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Rotea cell separation

Case Study

Rotea – (2018 - 2019)
Medical Industry

Tooling development and manufacturing of disposable components used in automated cell separation, wash and concentration system for cell therapies. 

Plastic Resins
Polyethylene Terephthalate Glycol (PETG) 

Support Processes
Clean environment manufacturing
Touchless processing


The team that invented and developed Rotea approached Forme Technologies with a functional prototype of their impressive technology. They had passed the research and development stage and needed to transfer the device to manufacturing. Prototype components were not sufficient anymore. They were in the hunt of a manufacturing partner that could fabricate its product to stringent technical specifications and under the guidelines of ISO 13485. 

The technology of Rotea is based on the principle of counterflow centrifugation where high rotational speeds of up to 8000 rpm are reached to process the cells. The prototype parts used to concept prove Rotea were not dimensionally consistent. In isolated cases they were generating excessive runout that translated in vibration resulting in separation of the parts and breakage. In addition to this, the dimensional variation increased the complexity in the assembly line and scrap was generated.

  • Touch free manufacturing.
  • Tight tolerances +/-  0.05mm
  • Developed under the guidelines of ISO 13485.
  • Design for manufacturability


Tool development and manufacturing of single-use components for a cell therapy device in Polyethylene terephthalate glycol - PETG with minimal or no human contact.

  • Biocompatible polymer.
  • Clean environment manufacturing.
  • Steel like tolerances.
  • Manufactured under ISO 13485 guidelines.
  • Must be able to assist product validation and generate supporting documentation.


Product Developement

We worked with Rotea’s Team to improve the design of the parts for manufacturability and to achieve the tight tolerances required on the product. 
It doesn’t matter how much pre-work, calculations sometimes you can find unforeseen challenges. 



For this project, we worked with one of our diamond international toolmaker partners. They were selected as the best match to meet the complexity, technical specifications, deadline, and budget for the product. We project managed the manufacturing of 9 components and 7 injection moulding tools. 

Forme Technologies provided the best combination of injection system, tool configuration and cavitation numbers to best suit the Rotea’s team requirements and budget. We used our Computational Flow Analysis software to optimise gate location achieving perfectly balanced fill time on the family tools and defect-free parts. 

We embedded in the tool design all the required controls to obtain quality parts without compromising on performance. We scrutinized the tool design to the detail. 



Forme Technologies manufactures Rotea’s components on a fully electrical injection moulding machine DEMAG INtElect2 50. This machine has an inbuilt statistical process control software.

Thresholds are set for the moulding variables that we know can impact the quality of the part. The machine alerts reject or stop based on these settings.


Forme Technologies aligned its processes to comply with ISO 13485 for these components. The keywords for Rotea’s components are traceability and repeatability. We are able to trace a component manufactured for Rotea down to the raw material. We also designed and manufacture a set of quick-change fixtures to hold Rotea’s components for measuring in our CMM machine. This allowed us to automate this process and ease production checks. 


For the manufacturing of a truly clean product, we developed what we called a “captive manufacturing environment”  to create an ”atmosphere” of clean air. The injection machine, tool and chamber are inside of this enclosed environment. An air quality monitoring company  measures the quality of air regularly and it had classified the environment as ISO 7.

The parts are taken off the machine with an overhead robot and deposited in a clean chamber that only open to let the freshly moulded parts deposited into the bag. 

Rotea cell separation


Rotea’s team now commercializes it’s cutting edge medical device and Forme Technologies manufactures its disposable components in our cleanroom.


  • Tight tolerances
  • Met the ISO 13485 specifications required for the manufacturing of the components.
  • Rotea's components exposed to accelerations of up to 5000 g-force perform without failure.


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