In Belgium, the start-up company Texere Biotech has recently taken possession of a globally unique, fully automated system. The company uses femoral heads (i.e. the top end of the human thigh bone) and processes them into cuboid implants known as “bone allografts”. Six Stericlean robots supplied by Stäubli handle this bone replacement tissue under cleanroom conditions.
Allografts (i.e. non-endogenous implants) are in high demand, because natural bone is the best material for bone transplants. Its microporosity ensures that it engrafts well. At the same time, the patient is spared the painful removal of autologous bone.
Precisely because the material is so well suited for grafting, it is in short supply. This is partly because bone banks have so far been preparing the hip bones entirely manually – a time-consuming process with low output. For this reason, Dr. Denis Dufrane, who himself spent many years working in a bone bank, founded Texere Biotech with the goal of automating the production of bone allografts.
Stericlean robots make the impossible possible
This project was on the drawing board in more than few years in the making, and it has now reached completion. The plant has the capacity to process 5,000 femoral heads a year. Because these are meticulously measured and optimally segmented, each produces an average of six blocks.
The details are as follows: Six identical TX60 Stericlean robots are positioned at six stations along the processing line. The first of them lifts one whole femoral head off a tray and conveys it to an image processor which assesses it for size and shape. This data is used to map out the cutting lines for the next stage, in which the second robot presents the bone tissue to the fully encapsulated water jet cutting machine.
Robot number three retrieves the resulting cuboid allografts and places them on a tray. The next two robots in line are responsible for handling the allografts as they undergo chemical treatment and sterilization. At station number six, the last of the Stericlean robots inserts the individual cubes in vials.
Multiple benefits for bone banks, hospitals and patients
In addition to increased efficiency in the processing of femoral heads, the other main advantages brought about by full automation are the traceability of each bone allograft block, the reliable removal of viruses transmission and of the elimination of the cross-contamination risks between the bone tissues from the different donors.
When the time came for Texere to select robots, Stäubli’s Stericlean range quickly proved to be the best solution – not least because of the unsurpassed hygiene standards and the numerous references from satisfied customers in the medical technology sector, including operating theaters. The machines are fully functional in VHP environments and are compliant with the strict GMP (Good Manufacturing Practice) guidelines. The robots not only impress by virtue of their cleanroom compatibility but also in terms of dynamics, precision and reliability.
The world’s first automated facility for the processing of bone material scores high marks for significantly better yield, higher production volumes, lower costs and a very high level of safety. Texere can establish itself as the new gold standard provider for bone implants. An assessment that is also borne out by GMP certification which manually operated systems by definition cannot qualify for.