Lateral Flow Assay

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Manufacturing technology of Lateral flow assay kits

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Lateral Flow Assay

  1. 1. ubio www.ubio.in LATERAL FLOW ASSAY PRODUCTION STRATEGIES
  2. 2. TYPICAL TEST STRUCTURE
  3. 3. Reagent Application Drying Process Lamination of Components Inspection/Marking Cutting Quality Control Assembly/Packaging SUMMARY OF MANUFACTURING PROCESSES
  4. 4. <ul><li>Reagent Application </li></ul><ul><li>Dispense: Test, control, conjugate </li></ul><ul><li>Coat: Conjugates, blocking, other pad treatments </li></ul><ul><li>Inspection/Marking </li></ul><ul><ul><li>Dispensing defects </li></ul></ul><ul><li>Drying Process </li></ul><ul><li>Objective is to reduce water content to less than 4 % level. </li></ul><ul><li>Used after reagent application processes. </li></ul><ul><li>Lamination of Components </li></ul><ul><li>Individual layers are bonded, using thin layers of adhesive. </li></ul><ul><li>Adhesive layers are usually prelaminated to plastic backing and </li></ul><ul><li>cover layers. </li></ul><ul><li>Inspection/Marking </li></ul><ul><li>Lamination alignment defects </li></ul>SUMMARY OF MANUFACTURING PROCESSES
  5. 5. <ul><li>Cutting </li></ul><ul><li>Separate into individual test strips: 3-10 mm </li></ul><ul><li>Remove bad parts marked in inspection process </li></ul><ul><li>Quality Control </li></ul><ul><li>Sample testing of manufacturing lot for functionality </li></ul><ul><li>Assembly / Packaging </li></ul><ul><li>Seal test strip in foil pouch with desiccant, pipette, etc. </li></ul>SUMMARY OF MANUFACTURING PROCESSES
  6. 6. Batch Manufacturing Equipment XYZ 3000 dispenser with BioJets and AirJets Clamshell benchtop laminator Manual Dip Tray CM 4000 Guillotine Cutter
  7. 7. Batch Process Line Layout T/C XYZ XYZ Conjugate Inspect/Mark Dip Tank Block Oven Dry Cutter Clamshell Clamshell Assemble Assembly Roller Assemble Assemble Seal Seal Seal Cut/Sort Inspect/Mark Laminate cover Laminate Master Strip Typ. 1.5 million tests limited by assembly & pouching 12-15 + operators Increase to 4-6 million by adding pouching and/or assembly machine Final QC
  8. 8. In-line manufacturing equipment Reel-to-reel web handling and dispensing platform Auto Laminator
  9. 9. In-Line Process Layout Reel-to-Reel Dispense with Coat/Dry T/C, Block, Dry, Inspect/Mark Reel-to-Reel Dispense with Dry Conjugate Cut/Bottle Laminate/Inspect/Mark 2 parts/sec. Package Package Typ. 10 tests/sec. 60 million + tests per year. Operators—2-5 Cut/Assemble Cut/Assemble 50 parts/bottle 1 bottle/10 sec. 30 million tests per year
  10. 10. <ul><li>For further details and consultancy contact us @ </li></ul><ul><ul><li>[email_address] </li></ul></ul><ul><ul><li>www.ubio.in </li></ul></ul>

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