The Problem
- Equipment qualification records scattered across paper files and spreadsheets
- Calibration due dates missed leading to out-of-spec production
- Unplanned breakdowns cause batch losses and delivery delays
- Preventive maintenance schedules based on time, not actual condition
- No visibility into equipment health trends across the facility
Modern Approach
- Digital equipment master with complete qualification history
- Automated calibration scheduling with advance alerts
- IoT sensors monitor critical parameters in real-time
- AI predicts failures before they happen based on trend analysis
- Maintenance dashboard shows equipment health and priorities
Frequently Asked Questions
What is equipment qualification in pharmaceutical manufacturing?
Equipment qualification (IQ/OQ/PQ) is the documented process of verifying that equipment is installed correctly, operates within specifications, and performs consistently for its intended use. It's required by GMP regulations.
How does predictive maintenance work for pharma equipment?
Sensors monitor parameters like vibration, temperature, and motor current. AI analyzes trends and compares against failure patterns. When early warning signs appear, the system alerts maintenance to act before breakdown occurs.
What equipment benefits most from predictive maintenance?
High-value and critical equipment: tablet presses, coating pans, fluid bed dryers, HVAC systems, and filling lines. Equipment where failure causes batch loss or long repair times offers the highest ROI.
How does digital calibration management help?
The system tracks calibration due dates, sends advance alerts, logs calibration results, and flags out-of-tolerance instruments. This prevents production on uncalibrated equipment and provides instant audit access to calibration records.
What is the cost of implementing equipment management software?
Costs depend on number of equipment items and sensor requirements. Most facilities see ROI within 12-18 months through avoided downtime, prevented batch losses, and reduced emergency repair costs.