Here’s a comprehensive Standard Operating Procedure (SOP) for the operation of a Rapid Mixer Granulator (RMG), tailored for pharmaceutical manufacturing environments:

                           Standard Operating Procedure (SOP) 

1.0 Objective

To establish a standardized procedure for the operation of the Rapid Mixer Granulator to ensure consistent product quality and operator safety.

2.0 Scope

This SOP applies to the operation of the Rapid Mixer Granulator in the granulation area of the production department.

3.0 Responsibility

• Operator: Execute the operation as per the SOP.

• Production Pharmacist/Supervisor: Verify and ensure compliance with the SOP.

• Head of Production: Overall accountability for the implementation of this SOP.

4.0 Procedure

4.1 Pre-Operation Checks

1. Cleanliness: Ensure the RMG and surrounding area are clean and a ‘CLEANED’ status label is affixed.

2. Line Clearance: Obtain line clearance from Quality Assurance (QA) personnel. Affix status labels with product name and batch details on the equipment and area.

3. Equipment Inspection:

   • Open the bowl lid by disengaging the clamps.

   • Install the mixer and chopper blades securely.

   • Close the discharge assembly.

4. Compressed Air Supply:

   • Open the compressed air valve to supply air to the impeller and chopper.

   • Maintain adequate air pressure as per equipment specifications.

   • Ensure air is venting through the designated port on the lid.

5. Electrical Supply:

   • Switch on the main electrical supply.

   • Verify that all phase indicators (R, Y, B) are illuminated.

   • Confirm that all control panel indicators are functioning properly.

4.2 Operation

1. Material Charging:

   • Load the pre-sieved material into the RMG bowl.

   • Close the lid securely.

2. Dry Mixing:

   • Set the timer for dry mixing as specified in the Batch Manufacturing Record (BMR).

   • Start the agitator at the required speed (slow or fast) as per BMR instructions.

3. Binder Addition:

   • After dry mixing, reset the timer as per BMR.

   • Add the binder solution through the charging port.

4. Wet Mixing:

   • Set the timer for wet mixing as specified in the BMR.

   • Operate the chopper at the required speed (slow or fast) as per BMR instructions.

   • Monitor the granulation process until the desired endpoint is achieved.

5. Discharge:

   • Place a Fluid Bed Dryer (FBD) bowl beneath the discharge port.

   • Open the discharge valve using the control panel.

   • Run the RMG at low speed to facilitate complete discharge of the granulated material.

   • Scrape any remaining material if necessary and transfer it to the FBD bowl.

4.3 Post-Operation

1. Cleaning:

   • After completion of the batch, clean the RMG as per the cleaning SOP.

   • Affix a ‘TO BE CLEANED’ label on the equipment.

2. Documentation:

   • Record all operational details in the Equipment Logbook and BMR.

   • Ensure all entries are accurate and complete.

5.0 Safety Precautions

• Always wear appropriate Personal Protective Equipment (PPE) during operation.

• Do not operate the RMG without proper training.

• Ensure all safety interlocks are functional before starting the operation.

• In case of any abnormalities, stop the operation immediately and inform the supervisor.

This SOP is designed to ensure the efficient and safe operation of the Rapid Mixer Granulator, maintaining compliance with Good Manufacturing Practices (GMP).

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