An innovative COVID-19 self-testing kit, developed in co-operation of Diagenode with the University of Liège, is in high demand of the Belgian authorities. The automation specialist KUM Technic has developed a robot-based machine to ramp up production. Three Stäubli robots – two FAST pickers and one six-axis robot – are able to handle 70,000 test kits per day.
The three most desirable items in 2021 can easily be determined, and it goes without saying that all are connected to the COVID-19 pandemic: It´s vaccines, tests and masks. And in each three cases it is very helpful to have domestic manufacturers at hand which can satisfy the demand.
Concerning the tests, Belgium is in the lucky position to be the home country of Diagenode. The company, located in Liège, is a leading developer and marketer of innovative life-science kits, reagents and integrated systems for epigenetics, genomics and diagnostics assays. Among the products are experimentally-validated, easy-to-use solutions and services for RNA, DNA, chromatin, and protein analysis, and the Diagenode scientists are already using the “CRISPR/ CAS9” technology for genome editing.
Innovation: A salivary self-testing kit
The company has a diagnostics branch which has successfully developed a wide range of PCR (“Polymerase Chain Reaction”) tests to detect many infectious diseases from bacterial, viral or parasite origin. And it offers a COVID-19 self-testing kit, developed in co-operation with the University of Liège. The unique feature of this kit: The sampling is carried out by the patients themselves and the virus neutralization step is done within the tube. So the laboratory sample processing can directly start with the following step: viral RNA extraction. This accelerates the testing procedure, and it decreases the need for trained personnel and strict laboratory conditions which are normally required to avoid contamination during processing of the samples.
Looking for automated production equipment
Due to these advantages, the Belgian federal government has ordered 1 million kits per month. In need for the respective production capacity (and considering many other customers and a high-volume market), Diagenode was looking for a way to ramp up production of the Test kits in a high-scale mode – and addressed this request to KUM Technic.
The request was logical and surprising at the same time. Logical because KUM Technic, based in Marloie/ Belgium, is a specialist for the automation of demanding production and packaging technologies in the pharmaceutic industry. And surprising because Diagenode was searching for a contract manufacturer, able to assemble and pack 70,000 sample tubes a day.
KUM Technic was founded in 2011 by Jonathan de Ceulaer who brought in 12 years of experience in high-level automation of sensitive processes. Since then, KUM Technic has engineered and produced many automation solutions for pharmaceutical production. And as one of the company´s core qualities is agility and openness to new challenges, the management agreed to set up a contract production with the shortest time schedule possible.
The task: Filling and assembly of PCR test kits
The task for KUM Technic was to design a machine which is able to fill tubes with the active RT-PCR test substance and cap them with high speed and accuracy. The automation specialists designed the process using three Stäubli robots.
The first robot – a Stäubli FAST picker TP80 – takes the empty tubes and places them in a rack to hold them upright for filling. The second, a six-axis TX90, picks up the rack and places it on a linear axis for automatic filling. Once the tubes have been filled, the robot picks the rack up again and places it in front of the third, another FAST picker TP80, which picks up the caps one-by-one and screws them onto the tubes.
Production in a clean room with laminar airflow
When the tubes are capped, the TX90 takes away the rack containing the 20 filled and capped tubes. So, this robot is acting as the “conductor” or “master” that coordinates the machine’s operations – with a volume of 70,000 tubes per day, produced in a two-shift mode from Monday to Saturday.
The machine is installed in an ISO 8 cleanroom, and the tubes are filled under laminar airflow (LAF). Each tube is covered with a label that is heat-resistant to 80°C and resistant to the reagents used in laboratories. It contains a removable bar code used to identify the patient at the national level. The robots themselves are ISO 5 Cleanroom certified. They are regularly disinfected with 70% IPA.
Selection of robots – speed, precision and good support
Jonathan de Ceulaer, founder and CEO of KUM Technic, explains the criteria for selecting the robots: “We needed speed and precision for this task, so the TP80 was essential in our choice. The speed was needed both for handling the tubes and screwing on the caps. The TP80 places the cap precisely and screws it onto the tube with a specific tightening torque. And the TX90 is flexible enough to fulfil different tasks with high precision.” Another strong point for Stäubli robots, from the perspective of KUM Technic, was the positive experience from other demanding pharmaceutical projects.
Start of production in record time
Stäubli Benelux helped KUM Technic by running simulations to determine the types of robots needed for this application and also with the development of the machine. Jonathan de Ceulaer: “This project was a real collaboration between the two companies, with the goal to complete the work with utmost precision and, very important, in record time.” This goal was achieved: “The first prototype machine was ready within four weeks, and the second machine was up and running in only one week.”
From the beginning on, it was clear that a robot-based solution was the only possibility to meet the demands of the project. This does not only refer to the high processing speed but also to flexibility, as Jonathan de Ceulaer explains: “Because requirements can change quickly, we need to be able to adjust the production process accordingly. A linear ´conveyor belt´ solution does not allow for potential changes, nor can it meet the necessary output volume.”
Positive perspective in a growing market
Concerning Diagenode´s request to KUM Technic for operating the robots as a contract manufacturer, KUM was open to enter a new business field and was lucky enough to find that a production site was available in the direct neighborhood.
Today, two machines for test kit production with three Stäubli robots each have been installed in the factory and are being used in production. Diagenode handles the ordering and distribution of the tubes and saliva test kits to test centers in Belgium.
As it is very likely that the demand for PCR tests will continue to grow – not only for COVID-19, but, for example, also for influenza tests), KUM Technic is ready to build more machines of this type. The prospective owners can be sure to have made a good long-term investment even in volatile markets: The machines are easily modifiable to fill with other liquids or with powders. And KUM Technic is currently preparing for further growth: Other EU countries have already contacted the company in order to acquire this filling technology using sample tubes for RT-PCR tests.
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