Smart Agitator SOP

GOOD MANUFACTURING PRACTICES (GMP)

Title: Operation and Maintenance of the Smart Agitation System

Document Number: SOP-AR-004

Effective Date: [Insert Date] ________________

Revision Number: 1.8

Prepared By: [Name] ________________

Approved By: [Name]________________

1. Purpose

To establish standardized procedures for the safe, efficient, and GMP-compliant operation, cleaning, and maintenance of the Smart Agitation System used in resin extraction processes, while minimizing the risk of injuries and ensuring operational safety.

2. Scope

This SOP applies to all personnel involved in the operation, cleaning, maintenance, and troubleshooting of the Smart Agitation System at [Facility Name] ________________________________________________.

3. Responsibilities

• Operators: Responsible for day-to-day operation, routine cleaning, and adherence to safety precautions.
• Maintenance Personnel: Conduct preventive maintenance, repairs, and ensure safe operation of components.
• Quality Assurance (QA): Monitor compliance with GMP and safety guidelines and maintain safety records.
• Supervisors: Train staff and ensure adherence to this SOP and safety protocols.

4. Definitions

• Pinch Point: A point where two or more mechanical parts move together, posing a risk of injury to fingers, hands, or other body parts.
• Slip Hazard: A surface or condition that increases the risk of falling due to reduced traction.
• Proximity Sensor: A sensor used to detect the position of mechanical components to ensure safety and proper operation.
• Pressure Safety Switch: A switch that requires a minimum of 100 psi to engage the pneumatic system and maintain operations.

5. Materials and Equipment

• Smart Agitation System (Model: [Insert Model])
• GMP-compliant cleaning agents
• Slip-resistant footwear
• Lint-free cloths
• Personal Protective Equipment (PPE)
• Warning stickers/signage (e.g., "Watch Your Step," "Pinch Point")
• Batch record logs
• Calibration tools for sensors and VFDs

6. Procedure

6.1 Programming a Recipe for Washing

1. Access the Settings Menu:
   • From the Home Screen, press the "Settings" icon to access the recipe programming interface.
   • Review the available parameters:
     • Initial water fill level
     • Water soak time
     • Five wash stages (speed, revolutions, time, velocity, pause time, and acceleration/deceleration)
     • Final rinse timer
     • Settle time
     • Drain timer
     • Tank temperatures (agitator and large heat exchanger tanks).
2. Determine Water Fill Levels:
   • Match the fill level with the amount of material being processed:
     • Example: 50 lbs of material may require a 50% water level, while 100 lbs may need 80%.
   • For calibration during the first wash:
     • Examine the water level visually. Material should float just above the tank’s sight glass, with visible water surrounding the top of the material.
     • Adjust the fill level manually until it meets this standard, then input the value into the recipe. Save this calibration for future batches.
   • For subsequent washes, reduce the fill level slightly to conserve water, as the plant material becomes waterlogged.
3. Input Wash Parameters:
   • Program the following for each of the five wash stages:
     • Speed
     • Revolutions
     • Time
     • Velocity
     • Pause time
     • Acceleration/deceleration.
   • Set the final rinse timer, settle time, and drain timer as needed for the batch requirements.
4. Check Water Temperature:
   • Before washing or pre-soaking material, ensure the water temperature being delivered into the agitator is between 30-34ºF (0-1ºC).
   • Optionally, add ice to the agitator to help maintain the desired water temperature if necessary.
5. Batch Record Requirements:
   • Document the following in batch records for traceability:
     • Recipe parameters (water fill level, soak time, wash stage settings, and temperatures).
     • Observations during calibration (e.g., material float level).
     • Deviations, if any, such as incorrect water levels or agitation inconsistencies.

6.2 Starting the Wash Cycle

1. Initiate the Wash Cycle:
   • From the Home Screen, press and hold the "Start Wash" button. The system will:
     • Fill to 50% of the programmed water level.
     • Display a prompt for the operator to load material into the machine.
2. Loading Material:
   • Open the lid to load material. The system will detect the open lid via proximity sensors.
   • Once loading is complete, close the lid. The system will:
     • Fill the remaining percentage of water to reach the programmed level.
     • Display "READY."
3. Start the Wash Cycle:
   • Press the green "Program" button to activate the water soak timer. The system will:
     • Automatically start the wash cycle after the soak timer ends.
     • Execute the programmed parameters for each stage.
4. Monitor the Process:
   • During the wash stages, ensure the system operates within the programmed parameters.
   • Observe system alerts or deviations.
   • Document any deviations in the batch log.
5. Settle and Drain:
   • After completing the final wash stage:
     • The system will activate the settle timer.
     • Once the settle timer ends, the buzzer will sound, indicating readiness for draining.
     • Open the drain spigot manually and activate the spin flow vibration sieve system switch.
   • Monitor the drain process:
     • If the valve must be closed temporarily, the system will wait.
     • Once the water level reaches 0%, the system will automatically start the drain timer.
   • When the system indicates "Close Valve," press the green "Program" button and close the drain valve simultaneously.
6. Repeat Wash Stages:
   • The system will refill to the next programmed water level and repeat the wash stages (Stages 2-5).
   • After the final stage drain, the system will activate the final rinse timer.
     • Water will pass through the material with the valve open.
7. Complete the Cycle:
   • After the rinse timer ends, the buzzer will sound, and the system will display "Wash Cycle Complete."
   • Press the green "Program" button one final time to reset the automation to the Home Screen.

6.3 Post-Wash Cleaning Procedure

1. Draining and Initial Cleaning:
   • Ensure the water drain is open and verify that minimal to no water is draining.
   • Confirm that the "Start Wash" button has reset to its default state.
   • Announce "CLEAR" to ensure no personnel are near pinch points.
   • From the Home Screen, press the "Manhole" icon, and confirm by pressing "YES" on the confirmation screen.
     • The system will unlock the manhole lock and slowly open the manhole.
     • Allow spent biomass to fall into the collection cart or automated auger screw.
2. Spray Down:
   • Use the sprayer wand to clean the filter plate inside the manhole:
     • Turn on the sprayer wand switch on the panel.
     • Set the water pump to 100%.
   • Push biomass to the sides of the manhole to ensure proper closure.
   • Spray the sight glass, paddle, and any visible residue.
   • If needed, spray through the top lid opening for thorough cleaning.
3. Tank Flushing and CIP Sprayer Balls:
   • Close the manhole and press the "Water Pump" icon to activate the CIP sprayer balls.
   • Fill the tank to 30% capacity and flush out material beneath the filter plate.
   • Open the manhole again to inspect and clean any remaining residue.
   • If necessary, repeat the fill-and-dump process:
     • Add 1 liter of isopropyl alcohol to 30% water.
     • Manually agitate the paddle to remove resin.
     • Drain and rinse thoroughly.
4. Deep Cleaning:
   • Remove the waste collection cart.
   • Open the manhole, press the E-Stop, and disconnect the air line.
   • Remove the filter plate from the manhole for full access to the tank.
   • Use isopropyl alcohol and a scrub brush to clean the tank walls.
   • Reassemble all components and close the manhole.

6.4 Cleaning Validation and Documentation

1. Visual Inspection:
   • Inspect the system post-cleaning for any residue or contaminants.
   • Record observations in the cleaning log.
2. Waste Documentation:
   • During the final flush, monitor material collected using a 220 sieve screen.
   • Document waste quantity and condition.
3. Daily Cleaning Logs:
   • Maintain daily or batch-specific cleaning logs.
   • Include observations, deviations, and corrective actions.
4. Calibration and Sensor Checks:
   • Inspect proximity sensors, pressure sensors, temperature probes, VFDs, and the planetary gearbox for functionality.
   • Check for physical or water damage to sensors.
   • Confirm the gearbox operates smoothly without clicking or obstruction.
   • Lubricate the AFR with air compressor oil.

7. Maintenance

• Perform preventive maintenance and inspect all safety features such as grip tape, signage, proximity sensors, and pneumatic cylinders.
• Confirm proper function of the E-Stop switch and secondary confirmation mechanisms for manhole operations.
• Address issues with pinch points or slip hazards immediately.

8. Safety

• Always wear PPE, including slip-resistant footwear, nitrile gloves, hair/beard nets, lab coats, and respirators.
• Inspect sieve bags for integrity and cleanliness between batches.
• Follow safety precautions outlined in Sections 6.1 and 7.

9. Documentation

• Record all safety checks, incident reports, and maintenance logs.
• Retain documentation for audits and reviews.
• Submit deviations to Access Rosin's helpline for assistance and documentation.

10. Training

• Provide initial and annual safety training to all operators, emphasizing slip and pinch point risks.
• Ensure training records are up to date and accessible for audits.
• Validate operator proficiency through walkthroughs with Access Rosin team members.

Revision History

Log Templates

Batch Record Log Template

Daily Cleaning Log Template

Calibration and Maintenance Log Template

End of Document