SOP Title: Operation and Calibration of Rapid Mixer Granulator (RMG)
- Objective:
To define procedures for Operation, Cleaning, Preventive Maintenance and Calibration of Rapid Mixer Granulator.
- Scope:
This SOP is applicable to Rapid Mixer Granulator used for dry mixing and granulation process in granulation area.
- Responsibility:
- Production Department: To prepare and review the SOP. To follow the procedures laid down for the operation and cleaning and to support for Preventive Maintenance and Calibration of Rapid Mixer Granulator.
- Engineering Department: To perform the Preventive Maintenance and Calibration of Rapid Mixer Granulator
- 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 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: 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
- Change in colour in granulation stage even if the product is same
- 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, quarterly and half yearly.
- Calibration: Tests performed to ensure that the equipment is functioning as per set parameters. These test are performed half yearly, yearly and also after repair or replacement of parts coming in direct contact with product
- Procedure
- Definition:
| Precautions | ||
| 5.2.1 | Ensure that the limit switch is working properly by switching “ON” the Rapid Mixer Granulator and by lifting and closing of lid. | |
| 5.2.2 | Do not touch the moving parts or do not put hand during running the machine. | |
| 5.2.3
|
During manual scrapping, loading, unloading put “OFF” the main supply of the machine. | |
| 5.2.4 | Ensure that the discharge valve is operating properly by visual observation from inside the RMG. | |
| 5.2.5 | Ensure that the validity of Calibration and Preventive Maintenance before starting any operations. | |
| Set Up / Assembling | ||
| 5.2.6 | Ensure that the equipment has a “cleaned” status label. | |
| 5.2.7 | Place the impeller blade at the bottom of the bowl and secure it with a lock nut. | |
| 5.2.8 | Place the chopper blade at the side of bowl and secure it with a lock nut. | |
| 5.2.9 | Place the vent filter on the lid of the vessel by fasting the screw. | |
| Operation | ||
| 5.2.10 | Before starting the operation make sure that the line clearance is taken and recorded in the BMR
Record the activity in the equipment log book. |
|
| 5.2.11 | Open the compressed air supply valve, the air pressure gauge will display the actual air pressure in kg/cm2 .
Note: The compressed air should be more than 4 Kg/cm2 . |
|
| 5.2.12 | Switch “ON” the main electrical supply line followed by switching “ON” the electrical line of the RMG panel by rotating knob from “I” position to right hand side. The main motor current and the chopper motor current will be displayed on the panel. | |
| 5.2.13 | Open the lid of the machine by unlocking four clamps provided in the RMG
Note: Ensure that, the vent filter is clean by checking pores visually. |
|
| 5.2.14 | Place the FBD bowl or container below the discharge port during the operation of machine to avoid the spillage of the product by non-functioning of the valve. | |
| 5.2.15 | Load the sifted raw material sequentially as mentioned in BMR. | |
| 5.2.16 | Close the lid of the RMG properly by locking clamps.
Note: if the limit switch is not pressed properly the machine will not start. |
|
| 5.2.17 | Set the required mixing time on the timer as mentioned in BMR. The number in timer represents minutes. Example, “3” in the timer indicates 3 minutes | |
| 5.2.18 | Dry mix the contents of the RMG. As mentioned in BMR set the speeds for impeller and chopper.
Push the impeller button (yellow colour for slow speed and green coloured for high speed) Rotate the green colour chopper button (right side for high speed and left side for low speed). Record the time and speed of impeller and chopper in BMR Record the ampere display in BMR. The impeller slow speed is 75 rpm and high speed is 150 rpm. The chopper slow speed is 750 rpm and high speed is 1500 rpm |
|
| 5.2.19 | Granulate the contents of the RMG by adding the binder solution / paste by opening the granulation port on the lid.
Record the time and speed of impeller and chopper in BMR. Record the ampere display in BMR . |
|
| 5.2.20 | Knead the wet mass if needed to achieve granules of desired consistency. Record the time and speed of impeller and chopper in BMR.
Record the ampere display in BMR. |
|
| 5.2.21 | Discharge the contents of the RMG by pressing the discharge button (green coloured) to collect the material in FBD bowl.
Note: Ensure that all the contents of the RMG are discharged and if required scrapping can be performed |
|
| 5.2.22 | Scrapping of the wet mass to be performed if needed to ensure complete discharge of granulated mass. | |
| 5.2.23 | Close the discharge valve by pressing the ‘stop’ button (red coloured) | |
| 5.2.24 | For multiple lots of same batch repeat steps 5.2.11 up to 5.2.23 | |
| 5.2.25 | After completion of batch, label the equipment as “To be Type A cleaned” or “To be Type B Cleaned”. | |
| 5.2.26 | Record the activity in equipment log book as per Annexure. | |
| 5.3 | Type A Cleaning | |
| 5.3.1 | Mention on the area status board as “Under Cleaning” prior to initiation of cleaning process. | |
| 5.3.2 | Ensure that the electrical utilities to the RMG are switched ‘off’ during the cleaning process | |
| 5.3.3 | Clean the outer surface of the RMG with clean lint free cloth | |
| 5.3.4 | Remove the adhered powder or granules with the help of Teflon scraper. If required, clean the interior surface of RMG with lint free cloth | |
| 5.3.5 | Ensure the cleanliness by checking visually for the presence of any granules or particles in the RMG, then affix “Type A Cleaned” label. | |
| 5.3.6 | Record the activity in equipment log book as per Annexure. | |
| 5.4 | Type B Cleaning | |
| 5.4.1 | Mention on the area status board as “Under Cleaning” prior to initiation of cleaning process | |
| 5.4.2 | Ensure that the electrical utilities to the RMG are switched off during the manual cleaning process | |
| 5.4.3 | Fill the RMG approx. 2/3rd of capacity with potable water and run the impeller at slow speed and chopper at slow speed for a duration of 15 minutes and flush the washed solution through discharge port | |
| 5.4.4 | Prepare an approx 0.1% v/v cleaning solution (1 ml of Teepol in 1000 ml of potable water) | |
| 5.4.5 | Dismantle the impeller and chopper after opening the lock nuts | |
| 5.4.6 | Scrub the impeller, chopper, interior and exterior surface of RMG with approx 10 liters of washing solution using a nylon scrubber | |
| 5.4.7 | Flush out the washing solution using approx. 40 liters of potable water | |
| 5.4.8 | Finally rinse the interior and exterior surface of RMG with approx.50 liters of purified water | |
| 5.4.9 | Fill the Swab / Rinse Sample Intimation Slip and submit to QA department for collection of samples. | |
| 5.4.10 | Record the activity in equipment log book. | |
| 5.4.11 | 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 5.4.3 to 5.4.9. | |
| 5.4.12 | After successful completion of cleaning process, mention on the area status board as “Type B Cleaned”. | |
| 5.5 | Breakdown | |
| 5.5.1 | If breakdown occurs during operation, hold the granules in closed condition. Inform to 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 | Unload the granules only if required for breakdown rectification | |
| 5.5.5 | Store the unloaded granules in suitable SS closed container. | |
| 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 material has been unloaded from the RMG. | |
| 5.5.9 | Collect and file a copy of the “Complaint Note” certifying that the repair works have been successfully completed. | |
| 5.5.10 | Record the repair completion activity in Equipment Log Book. | |
| 5.5.11 | Describe the breakdown activity in the respective product BMR. | |
| 5.6 | Preventive Maintenance | |
| 5.6.1 | Perform the preventive maintenance as per define 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 | |
| 5.7 | Calibration | |
| 5.7.1 | Perform the calibration as per define Annexure . | |
| 5.7.2 | 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 |
| RMG | Rapid Mixer Granulator |
| Kg/cm2 | Kilogram |
| SS | Stainless Steel |
| LHS | Left Hand Side |
| RHS | Right Hand Side |
| BMR | Batch Manufacturing Record |
| % | Percent |
| v/v | Volume by volume |
| FBD | Fluid Bed Dryer |
| rpm | Rotation Per Minute |
| ml | Mililitre |
CALIBRATION OF RAPID MIXER GRANULATOR
ANALOG TIMER
OBSERVATIONS
| Sr. No | Reading on UUC
In MIN |
Reading on Standard instruments
HRS:MIN:SEC:MSEC |
Deviation
± 2 MIN |
Remarks |
| 1 | 10 | |||
| 2 | 20 | |||
| 3 | 40 | |||
| 4 | 60 | |||
| 5 | 120 | |||
| UUC : Unit under calibration | ||||
PRESSURE GAUGE
OBSERVATIONS
| Sr. No. | UUC Reading (Kg/Cm2) | Reading on Standard instruments
(Kg/Cm2) |
Deviation
±0.14 Kg/Cm2 |
Remarks: |
| 1 | 0.0 | |||
| 2 | 1.0 | |||
| 3 | 2.0 | |||
| 4 | 4.0 | |||
| 5 | 6.0 | |||
| 6 | 7.0 | |||
| UUC : Unit under calibration | ||||
| Result: The results Complies / Not Complies with the acceptance criteria. | ||||
*Note – Ready to use SOP available in “DOWNLOAD” Section.