Quality product & management
Regen Lab develops, manufactures and distributes easy-to-use medical devices,
guaranteeing safety and biological efficacy.
REGEN LAB’s ambition is to become a international leader in regenerative medicine based on autologous medical/surgical treatments and to provide medical medical devices of the highest quality and safety for the patient and the user. This is a commitment to public health and patient welfare.
Thus, Regen Lab has set up a typical production centre with the installation of new infrastructure with innovative and efficient technologies, in order to ensure the production of the production of reliable and high value-added devices while respecting the well-being of well being of our employees.
Regen Lab Quality System Management ensures the consistency of our products quality in total GMP compliance. Our production facility rooms atmosphere is monitored to satisfy non-pyrogenic medical devices manufacturing.
Regen Lab follows a stringent approach to regulatory matters and Quality System Management. We operate within the framework of the ISO 13485 Norms, which combines the requirements medical device manufacturers must incorporate into their management systems. Our quality system also complies with the requirements of the European Regulation 2017/745 on medical devices.
Our Technologies
The Regen Lab technology is based on the use of a thixotropic gel to separate the blood components.
This process is protected by many patents (US8529957, EP2073862, US2014010857).
Thixotropy is a physical property of some gels. The gel is thick under static conditions. It becomes more fluid when submitted to physical stress (in this case, a centrifugal force of 1500 g) and regains its original consistency when the physical stress stops (Barnes, 1997).
The gel acts as a mechanical separator of the blood components. Two types of thixotropic gels with different specific densities are used in Regen Lab devices. One type is designed to separate platelets only, while the other allows the recovery of platelets with mononuclear cells (lymphocytes and monocytes). Performance studies have shown that the Regen tubes are reliable and produce a consistent separation of platelets and plasma from erythrocytes and leukocytes.
Regen Lab medical devices consist of evacuated pharmaceutical grade borosilicate tubes that contain a pharmaceutical grade anticoagulant solution and a separating polymer gel specifically designed for PRP isolation. The vacuum in the tube allows the preparation of PRP in fully closed circuit. A predetermined amount of blood (8-10 mL) is automatically collected in the tube by connecting it to a blood collection set. Using an evacuated tube for blood collection is not only less traumatic for the blood than using a syringe but is also safer for the operator and the patient.
Blood is mixed with the pre-loaded anticoagulant by gentle inversion of the tube and centrifuged for 5 to 9 minutes depending on the model of tube and the type of separating gel. The centrifugation can be performed using either a small tabletop centrifuge equipped with a 45° fixed angle rotor or in a larger centrifuge with a swing out horizontal rotor.