📋 Case Study
Pharmaceutical Aseptic Fill Line Capacity Expansion
High overhead absorption masking true product-level profitability due to shared cleanroom utilities
🏗️ Project Overview
FDA-approved biologics fill-finish facility upgrade in North Carolina
🎯 Challenge
High overhead absorption masking true product-level profitability due to shared cleanroom utilities
🔧 Design Approach
Activity-Based Costing (ABC) with utility metering zones and batch-level resource tracing
📐 Design Diagram
AI-generated project design illustration
📐 Key Calculations
Cleanroom Utility Cost per Batch
(HVAC kWh × Rate) + (WFI Usage × Cost)
Result: $12,480
Revealed 34% higher cost than allocated average
Sterility Validation Cost Allocation
Validation Hours × Rate / Batches Validated
Result: $8,250/batch
Critical hidden driver for low-volume SKUs
📊 Results
Accurate product margin stratification enabled SKU rationalization; $2.3M annual cost avoidance realized💡 Lessons Learned
- •Shared infrastructure requires sub-metering for credible modeling
- •Regulatory validation is a fixed cost pool requiring dynamic allocation
- •Batch size directly impacts unit overhead
✅ Key Takeaways
- 1Shared infrastructure requires sub-metering for credible modeling
- 2Regulatory validation is a fixed cost pool requiring dynamic allocation
- 3Batch size directly impacts unit overhead
📐 Prerequisites
Understand these before this topic
➡️ Next Step
Continue your engineering workflow
🔗 Engineering Applications
See how this applies across industries