SOP for operation of rapid mixer granulator (RMG) with cone mill in Pharma Industry

SOP for operation of rapid mixer granulator (RMG) with cone mill in Pharma Industry

Standard Operating Procedure (SOP)

Objective

  • To lay down a procedure for operation of rapid mixer granulator with cone mill in Pharma Industry

Scope

  •  This SOP is applicable for operation of rapid mixer granulator with cone mill to the formulation plant of Pharma Industry

Responsibility

  • Production Operator/ Technician – For operation of the machine.
  • Production Officer/Executive- To ensure that operation of the rapid mixer granulator with cone mill is carrying out as per SOP.

Accountability

  • Production Head shall be accountable for compliance of SOP.

Procedure

Pre-startup

  • The Production Executive/ Officer shall visually inspect the machine and room for Ensure that the area and equipment are free from remains of previous batch or product and the BMR of previous batch or product.
  • Check the rinse water/ swab analysis report in case of product change over.
  • Remove the “CLEANED” label from the machine as per SOP.
  • Affix the “EQUIPMENT STATUS” label on the machine as per SOP.
  • Check the temperature and relative humidity of the area and record it in the environmental control record as per SOP.
  • Turn “ON” compressed air supply.

Equipment Details

    • Name of the equipment:       Rapid Mixer Granulator with cone mill
    • Manufactured by:       Sainath Boilers & Pneumatics

Equipment Specification 

Equipment No. Capacity        Motor HP Location
600 Ltrs. 50 HP Wet Granulation

Procedure for operation in manual mode 

  • Control panel of the machine is as follows
  • Switch ON the main power supply of the machine.
  • Release the emergency switch provided on the control panel.
  • Rotate the AUTO/MANUAL switch to “MANUAL” side from the control panel as shown in above picture.
  • Rotate the OPEN/CLOSE switch to “CLOSE” side to close the discharge gate.
  • Open the lid the hopper of RMG by loosing the clamps.
  • Transfer the powder to hopper of RMG.
  • Close the lid of the hopper and tighten the clamps.
  • Add the purified water from the port given on the lid.
  • Ensure that compressed air pressure is between 6-8 Kg/cm2 through the shift.
  • Press the button “MIXER SLOW” from the control panel.
  • Press the button “CHOPPER SLOW” from the control panel.
  • Mixer and chopper shall start revolving and start the mixing of powder with solution.
  • Increase the speed of mixer and chopper by pressing buttons “MIXER FAST” and “CHOPPER FAST” if required.
  • Continue the operation for specific time as mentioned in BMR.
  • If there is lumps of powder in the batch, start the conmill by pressing button “CONMILL ON”.
  • Conmill shall break the powder lumps in the appropriate size of the granules.
  • After Completion of mixing, press the button “MIXER OFF”. “CHOPPER OFF” and “CONMILL OFF” (if conmill is in operation).
  • Assemble the Cleaned FBD bowl just beneath the discharge chute of the RMG.
  • Rotate the OPEN/CLOSE switch toward OPEN side to open the discharge gate.
  • Record the operation time in Equipment operation, maintenance and cleaning log book.

Procedure for Operation (In Auto Mode)

  • Switch On the main power supply of the machine.
  • Ensure that line clearance has been taken as per SOP.
  • Follow the below mentioned procedure for entering a recipie for new product.
  • Click on the “LOG IN” button on the screen below
  • Enter the password from below screen by using navigation keys and click on “SEL”  and click on the key “ENTER”.
  • Click on the “SELECT MODE” from below screen
  • Select the “AUTO” mode from below screen.
  • Click on the “NEXT” from below screen.
  • Enter the Product code, Lot No., Operator Name, Supervisor name from the below screen and click on the “SETTING”.
  • Enter the Batch details like product code, Product name, mfg. date, exp date and batch size from below screen. Click on the “NEXT SCREEN”
  • Enter the required parameters given below as mentioned in the BMR and click on the  “NEXT SCREEN
  • Enter the required parameters given below as mentioned in the BMR and click on the “NEXT SCREEN”.
  • Enter the required parameters given below as mentioned in the BMR and click on the “NEXT”.
  • Enter the required parameters given below as mentioned in the BMR and click on the  “NEXT”.
  • Enter the required parameters given below as mentioned in the BMR and click on the “ENTER TO RECIPE”. Click on the “MAIN”.
  • Click on the “NEXT” from below screen.
  • Click on the “SETTING” from below screen.
  • Click on the “SELECT RECIPE” from below screen.
  • Select the Entered recipe of the product and click on the “START” from below screen
  •  The RMG operation shall be started in auto mode.
  • After completion of the process, Click on the “END” button to stop the process.
  • Shut down the system as mentioned.
  • If Recipe is already present on the system for product.
  • Record the operation time in Equipment operation, maintenance and cleaning logbook

Shutdown

  • Click on the “LOG OUT” from screen.
  • Switch off the machine by rotating the isolator switch.
  • Switch off compressed air supply.

Safety & Precautions 

  • Wear hand gloves during handling of powder to avoid the contamination.
  • Avoid unauthorized access to the system.
  • Follow the processing instructions given in the BMR.
  • Set the parameters as mentioned in the BMR.

List of Annexure / Format

  • Not Applicable

References (if any)

  • Instruction Manual

Reason for revision

    • New SOP

Abbreviations

  • SOP: Standard Operating Procedure.
  • RMG : Rapid Mixer Granulator.
  • FBD:  Fluid Bed Dryer.
  • MMI: Man-Machine Interface.
  • QA:  Quality Assurance.

END OF SOP

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About Pharmaceutical Guidanace

Ms. Abha Maurya is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 18 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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