Lateral Flow Assay

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Information about Lateral Flow Assay

Published on March 11, 2008

Author: bishorvi

Source: slideshare.net

Description

Manufacturing technology of Lateral flow assay kits

ubio www.ubio.in LATERAL FLOW ASSAY PRODUCTION STRATEGIES

TYPICAL 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 treatments Inspection/Marking Dispensing defects Drying 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

Reagent Application

Dispense: Test, control, conjugate

Coat: Conjugates, blocking, other pad treatments

Inspection/Marking

Dispensing defects

Drying 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

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

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.

Batch 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 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

In-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/bottle 1 bottle/10 sec. 30 million tests per year

For further details and consultancy contact us @ [email_address] www.ubio.in

For further details and consultancy contact us @

[email_address]

www.ubio.in

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