Optinova - Precision Extrusion of Medical Tubing

Optinova is a leading company in the precision extrusion of tubing for medical applications.Tubing from Optinova can be found as components in a large variety of medical devices. All products from Optinova are produced according to a customer specification and purchase order.

We are frequently involved in the design process to make the optimal combination of the customer's knowledge of the function and our experience in extrusion.

INFUSION AND CARDIOVASCULAR TUBING APPLICATIONS

Our tubing for medical devices focuses on two main areas:

Infusion - we are the world leading manufacturer of tubing for infusion applications. Our quality and service level is well known all over the world. We supply tubing that is transparent, striped or homogenously filled with a filler to enhance the radiopacity.

Cardiovascular - we produce all different kinds of close tolerance tubing to be used as components or tools in the assembly of a variety of cardiovascular devices.

Apart from our two main areas we supply tubing for other demanding applications that need the quality and services that Optinova offer.

The demands within the medical device business increase every day. We at Optinova fully understand our part in this complex situation.

MEDICAL DEVICE COMPONENTS – ADVANCED EXTRUSION TECHNIQUES

Optinova has a vast range of experience in the precision extrusion of customer-designed components for the medical device industry. Today, our components are incorporated into millions of lifesaving products throughout the world.

Our experience ranges from idea, via the choice of material, to the delivery of precise medical device components. This is achieved through use of our new advanced extrusion techniques, automated or semi-automated secondary operation equipment and a highly efficient production system.

INNOVATIVE PRODUCTION MATERIALS AND EQUIPMENT

The production equipment at Optinova is of the latest design. Materials used are fluoropolymers like PTFE, FEP, ETFE, PFA, and PVDF, thermoplastic polymers such as PE, PP, PA, PET and PC, thermoplastic elastomers as TPE-U (PUR), TPE-A (Peba) and TPE-E.

Together with our extrusion services we can offer subcontracting services and a variety of conversion operations such as state-of-the-art catheter shafts, welding of soft tips to braided tubing, pre-fabricated packaging coils, protection sleeves and welding sleeves.

CLEAN ROOM ENVIRONMENT

Optinova’s 5,800m² facility is located on the Åland islands in the Baltic Sea between Finland and Sweden. Great care is taken by the islanders to maintain a clean environment. This makes the islands the perfect surroundings for a factory operating under the stringent requirements needed in a clean room manufacturing environment.

Our production area of 2,800m² is in clean environment, ISO class 6 - 8. The status is secured regularly by our trained staff and is complemented through annual inspections from an independent, authorised company.

TRACEABILITY AND DOCUMENTATION

Key factors in our business are tight tolerances, traceability, design services and personal customer service. Optinova is certified according to ISO 9001:2000 and ISO13485:2003, and operates under cGMP guidelines.

A system for documentation and follow-up has been set up in response to the stringent requirements of the medical device industry.

Our long experience of extrusion line design and production, in combination with the latest, most efficient in-line control equipment like ultrasonic wall thickness and laser OD monitoring, guarantees that our products meet the highest expectations.

During production the operators perform regular, documented tests of the production performance.

Extensive experience in processing a wide variety of materials such as PTFE, thermoplastic fluoropolymers and other thermoplastic polymers sets the platform to ensure the highest consistency and minimum batch-to-batch variation.

MATERIAL QUALITY

Our raw material, as well as all in-house compounded material, is carefully inspected. This ensures that we remain aware of material quality from batch to batch.

The core in our production is our highly trained and experienced operators; when producing tubing at the very highest level, we depend on the individual operators’ final touch.

Optinova engineering expertise takes you from idea to product. Optinova constantly attracts interest as an R&D partner from ‘world class producers’. Our knowledge and long experience in the extrusion of many different raw materials, combined with our customer’s expertise in the desired functionality, results in the optimal final component.

You can turn to Optinova and trust that we will do our utmost to fulfil your expectations. Our integrity is without compromise and we guarantee client confidentiality.