Smart Agitator SOP

GOOD MANUFACTURING PRACTICES (GMP)

Title: Operation and Maintenance of the Smart Agitation System

Standard Operating Procedure (SOP)

Title: Operation and Maintenance of the Smart Agitation System

Document Number: SOP-AR-001

Effective Date: [Insert Date]

Revision Number: 2.0

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. This includes staged or continuous operation, validation of wash cycles, cleaning verification, maintenance scheduling, and documentation.

2. Scope

This SOP applies to all operators, technicians, and QA personnel responsible for the preparation, use, maintenance, and inspection of the Smart Agitation System at [Facility Name].

3. Responsibilities

• Operators: Execute wash cycles, monitor performance, clean equipment, and maintain records.
• Maintenance Technicians: Perform scheduled maintenance and inspections, and respond to mechanical issues.
• QA Personnel: Review log accuracy and ensure GMP compliance.
• Supervisors: Ensure operator training and adherence to this SOP.

4. Definitions

• CIP: Clean-in-place system
• AFR: Air filter regulator
• GMP: Good Manufacturing Practices
• VFD: Variable frequency drive
• PPE: Personal protective equipment

5. Required Materials

• Smart Agitation System
• Clarifying and sieve tanks
• Water supply (chilled to 0–1°C)
• Solvent (IPA)
• Grease: Klüber Microlube GB 00 or Mobilith SHC 220
• PPE: gloves, lab coats, hair/beard nets, non-slip shoes, respirators
• 220u collection bags
• Cleaning tools, spray wand
• Pneumatic displacement pump (for recirculation)
• Batch, cleaning, and maintenance log sheets

6. Procedure

6.1 Programming the Wash Recipe

• Press Settings and input:
  • Water Fill %
  • Water Soak Time
  • Stages 1–5 (speed, revolutions, time, velocity, pause time, acceleration/deceleration)
  • Final rinse timer
  • Settle and drain timers
  • Temperature for agitation and heat exchanger tanks
• Match water level to biomass (e.g., 50 lbs = 50%) using sight glass
• Save recipe

6.2 Starting the Wash Cycle

1. Press and hold Start Wash
2. System fills to 50% capacity
3. Lid opens → operator loads material
4. Lid closes → remaining water fills
5. Press Green Program to start soak, then agitation
6. After each stage:
   • System settles
   • Buzzer alerts operator
   • Operator drains manually, engages sieve system
7. System repeats stages and performs final rinse
8. Operator presses Green Program to return to Home Screen

6.3 Post-Wash Cleaning

• Announce “CLEAR,” ensure cart is inserted
• Open manhole via HMI, confirm YES
• Dump biomass, spray interior
• Rinse with CIP balls at 30% fill
• Optional: add 1L IPA and agitate for deep resin cleaning
• For full clean: engage E-stop, disconnect air, remove and scrub filter plate

6.4 Cleaning Validation

• Visually inspect for residue
• Use 220u sieve during final rinse
• Log debris presence and corrective action
• Clean between material types or batches to prevent cross-contamination

6.5 Modes of Operation

6.5.1 Mode 1: Drain-to-Waste (Standard Operation)

• Described in Sections 6.1–6.4
• Involves staged agitation with settling and draining
• Maximizes control over resin fractions
• Suitable for quality-controlled, smaller batches

6.5.2 Mode 2: Recirculation Mode (Continuous Agitation)

• Place 220u bag over clarifying tank
• Drain from sieve → clarifying tank → 2” T:
  • One side: drain with ball valve
  • Other side: braided hose to pneumatic displacement pump
• Pump output goes through check valve into agitation tank inlet (Through CIP sprayer balls) 
• Run a drain wash with a agitate 20 minutes agitation then drain. (This helps with chlorophyll, foam, and contaminates).
• Refill, and Agitate continuously for up to 90 minutes
• Collect sieve while keeping water inside tank (Choked off at the agitator), then run recirculation for up to 60 minutes before final drain
• Maintain balanced flow rate between air flow to the PD diaphragm water pump and 2" agitator drain valve
• Benefits:
  • Eliminates settle time
  • Reduces water use
  • Prevents resin compaction
  • Improves pH stability
  • Increases batch throughput

7. Maintenance

7.1 General Preventive Maintenance

• Check lid and lock proximity sensors
• Confirm VFD and AFR function
• Inspect pressure safety switch (100 PSI minimum)
• Verify E-stop and safety labels
• Lubricate AFR weekly
• Inspect gearbox for noise or resistance

7.2 Gearbox Rebuild (GBP090-2-NM-025)

Tools & Supplies:

• Allen keys, snap ring pliers, rubber mallet, torque wrench
• Degreaser, synthetic grease, thread locker
• Replacement bearings/seals

Steps:

1. Disconnect and clean gearbox
2. Remove housing bolts and disassemble gears
3. Degrease and inspect components
4. Apply fresh EP grease (30–50% housing fill)
5. Reassemble gears and housing, torque bolts
6. Spin manually to confirm smooth rotation
7. Test under low load, monitor for heat/noise

8. Safety

• Wear PPE at all times
• Ensure collection cart is fully inserted before opening manhole
• Never bypass proximity or pressure sensors
• Maintain cold water (0–1°C) for optimal resin protection

9. Documentation

• Complete and sign batch, cleaning, and maintenance logs
• Report all deviations to QA and Access Rosin helpdesk
• Retain documents for 2 years or per facility protocol

10. Training

• All operators must be trained and validated before system use
• Annual requalification required
• All training records shall be documented and audit-ready

Revision History

Log Templates

Batch Record Log Template

Daily Cleaning Log Template

Calibration and Maintenance Log Template

End of Document