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Variation Analysis of Liquid Delivery Using Blister Packs Manufacturing of Lab-on-a-Chip Devices: Variation Analysis of Liquid Delivery using Blister Packs by Sivesh Selvakumar B.E. Mechanical Engineering (2009) College of Engineering, Guindy, India Submitted to the Department of Mechanical Engineering in Partial Fulfillment of the Requirements for the Degree of Master of Engineering in Manufacturing MASSACHUSETTS INSTITUTE OF TECHNOLOGY at the Massachusetts Institute of Technology NOV 0 4 2010 September 2010 LIBRARI ES ARCHIVES © 2010 Sivesh Selvakumar All rights reserved The author hereby grants to MIT permission to reproduce and to distribute publicly paper and electronic copies of the thesis document in whole or in part in any medium now known or hereafter created Signature of Author............ .......... e artm t of Mechanical Engineering ......................g '21ust 2 " 10 Certified by........... .... A..h. Lectu epartment of Mecanical Engineering 71 A -"Ii ThesMwSupervisor A ccepted by............................................ David E. Hardt Chairman, Committee on Graduate Students This page has been intentionally left blank Manufacturing of Lab-on-a-Chip Devices: Variation Analysis of Liquid Delivery using Blister Packs by Sivesh Selvakumar B.E. Mechanical Engineering (2009) College of Engineering, Guindy, India Submitted to the Department of Mechanical Engineering in Partial Fulfillment of the Requirements for the Degree of Master of Engineering in Manufacturing Abstract Components for on-chip storage and delivery of liquid reagent are necessary for many commercial applications of lab-on-a-chip technology. One such system uses a 'blister pack' that is pushed by an actuator. Over the course of product development, Daktari Diagnostics had completed nominal design of a blister pack for their flow rate requirements. This work involved performing a thorough variation analysis of the blister pack to determine the critical sources of variation. For this purpose, the tool of variation simulation modeling (VSM) was used. A numerical model of the blister performance was developed and Monte Carlo simulations were conducted. The results showed that this fluid delivery technique is robust and the number of out-of-specification parts was less than 2%. The critical blister pack parameters that must be controlled were also determined and these can be used to improve process capability. Thesis Supervisor: Dr. Brian Anthony Title: Lecturer 4 Acknowledgements I wise to convey my gratitude to: Aaron, Bill, Robert, Peter,Andy and Betsy, for being such great hosts at Daktari Diagnostics. Your enthusiasm and drive for the tasks at hand never ceased to amaze me. Working for Daktari has been an absolute pleasure. Rodrigo, my team-mate and friend, for his motivation and for the 'occasional' advice. Much of this work owes its existence to your input and hard work. It has been a pleasure to work with you. Dr. Brian Anthony, our thesis advisor, for his support and encouragement throughout what has been, in many ways, a unique project experience. Jennifer Craig, our writing advisor, who surely spent many hours reading several last-minute drafts. Without her support and eye for detail, this thesis would have suffered in quality. The folks at the Edgerton Student Shop for their understanding and much-needed suggestions through many hours of machining. This project has gained a lot from their experience. Amma, Appa and Appayya for making all of this possible. 6 Table of Contents Acknowledgements 5 Table of Contents 7 List of Figures 11 List of Tables 13 1. Introduction 15 1.1 The M.Eng. Capstone Project 16 1.2 Overview of the Thesis 16 2. Product and Project Overview 19 2.1 Company Background 19 2.2 Product Description 19 2.2.1 The Cartridge 20 2.2.2 The Instrument 21 2.2.3 Product Timeline 22 2.3 Problem Statement 23 2.3.1 Survey of Manufacturing Issues 23 2.3.2 Selection of Subset of Problems 25 3. Background Research 27 3.1 Lab-on-a-ChipApplications 27 3.1.1 CD4+ Cell counting through Cell Lysate Impedance Spectroscopy 27 3.2 Microfluidic Device Architecture 28 3.2.1 Central Layer 29 3.2.2 External Layer 29 3.2.3 Additional Components 29 3.3 Lab On a Chip Technologies 30 3.4 Lab-on-a-Chip Manufacturing Processes 31 3.4.1 Part Manufacturing 31 3.4.2 Functionalization Process 32 3.5 Monte Carlo Analysis 33 3.6 Machine Vision for Metrology 34 3.6.1 Choice of Metrology System 34 5.1.2 Components of a Machine Vision System 34 4. Development of the Blister Performance Model 37 4.1 Working of the Daktari Blister Pack 37 4.2 Requirements of the Blister Numerical Model 38 4.2.1 Blister Outputs and Noise Factors 40 4.3 The Numerical Model 41 4.3.1 Input Blister Dimensions and Speed of Travel 43 4.3.2 Step Size 43 4.3.3 Determine Actuator Positions according to Step Size and Misalignment 44 4.3.4 Calculate the total volume of fluid expelled up to the current step 46 4.3.5 Volume expelled in the current step 51 4.3.6 Getting the 'instantaneous' flow rate 51 4.3.7 Calculate the average, maximum and minimum flow rates 53 4.4 Assumptions 53 5. Validation of the Blister Model 55 5.1 Measurement Setupfor Blister Dimensions 55 5.1.2 Selection of Hardware 55 5.1.3 Selection of Software 56 5.1.3.1 Gauge Repeatability and Reproducibility 57 5.2 Measurement Setup for Blister Flow 58 5.3 Validation of Blister Numerical Model 58 6. Monte Carlo Analysis and Regression Models 61 6.1 Manufacturing Variation Data 61 6.2 Monte Carlo Algorithm 62 7. Results and Discussion 63 7.1 Flow Rate Variation after considering only Blister Dimensional Variation 63 7.2 Flow Rate Variation after considering the variation in all dimensions 65 7.3 Regression on the Average Flow Rate 67 7.4 Regression on the Range of Flow Rates 68 7.5 Effect of Variation in Individual Dimensions on Flow Rate 69 7.5.2 Effect of Spherical Radius Variation 69 7.5.3 Effect of Blister Height Variation 70 7.5.4 Effect of Actuator Radius Variation 71 7.5.5 Effect of Starting Height Variation 72 7.6 Flow Rate Variation after consideringthe effect of shimming 73 8. Conclusions and Recommendations 75 9. Future Work 77 9.1 Blister Model Validation 77 9.2 Study of Dimensional Variation in Blisters 77 9.3 Increasing the Number of Runs in the Monte Carlo Simulation 77 9.4 Electrode Foils - ConfigurationStudy and ProcessAnalysis 77 9.5 FunctionalizationProcess Optimization 78 9.6 Injection Molding of the Backbone - Normalization Time Optimization 78 9.7 Valve-Solenoid Interaction Robustness Study 78 9.8 Effect of Imprecise Actuator Movement 78 References 81 10 List of Figures Figure 1: Daktari Diagnostics CD4 Cell Counting Platform 19 Figure 2: The Daktari cartridge - with parts marked 20 Figure 3: The Daktari instrument - with parts marked 21 Figure 4. Assay Process Diagram 28 Figure 5. Microfluidic Device Architecture 29 Figure 6. Functionalization Process 33 Figure 7: Schematic of Metrology System using Machine Vision 35 Figure 8: Photograph of a Blister Pack (above) and Actuators (below) 37 Figure 9: Blister actuation process 38 Figure 10: Required Outputs from a Mathematical Model of the Blister 39 Figure 11: Particular blister dimensions that affect the flow rate 40 Figure 12: Flowchart of Blister Numerical Model 42 Figure 13: Effect of small step size on flow rate measurement 43 Figure 14: Effect of large step size on flow rate measurement 44 Figure 15: Introducing the effect of actuator misalignment and step size 44 Figure 16: Usage of transformation matrices to convert actuator coordinates to the blister coordinate system 45 Figure 17: Discrete Volume Calculation 46 Figure 18: Flowchart for Blister Volume Calculation 47 Figure 19: Intersection of Actuator and Blister at a particular height 48 Figure 20: Possible Scenarios when a Blister and Actuator Intersect 49 Figure 21: Calculating the area of a Circle-Circle Intersection 50 Figure 22: Volume Expelled in the Current Step 51 Figure 23: Total Volume Expelled vs. Crush Depth 52 Figure 24: Time taken for a Step versus the Crush Depth 53 Figure 25: Schematic of Blister & Camera Setup 55 Figure 26: Photograph of Blister Measurement Setup 56 Figure 27: Photographs of the Blister Using the Current Setup 56 Figure 28: Blister diameter (in no. of pixels) measured by 2 operators 57 Figure 29: Blister Height (in no. of pixels) measured by 2 operators 57 Figure 30: Plot of Experimental and Predicted Flow Rates from 5 Blisters 59 Figure 31: Flowchart of the Monte Carlo Algorithm 62 Figure 32: Distribution of Flow Rates considering only Blister Variation 64 Figure 33: Distribution of Flow Rates considering variation in all dimensions 66 Figure 34: Flow Rate Profile with a Smaller Spherical Radius 69 Figure 35: Flow Rate Profile with a Larger Spherical Radius 70 Figure 36: Flow Rate Profile with a Smaller Blister Height 70 Figure 37: Flow Rate Profile with a Larger Blister Height 71 Figure 38: Flow Rate Profile with a Smaller Actuator Radius 71 Figure 39:Flow Rate Profile with a Larger Actuator Radius 72 Figure 40: Flow Rate Profile with Lower Actuator Starting Height 72 Figure 41: Flow Rate Profile with Higher Actuator Starting Height 73 Figure 42: Distribution of Flow Rates considering the effect of shimming 74 List of Tables Table 1: Product Development timeline 22 Table 2: List of Potential Cartridge-Instrument Interaction Issues 25 Table 3: List of Potential Issues during Ramp-up 26 Table 5: Variation Data for the Blister and Actuator Dimensions 61 Table 6: Summary of Output Distribution Properties considering the variation in blister dimensions alone63 Table 7: Increase in Percentage of Non-conforming Blisters with tighter tolerance ranges 65 Table 8: Summary of Output Distribution Properties considering the variation in all relevant dimensions 67 Table 9: Increase in Percentage of Non-conforming Blister-Actuator Systems with tighter tolerance ranges 67 Table 10: List of Coefficients for Linear Regression on Average Flow Rate 68 Table 11: List of Coefficients for Linear Regression on Range of Flow Rates 68 Table 12: Summary of Output Distribution properties considering the variation in all relevant dimensions73 Table 13: Percentage of Non-conforming Blister-Actuator Systems after shimming 74 14 1.
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