Point of Care diagnostics

Customized rapid test using the example of SARS-CoV-2

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

Together with the customer, the entire assembly process was optimized and all customer requirements for hygiene and production conditions were implemented in a short time and with the highest priority. 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. Translated with www.DeepL.com/Translator (free version)

  • Process development according to ISO 13485
  • Manual and semi-automated assembly under controlled production conditions
  • Sealing of primary packaging with moisture barrier (using SARS-CoV-2 as an example)
  • Labeling and packaging in folding carton
  • Moisture and hygiene monitoring
  • Series-accompanying verification of the function of rapid test with an external test laborator
  • Printing of customer-specific user information, labels
  • Customer-specific final packaging, logistics and supplier management

We create the basis for a 100% reliable diagnosis jointly with our customers. How do we succeed ? By keeping the quality constantly high, also for volumes of several million molded parts per year.

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