Standard Operating Procedure for rapid mixer granulator or high shear granulator.
The purpose of this SOP is to establish a procedure for operating the rapid mixing granulator or high shear granulator.
This SOP will be applicable for RMG or high shear granulator installed in the granulation area of the production section.
3.1 Machine Operator is responsible for operating the RMG.
3.2 Production Pharmacist is responsible for implementation of this SOP.
3.3 Head Of Production is responsible to ensure the implementation of this SOP.
3.4 Quality Assurance Officer monitors the compliance of this SOP.
4.1 Production Pharmacists will ensure that the RMG or High Shear Granulator and area is properly cleaned.
4.2 Production Pharmacist will ensure that RMG and Area is labelled with Cleaned label status.
4.3 Before starting the operation of RMG take line clearance from the QA officer and affix product related labels to the RMG and Area.
4.4 After line clearance Switch ON the electric power supply and air supply valve of RMG.
4.5 Open the lid of RMG and ensure proper fitting of all parts and also ensure that impeller blades are not lifted.
4.5 Close the discharging chute of RMG from HMI.
4.6 Load the sieved material in the bowl of RMG which is required to be granulated.
4.7 Close the lid of RMG by pressing the Close Lid button on the HMI.
4.8 Air tight the lid over the bowl by pressing the Air Sealing Button on HMI.
4.9 Start dry mixing of sieved material by switching ON the Start Mixing Button to rotate the impeller blades.
4.10 Set the rpm of impeller blades and mixing time according to the BMR.
4.11 After set time mixing will stop automatically.
4.12 Add binder solution or solvent in the hopper of RMG.
4.13 Adjust the chopper and impeller speed according to BMR and press on button for impeller blades and chopper.
4.14 After switching ON the impeller blades and chopper,open the valve of the binder solution hopper to sprinkle the binder solution over premixed powder material.
4.15 Continue this kneading process for the time mentioned in BMR or till the desired end point to achieve good quality granules.
4.16 Stop the chopper and impeller blades after the end point of wet granules and open the discharging chute from HMI.
4.17 Place SS tub or product trolley below the wet mill attached to the RMG.
4.17 Collect the material in the product trolley after sieving through the wet mill.
4.18 After removal of wet granules from the bowl of RMG,properly clean the sticky material from the walls of the bowl,impeller blades and chopper and pass it through the wet mill.
4.19 Remove the sticky material from the wet mill and all the wet granules collected in the product trolley are transferred for drying.
4.20 Close the discharging chute and lid of RMG.
4.21 Put OFF the electric supply and air supply valve.
4.22 Affix to be cleaned Label to the RMG.
4.23 Record the activity in the logbook of RMG and sign it.
5.1 SOP: Standard Operating Procedure
5.2 rpm: Rounds per minute
5.3 BMR: Batch Manufacturing Record
5.4 QA: Quality Assurance