Innovative Automation Processes for Life Science
For MedtecLIVE in Stuttgart, IMSTec presented its range of services for medical technology.
Networking @ MedtecLive
We look back on exciting days at MedtecLIVE in Stuttgart, where our team informed interested visitors about our automation solutions for stents, orthopaedic implants and medical implants.
As a meeting place for medical technology manufacturers, the focus of MedtecLIVE was also on networking. Managing Director Edgar Mähringer-Kunz is a member of the board of the Medical Technology Working Group in VDMA and is supporting the network:
In discussions with experts from development, product management, production and quality control, new contacts were made and our network was expanded. In cooperation with our cooperation partners, IMSTec can provide customers worldwide with optimal support in the development of automation solutions and deliver systems.
In focus: Orthopedic Implants and Medical Implants
In particular, the last product group was in focus: IMSTec Managing Director Edgar Mähringer-Kunz explained how we successfully developed an automated manufacturing process for our customer and built a system that includes all process steps: Extrusion of medications, production of needles, assembly and packaging of applicators.
"Process development is a core element of IMSTec. Our customers approach us with a product or a problem and we develop the production processes, build the systems including the complete validation," says Edgar-Mähringer-Kunz.
Types of Application
In the field of ophotology, especially in the case of chronic diseases, a medical depot can be implanted in the patient's eye, which continuously dispenses the medication over a period of six months to one year. In addition to higher compliance, this application also more convenient for the patient. "This procedure is the future," summarizes Edgar Mähringer-Kunz.
Project challenges
The challenges in developing these processes and systems are the product sizes (smaller than 0.5 mm in diameter), and single part traceability: All components and all process parameters must be 100% traceable.
The entire manufacturing process is carried out under GMP conditions: High cleanroom classes, hygienic cleaning of the systems and exact documentation of product-contacting parts.
Edgar Mähringer-Kunz emphasizes one challenge in particular: "The high availability and high throughput combined with high variability are also challenging conditions to which the plants have to adapt permanently and fully automatically." In addition, all process steps must be efficient and fully validable.
Manufacturing of medical implants
Extrusion of medications
At a extruder station, a medical implant (polymer medication mixture) with a diameter of a few μ meters is produced and cut into the desired size.
Production of needles
The needle must be extremely sharp to be inserted into the patient´s eye. In this context, the surface of the needle is processed with special siliconization processes.
Assembly of applicators
Features are built in so that the implant cannot fall out of the needle (implant retention). The individual parts are joined together to complete applicators.
Packaging of applicators
In the last step, applicators are labeled and packaged in pouches. They are also given serial numbers for exact traceability.