3. Reagent Application Drying Process Lamination of Components Inspection/Marking Cutting Quality Control Assembly/Packaging SUMMARY OF MANUFACTURING PROCESSES
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6. Batch Manufacturing Equipment XYZ 3000 dispenser with BioJets and AirJets Clamshell benchtop laminator Manual Dip Tray CM 4000 Guillotine Cutter
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
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