Common Fault Diagnosis and Maintenance Specifications for Capsule Filling Machines

CELINE PHARMA

· Industry Insights

Common Fault Diagnosis and Maintenance Specifications

for Capsule Filling Machines

I. Equipment Overview

Capsule filling machines, as core equipment in the pharmaceutical industry, are widely used in solid dosage production. These devices employ precision mechanical structures to achieve quantitative filling of drug powders or granules, with operational stability directly impacting product quality and production efficiency. This document systematically analyzes common equipment failures and provides standardized maintenance solutions.

II. Typical Fault Analysis and Remediation Measures

1. Filling Accuracy Deviation

- Symptom: Excessive weight variation in filled capsules.

- Root Causes:

  • Pressure regulation system malfunction (standard operating pressure: 0.5–0.7 MPa).
  • Positioning deviation of the measuring disc (tolerance < 0.05 mm).
  • Seal component degradation causing pressure leakage.

- Solutions:

  • Calibrate pressure sensors and adjust pressure valves to standard values.
  • Measure mating clearances of the measuring disc using a micrometer.
  • Replace polytetrafluoroethylene (PTFE) sealing rings (recommended every 2 million capsules).

2. Operational Efficiency Decline

- Symptom: Production output reduced by over 30% per unit time.

- Key Factors:

  • Abnormal bearing wear in the turret (replace if vibration exceeds 4.5 mm/s).
  • Lubrication failure in the transmission system.
  • Excessive mold clearance (standard: 0.02–0.03 mm).

- Remediation:

  • ① Monitor bearing condition using vibration analyzers.
  • ② Apply food-grade lubricant during scheduled maintenance.
  • ③ Inspect mold dimensions with feeler gauges.

3. Unexpected Equipment Shutdown

- Common Triggers:

  • Safety interlock activation (90% caused by contaminated photoelectric sensors).
  • Power system overload (current exceeding 15% of rated value).
  • Foreign object obstruction in mold stations.

- Emergency Protocol:

  • Clean photoelectric sensor lenses with anhydrous ethanol.
  • Check motor insulation resistance (standard > 5 MΩ).
  • Inspect mold cavities using borescopes.

III. Preventive Maintenance System

1. Periodic Maintenance Schedule

  • Daily: Clean guide rails, inspect pneumatic pressure.
  • Weekly: Lubricate critical transmission components.
  • Monthly: Calibrate measurement system accuracy.
  • Quarterly: Replace filter elements.

2. Critical Component Lifecycle Management

| **Component** | **Service Life** | **Replacement Criteria** |

|---------------------|----------------------|--------------------------------------|

| Measuring Disc | 5 million capsules | Surface roughness Ra > 0.8 μm |

| Vacuum Pump | 3,000 hours | Vacuum level < -0.08 MPa |

| Servo Motor | 10,000 hours | Temperature rise > 65°C |

3. Digital Maintenance Recommendations

Implement an Equipment Health Management System (EHS) with IoT sensors for real-time monitoring of:

  • Vibration spectrum analysis
  • Temperature trends
  • Pressure fluctuation curves

IV. Safety Operating Protocols

1. Perform Lockout-Tagout (LOTO) procedures before maintenance.

2. Use specialized tools for mold assembly/disassembly.

3. Electrical maintenance must be conducted by certified personnel.

V. Technological Advancements

1. Apply laser micro-engraving to enhance mold wear resistance.

2. Implement machine vision for in-process quality control.

3. Upgrade servo-driven systems to improve positioning accuracy.

This maintenance protocol is developed in compliance with GMP standards. Adjustments should be made based on specific equipment models and parameters. It is recommended to establish comprehensive maintenance records and adopt a PDCA (Plan-Do-Check-Act) cycle to continuously optimize equipment management systems, ensuring stable and reliable production operations.

If you have any technical questions about the equipment, please feel free to contact us~