Lean Strategies for Laboratory Testing Jenny Watson Global Pharmaceutical Applications Manager GE Analytical Instruments
Agenda Operational Excellence & Lean Case Study
The Balancing Act Time Quality Cost Scope
Operational Excellence & Lean Operational Excellence Organizational leadership strategy Applies a variety of principles, systems, and tools to improve key performance metrics Includes application of new technology Lean Methodology Focus on organizing human activities Reduce the 7 wastes Transport Inventory Motion Waiting Overproduction Over processing Defects
SOPs Business Practices Technology Evaluation Example: New Instrumentation, New Manufacturing Technology Data Handling Example: Laboratory Data Management Systems, Electronic Batch Records
What areas does this apply? Manufacturing Process Development Quality Systems Quality Control Looks at Procedures and New Technologies
Quality Control Environmental Monitoring Ongoing Operational Testing Final Product Testing Stability Testing Maybe Process Development Testing
Case Study: Evaluation of Lab Testing for Water Samples
Customer Current State Conductivity P.O.U. Sampling Transfer to Lab Set up Manual Analysis Analyze for Stage 1 Manually Record Results Analyze for Stage 2 (if fails) Transpose Results to LIMS Sample collection, testing, data entry, and review of 50-200 samples/week Stage 1 or 2 Conductivity performed in lab Manual analysis Data transcription
Conductivity Background USP requires conductivity monitoring for bulk purified water and water for injection USP <645> Water Conductivity provides the following guidance:
USP <645> Conductivity Stage 1 Measured Online or Offline in suitable container Measure temp & raw conductivity Compare to Pass/ Fail criteria < 15 min Stage 2 Offline test 100 ml sample Temperature control (25 C) Vigorous agitation Conductivity measurement must stabilize (Δ 0.1 µs/cm over 5 min) Pass if sample < 2.1 µs/cm ~ 4 hours Stage 3 Uses sample from Stage 2 within 5 minutes Addition of KCl salt to sample Measure ph Determine corresponding conductivity Value must be less than conductivity measured at Stage 2 ~ 6 hours
Instruments and Consumables Current State Future State
The Challenge Conductivity and TOC measurements typically require different sample containers Conductivity Measured in Plastic Total Organic Carbon Measured in Glass Glass has ionic interferences Plastic leaches TOC Solution DUCT Vials
Customer Success A large, global pharmaceutical company wanted to lean out processes, gain efficiency, and reduce costs related to TOC and conductivity testing Purchased Sievers M9 Laboratory Analyzer for simultaneous TOC and Conductivity measurements with DUCT Vials Integrated instrument with laboratory data management system for paperless workflow Determined payback period and savings based on labor and costs
Implementation Method Transfer Conductivity Manual to Automated TOC Upgraded to Current Model Activities Stage 1 Conductivity on the M9 viewed as automated Accuracy, Precision and Linearity performed to establish suitability Instrument Comparability Container Comparison Side by side testing
TOC Method Transfer Results % Response Efficiency 120 115 110 105 100 95 90 85 80 Run 1 Run 2 Run 3 Acceptance Criteria = 85-115% DUCT Vial System Suitability Kit Borosilicate Vial System Suitability Kit 900 Borosilicate Vial System Suitability Kit
Integration with Lab Data System Original Process Conductivity was recorded on controlled worksheets and then manually entered into lab data system Results were then reviewed/approved by quality New Process Results automatically transferred to lab data system No review/approval required Generated data module to accept conductivity measurements
Streamlined Process Current State Compendia Process Flow: Conductivity P.O.U. Sampling Transfer to Lab Set up Manual Analysis Analyze for Stage 1 Manually Record Results Analyze for Stage 2 (if fails) Transpose Results to LIMS TOC P.O.U. Sampling Transfer to Lab Set up Analysis Analyze TOC Results direct to LIMS Future State TOC and Conductivity Process Flow: P.O.U. Sampling Transfer to Lab Set up Analysis Analyze TOC & Cond. Go To Stage 2 if Fail Results direct to LIMS
Payback Period: Cost per Sample PM Labor Consumables Cost Type Current Future Conductivity Sample Containers & Verification Standards $ 2.58 $ 15.70 TOC Sample Containers $ 4.83 N/A TOC Verification Standards No change Total Consumable Cost per Sample $ 7.41 $ 15.70 Analysis Time (minutes) 7 2 Labor Rate per sample $1.17 $1.17 Total Labor Cost per Sample $ 8.17 $ 2.33 Maintenance per sample (PM cost divided by # samples per year) $ 0.44 $0.88 Overall Total Cost per Sample $ 16.01 $18.91 Current 40 ml TOC vial 125 ml Conductivity bottle 125 ml Conductivity back-up Future 30 ml DUCT vial 125 ml Conductivity back-up
Payback Period Cost Factors Current Process Future Process Instrument & Installation Costs N/A $ (99,710) 1 Labor Costs $ (115, 500) $ (16,500) Consumable Costs $ (122, 220) $ (129, 500) Maintenance Costs $ (14, 484) $ (14, 484) Projected Labor Savings N/A $ 62,400 Total Cost $ (252,204) $ (197, 794) Overall Cost Savings N/A $ 54,410 Payback Period (months) N/A 8 Based on labor rate of $60/hour Labor rate = $40/hour; payback is 12 months
Summary When evaluating opportunities for more efficient operations it is important to look at the whole process. How could a new technology change my overall process?
Jenny Watson Global Pharmaceutical Applications Manager W +1 720 622 0241 C +1 303 349 0103 Email: jenny.watson@ge.com 6060 Spine Rd Boulder, CO 80301-3687 USA www.geinstruments.com