PLASTICISERS | MATERIALS
New plasticisers include bio-based and biomass balanced
technologies. Jennifer Markarian reports on new options for PVC formulators
Searching for sustainable solutions for flexible PVC
Plasticisers are an essential component of flexible PVC formulations. With ongoing regulatory pressure on some plasticiser chemistries, PVC compounders and their customers continue to keep a close eye on plasticiser options. It is important to note that, while regulatory compliance is certainly required, alterna- tives to conventional products must also meet the performance requirements for their intended application. In addition, new plasticisers look to improve sustainability and reduce carbon footprint. The EU continues its phase-out of some phtha-
late chemistries. In late 2023, the EC amended the sunset date for bis(2-ethylhexyl) phthalate (DEHP) in medical devices under the Reach regime and extended it to 1 July 2030. Alternative plasticisers that can be considered include trioctyl trimellitate (TOTM), diisononyl cyclohexanoate (DINCH), and bio-based citrates, such as acetyl tributyl citrate (ATBC) and butyryl trihexyl citrate (BTHC). In bags for storing blood, one of the challenges is that DEHP helps stabilise red blood cells, so the shelf-life of blood in bags using alternative plasti- cisers must be considered. Aurorium (formerly Vertellus) offers Citroflex B-6, a BTHC that was formulated specifically for
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PVC used in blood transfusion products, as an alternative to replace DEHP and meet the Reach mandate. The company says the non-phthalate plasticiser is listed in the European Pharmacopoeia and has been field-tested for more than 20 years by blood bag manufacturers. Studies have shown that BTHC protects red blood cells in bags equally or better than other plasticisers, including DEHP, according to the company. The plasticiser provides PVC with good flexibility and durability at low temperatures, which is important for the tempera- ture variations that bags might experience during shipping, said Nina Waranica, Strategic Marketing Manager for Medical at Aurorium. In the US, DEHP above certain levels has been
restricted nationally in children’s toys and certain childcare articles. More recently in medical applica- tions, California state legislation to restrict the use of DEHP in intravenous solution containers and tubing is being considered. The US Environmental Protection Agency (EPA) added a reporting requirement for the plasticiser di-isononyl phthalate (DINP) to the Toxic Release Inventory (TRI) in mid-2023 with initial reporting due July 2025. Suppliers such as Evonik Oxeno and
August 2024 | COMPOUNDING WORLD 25
Main image: The biomass balance approach is being adopted by a number of plasticiser producers
IMAGE: SHUTTERSTOCK/POWEROFFLOWERS
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