Considerable efforts are underway to improve the diagnosis and treatment of a wide range of diseases.

One idea revolves around speeding up not only classical diagnostics at family practices but also subsequent laboratory analyses – as well as bringing these processes closer to the patient. This would allow a wealth of information to be obtained about physiological processes in the body without the need for an elaborate and resource-intensive information chain between physicians and laboratories.

For example, one key element of this idea are biomarkers, whose rapid identification paves the way for faster and more effective diagnostics. At the same time, the boundaries between diagnosis and monitoring are becoming increasingly blurred. Whereas the development of therapies tailored to specific patients currently relies on elaborate and cost-intensive analytics to determine a range of laboratory parameters, this process could be streamlined with the help of pioneering point-of-care technologies. In the future, innovative technologies for sample collection at medical practices or even by patients themselves could open up a raft of new possibilities, including cost savings, a reduced burden on the healthcare system, and the oft-cited early detection of diseases – along with accompanying improvements in prognosis.

The demo­cratization of analytics: why technology matters

Let’s look at one current example: the coronavirus pandemic, where millions of test kits were required on an ad hoc basis so that people could test themselves for a possible infection. In many cases, a positive result meant that the authorities had to carry out a molecular diagnostic procedure known as a polymerase chain reaction (PCR) test. These cannot be performed without expensive analytical technologies that are not yet standard equipment at medical practices and hospitals. The result: long waiting times.

Today’s commonly used techniques for PCR testing rely on PCR tubes, numerous containers for reagents, and large analytical instruments that are installed in a central and often regional analytical laboratory. If the idea of point-of-care analytics is to become a reality for more complex diagnostic procedures such as PCR tests, it will require cartridges in addition to analytical instruments. These cartridges combine a set of reagents needed for the test to be performed as well as a certain degree of intelligence, paving the way for analytical instruments that are small and simple enough to be used even by amateurs at the point-of-care. This is the only way to offer universal access to diagnostics of numerous physiological or pathological conditions through simple tests of bodily samples – allowing treatments to be initiated more quickly.

MC 1400

There are many approaches to in-vitro diagnostics

Rychiger AG has demonstrated during the coronavirus pandemic that, as a mechanical engineering company, it covers the entire spectrum of in-vitro diagnostics manufacturing.

The best example of this is the MC 1400, a modular machine that has been used to fill, seal, and assemble complex and proprietary POC cartridges. The machine is just one of many systems that can be used, for example, to manufacture COVID-19 tests. Fully automated and with the help of up to 20 different production processes, the MC 1400 uses state-of-the-art automation technologies and production techniques to produce between 20 and 60 test cartridges per minute. 

A small yet powerful machine

The smaller standard entry-level platform known as the TM 05 standalone unit was developed in order to enable a low-automation approach to manufacturing of IVD products.

The platform is designed specifically for production in a start-up-likesetting and for products on the laboratory scale in the field of molecular diagnostics or immunodiagnostics. Compared with its larger “siblings”, it only offers semiautomatic production and comes with a lower throughput (approx. 5-15 pcs/min). The key aspect in terms of research is that the process parameters in the laboratory are identical to the ones in series production. At the same time, the TM 05 standalone unit allows small contract manufacturing organizations (CMOs) to scale up quickly and easily, allowing them to respond immediately to the development of new test kits. This has proven to be an indispensable capability, particularly during the COVID-19 pandemic.

lt 20

Customized client application

With the LT 20, Rychiger once again emphasizes versatility. Designed as a complement to the established machinery portfolio, the linear transporter ensures that multiwell cartridges, ID gel cards, and POC products for molecular-diagnostic, clinical, and immunohematological screenings can leave the production line quickly and in large quantities. The output ranges from 20 to 40 pcs / min. The automation degree can be freely defines as to be semi-automated or fully automated.

Different paths to individuality

With the FS 200 machinery platform, Rychiger includes a rotary indexing system in its portfolio whose fundamental design centers around a compact and versatile machine.

This features a cycled rotary transport system with optimized and modular options for infeed, forming, filling, sealing, and labeling that allows fully automatic operation. Particularly during the pandemic, having the liberty to make decisions about the inner workings of the FS 200 and therefore about the in vitro diagnostic test has been of vital importance. After all, the concept of a machine with freely accessible stations means that anything is possible – from molecular biological reagents to products for immunohematology and even products for forensic applications. Laminar flow units integrated into the machine ensure contamination-free operation.

Let's work together
Let's work together

The machines presented here are just a few examples of Rychiger’s well-thought-out product range for in-vitro diagnostics. Depending on the desired machine output and the required degree of automation, every customer will find a suitable system for producing their unique in vitro diagnostics product.