With volatile supply chains, local production is regaining importance. This is also reflected in the cooperation between the automation specialist MA micro automation and Sanner, a leading supplier of primary packaging as well as medtech and diagnostics applications. With fully automated production, rapid tests and other medical technology products can be manufactured in Germany just as cost-effectively as elsewhere - as the new CERES POC system at Sanner clearly shows.
The distance between Bensheim and St. Leon-Rot is just 60 km. So the partner companies Sanner and MA micro automation don't have far to go. And yet that can still be beaten by far: The assembly cycle time of the new CERES POC system for small batch sizes is just 750 milliseconds per part. This is particularly relevant for the German laboratory landscape. And this is diverse: Highly competent small and medium-sized companies develop test strips including chemical equipment in order to be able to detect a wide variety of substances. The current Covid test is just one example; it is also about diabetes, heart attack early detection, pregnancy or drug tests.
As simple as the application of lateral flow tests (LFTs) is for laypersons, their development and manufacture remain challenging: Manufacturing companies have to take into account a wide variety of biological, chemical and physical conditions in order to be able to offer high-quality test instruments that deliver reliable results, especially in early detection deliver. Sanner also supports medical technology and diagnostics companies in developing their ideal solutions, for example for PoC tests or in-vitro diagnostics items. MA micro automation GmbH designs and implements complex automation solutions, also with a focus on medical technology. Both companies are now combining their expertise.
Local for local
For many laboratories, the production of test cassettes is not profitable due to the small quantities. That's why many currently still buy standard products from Asia and installing them accordingly. However, if you combine the volumes of many small laboratories with a highly efficient assembly line, LFTs and other medical technology products can also be manufactured locally - with simpler logistics, better quality monitoring and individual procurement and without international transport.
The basis for this is the CERES POC system from MA micro automation, with which test cassettes can be fitted with up to three test strips and assembled - in just 750 milliseconds per cassette. This gives Sanner the opportunity to offer both customer-specific and standard cassettes that can be used flexibly and cover the needs of many customers. The important thing here is that the parts fit perfectly in order to achieve an effective lateral flow, i.e. the even spreading of the sample liquid along the test strip.
The importance of the plastic housing
LFTs require a complex interaction of many individual components: from the selection of the chemical reagents to the quality and precise cutting of the test strip material to the alignment and precise overlapping of the individual pads, which are fixed using pressure points on the plastic housing. When designing such rapid tests, the focus is on usability, so that both users and specialist staff receive reliable test results in the shortest possible time. That is why Sanner ensures, for example, in the area of precision injection molding and using its own tooling expertise, that the housing is developed in line with requirements and that the parts are functional – and thus precise measurement results.
Thanks to their ease of use and short reaction time, LFTs are even suitable for use by laypersons. However, their reliability depends on how precisely the tests themselves are designed. Several factors are therefore decisive in the manufacturing process: material properties, chemical composition, sample structure and the plastic housing. The functionality of the housing is often underestimated.
But it not only protects the test strip from external influences such as moisture and stabilizes its positioning. It also enables optimal flow direction and flow rate at specific key points through various design features. The structure of the housing provides a microfluidic channel through precisely coordinated and designed openings, depressions and fixing points, through which the sample liquid flows until the result is displayed. The design concept of the plastic housing is therefore one of the most important project phases in the product development of an LFT.
A demanding assembly process
The assembly process is just as complex as the product development: Pre-produced and available as bulk material, the cassettes are separated, aligned and fed to the assembly line. Up to three cutting modules are docked to it, which prepare the material for the test strips - with a length of 300 millimeters, the cards are around 60, 80 or 95 millimeters wide. After a visual check to see whether the reactant or the test chemical has been applied everywhere, the cutting modules shred the cards into individual test strips and automatically eject missing parts in the raw material.
This is followed by the exact loading of the lower parts of the cassette with the test strips and the subsequent check using 3D scanning technology for correct positioning, followed by the assembly and testing of the upper parts. Depending on the type of manufacture, their dimensional accuracy is usually sufficient for manual assembly, but not for the trouble-free operation of a high-performance machine. The production of all cassette components by Sanner on the new CERES POC system solves this problem.
Optical customization and integrated desiccants
The optical individualization of the tests is the heart of the MA micro automation concept: LFTs and similar products are usually marked using the pad printing process. However, when changing products, this technology also requires a complex conversion to a new template and causes downtimes. In contrast, two marking lasers are active in the CERES POC. They apply comprehensive inscriptions in a short cycle time and are simply switched from one program to the next when there is a variant change. In this way, each laboratory can implement its individual labeling including logo. When changing customer orders, only the card material for the test strips is exchanged and the already written laser program is activated.
A defined pressing force combines the upper and lower parts into a finished cassette, with sensory testing monitoring whether everything has been properly assembled. A final camera checks the labeling again before the finished tests leave the machine on a conveyor belt in the direction of the packaging system. In addition to the cassettes, desiccants can also be added here.
These are decisive for the safety and functionality of the LFTs. As a pioneer in Europe in the integration of desiccants in the packaging of moisture-sensitive products and devices, Sanner can take over the final packaging of the test in aluminum pouches, including the addition of a Sanner desiccant sachet.
A cooperation with vision
With the cooperation between Sanner and MA micro automotion, many smaller production volumes add up; the flexible CERES POC makes local test production attractive and efficient. MA micro automation has the necessary know-how in-house, so that image processing, IT and mechanical construction of the automation complement each other.
Sanner, in turn, is the world market leader in the field of desiccant packaging and also a sought-after provider of individual development services and contract manufacturing in the fields of medical technology, diagnostics and pharmaceuticals .