Rapid test production for the detection of SARS-CoV-2

Kundenspezifische Point-of-Care Schnelltest- / Diagnostiklösungen werden unter kontrollierten Reinraumbedingungen gefertigt. / Customized point of care rapid tests/ diagnostic solutions under controlled clean room conditions.

A quick and early diagnosis at first symptoms of illnesses, such as with a suspected coronavirus infection, can save lives and reduce the risk of spreading. The faster an infection screening is carried out, the earlier treatment measures can be implemented purposefully in the case of a positive result. Due to the corona pandemic, some customers have required new supply chains and have asked for powerful suppliers with fast and flexible development and production. By the example of a corona rapid test production, the entire team of Wirthwein Medical GmbH & Co. KG was able to meet these challenges in a short period of time under controlled production conditions and additional hygiene measures.

Due to the corona pandemic, the customer needed a flexible, reliable, and experienced partner in the field of diagnostics / point of care. After only a few days, the first rapid tests were manually assembled in controlled production areas. Special attention was paid to controlled humidity conditions with corresponding monitoring. Step by step the processes were partially automated and the output quantities of the SARS-CoV-2 rapid test production were successively increased. In addition to the preparation of documentation and implementation of all assembly services, Wirthwein Medical rounded off the entire range of services, such as sealing in a special primary packaging and complete labeling of the corona rapid tests.

The entire assembly process was optimized according to customer requirements and always in close cooperation with the customer. The whole process development was based on DIN EN ISO 13485. In addition, the function of the SARS-CoV-2 rapid test was verified by an external specialized test laboratory during series production. Customer-specific final packaging as well as logistics and supplier management round off the services of the medical technology expert Wirthwein Medical. The company has already worked out further modular and customized expansion stages to increase automation for a possible future increase of the number of units, which, depending on the development of the pandemic, may become necessary even at short notice.