SOP Title: Operation and Cleaning of Stirrer
- Objective:
To define procedure for Operation, Cleaning and Preventive Maintenance of Stirrer.
- Scope:
This SOP is applicable to Stirrer used for stirring of coating solution during coating activity in coating area 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 preventive maintenance of stirrer.
- Engineering Department: To perform the preventive maintenance of stirrer.
- 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 reports. To review and approve the SOP and Annexure.
- Accountability:
Head, Production, Engineering and QA Department
- Procedure:
- Definition:
- Production Associate: Executive or Operator of Production Department trained to perform duties as per this SOP.
- QA Associate: Executive of QA Department trained to perform duties as per this SOP.
- QC Associate: Executive of QC Department 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: Wet cleaning with clean moist duster and purified water in the following cases:-
- Remove the previous batch residue.
- During end of the shift.
- Before starting the next batch 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.
- After continuous five batches of the same product.
- After seven days of cleaning before use, if cleaned equipment not in use.
- After replacement or repair of any product contact part.
- Monthly , if cleaned equipment not in use.
- 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.
- Definition:
- Procedure:
| Precautions | ||
| 5.2.1 | Switch “OFF” the main supply of the Stirrer during cleaning, assembling and dismantling. | |
| 5.2.2 | Do not wash the motor assembly with water or IPA. | |
| 5.2.3 | Ensure that Stirrer fan is not touching to the bottom or side of the container during stirring. | |
| 5.2.4 | During stirring use safety goggles, gloves and nose masks. | |
| 5.3 Operation | ||
| 5.3.1 | Visually ensure that, the Stirrer is cleaned and line clearance is taken on specific product BMR from QA Department. | |
| 5.3.2 | In a clean SS container take required quantity of solvent/ water to prepare the solution as mentioned in the BMR. | |
| 5.3.3 | 1. Place the Stirrer rod with fan inside the container in which solution to be prepared and fix the Stirrer blade assembly (rod) to the motor shaft by tightening the bolt provided on the shaft. | |
| 5.3.4 | Adjust the height of the Stirrer with the help of adjusting arm by loosening the clamp screw provided on the stand. | |
| 5.3.5 | Check the required height and tight the arm screw of the stirrer stand. | |
| 5.3.6 | Keep the Stirrer at the centre of the solution container. | |
| 5.3.7 | Switch “ON” the Stirrer and check the proper working. | |
| 5.3.8 | Start the Stirrer and slowly add the material to be mixed in to the container and cover the solution with cleaned poly bag to avoid the spillage from the container. | |
| 5.3.9 | Stir the solution for specified time as mentioned in specific product BMR. Note down the stirring time on the product BMR. | |
| 5.3.10 | After completion of stirring, switch “OFF’ the main supply and dismantle the fan rod from the motor shaft. | |
| 5.3.11 | Remove the solution tank and check for proper mixing. Transfer the solution for further process. | |
| 5.3.12 | Record the activity in “Equipment Log Book”, refer attached Annexure. | |
| 5.3.13 | After completion of batch, label the equipment as “To be Type A cleaned” or “To be Type B Cleaned”. | |
| 5.4 | Cleaning | |
| 5.4.1 | Type A ( Batch to Batch) Cleaning: | |
| 5.4.1.1 | Dismantle the stirrer fan rod from the motor shaft, and then clean with purified water. | |
| 5.4.1.2 | Wipe the stand and motor assembly with dry clean duster. | |
| 5.4.1.3 | Ensure the absence of previous batch solution on the stirrer and affix “Type A Cleaned “label. | |
| 5.4.2 | Type B (Product to Product) Cleaning | |
| 5.4.2.1 | Switch “OFF” the main supply of Stirrer and disconnect from electrical socket. | |
| 5.4.2.2 | Dismantle the fan rod from the motor shaft, with the help of bolt provided on the shaft. | |
| 5.4.2.3 | Clean the stand and motor cover by using moist clean duster and then dry with dry clean duster. | |
| 5.4.2.4 | Clean fan and rod with 5-7 litres potable water using 0.1% soap (teepol) solution, then wash with 10-12 litres of potable water to remove the traces of the soap solution .Finally rinse the Stirrer with 5-7 litres of purified water. | |
| 5.4.2.5 | Fill the Swab / Rinse Sample Intimation Slip and submit to QA Department to collect the samples. | |
| 5.4.2.6 | Collect the Swab/Rinse sample result from QA. If the result is complying, label the equipment as “Type B Cleaned”. If the result is not complying repeat the step No.5.4.2.4. | |
| 5.4.2.7 | After successful completion of cleaning process, mention on the area status board “Type B Cleaned”. | |
| 5.4.2.8 | Affix “Type B Cleaned ‘label to the Stirrer and cover it with a fresh poly bag. | |
| 5.4.2.9 | Record the cleaning and usage activity in “Equipment Log Book” refer annexure. | |
| 5.5 | Breakdown | |
| 5.5.1 | If breakdown occurs during operation, hold the solution in closed condition. Inform the Head Production. | |
| 5.5.2 | Fill the “Complaint Note” and submit to Engineering Department. | |
| 5.5.3 | Fill the “Incident Report” and submit to Quality Assurance Department. | |
| 5.5.4 | Remove the stirrer from solution, only if required for breakdown rectification. | |
| 5.5.5 | Store the solution separately in closed container with proper status label. | |
| 5.5.6 | If breakdown occurs prior to start of operation, follow step 5.5.2. | |
| 5.5.7 | Record the breakdown activity in ‘Equipment Log Book”. | |
| 5.5.8 | After completion of repairs, the operations can be resumed. Perform ‘Type A” or “Type B” cleaning if the solution has been removed from the Stirrer. | |
| 5.5.9 | Collect and file a copy of the “Complaint Note” certifying that the repair works have been successfully completed. | |
| 5.6 | Preventive Maintenance | |
| 5.6.1 | Perform the preventive maintenance as per attached Annexure. | |
| 5.6.2 | If preventive maintenance activity is outsourced, the values are to be transcribed in the Annexure, and external party certificate to be attached. | |
| 5.6.3 | Attach the preventive maintenance label on the equipment. | |
- Abbreviation:
| Abbreviation | Expansion |
| % | Percent |
| SS | Stainless Steel |
| SOP | Standard Operating Procedure |
| IPA | Iso Propyl Alcohol |
*Note – Ready to use SOP available in “DOWNLOAD” Section.