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technology | Medical

a cycle time of just 5.6s, which corresponds to a daily output of around 2m units. Each pipette tip is an extremely delicate component with a wall thickness of 0.38mm and a part weight of just 0.26 g. Netstal says that the high precision processing of the all-electric ELION machine ensures that the shot weight of 33.28g is distributed equally over the 128 cavities. Despite the higher mould cavitation, the production

system is compact. “The related automation solution of Zubler Handling does not require a larger footprint than a comparable 64-cavity system. This enables manufac- turers to double their productivity in the same space,” says Dr Patrick Blessing, Head of Medical Technology and Precision Parts at Netstal. “A composite removal gripper made of carbon and aluminium removes the 128 pipette tips during a mould open time of less than 0.9 seconds. The presence of each individual part is checked at the same time. The pipette tips then directly and separately (according to cavity) go onto the tray. To ensure the high quality of the sensitive product, there is no reaching into the collar at any time and the outlet opening of the pipette tip also remains untouched.”

Below: A 128-cavity mould for pipette tip production by Tanner of Switzerland

Pre-filled syringes According to Barbara Canale, Director of Strategic Accounts at Topas Advanced Polymers, medical injection moulded plastics growth continues in drug delivery devices and diagnostics for it Topas COC (cyclic olefin copolymer), with prefilled syringes a particular hotspot. “The prefilled syringe market was about $4.3bn last year. While the prefilled syringe market continues to be dominated by glass with 90% market share, plastic prefilled syringes have grown over the last decade from about 3% to about 10%. However, glass can have issues with leachables, extractables and protein aggregation in biological drugs. Therefore, biologics - very large, complex molecules - will drive

plastic prefilled syringe growth,” she says. “Biosimilars are a fast growing, emerging area as

biologic patents expire on products with high sales volume including diabetes and arthritis. These drugs are delivered to the patient via prefilled syringes, pens and creative wearable devices for administration ease. Trends for the ageing population favour self-adminis- tration for chronic diseases and will increase as drug therapies become available in a wider range of therapeutic areas in prefilled syringe devices as well as alternative wearable products,” predicts Canale. “Novel wearable drug delivery devices are replacing

some traditional systems since they allow the patient to be effectively treated without invasive repeated scheduled injections. Unique delivery devices with tiny, hidden needles inside the devices challenge traditional prefilled syringes with exposed needles. Hidden needles, designed internal to the device, eliminate pain and needle-phobia for improved medication compliance,” she says. “These competing technologies to prefilled syringes include bolus injectors with controlled drug delivery over time, microneedle patches, needle-free injectors and insulin pumps that offer the patient convenience and can be electronically managed for automated drug dispensing. Topas COC has been commercial in wearable drug delivery devices for over a decade.” Canale adds that another area of growth for Topas

COC is diagnostics, especially point-of-care and microfluidics. Excellent chemical resistance, low auto fluorescence, very good UV transmission, and excellent surface properties are critical to point-of-care devices, micro-titre plates, cartridges, and biochips. “One of the most popular technical achievements of the last few years for diagnostics and drug discovery is 3D printing,” she adds. “The Fluidic Factory is the first commercially available 3D printer capable of creating fluidically sealed devices in any lab. It can achieve fast, low cost disposable parts for prototype and low volume produc- tion to create microfluidic chips, cartridges, fluid manifolds, connectors and valves.” Legislative and regulatory influences continue to

affect the medical moulding sector. “Regulation demands more control and information over recent years to minimise risk with no change control,” explains Canale. “Changes can result in delays in 510(k) approvals. Raw material changes can give rise to issues with leachables and extractables, or can affect secondary issues such as tolerance variations. The same chemistry or CAS number does not mean the material is the same from different suppliers. Change control is critical. The product has to be the same as it was when it was approved.” This year saw a change in the medical regulatory framework in the US. “On May 1, 2016 the United States

18 INJECTION WORLD | September 2016


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