Delilah LFA white paper (pdf)

9/2014
White paper
v. 1.3
Ginolis Delilah™ Lateral Flow Assembly (LFA)
Ginolis Delilah™ LFA is a complete solution for final assembly and quality control of lateral flow test
cassettes.
Introduction
Ginolis Delilah™ LFA is built on Ginolis’s productised modular Ginolis Delilah™ robotic platform, which
has a proven track record in various Point of Care (POC) diagnostic applications such as microfluidic
device and microneedle manufacturing.
Picture 1. Ginolis Delilah™ Lateral Flow Assembly (LFA) solution for start-up volumes
The Ginolis Delilah™ platform is now also introduced with features to transform it into a world leading
solution for lateral flow test manufacturing enabling the world’s highest production volume by
solution footprint.
Functionalities like strip cutting, part feeding, module assembling, vision-based Quality Control,
cassette labelling, barcode printing, pouching, etc. are formed out of existing robotic modules, and the
whole manufacturing solution is controlled by the Ginolis Delilah™ platform.
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Picture 2. Ginolis Delilah™ Lateral Flow Assembly (LFA), single-cell and higher capacity solutions
The delivered solution for each specific lateral flow test cassette manufacturing case is assembled
using modules customer requires. Furthermore, post-processing of lateral flow test cassettes can also
be arranged according to customer’s requirements (e.g. printing or pouching solutions, sample test
handling).
The Ginolis Delilah™ LFA solution is able to reach a 2-second cycle time with high volumes (up to 1,800
cartridges per hour) for full assembled tests including batch specific labelling and barcodes. On the
other hand, the Ginolis solution needs only a footprint less than 0.5 m2 when solution is needed for
plain test assembly for smaller volumes.
Platform Setup
The Ginolis Delilah™ robotic cell with integrated control computing for the whole production line, and
with wireless control tablet with customized Graphical User Interface (GUI), is the base element
around which the Ginolis Delilah™ LFA solution is created. For related tasks for planned lateral flow
test manufacturing case, the needed units out of wide set of existing modules are attached.
In the smallest lateral flow test assembly solution, all the peripherals are installed with one single
Ginolis Delilah™ robotic cell, which takes care of the full assembly process. Where needed speed for
single test assembly approaches 2 sec, tasks for cartridge halves pick-up and assembly are split over
two Ginolis Delilah™ robotic cells; one picking the bottom part from bulk feeder and assembling the
strips, and the second picking the top part, closing the test cassette and transferring the assembled test
cassette further.
The Ginolis Delilah™ Lateral Flow Assembly (LFA) solutions consist of selected number of robotic cells
and module variants, such as:
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The Ginolis Delilah™ robotic cells
Cartridge part feeding modules
Strip feeder and cutting modules
Machine vision system
Printing & labelling cell
Pouching unit
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Picture 3. Ginolis Delilah™ Lateral Flow Assembly (LFA) solution, a 2-cell solution with printing & labelling on both
sides of the cassette
Cartridge Feeding
For cartridge feeding into the assembly process, there are several options to choose from. Cartridges
are fed in from:
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pre-loaded racks
tape, where cartridges are attached
bulk storage by level vibration and machine vision
bulk storage by bowl feeder
For small footprint and capacity needs, the usage of pre-loaded racks for cartridge halves is the most
optimal alternative. For a high-volume case, feeding cartridge halves out of bulk is more efficient and
minimizes the manual loading workload. Alternative for bulk feeding can be selected based on the
material availability and customer preferences.
All cartridge feeding options have adaptation capability to handle different cartridge sizes and shapes.
Strip Feeding
The strip feeding and cutting can be chosen from the following options:
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to use pre-cut sheets,
to use material out of roll, or
to use a feeder that utilises a combination of the above two.
Strip and sample & ABS pads may be available as pre-clued strip or alternatively robot can pick items
individually and load them into the cartridge base in defined locations.
The width of strips cut by the strip cutter is adjusted by GUI driven parameterization. Similarly the
location of strips in the cartridge base is defined by parameters in GUI and successful strip insertion
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checked by machine vision system. The same machine vision system is used to check the closure of
cartridge halves.
Post Processing
Cassettes after the assembly in the simplified solution are pushed into a bin/storage to be further
taken for post-processing. Alternatively, cassettes can be further transferred by the assembly robot
into a printing/labelling phase for batch specific labelling and also further into bagging/pouching if
packaging is preferred. Both top and bottom labelling of the cassette is supported, and options
implemented as per needed.
The machine vision system will also check the success and quality of printing and label attachments on
the assembled test cassettes, and the QC secures also the success of pouching if implemented.
Quality Control (QC)
Quality control for correct strip inserting and successful cartridge closure is done by machine vision
system in all Ginolis Delilah™ Lateral Flow Assembly (LFA) solutions. Machine vision system is used
also to check the success and quality of printing and label attachment on the assembled test cassettes,
in case printing/labelling option is requested in the solution.
For Quality Control purposes of the test cassette functioning, randomly selected samples of assembled
test cassettes can be taken aside from the test manufacturing flow for further manual or automated
tests.
Flexibility to meet a variety of needs
Due to high modular structure, the manufacturing line for lateral flow test assembly can be individually
created for any manufacturing case handing any kind of cartridge shapes and any kind of needed
production volume.
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Paper. All other use of the material presented or expressed in this White Paper except for getting acquainted with, quoting,
ordering or use otherwise related business with Ginolis Ltd. is strictly prohibited.
GINOLIS LTD – AUTOMAATIOTIE 1, FI–90460 OULUNSALO, FINLAND - WWW.GINOLIS.COM
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