MEDICAL | TECHNOLOGY & MATERIALS
ing to the end use of the product to lessen their risk, a request which did not happen until recently.” Kvalo adds that new technical developments in injection moulding for medical applications include high tolerances that require immense amounts of data. EVCO has been able to tap into Industry 4.0 (process monitoring) to help remedy issues with the end product before they happen. He also says that customers are also looking for machines to detect a good/bad part in lieu of QA inspection (accept- ance/rejection criteria). In addition, the company is looking to cut down on fixture costs through flexible nesting systems, such as 3D printing for example, as well as continuing to increase automa- tion to elimate any human error in its operations.
Right: The Electrical Motion ultrasonic welding machine’s
electrical drive means it is capable of meeting the high quality requirements applicable in medical
technology
Early stage development According to Robert Fesus, Vice-President of Sales and Marketing at Plas-Tech Engineering, there is continued interest in the need for low-volume, highly engineered components and devices. “Because of the economic turnaround, more pharma and bio-tech companies are focusing on R&D,” he says. “This includes the use of highly engineered resins. A lot of development is being spent on miniaturisation, pre-filled pharmaceuticals and chemical/biological compatibility with plastic materials. “One of the biggest problems is that many plastics manufacturers struggle to support early stage development and R&D, but our business model supports this not only in scale-up operations but with the use of engineering resins like cyclic olefins (COC and COP), PEEK, oxygen and chemical barrier materials, and new develop- ment formulations in conjunction with resin manufacturers. More specifically regarding resins, because of recent high-profile supply issues with some pharma- ceuticals, the functionality of resins are being pushed to the limit. The use of barrier materials, sterilisa- tion, and shelf life have increased the need for new solutions.” Plas-Tech and sister business
Equinox Medical have recently developed new injection and drug delivery systems for parenteral, oral and topical dosing in pre-filled applica- tions. This also includes tamper-evident closure containers for consumer and professional use. The dosing systems are
26 INJECTION WORLD | September 2017
designed for easy ergonomics, low pressure for injection and low-hold up volumes. The materials used are suitable for sterilisation with EtO, steam and gamma and also surpass container closure integrity tests for sterile pre-filled applications. Fesus adds that the company is currently engaged in projects involving high viscosity and silicone free applications, as well as working well in the aesthetics and surgical markets largely because it can manage development projects of a custom/ bespoke nature. Equinox is growing its line of products for injection and fluid management and there are likely to be the addition of SKUs relevant to various material properties and a line of open- bore syringes for different pre-filled applications. According to Barbara Canale, Director of
Strategic Accounts at Topas Advanced Polymers, medical plastics market trends demand conveni- ence in home healthcare for individualised treat- ments that are portable and can be conducted in the home. This spans all areas of medicine from wearable drug delivery to home dialysis treatments. “Many designs for medical devices today require a combination of rigid injection moulded parts with attachable flexible components such as drug reservoirs, pouches, tubing, and fitments for connectivity,” she says. “Convenience and cost savings are needed in new medical devices, giving products that are lightweight and easy to use without complex instructions, or requiring a trained healthcare professional. In addition, in medical moulding minute medicine dosage accuracy and fail-proof repeatability in micro-moulding is re- quired. These mechanical parts are the mechanisms that can define dosage or function. They require intense precision for refined geometries. Precision moulding requires the dimensional stability of Topas cyclic olefin copolymer (COC).” The company has developed Topas Elasto- mer E-140, a 100% COC with 450% elongation. “It bridges the TPE gap as a pure TPE, without the addition of dissimilar additives,” Canale says. “Being composed of only COC, this is not a typical TPE. TPEs are usually made up of many components that may not be the best for extraction testing. Standard Topas rigid grades can be tempered with Topas Elastomer E-140
resulting in a 100% cyclic olefin resin with flexibility and dissimilar additives. Elastomer E-140 can be used straight in pure flexible products such as tubing and fitments too. Both rigid and elastomer
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