Playing by the rules: Regulatory compliance in the healthcare industry

Bernd Elbert, healthcare & diagnostics, Ineos Styrolution, outlines the importance of regulatory compliance for styrenic materials in the healthcare industry.

The patient’s wellbeing is the highest priority in regulatory systems for medical products and materials used in healthcare. Authorisation procedures are particularly time consuming to ensure safety, with a detailed risk analysis, compliance with regulatory demands, clinical evaluation of the performance, effectiveness and efficiency, and finally,  thorough quality management system.

Plastics-based applications have to comply with the same rule and  plastics can be found in countless medical applications, from small mobile measurement devices to drug delivery systems, to tubes and connectors and drip chambers for IV sets.

Ineos Styrolution offers styrenic-based products aimed at healthcare applications. Our production environment delivers products that meet a range of compliance requirements and quality standards. For certain product lines, production protocols have been implemented so the company can offer two different levels of notification of change commitments (up to 12 or 36 months). Consistency in formulation provides another level of assurance to medical device designers that their efforts in qualifying new materials and obtaining the corresponding biocompatibility documentation will be valid for the years to come.

Compliance testing of styrenics

I believe that testing the raw materials against these common biocompatibility standards (ie ISO 10993 and USP class VI), elevates Ineos Styrolution above industry requirement. Medical device manufacturers are required by law to conduct these tests on their final application. Since we tests our products against these same standards, medical device manufacturers have greater confidence when these products are used in their final application. They can reduce the risk of failure when introducing new applications in the medical market since their key raw materials are already compliant. Working with a pre-certified raw material would certainly lead to a reduction in time and cost for the application provider.

Ineos Styrolution’s styrenic healthcare packages are designed for use in risk class I and risk class II applications. ABS grades such as Novodur HD grades and Lustran ABS are available with food contact statements in regards to the US (FDA) and European regulations. They meet the requirements of European and Japanese pharmacopoeia and have tested according to the USP Class Biological Reactivity Tests Class VI and relevant ISO 10993 standards.

What is next?

Styrenics are popular materials for a range of applications due to their excellent flowability, impact strength, chemical resistance, hard-, softness and surface qualities. They combine excellent physical performance along with aesthetically pleasing attributes.

We are current developing new materials for the healthcare market. One new grade will be tailored to meet the specific needs of IV drip chambers. It was designed to meet the ever-increasing demand for products that have superb bonding performance, have excellent flowability for multi cavity tools, and address the need of designers who are looking for an alternate grade to products commonly used in the market space.

We are also looking at the first fibre-filled ABS which will not only meet the challenges of very demanding applications, but also fulfil regulatory requirements as mentioned above. In fact, initial indications are so promising that further results are expected to be announced at the Pharmapack in Paris in February 2017.