Sample testing of manufacturing lot for functionality
Assembly / Packaging
Seal test strip in foil pouch with desiccant, pipette, etc.
SUMMARY OF MANUFACTURING PROCESSES
Temperature and humidity controlled facility.
Relative Humidity below 25%
Batch Manufacturing Equipment Line dispenser laminator Manual Dip Tray Guillotine Cutter Reel-to-reel web handling and dispensing platform Auto Laminator In-line manufacturing equipment
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