Post on 22-Jan-2015
description
ubiowww.ubio.in
LATERAL FLOW ASSAY LATERAL FLOW ASSAY PRODUCTION STRATEGIESPRODUCTION STRATEGIES
TYPICAL TEST STRUCTURETYPICAL TEST STRUCTURE
Reagent Application
Drying Process
Lamination of Components
Inspection/Marking
Cutting
Quality Control
Assembly/Packaging
SUMMARY OF MANUFACTURING PROCESSES
Reagent Application
Dispense: Test, control, conjugate
Coat: Conjugates, blocking, other pad treatmentsInspection/Marking
Dispensing defectsDrying Process
Objective is to reduce water content to less than 4 % level.
Used after reagent application processes.Lamination of Components
Individual layers are bonded, using thin layers of adhesive.
Adhesive layers are usually prelaminated to plastic backing and
cover layers.Inspection/Marking
Lamination alignment defects
SUMMARY OF MANUFACTURING PROCESSES
Cutting
Separate into individual test strips: 3-10 mm
Remove bad parts marked in inspection process
Quality Control
Sample testing of manufacturing lot for functionality
Assembly/Packaging
Seal test strip in foil pouch with desiccant, pipette, etc.
SUMMARY OF MANUFACTURING PROCESSES
Batch Manufacturing EquipmentBatch Manufacturing Equipment
XYZ 3000 dispenser with BioJets and AirJets
Clamshell benchtop laminator
Manual Dip Tray
CM 4000 Guillotine Cutter
Batch Process Line Layout
T/C
XYZ XYZ
Conjugate Inspect/Mark
Dip Tank
Block
Oven
Dry
Cutter Clamshell Clamshell
Cut/Sort Inspect/Mark Laminate cover Laminate Master Strip
Assemble
Assembly Roller
Assemble Assemble
SealSealSeal
Typ. 1.5 million tests limited by assembly & pouching
12-15 + operators
Increase to 4-6 millionby adding pouchingand/or assemblymachine
Final QC
In-line manufacturing equipmentIn-line manufacturing equipment
Reel-to-reel web handling and dispensing platform
Auto Laminator
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/bottle1 bottle/10 sec.30 million testsper year