SOP Title: Operation and Calibration of Roto Cube Blender
- Objective:
To define procedure for Operation, Cleaning, Calibration and Preventive Maintenance of Roto Cube Blender.
- Scope:
This SOP is applicable to Roto Cube Blender used for mixing/blending/lubrication of
granules /ingredients in granulation area.
- 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 and Calibration of Roto Cube Blender.
- 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.
- Engineering Department: To perform the Preventive Maintenance and Calibration of Roto Cube Blender, wherever applicable.
- Quality Control Department: To analyse and report the swab/rinse samples.
- 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 in the following cases,
- Remove the previous batch residue.
- 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 and 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 or change in colour.
- Monthly, if it is not in 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 monthly, quarterly and half yearly.
- Calibration: Tests performed to ensure that the equipment is functioning as per set parameters. These tests are performed yearly and also after repair.If repair work effects on the product quality or replacement of parts coming in direct contact with product.
- Procedure
- Definition:
| Precautions | ||
| 5.2.1 | Switch “OFF” the mains of the Roto Cube Blender during loading, unloading and manual cleaning. | |
| 5.2.2 | Ensure that, starter is switched “OFF” and red colour press (stop) button is locked by pressing the button with lock provided. | |
| 5.2.3 | During loading, ensure that the out let lid (unloading lid) properly fitted by tightening with ring nut. | |
| 5.2.4 | Before starting the blender, ensure that the inlet lid (top lid) is properly fitted by tightening the nut provided. | |
| 5.2.5 | Before start of operation, engage the safety guard by putting lock (rod piece) at both sides of the guard. | |
| 5.2.6 | During unloading / loading, keep the position of blender with the help of handle provided at the bottom of the base of the blender. | |
| 5.3 | Operation of Roto Cube Blender | |
| 5.3.1 | Before starting the blending process make sure that the line clearance is taken and recorded in the respective BMR. | |
| 5.3.2 | Record the activity in the equipment log book as per Annexure. | |
| 5.3.3 | Before starting the operation ensure that the temperature and relative humidity of the area is within the limit specified in the BMR. Refer SOP of Temperature and Relative Humidity Monitoring. | |
| 5.3.4 | Remove “Cleaned” status label and affix “In-process” label. | |
| 5.3.5 | Before loading, check all the granules and lubricants to be loaded are as per the procedure mentioned in BMR and to be certified by production officer. | |
| 5.3.6 | Keep the blender in loading position in such a way that the blender mouth (bigger size) should be on top side. | |
| 5.3.7 | Adjust the Blender to correct loading position manually with the help of handle. | |
| 5.3.8 | Open the lid of the Blender mouth by loosening the round nut. | |
| 5.3.9 | Load the material (by using ladder) in the Blender sequentially as mentioned in product BMR. | |
| 5.3.10 | After completion of loading, close the lid properly by keeping gasket in between the lid to avoid the spillage of material. | |
| 5.3.11 | Engage the safety guard by keeping the rod in horizontal position then lock both the sides with the help of lock provided. | |
| 5.3.12 | Switch ‘ON’ the main power supply of the blender, then switch “ON” the blender by pressing green colour start button. | |
| 5.3.13 | Check the start time of mixing/blending/lubrication on digital wall clock and write down in product BMR. | |
| 5.3.14 | After completion of mixing/blending/lubrication time as mentioned in BMR, stop the blender, by pressing red colour stop press button of the starter. | |
| 5.3.15 | Check the mixing completion time on digital wall clock and record in specific product BMR. | |
| 5.3.16 | Keep the blender in unloading position (horizontal) in such a way that on opening of mouth lid granules /blend/powder should not freely flow down from the blender unless it is drawn by the scoop. | |
| 5.3.17 | Disengage the safety guard by unlocking the guard from the locking rod. | |
| 5.3.18 | Take the tare weight of cleaned container lined with double fresh poly bag and keep the container/drum below the out let of the blender for collection of mixed or lubricated granules/powder. Remove the unloading lid by loosening the nut. | |
| 5.3.19 | Unload the granules/powder in drum slowly by rotating the unloading port down word with the help of handle provided. After completion of unloading, affix in- process label to the drum with product details and processing stage. | |
| 5.3.20 | Weigh the unloaded granules/powder container and note down the gross weight, tare weight and net weight of the each container in the BMR. | |
| 5.3.21 | After completion of unloading, fix the lid with bolt then keep the blender in loading position and engage the safety guard. | |
| 5.3.22 | Record the usage time in equipment log book as per attached Annexure No. 01. | |
| 5.3.23 | After completion of blending activity, 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 | Remove all previous batch documents, containers and labels from the area. | |
| 5.4.3 | Disengage the safety guard (if it is engaged) by unlocking the lock and keep guard down in vertical position. | |
| 5.4.4 | Clean the adhered material or blend inside the blender with the help of dry duster. | |
| 5.4.5 | Dry clean the outer surface, platform and lid of the blender with vacuum cleaner/dry clean duster. | |
| 5.4.6 | Dry clean the blender with vacuum cleaner /dry clean duster. | |
| 5.4.7 | After ensuring cleanliness visually for absence of previous batch granules, affix “Cleaned” label. | |
| 5.4.8 | Ensure the cleanliness and affix “Type A CLEANED” label as per SOP. | |
| 5.4.9 | Record the cleaning time in equipment log book as per Annexure. | |
| 5.5 | TYPE B Cleaning | |
| 5.5.1 | Mention on the area status board as “Under Cleaning” prior to initiation of cleaning process. | |
| 5.5.2 | Remove all previous batch documents, containers and labels from the area. | |
| 5.5.3 | Clean the adhered material or blend inside the blender with the help of dry duster. | |
| 5.5.4 | Remove the lid and gasket (if it is closed) by unclamping wing nuts. | |
| 5.5.5 | Clean the external body of the blender and platform with dry duster first and then wash the outer body with potable water to remove the any powder present on the blender. | |
| 5.5.6 | Apply 0.1 % soap solution (teepol) to clean the blender, and then wash with 30-35 litres of potable water. | |
| 5.5.7 | Set the position of the blender vertically so that, the outlet valve is facing the floor. | |
| 5.5.8 | Wash the inside surface with 40-50 litres potable water to remove any granules / powder. | |
| 5.5.9 | Drain out water through opening below after bringing the blender in vertical position. | |
| 5.5.10 | Apply 0.1% soap solution (teepol) to the inside surface of the blender by bringing the blender in horizontal position. | |
| 5.5.11 | Again flush 40-50 litres potable water inside and outside of the blender to remove traces of the liquid soap. | |
| 5.5.12 | Remove the water by bringing the blender in a vertical position and opening the outlet valve. | |
| 5.5.13 | Finally rinse inside and outside of the blender with 40-50 litres purified water. | |
| 5.5.14 | Cleaning of gasket: Remove the gasket and wash with 10-15 litres of potable water to remove the powder. Clean the gasket with 0.1 % soap solution (teepol) then wash with 10-15 litres potable water. Finally rinse with 10-15 litres purified water. | |
| 5.5.15 | Dry the cleaned gasket with the help of dry clean duster. | |
| 5.5.16 | Cleaning of blender lids: Remove the lids and wash with 15-20 litres of potable water to remove the powder. Clean the lids with 0.1 % soap solution (teepol) then wash with 15-20 litres potable water. Finally rinse with 10-15 litres purified water. | |
| 5.5.17 | Fill the Swab / Rinse Sample Intimation Slip and submit to QA department to collect the Swab / Rinse samples. | |
| 5.5.18 | 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 steps 5.5.6 to 5.5.13. | |
| 5.5.19 | Record the activity in equipment log book. | |
| 5.5.20 | After successful completion of cleaning process, mention on the area status board as “Type B Cleaned”. | |
| 5.6 | Breakdown | |
| 5.6.1 | If breakdown occurs during operation, switch “OFF” the main supply and inform to Head Production and QA Associate. | |
| 5.6.2 | Record the blending time in the product BMR. | |
| 5.6.3 | Fill the “Complaint note” and submit to Engineering Department. | |
| 5.6.4 | Fill the “Incident report “and submit to Quality Assurance Department. | |
| 5.6.5 | Unload the product / material only if required and keep the product/ material in closed condition as per requirement. | |
| 5.6.6 | If breakdown occurs prior to start of operation, follow step 5.6.3. | |
| 5.6.7 | Record breakdown activity in Equipment log book . | |
| 5.6.8
|
After completion of repairs, the operations can be resumed. If break down is major perform Type A or Type B cleaning as per the requirement. | |
| 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. | |
| 5.8 | Calibration: | |
| 5.8.1 | In-house Calibration of Roto Cube Blender for RPM should be done once in a six month and if any major maintenance work done to the blender. Record the observation in attached Annexure. | |
| 5.8.2 | If calibration activity is outsourced, the values are to be transcribed in the Annexure and external party certificate to be attached. |
- Abbreviation:
| Abbreviation | Expansion |
| TAB | Tablet. |
| BMR | Batch Manufacturing Record. |
| % | Percent. |
| v/v | Volume by Volume. |
| ml | Mili Litre. |
| ltr | Litre |
| RPM | Rotation Per Minute |
Calibration Recort FOR RPM
Note:
- During calibration check that blender is “cleaned’ and switches are working properly.
- Switch “ON” the main supply of the blender and start the blender as well as stop watch, manually count the number of rotation in one minute. Record the observation in the below table.
- Similarly take two more reading for same speed and record the observation in the below table.
- Calculate the mean of the three reading which is the RPM of the blender.
| Sr.No. | Standard Reading | Observation Reading | Acceptance Criteria | Deviation |
| 1 | 12 RPM |
± 1 RPM |
||
| 2 | 12 RPM | |||
| 3 | 12 RPM |
Remark :
Calibration of Blender RPM is performed successfully and readings are within limit / not within limit and Can be Used / Do Not Use for regular activity.
*Note – Ready to use SOP available in “DOWNLOAD” Section.