📋 Case Study

Medical Device Contract Manufacturer – Cleanroom CNC Validation

Regulatory auditors questioned inclusion of HVAC, HEPA, and gowning labor in machine rate

🏗️ Project Overview

Validating machine hour rate for Class 7 cleanroom CNC machining of implant-grade stainless steel

🎯 Challenge

Regulatory auditors questioned inclusion of HVAC, HEPA, and gowning labor in machine rate

🔧 Design Approach

FDA-aligned cost segregation: direct cleanroom support hours tied to machine runtime via PLC-triggered loggers; validated with ISO 14644-1 particle counts

📐 Design Diagram

AI-generated project design illustration

📐 Key Calculations

Cleanroom Support Time Ratio

Cleanroom HVAC Runtime / Machine Runtime

Result: 1.08

Justified full HVAC cost attribution

Gowning Labor Allocation

(Operator Gowning Time × Shifts) / Annual Machine Hours

Result: USD 3.17/hr

Auditable time-stamped video logs provided evidence

📊 Results

FDA 483-free audit; approved as compliant cost methodology for FDA 21 CFR Part 820 submissions

💡 Lessons Learned

• •Regulatory-grade traceability requires timestamped, machine-synced logs
• •Cleanroom costs are not overhead—they’re direct process enablers

✅ Key Takeaways

• 1Regulatory-grade traceability requires timestamped, machine-synced logs
• 2Cleanroom costs are not overhead—they’re direct process enablers