SOP Title: Operation and Cleaning of Spraying Gun
- Objective:
To define Operating and Cleaning Procedure for Spraying Gun.
- Scope:
This SOP is applicable to Spray Gun used for spraying of coating solution on the tablet bed during coating process in coating section of Production Department.
- Responsibility:
- Production Department: To prepare and review the SOP. To follow the procedures laid down for the Operation, Cleaning and to support the Preventive Maintenance.
- Engineering Department: To perform the Preventive Maintenance.
- Quality Assurance Department: To provide line clearance prior to operation. To review and approve the SOP and Annexure.
- Accountability:
Head, Production.
Head, Engineering.
Head, Quality Assurance.
- Procedure:
- Definition:
- Production Associate: Executive or Operator of Production department trained to perform duties as per this SOP.
- QA Associate: Personnel of QA department trained to perform duties as per this SOP.
- Engineering Associate: Personnel or operator of engineering department trained to perform duties as per this SOP.
- 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, same strength and colour.
- 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.
- Change in product or change in 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.
- Monthly, if it is not used after cleaning.
- 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 six monthly.
- Procedure:
- Definition:
| Precautions | ||
| 5.2.1 | During coating operation use safety goggles, latex hand gloves and nose masks. | |
| 5.2.2 | Before start of spraying, the atomisation air controller knob should be kept open as per product requirement. | |
| 5.2.3 | Check the blocking of gun nozzle visually during coating. | |
| 5.3 | Operation | |
| 5.3.1 | Visually check and ensure that, spraying gun is clean. | |
| 5.3.2 | Connect the compressed air pipe at the back end of the Spraying Gun. | |
| 5.3.3 | Connect the solution funnel on the top of the gun by turning the funnel in clockwise direction. | |
| 5.3.4 | Open the compressed air and set required pressure as mentioned in specific product BMR. | |
| 5.3.5 | Put around half funnel of the coating solution in the solution funnel | |
| 5.3.6 | Check the movement of needles trigger leakage of solution from needle and spray pattern by operating the spraying gun on the poly bag. | |
| 5.3.7 | If spraying found satisfactory, stir and fill the solution in to the funnel. | |
| 5.3.8 | Load the tablets to be coated in the coating pan and pre-heat the tablets as mentioned in product specific BMR. | |
| 5.3.9 | Adjust the other parameters such as inlet temperature, atomization air pressure, Pan RPM as mentioned in product BMR. | |
| 5.3.10 | Fit the spraying gun to the gun stand and set the position of the gun in such a way, the solution should be sprayed over the centre of the tablet bed. | |
| 5.3.11 | Pull the trigger and adjust the flow rate of solution by moving the control needle forward or backward with the help of knob provided on the back side of the spraying gun. | |
| 5.3.12 | Adjust the spray pattern by adjusting the atomisation air screw provided on the front left side of the Spray Gun. | |
| 5.3.13 | Note:
i) During coating, Spray Guns are kept at a distance of 10 to 12 inches from the tablet bed or as distance given in the BMR depending on the tablet load in Coating Pan. ii) Adjust the spray rate, compressed air pressure and Pan speed by observing appearance of the tablets. iii) During spraying of coating solution, if nozzle chocking observed, clean the nozzle with nylon brush. |
|
| 5.3.14 | Pull the trigger and tie with tag, to continue the spraying of coating solution on the tablet bed. | |
| 5.3.15 | After completion of coating solution, stop the main supply of compressed air with the help of valve provided in the back side of the coating Pan. | |
| 5.3.16 | Record the activity in equipment log book as per Annexure. | |
| 5.3.17 | Label the equipment as “To be Type A cleaned” or “To be Type B Cleaned”. | |
| 5.4 | Type A Cleaning | |
| 5.4.1 | Mention on the area status board as “Under Cleaning” prior to initiation of cleaning process. | |
| 5.4.2 | Clean the outer body of the gun with moist clean duster. | |
| 5.4.3 | Pass the purified water into the Spraying Gun till the clear water discharges through gun. | |
| 5.4.4 | Dismantle the solution funnel by turning to anticlockwise direction. | |
| 5.4.5 | Remove the solution controlling needle and clean with purified water. | |
| 5.4.6 | Finally wipe the clean dismantled parts with clean dry duster and fix in their place. | |
| 5.4.7 | Note: Clean the gun at the end of shift by passing water till the clear water discharges through the Spray Gun. | |
| 5.4.8 | Ensure the cleanliness by checking visually for the presence of any coating solution in the spraying gun.Affix “Type A Cleaned” label. | |
| 5.4.9 | 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. | |
| 5.5.2 | Pass the potable water through the gun by pressing trigger, till the clear water discharges through the Spraying Gun. | |
| 5.5.3 | Dismantle the solution funnel by turning in anticlockwise direction. | |
| 5.5.4 | Cleaning for Film Coated Products: | |
| 5.5.4.1 | Wash the funnel with 4-5 litres of potable water then clean with 0.1 % soap (Teepol) solution. | |
| 5.5.4.2 | Again wash with 4-5 litres of potable water to remove the traces of soap solution .Finally rinse with 4-5 litres of purified water. | |
| 5.5.4.3 | Dismantle air cap, needle, and nozzle then dip the gun in to the potable water for about 10 minutes. | |
| 5.5.4.4 | Clean the external surface of the gun, air cap, nozzle and needle with the 0.1% soap (Teepol) solution. | |
| 5.5.4.5 | Wash the above cleaned parts with about 5 litres of potable water then rinse with about 5 litres of purified water. | |
| 5.5.5 | Cleaning For Enteric Coated Products:. | |
| 5.5.5.1 | Clean the gun and solution funnel with 4-5 litres of 2 % caustic solution then clean with 6-8 litres of potable water. Finally rinse with 4-5 litres of purified water. | |
| 5.5.5.2 | Visually check the cleanliness and dry the gun with dry clean dry cloth or in tray drier. | |
| 5.5.5.3 | Apply food grade oil to the needle and then assemble the gun parts. | |
| 5.5.5.4 | After successful completion of cleaning process, store the gun in a clean poly bag. Label the Spray gun “Type B Cleaned”. | |
| 5.5.5.5 | Record the cleaning activities of Spray Gun in “Equipment Log Book” refer Annexure. | |
| 5.6 | Breakdown | |
| 5.6.1 | If breakdown occurs during operation, remove the Spray Gun from outside the Coating Pan. Hold the coating solution in closed condition. 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.
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| 5.6.4 | Unload the coating solution, if required for breakdown rectification. | |
| 5.6.5 | If breakdown occurs prior to start of operation, follow step 5.6.2. | |
| 5.6.6 | Record the breakdown activity in Equipment Log Book. Refer Annexure. | |
| 5.6.7 | After completion of repairs, the operations can be resumed. Perform “Type A” or “Type B’ cleaning if the material have been unloaded from the Spraying Gun. | |
| 5.6.8 | Collect and file a copy of the “Complaint Note” certifying that the repair works have been successfully completed. | |
| 5.6.9 | Describe the breakdown activity in the respective product BMR. | |
| 5.7. | Preventive Maintenance | |
| 5.7.1 | Perform the preventive maintenance as per attached 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 |
| TAB | Tablet |
| BMR | Batch Manufacturing Record |
| QA | Quality Assurance |
| RPM | Rotation Per Minute |
| ml | Milliliter |
| % | Percent |
| QAD | Quality Assurance Department |
| v/v | Volume by Volume |
*Note – Ready to use SOP available in “DOWNLOAD” Section.