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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

For further details and consultancy contact us @contact@ubio.inwww.ubio.in