IME launches MediSpin XL production platformJuly 4, 2019
IME Medical Electrospinning announced the launch of its MediSpin XL platform for large-scale industrial manufacturing of reproducible and scalable fibre-based scaffolds for Class I, II and III medical devices.
IME’s advanced equipment creates fibre-based medical device solutions that mimic the natural human extracellular matrix in nanometer and micrometer format for implants and membranes in the human body.
Human cells recognize this artificial matrix (scaffold) as the body’s own facilitating the repair of the damaged tissue for heart valves, blood vessels, nerves, tendons, skin and bone etc.
This is in contrast to implants and membranes of traditional structures, which are seen as foreign and therefore can lead to scar tissue or rejection phenomena, the company said.
The MediSpin XL platform has been developed specifically for MedTech industrial manufacturing of medical devices and ensures the firm control of the crucial parameters of the electrospinning process, leading to identical and consistent end-products.
The electrospinning process is governed by a number of variables that are crucial for success in research and development, but certainly also for large-scale manufacturing of fibre-based medical device solutions.
Crucial parameters in fiber diameter and structure, porosity, mesh thickness and tensile strength are vital for the in- vitro and in- vivo functionality of products but were challenging to control in the past. In particular, changes in temperature and relative humidity between the seasons and during the day, could lead to inconsistencies within one batch as well as between batches.
MediSpin XL eliminates all the important factors that might distort the electrospinning process, enabling an optimal process set-up and stability, including climate control and on-line quality monitoring measurements, ensuring a consistent end-product.
The MediSpin XL equipment is built using state-of-the-art materials and process controls. Down-stream process steps such as cutting and blistering can be easily included in the system. Automation minimises the need for operator intervention, which further adds to a reproducible process and minimization of product contamination during the process.