Grade A: the trends in medical grade plastics for in-vitro diagnostics
Paulo Cavacas, business development manager, healthcare, Borealis highlights the trends in medical grade plastics for in-vitro diagnostic applications.
An increasingly important trend in the healthcare industry in recent years has been the stringent regulatory demands on the entire value chain with the end goal to ensure patient safety. High level of quality, protection and health for the end users as well as supporting innovation and making sure that the new innovative medical and diagnostic devices reach patients in a timely manner have been at the heart of the transition to Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) in Europe.
What role does the raw material play?
Along with the changes in classification system for IVDs, the IVDR requires clinical studies and evidence in many IVD applications where previously self-assessment was accepted.
In practice, this highlights the need for assurance that the material and the IVD that you qualify for today remains unchanged so that the validity of the clinical study is intact.
This also safeguards the investment in material qualification and ensures that any final item testing maintains its relevance.
On top, project timelines during new healthcare product developments are critical; often a quick access to advanced raw material technical data that goes beyond the product data sheet is needed. Additionally, a rapid confirmation from the supplier on substances of concern or even a composition disclosure and extractable data may be crucial for accelerating time-to-market.
Fast technical and regulatory reaction globally and peace of mind for the healthcare value chain is at the heart of the Borealis Bormed medical grades service package.
Choosing the right material for IVDs, consumables and labware often turns out to be crucial for the end performance of the product itself. Polyolefins are frequently being selected due to their combination of good property profiles and value in use as well as often offering a better sustainability profile by being lighter, easier or safer to use, chemically inert and recyclable.
Value chain cooperation
The validation of the recently developed Bormed BJ868MO is the result of close cooperation among Premix Oy (a leading manufacturer of electrically conductive and high frequency plastics), and a leading provider of in-vitro diagnostic solutions. These electrically conductive compounds enable extremely accurate liquid level detection and are widely used in in-vitro diagnostic consumables to ensure precise measurement. Bormed BJ868MO functions as a base for such an electrically conductive compound used in the production of high precision pipette tips.
Why is the choice of sterilisation so important?
Sterilising IVD and consumables is a common requirement in the industry and can be carried out by several different approaches with chemicals e.g. ethylene oxide (EtO) and irradiation (e-beam or gamma) being the most common ones for such applications.
Gamma rays have high energy and penetration capability and as such are frequently used for items that are bulk packaged. Extensive safety measures are required for both operators and additionally the radioactive isotopes from where the gamma rays originate. Some polymers, especially PP, are sensitive to degradation (formation of radicals) due to the high energy used. As a result of the radiation the final product can become brittle and/or yellow either directly after radiation or after a certain undefined time. Additionally, it is important to consider the ‘delivered’ dosage of irradiation, rather than the ‘emitted’ level as bulk irradiation will mean full dosage is not delivered to every part. In order to mitigate the effects of the irradiation, PP resins can be specially added.