Material gains: polyolefins for healthcare
James Stern, Borealis Healthcare, looks at broadening horizons for the healthcare industry through use of polyolefins
The use of plastics in healthcare applications continues to increase as the rising costs from spiralling healthcare demand need to be managed by governments, companies and individuals on a global basis. Whether it be moving from non-plastic materials like glass or metal or the iterative upgrade of materials as the new generations of medical devices are developed, polyolefins are increasingly being used as an alternative material due to their combination of excellent property profiles and good value in use.
Today, polyolefins are an integral part of many pharmaceutical packaging solutions such as container and closure systems. They are also widely used in medical devices such as drug delivery systems, syringes, MDPIs or nasal sprays and devices involved in surgery from bowls and handles through IOL components, sheaths for protection whilst manipulating devices for sensitive repairs (eg meniscal tears, tracheoesophageal puncture) to the associated packaging often used to maintain sterility. The use of plastics in healthcare applications continues to increase, even against a backdrop of ever increasing regulatory oversight, economic volatility and customer sensitivity.
In order to continue to be a key material of choice, however, the producers of such materials need to undergo a number of paradigm shifts in how they manage the production of their materials destined for use in healthcare applications. They must not only understand the requirements of the healthcare/pharma industry, but practically translate them into what is possible within a chemical industry traditionally producing materials for applications needing less material control and thus manage the regulatory focus that is moving deeper and deeper into the supply chain.
In order to offer medical device and pharmaceutical packaging producers extended confidence that the material they qualify for use today will be the same material they can use for years, polyolefins need to be supplied with a strong service support package that addresses the needs of the healthcare industry. For example, this means providing a recipe/formulation lock-down commitment, extended notification of change period as well as appropriate pharmacopeia testing results and FDA DMF registration. This additionally secures the investment in material qualification and means any final item testing remains relevant because if the material should change, for example, the recipe, production location or production technology, it is highly likely that testing needs to be renewed as the interactions between these materials and any drugs, bodily fluids or tissues is critical. Timely and accurate communication of what has changed allows for a risk assessment of potential consequences and should be considered an essential part of the service package. Should these materials change without notice, all the information developed has little value as no risk assessment of the change will have taken place further down the supply chain. Whilst testing such as extractable profiles and interaction studies fall under the aegis of the pharmaceutical companies and need to be completed on the final article, it is important that the suppliers of such materials strictly control the material compositions to minimise any unforeseen changes once the studies have been completed.
Reacting to strong driving forces for performance improvement and increasing regulatory pressures, new polyolefin materials have been developed. These solutions provide innovative material properties whilst increasing production efficiency of pharmaceutical packaging and medical devices. Reduction of costs and matching regulatory requirements with a reduced environmental footprint are further up-side potential benefits from their use in new applications.
Borealis, a provider of innovative solutions in the fields of polyolefins, base chemicals and fertilizers, launched one such polyolefin material in 2013, Bormed SB815MO, as an extension of its family of Bormed polypropylene (PP) material specifically tailored to healthcare packaging applications.
Bormed SB815MO is a step-change innovation in soft PP addressing some of the most pressing challenges in the healthcare industry today. With regards to performance, the material is the softest PP grade yet within the Bormed portfolio and the use of the Borstar® technology enables good transparency without the addition of clarifiers. Bormed SB815MO enables sterilisation of the final pack at 121°C, meaning a reduction in sterilisation time and significant advantages for those production processes in which terminal sterilisation has become the rate determining step (RDS). Compared to low density polyethylene (LDPE) that can be sterilised at 110°C, the sterilisation cycle may be completed in half the time. The material is also flexible enough to be easily self-collapsible without venting, thus avoiding contamination. This quicker sterilisation can potentially enhance sustainability, for example by extending the lifetime of autoclaves.