MEDICAL | INNOVATION


Right: KraussMaffei will demonstrate production of insulin pen caps at K 2022


IMAGE: KRAUSSMAFFEI


formulations based on two existing biocompatible grades, M203FC and M205FC, suitable for drug delivery and other medical devices. “The right laser settings matched to the appro-


The already high energy efficiency of the system


is improved by a novel mould cooling system from Jurke Engineering. Unlike a conventional water distributor, it uses ultrasound to measure the water flow velocity and volume. The distributor block does not have any cross-section narrowing, meaning fewer pressure losses. Apart from increasing energy efficiency, this also helps cut cycle times (down to 6 s in this case). Laser marking is considered an ideal method for medical devices to be linked or attached to a UDI. The process requires specific materials to provide optimal results, says Fabian Herter, Marketing Manager at Speciality ABS producer Elix Polymers. “In addition to the material, operators need to pay further attention to its colour formulation to achieve compatibility with the base material and create exceptional durable quality and contrast markings,” he says. Herter says that to tackle the challenges associ-


ated with formulating the appropriate colours and manufacturing the materials required for laser marking, the company has created distinct pre- coloured acrylonitrile butadiene styrene (ABS)


priate ABS material and pigments will create the desired laser marking results,” says Herter. “How- ever, only selected colour pigments in strictly controlled concentrations can be used due to the need of compliance with legislation (such as the requirement for biocompatibility according to ISO 10993).” Otherwise, the text to be laser-marked may generate an undesirable colour, degree of contrast, or resolution. “Furthermore, the text may fade away with time, so it is important to make it readable during the entire lifetime of the medical device.” Chemical resistance to repeated cleaning, disinfection, and sterilisation procedures is also required. Elix Polymers coloured ABS formulations are optimised to achieve a specific colour shift when laser marked, and a targeted level of contrast over a specific colour background, while staying compliant with regulations. They also provide a balance of optimal surface quality and reliable mechanical properties while retaining these attributes even under gamma radiation sterilisations, Herter says. When selecting a medical grade of ABS, plastics


processors can either use a pre-coloured product or use an ABS in its natural colour and blend it using a colour masterbatch. “Various medical OEMs prefer Elix’s pre-coloured medical ABS to reduce regulatory compliance risk,” says Herter. “This is because Elix ensures the biocompatibility of the whole material composition, including all additives and colour recipes.” Medical ABS grades M203-FC and M205-FC are used in several medical device applications in both Europe and the US. They have their own registered


Coping with Far UV-C light


Ushio in Japan is a leading manufacturer of sources of light radiation ranging from ultraviolet through visible to infrared. In recent years, it has become involved with the life science industry, including medical and environmental applications. It has developed a new disinfection module that operates with a peak wavelength of 222nm (Far UV-C). This wavelength is known not to penetrate past the outer layer of human skin and eyes. Ushio was challenged to identify a material for the inner housing of the


54 INJECTION WORLD | September 2022


module that could maintain excellent mechanical strength, demonstrate flame retardant properties and keep surface appearance under harsh Far UV-C light exposure. SABIC delivered a solution that uses Ultem 1000 resin, a high performance polyetherimide (PEI) material that met Ushio’s stringent requirements. To better facilitate customers’ material evaluation and data generation, SABIC has installed equipment for UV-C irradiation (covering 222 nm and 280 nm) testing at its Moka technology centre in Japan.


Above: Ultem 1000 resin met stringent requirements for Ushio’s Far UV-C module inner housing


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