📋 Case Study

Collaborative Robot Trajectory Certification for Pharma Packaging Line

Need for ISO/TS 15066-compliant motion profiles validated for human-robot proximity during carton loading

🏗️ Project Overview

FDA-regulated sterile packaging line for injectable biologics (Pfizer, Kalamazoo MI)

🎯 Challenge

Need for ISO/TS 15066-compliant motion profiles validated for human-robot proximity during carton loading

🔧 Design Approach

Power & force limiting mode with real-time torque monitoring; pre-validated trajectory library generated via digital twin simulation with 10,000 Monte Carlo contact scenarios

📐 Design Diagram

AI-generated project design illustration

📐 Key Calculations

Contact Force Limit (Torso)

F_max = 150 N (ISO/TS 15066 Table 1)

Result: 150 N

Non-negotiable regulatory threshold

Validated Trajectory Coverage

Coverage = ∫_Ω p(x) dx

Result: 99.998%

Meets FDA ALARA principle for residual risk

📊 Results

FDA 510(k) clearance achieved in 4 weeks, zero safety incidents, 100% audit compliance

💡 Lessons Learned

• •Digital twin validation must include worst-case sensor delay (120ms)
• •Trajectory libraries require version-controlled traceability per 21 CFR Part 11

✅ Key Takeaways

• 1Digital twin validation must include worst-case sensor delay (120ms)
• 2Trajectory libraries require version-controlled traceability per 21 CFR Part 11