potable water to remove traces of soap solution. | |
| 5.5.8 | Finally rinse with 10 litre purified water then intimate QA to collect the rinse sample for testing. | |
| 5.5.9 | Fill the Swab / Rinse Sample Intimation Slip and submit to QA Department for collection of samples. | |
| 5.5.10 | Record the activity in equipment log book as per Annexure. | |
| 5.5.11 | 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 5.5.6 to 5.5.8. | |
| 5.5.12 | After successful completion of cleaning process, mention on the area status board as “Type B Cleaned”. | |
| 5.5.13 | Cleaning of inspection belt: Wipe the inspection belt outer side as well as inner side, machine body, collection tray, magnifying glass, lamps, machine cover, base screw, wheels foot break with moist clean duster. | |
| 5.5.14 | Then clean the above parts with clean moist cloth dipped in purified water. | |
| 5.5.15 | Ensure the cleanliness visually and dry the machine with dry clean duster. | |
| 5.6 | Breakdown | |
| 5.6.1 | If breakdown occurs during operation, hold the Inspection activity. Inform to 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. | |
| 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 | Affix the preventive maintenance label on the equipment. | |
- Abbreviation :
| Abbreviation | Expansion |
| LHS | Left Hand Side |
| RHS | Right Hand Side |
| % | Percent |
| BMR | Batch Manufacturing Record |
| oC | Degree Centigrade |
| v/v | Volume by Volume |
| ml | Milliliter |
*Note – Ready to use SOP available in “DOWNLOAD” Section.