MATERIALS | MEDICAL
Above: Exolon’s Vivak Med solid sheet uses Eastman’s Eastar 6763 medical
copolyester resin
designers create medical devices, says the company. The first product, Cyrolite G-20 CP, is a PMMA- based copolymer for injection moulding and extrusion of UV-light protective medical applica- tions. It ensures integrity of photosensitive sub- stances such as oncology drugs, antibiotics, and antifungal agents that require superior UV-light protection, says the company. Roehm says it has five times the impact resist-
ance of unmodified acrylics and high resistance to body fluids and other chemicals. It has a UV-light transmission of <1.0% (260 - 480nm) and high transmittance between 500 and 780nm. “Cyrolite G-20 CP allows designers the flexibility
to create medical devices that offer dynamic properties which are crucial to innovation,” said Thomas Spagnuolo, vice president and general manager of moulding compounds at Roehm America. The second grade, Cyrolite MD zk6, offers enhanced impact resistance. It is an amorphous, impact-modified acrylic polymer for injection moulding and extrusion applications, based on PMMA.
DEHP alternative Citroflex B-6, from Vertellus, is partially derived from bio-based raw materials and is said to demonstrate biodegradability. It is marketed as a phthalate-free plasticiser solution for flexible PVC blood storage and transfusion systems that can provide an alternative to di-2-ethylhexyl phthalate(DEHP). The company says DEHP has long been the
predominant plasticiser used in PVC medical devices. While questions about its safety in blood bag systems have been raised since the 1970s, it says it has only recently been labelled as a repro- ductive toxin. “With the recent changes in the European
32 FILM & SHEET EXTRUSION | January/February 2023
Union’s Medical Device Regulation (MDR; EU 2017/745), as well as Amendment Annex XIV per ECHA REACH mandates, use of DEHP will require authorisation based on Benefit Risk assessment, complicating supply and prolonging the path to product commercialisation,” the company said. “Medical PVC compounders and blood transfusion product brand owners are now preparing for next-generation products, fast-tracking the devel- opment of alternative, phthalate-free technologies.” Citroflex B-6 is a butyryl trihexyl citrate (BTHC), listed in the European pharmacopoeia as an approved alternative to DEHP for medical products. Vertellus says it enables brand owners to comply with various regulatory mandates – not only the MDR and REACH Regulations but also RoHS EU Directive 2015/863 (RoHS 3). PVC films plasticised with Citroflex B-6 are said to display similar physical properties to those containing DEHP, says Vertellus.
Medical conversion US-based Delta ModTech recently supplied a custom-designed converting press to ATL Corp – a specialist in printing, material converting, and contract manufacturing – to create a new medical device for a new customer. KelCor, a medical start-up, proposed a new
product concept: single-use adhesive tape that could be removed from sterile packaging. The tape would be used to secure an airway tube to an intubated patient. The tape, called a drape support, can be subject to airborne particulates and splash – and could become a source of healthcare-ac- quired infection. KelCor developed a general concept of the securing device but needed a methodology to manufacture the product in cost-effectively – and in adherence with regulatory guidelines. ATL helped create a prototype of the securing device. The drape support was a die-cut, multi-layer lamination with adhesive. It would be made on the Delta ModTech Crusader converting machine. Once the prototype proved viable, ATL could make the first 5,000 parts.
CLICK ON THE LINKS FOR MORE INFORMATION: �
www.cflex.com �
www.aimplas.es �
www.eastman.com �
www.exolongroup.com �
www.gelpak.com �
www.roehm.com �
www.vertellus.com �
www.deltamodtech.com
www.filmandsheet.com
IMAGE: EXOLON
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