Recent Developments in Handheld Raman Technology and Reducing Costs. Enrique Lozano, Ph.D. Business Development Manager B&W Tek, Inc

Transcription

1 Recent Developments in Handheld Raman Technology and Reducing Costs Enrique Lozano, Ph.D. Business Development Manager B&W Tek, Inc 1

2 Portable Raman Instruments Units in each market are designed with key features and characteristics to address specific needs within the market. Some common considerations are: High resolution requires a larger footprint Handheld instruments require fast on-board analysis Portable instruments require highly flexible sampling capabilities 2

3 Handheld Raman Instrument Requirements Easy to use by administrators, materials managers and QA technicians Open systems architecture for developing and transferring of methods, data and libraries Range of sampling accessories for gels, liquids, powders and solids in various containers Support large scale deployment for QA/QC applications to achieve 100% testing of materials Compliant with FDA cgmp procedures Short term ROI and cost savings 3

4 New Developments in Handheld Raman Technology Intuitive Software for Technical & Non-technical Users Minimal training for warehouse/loading dock employees Advanced Statistical Algorithms for Identification and Verification Both HQI value & P-value in One Instrument Wi-Fi & USB Communication for Data Sync & Management In Real-time Sampling Accessories for Almost Any Environment 4

5 New Developments in Handheld Raman Cont d Easy Library & Data Transfer Capabilities Open Software Architecture Compact and Self-contained Small, Lightweight, Ergonomic Temperature Controlled Improved Data Quality & System Stability Large Touch-Screen User Friendly Clear Results 5

6 Preparation of an Action Plan Objective: To increase the analytical capabilities for full verification of incoming materials. Scenario #1: Introduce Handheld Raman Technology Scenario #2: Increase Capabilities of Central Laboratory 6

7 Scenario #1: Introduction of Handheld Raman Technology Pros Reduced time from reception of materials to manufacturing Reduction of required warehouse space for isolation area Consumables and waste materials decrease Cons Changes in existing SOP New validation process will be required Cost per sample analyzed in the laboratory will increase Risk of hazardous exposure will decrease since bags don t need to be opened to verify materials Not suitable for all samples, typically 85-95% of samples can be analyzed using handheld Raman Decreased potential for cross-contamination No additional increase in manpower Overall warehouse and operational cost decreases Maintenance costs are greatly decreased compared to dated laboratory instruments. 7

8 Scenario #2 : Increase Capabilities of Central Laboratory Pros Use of existing facilities Cons Will require extra manpower to cope with new level of analysis Material validation process already in place Not too many changes in existing SOP Warehouse and laboratory operational costs will increase significantly Risks of hazardous exposure may increase Consumables and waste materials will increase Potential for cross-contamination increases Expansion of isolation area Potential delays in manufacturing 8

9 Scenarios #1 and #2 Simplified General Assumptions Operation days 300 days Trucks unloaded on average (per day) 3 trucks Batch per load 25 packages New number of samples/year: (target) x Actual samples/year Central laboratory Employees $83K each Estimated maintenance cost of full laboratory capabilities $417,500 Percentage of time laboratory is used for material identification/ verification purposes 60% Estimated actual cost of analysis in laboratory for material verification $17.8/sample 9

10 Cost Calculations for Scenario #1 3 year plan Scenario #1 Year Number of samples Estimated cost per sample Samples sent from the warehouse to the lab will be reduced by 85% within 3 years. 15% of total will still need to be sent to the lab (10 % are not suitable for Raman and 5 % for quality control assurance and extra testing) By the 3 rd year, 90% of all samples will be analyzed by handheld Raman. Of these, 5% will be sent to the lab for further analysis 1 (50% drop) $ (75% drop) $ (85% drop) $ (50%) $ (75%) $ (90%) $0.40 Cost per sample (year 3), Scenario #1 $3.91 Approximate Investment $100,000 Approximate Cost Savings $250,000 Total Incremental Cost ($150,000) 10

11 Cost Calculation for Scenario #2 Estimated Impact on Operation Cost Year 1-3, Scenario #2. +$300,000/year New cost per sample $6.24 Total Incremental Cost $900,000 Cost Savings Calculation for Scenarios #1 vs. #2 Total Cost For Scenario #2 $900,000 Total Cost For Scenario #1 ($150,000) Incremental Cost Savings: $900,000 ($150,000) $1,050,000 11

12 Conclusion Based on this analysis, handheld Raman proves to be the better solution of the two. It is important to note that each industry and facility are different, and the analysis should be performed for each actual operating parameter. image. Source Web 12

13 Summary: Raman has proven to be a promising resolution to increasing operation capabilities and reducing cost. 13

14 Thank you for your attention! Dr. Enrique Lozano Business Development Manager B&W Tek, Inc