COLLIN Medical Line: Production of multi-layer multi-lumen resp. plastic hoses for medical applications
In modern medicine, a nearly immense variety of hoses is used. Examples for their field of application are hoses for invasive surgeries, dialysis hoses, infusion hoses, catheter hoses, drainage hoses etc. The range of diameters reaches from thinner than a human hair (<100 µm) up to approx. 5 mm.
Up to 7 separate channels in one multi-lumen hose
„The inner geometry of the hoses ranges from mono-lumen up to multi-lumen hoses containing up to seven separate channels. It is clear, that all geometric parameters are extremely narrowly tolerated. This geometric variety is multiplied by using different plastics “, explains DI Dr. Friedrich Kastner, CEO / Managing Partner COLLIN Lab & Pilot Solutions.
Depending on the application, five-layer design by coextrusion
„This ranges from PVC with special plasticizers via polyethylene, cross-linked PE, silicone rubber, thermoplastic polyurethane, polyamide up to fluoroplastic. Of course, also coextrusion is used by using up to 5 layers in order to increasingly adapt the property profile of the hose to the requirements of the field of application “, says Thomas Nick, Sales Director Medical Line COLLIN Lab & Pilot Solutions. „Furthermore, there is the combination of polymer material with metal support bodies with different geometric characteristics. “
Flexibility, precision & clean room conformity necessary
To an increasing degree, there are also requirements of variable diameters in longitudinal direction or different materials which are strung together at short distances. It is obvious that in such an environment, highest requirements regarding flexibility and precision of an extrusion line have to be fulfilled.
Beside these characteristics, it has to be noted that clean room production requires the use of special materials. Abrasion, release of dust, lubricants or vapours, which can cover the product have absolutely to be avoided. Moreover, it is necessary that there is easy access to all product-guiding line components in order to guarantee easy cleaning.
Safe documentation of process-relevant process parameters
Beside technical requirements for the production of high-precision hoses, also the control of such a line has to fulfil further characteristics: Here, the documentation of all process-relevant process parameters should especially be mentioned. These have to be recorded and stored in such a way that a manipulation of the data can safely be excluded. This requirement results in complex measures in the control software.
Beside the technical requirements of the line, also the FDA (Food and Drug Administration) standards have to be met. For that purpose, special know how is required, especially regarding the very strict documentation principles during the complete production phase of the line.
Essentially, it is divided into
- Design Qualification DQ
- Installation Qualification IQ
- Operation Qualification OQ
- Process Qualification PQ
The latter is not made at the manufacturer of the line but at the user.
Market leader with more than 45 years of experience
COLLIN Lab & Pilot Solutions, certified according to ISO 9001:2000, has been manufacturing high-precision and compact extrusion components and lines for laboratory and pilot applications for more than 45 years. This market segment requires machines and lines which can be used very flexibly under continuously changing edge conditions. As market leader in this field, all necessary pre-conditions are given to develop and successfully commission lines for the production in the medical sector.
Beside a number of special roll mills for the pre-development and production of pharmaceutical products, also lines for the production of IV bags, medical sutures and wound dressing are manufactured. The latest development is a production line for the production of medical face masks.