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SStandard Operating Procedure (SOP) and Guideline for Operation and Cleaning of Rapid Mixer Granulator (RMG) used in granulation section of Oral solid dosage form at pharmaceuticals drug manufacturing plant.

Rapid Mixer Granulator (RMG)

1.0   Objective :

• • To lay down the procedure for cleaning and operation of Rapid Mixer Granulator (RMG). 

2.0   Scope :

• • This SOP is applicable in Granulation area of Manufacturing Area Tablet for Operation and Cleaning of Rapid Mixer Granulator (RMG).

3.0   Responsibility

• • Production chemist / Operator           : To follow the procedure

• • Accountability – Head Production : For SOP compliance

4.0   Procedure – Rapid Mixer Granulator (RMG) :

• • Product change over (Type A) :

• • Check the status of area, and ensure that area is displaying the current status along with sign & date of respective production chemist.

• • Use High Pressure Water Jet cleaning Machine for cleaning of Rapid Mixer Granulator (RMG) as per the instruction given in SOP.

• • Pressure adjustment shall be done during performing the cleaning activity with High Pressure Water Jet cleaning Machine.

• • Before performing cleaning operation of Rapid Mixer Granulator (RMG), ensure that AHU of the respective area shall not be in working condition.

• • Follow SOP “Procedure for Cleaning of Equipments/ Machine” for cleaning of equipments / machine.

• • Cleaning of bowl, agitator blade and chopper assembly of Rapid Mixer Granulator (RMG)

• • Dismantle the filter and clean it.

• • Connect the high pressure water jet cleaning machine with line of water.

• • Before opening the valve of potable water ensure that proper connection of both ends of pipe is done properly.

• • Open the valve of potable water so that water shall flow in the pipeline of high pressure water jet cleaning machine.

• • Open the lid of Rapid Mixer Granulator (RMG), remove the scrap materials which are adhered in the inner wall by releasing the pressure of potable water directly on the affected area with high pressure water jet cleaning machine.

• • Drain the water through discharging port.

• • Clean the bowl, agitator blade and chopper assembly of Rapid Mixer Granulator (RMG) with nylon scrubber dipped in potable water.

• • Clean the bowl, agitator blade and chopper assembly of Rapid Mixer Granulator (RMG) with high pressure water jet cleaning machine to remove the traces previous material.

• • Visually check the cleanliness of the bowl, agitator blade, chopper assembly and all accessories.

• • If cleanliness is found satisfactory proceed for further activity otherwise repeat the cleaning steps as mentioned above.

• • Cleaning of Filter:

  • Dip the filter in potable water for approx. 5-10 minutes.

• • Clean the filter by shaking it inside the vessel to remove the traces of previous product.

• • Finally clean the filter with Purified water till it is visually found cleaned.

• • If cleanliness of filter found satisfactory proceed for further activity otherwise repeat the cleaning steps.

• • Dry the filter in FBD during drying of finger bag.

• • After cleaning ensure that filter is properly installed in Rapid Mixer Granulator (RMG) machine.

Note: Filter shall not be cleaned with high pressure jet cleaning machine because it is delicate matter and high pressure may result in damage of filter.

• • Cleaning of Discharge Port:

• • Clean the port with nylon scrubber dipped potable water.

• • Clean the port with high pressure water jet cleaning machine to remove previous material.

• • Visually check the cleanliness of port.

• • If cleanliness is found satisfactory proceed for further activity otherwise repeat the cleaning steps.

• • Cleaning of external surfaces of Rapid Mixer Granulator (RMG) :

• • Clean the external surfaces of Rapid Mixer Granulator (RMG) with nylon scrubber dipped in potable water.

• • Clean the external surfaces with high pressure water jet cleaning machine to remove the previous material.

• • Visually check the cleanliness of external surface.

• • If cleanliness is found satisfactory proceed for further activity otherwise repeat.

• • Assemble the Rapid Mixer Granulator (RMG) parts accordingly and finally clean the bowl, agitator blade, chopper discharge port and external surfaces with Purified water.

• • Dry the bowl, agitator blade, chopper discharge port and external surfaces with the help of compressed air or by mopping with dry lint free cloths.

• • Inform QA to take the swab sample from chopper, Impeller and discharge port, send to QC for testing along with the filled ”Swab Test Intimation Slip / Analysis Report”.

• • After analysis QC chemist shall enter the details in “Swab Test Intimation Slip / Analysis Report” and send back to production.

• • If the report is satisfactory then affix dully filled and signed status label as per SOP.

• • If the report is not satisfactory comply then repeat the above procedure.

• • Clean the area.

• • Validity: 72 Hours.

• • After validity period, Type A cleaning shall be performed, before start of next activity, and QC release is not required.

• • Batch change over (Type B) :

• • Change the status of area.

• • Clean the outer surface and all the parts of Rapid Mixer Granulator (RMG) with dry clean lint free cloth.

• • Enter the details.

• • Filters shall be cleaned externally by using compress air.

• Operation of Rapid Mixer Granulator (RMG) :

• • Ensure that the RMG is clean and status label is affixed on the RMG.

• • Make sure that the proper working of HVAC system by checking the differential pressure of area, temperature and RH.

• • Ensure that the workmen are properly gowned as per procedure define in SOP.

• • Get the line clearance from QA chemist before starting the operation.

• • Set the accessories.

• • Check the pressure of compressed air of main supply and it should be 6-7 kg/cm².

• • Check the pressure of compressed air for purging and it should be 4 kg/cm².

• • Release emergency switch mounted on MMI panel.

• • To run the machine in manual mode only operator level password is required and to run the machine in Auto mode 5 level password is required the details are given below.

• • • 1^st level for operator to run the machine and to check the parameters.

• • • 2^nd level for supervisor to change the recipe, monitoring machine operation and controlling of parameters.

• • • 3^rd level for manager to load the recipe, change the recipe and control all the parameters, to operate the machine and download the recipe.

• • • 4^th level for engineering to control HMI operates the machine, monitoring of parameters, data printing and trouble shooting.

• • • 5^th level for admin to controlling all the parameters, trouble shooting and software modification if any by SSPM only.

  • Select the mode of operation.

• • Check the discharge gate in close position and purge air should be ON during operation.

• • Set the impeller motor & chopper motor time.

• • Set the SLOW & FAST mode of impeller & chopper motor as per product requirement.

• • Start the process.

• • After completion of process stop the machine.

• • Place the bowl under discharge of RMG.

• • Press the open discharge gate, run impeller & chopper motor in slow mode.

• • After completion of activity change the status of area and affix dully filled and signed status label on the Rapid Mixer Granulator (RMG) as per SOP.

• • Clean the Rapid Mixer Granulator (RMG) following above procedure.

• • Enter the details in BMR and in Equipment log.

5.0   Annexure – Rapid Mixer Granulator (RMG) :

Annexure I: Cleaning Checklist for Rapid Mixer Granulator (RMG)

Previous Product Name………………. Batch No………………..  Machine ID. No. …..…….

Cleaning check list for RMG

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