Optinova has been a supplier for the medical device industry for more than 40 years. Over the years, we have learned what demands our customers have of their suppliers and partners.
The raw material used at Optinova is always virgin material. Many of our materials have been previously approved as USP class VI or for food contact use and supporting documentation can be provided upon request. A certificate is always required from the raw material supplier. Incoming testing and inspection is performed according to each type of material and to our internal requirements. Samples and records from all tests are retained for a minimum of five years.
During start-up, samples are taken frequently and all the critical specifications of the tubing are reviewed. This also includes reviewing visual and tactile attributes that may impact the physical appearance of the tubing. When the extrusion process is stable and the tubing is within specifications, the production starts.The extrusion process is monitored throughout the entire production run by measuring the product for dimensional specifications including; OD, wall-thickness, ID, eccentricity and ovality. Additionally, all extrusion parameters are recorded in our process documentation, which is kept on file for a minimum of five years. All operators are responsible for the quality of each batch they produce and verify their work by taking samples and recording measurements randomly throughout the production run.
All samples are taken randomly from each manufacturing batch. A test report with measurements from each batch and a CoC is included in each shipment, if required. We have full traceability on raw materials, process parameters and product control for each can, bag or spool of tubing. We keep all quality records in our files for a minimum of five years. We are always open to discussion if our customers have special requirements.
In May 2020, national authorities of five European countries began the official procedure to restrict Per- and polyfluoroalkyl substances (PFAS) in the EU. The aim of the restriction is to phase out the manufacturing, import, sales and use of PFAS in production. The proposed regulation is currently driven by EPA authorities in Germany, the Netherlands, Denmark, Sweden and Norway. As PFAS is a broad definition, the proposed blanket regulation could result in a ban of fluoropolymers that are imperative to the production of vital components for critical sectors of a socially, environmentally sustainable economy such as medical devices and renewable energy.
Taking into account recent publications and research on the matter, Optinova supports the position that fluoropolymers including PTFE and FEP should be considered as polymers of low concern. Justified usage of such fluoropolymers in production of vital components for crtical sectors should be permitted until viable alternatives are available. Optinova is working closely with our partners to educate and inform the authorities about the consequences of a broad ban of all PFAS.
As the leading sustainable player in the extrusion industry, Optinova is actively taking responsibility to support and educate our employees, suppliers and customers about the appropirate handling of potentially harmful chemicals like PFAS during storage, manufacturing and end-of-life handling of the products. Additionally, Optinova is taking the initiative to foster collaborative efforts within the industry to investigate alternative materials to replace PFAS.