COMPOUNDS | MEDICAL
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Non-phthalate plasticiser DOTP forms the basis for new Teknor Apex products for PVC applications
materials need to go through a long qualification process. The supply of medical ABS and SAN, for example, has been tightened due to changes in supplier footprints, said Wessner. “Healthcare manufacturers are now in the process of requalify- ing alternative materials, which can take anywhere from one to three years,” she reported. “The challenge is to make sure that the alternative material meets regulatory requirements and performs reliably in life-critical applications. Companies that can navigate this transition with strong inventory strategies and deep technical support from their suppliers will come out ahead.” To mitigate supply-chain risks, manufacturers are looking to dual-sourcing strategies and diversifying material portfolios by sourcing from multiple regions, said Wessner. “Many manufacturers are looking at Southeast Asia as a key alternative to China. For example, we recently expanded opera- tions in Malaysia to help medical OEMs secure supply closer to production hubs,” she said. Another significant trend is material consolidation. “By reducing the number of unique materials used across various end products, companies can simplify logistics, cut costs, and streamline regula- tory compliance,” she explained.
PVC compounds Flexible PVC has been widely used in medical applications, and new plasticisers seek to meet global market needs. The latest from Teknor Apex is a new line of
DOTP-plasticiser based products that extends the company’s portfolio of next-generation medical PVC compounds for the global medical device market. The products include APEX 32044RV grades for moulding and APEX 33044RV grades for extrusion. The non-phthalate plasticiser DOTP (dioctyl terephthalate), which can also be written as bis
28 COMPOUNDING WORLD | April 2025
(2-ethylhexyl) terephthalate (DEHT), is growing in use in medical PVC compounds as an alternative to the conventional ortho-phthalate DEHP (di(2-ethyl- hexyl)phthalate, also known as DOP) plasticiser. DEHP has been commonly used in PVC medical devices and other applications, but due to regula- tory restrictions, particularly in Europe, there is a shift to replace it with alternative non-ortho-phtha- late plasticisers where possible. “DOTP/DEHT is a drop-in replacement for DEHP as far as processability of the formulated com- pounds in moulded and extruded parts,” said Derek Laffey, Global Healthcare Market Manager at Teknor Apex. “As with any formula change, existing medical applications would need to go through re-evaluation, but processors should need to make only minor processing changes, if at all. With the growing availability of DOTP supply and its good price/performance balance, it is a logical alterna- tive.” Legacy grades with DEHP continue to be available, as change is difficult for existing uses, but there is increasing interest in DEHP replacements, particularly for new applications, said Laffey. “We are addressing the needs of global medical device companies that have global manufacturing or sell into global markets,” said Laffey. “We are building a portfolio of medical grade PVC products that meet all known regulatory requirements globally, with supporting documentation. In addition, our next-generation compounds are avail- able globally from our manufacturing sites in the US and Singapore and from our distribution partners with warehouses in Europe.”
TPE applications Teknor Apex recently introduced its Medalist MD-90000 Series, expanding on its already broad portfolio of medical-grade thermoplastic elasto- mers (TPEs). The new TPEs, designed for biophar- maceutical tubing applications, offer excellent clarity, flexibility, chemical resistance and biocom- patibility for a wide range of medical applications, including drug delivery, fluid transfer and analytical instrumentation, the company said. The new grades are made with new raw
material technology that offers very low spallation with good clarity, which is particularly beneficial for peristaltic or roller pump applications, where the ability to see fluid flowing through the tubing is important. Spallation is particles of material coming out of the plastic matrix due to the repeated stress of the pump operation; low spallation reduces contamination risks during extended pump operation. In addition, increased durability and longevity of tubing reduces mainte-
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IMAGE: TEKNOR APEX
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