Standard Operating Procedure (SOP) for Rapid Mixer Granulator (RMG)

1. Purpose: The purpose of this SOP is to establish a standard procedure for operating the Rapid Mixer Granulator (RMG) to ensure uniform granulation of pharmaceutical powders, achieving batch-to-batch consistency and compliance with Good Manufacturing Practices (GMP).

2. Scope: This SOP applies to the operation of the Rapid Mixer Granulator in the pharmaceutical manufacturing unit, ensuring that the process is carried out efficiently, safely, and in compliance with regulatory requirements.

3. Responsibility:

• Machine Operator: Responsible for operating the RMG as per the SOP and maintaining proper documentation.
• Production Supervisor: Ensures compliance with the SOP and supervises operations.
• Quality Assurance (QA) Officer: Verifies process compliance, reviews documentation, and ensures GMP adherence.
• Maintenance Personnel: Responsible for machine upkeep, troubleshooting, and preventive maintenance.

4. Equipment and Materials Required:

• Rapid Mixer Granulator (RMG)
• Raw materials (as per batch manufacturing record)
• Lubricants and binders (as specified in formulation)
• Cleaning agents (approved disinfectants)
• Personal Protective Equipment (PPE) – gloves, masks, goggles, and aprons

5. Procedure:

5.1 Pre-Operational Checks:

1. Ensure that the RMG is clean, dry, and free from any residues of the previous batch.
2. Verify that all safety guards are in place.
3. Check the functionality of interlocking systems.
4. Ensure that the main power supply is switched OFF before conducting inspections.
5. Inspect the chopper, impeller, and discharge valve for proper assembly and alignment.
6. Record the pre-operational checks in the equipment usage log.

5.2 Machine Start-up:

1. Switch ON the main power supply.
2. Set process parameters as per the batch manufacturing record (BMR), including impeller speed, chopper speed, and mixing time.
3. Ensure that the control panel is functioning properly.
4. Load the required quantity of dry powders into the RMG.

5.3 Granulation Process:

1. Start the impeller at a pre-set speed to mix the dry powders uniformly.
2. Activate the chopper at the recommended speed to break lumps and improve powder dispersion.
3. Gradually add the binder solution while monitoring the granulation process.
4. Continue mixing until the desired granule size and consistency are achieved.
5. Perform in-process checks such as granule size and moisture content to ensure compliance with specifications.

5.4 Discharge of Granules:

1. Open the discharge valve to transfer the wet granules to the next processing unit (e.g., Fluid Bed Dryer).
2. Ensure complete discharge of granules from the RMG to avoid material loss.
3. Record batch details in the batch processing record.

5.5 Machine Cleaning and Shutdown:

1. Switch OFF the power supply.
2. Disassemble removable parts like the impeller, chopper, and discharge valve for cleaning.
3. Clean all machine surfaces with an approved cleaning agent.
4. Dry all components thoroughly before reassembling.
5. Record cleaning details in the equipment cleaning log.

6. Precautions:

• Always wear appropriate PPE while operating the RMG.
• Avoid overloading the machine beyond its specified capacity.
• Ensure binder solution is added gradually to prevent over-wetting.
• Regularly monitor machine temperature to prevent overheating.
• Do not open the discharge valve while the machine is running.

7. Safety Guidelines:

• Ensure emergency stop buttons are functional and accessible.
• Keep hands away from moving parts while the machine is in operation.
• Do not bypass safety interlocks.
• In case of any malfunction, stop the machine immediately and inform the maintenance team.

8. Documentation and Record-Keeping:

• Maintain batch manufacturing records (BMR) for each operation.
• Log pre-operational checks, cleaning records, and maintenance activities.
• Document any deviations or incidents and report them to the QA department.

9. References:

• Manufacturer’s Operating Manual for Rapid Mixer Granulator
• GMP and FDA Guidelines for Pharmaceutical Manufacturing
• Internal Quality Assurance Guidelines

10. Revision History:

• SOP Version: 1.0
• Effective Date: [Insert Date]
• Last Reviewed: [Insert Date]
• Next Review Date: [Insert Date]

This SOP ensures efficient, safe, and compliant operation of the Rapid Mixer Granulator, contributing to high-quality pharmaceutical production.