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. Copyright© Ginolis Ltd. Page 1/4 9/2014 White paper v. 1.3 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: The Ginolis Delilah™ robotic cells Cartridge part feeding modules Strip feeder and cutting modules Machine vision system Printing & labelling cell Pouching unit Copyright© Ginolis Ltd. Page 2/4 9/2014 White paper v. 1.3 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: 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: 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 Copyright© Ginolis Ltd. Page 3/4 9/2014 White paper v. 1.3 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. All trademarks are the property of Ginolis Ltd. All rights reserved. Information contained herein is subject to change without notice. No part of this White Paper may be reproduced in any form on by any means, electronic, mechanical, photocopying, recording or otherwise, without the prior written permission of Ginolis Ltd. Ginolis Ltd. retains ownership and all other rights of all drawings, models, shapes, solutions, ideas or any kind of industrial property rights presented or expressed in this White 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 Copyright© Ginolis Ltd. Page 4/4
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