Contract manufacturing
Overcome supply and sterilisation challenges
Qosina explains how it mitigates the impact of material shortages and offers insights into sterilisation modalities including regulatory considerations.
N
ylon is used in the manufacture of many single-use components for medical device and bioprocessing applications. With surging customer demand, lead times for nylon have extended beyond explanation, causing significant disruptions in the global supply chain and unprecedented shortages. Consequently, manufacturers have had no choice but to source alternative materials.
Qosina addresses the shortage of Zytel 101F nylon and an alternative polyamide, Vydyne 21SPF, which is being used to manufacture many single-use components including a variety of luer lock connectors.
Force majeure
In 2021, DuPont declared force majeure globally on Zytel 101F nylon, a polyamide 66 resin that delivers high-performance benefits ranging from excellent balance of stiffness and toughness, and good heat resistance across a wide range of applications. The shortage traces back to a scarcity of a precursor material, adiponitrile (ADN), one of the main chemical components used to manufacture nylon. Unfortunately, catastrophes such as chemical factory explosions and significant weather events, plus a spike in global demand for nylon, have exacerbated the shortage.
Zytel 101F nylon has a range of high-performance benefi ts, including good heat resistance.
time for injection-moulding fabrication and offers a combination of engineering properties characterised by high-strength rigidity, good toughness, high melt point, good surface lubricity, abrasion resistance and resistance to many chemicals. Qosina is a global supplier and one- stop source of over 5,000 single-use stock components to medical device and pharmaceutical manufacturers. It continues to successfully support its customers’ component requirements and is committed to ensuring security of supply through accredited business opportunity management and quality systems. The company is pleased to offer a selection of luer connectors made of
“Qosina is a global supplier and one-stop source of over 5,000 single-use stock components to medical device and pharmaceutical manufacturers.”
An alternative to Zytel Vydyne 21SPF is a general-purpose, lubricated PA66 resin with an enhanced crystallisation temperature. The product has been designed primarily for fast cycle
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Vydyne that are in stock and ready for immediate shipment. These connectors are RoHS compliant and include regulatory documentation, CAD drawings and validation test data.
Minimise supply interruption ■ Assurance of supply: As part of its ongoing commitment to business continuity, Qosina has established a high service level for its customers through effective supply chain management, demand planning, forecasting and inventories. Additionally, the company proactively assesses the supply chain for its products for potential issues and take steps to mitigate the risks of interruption. In the case of a resin supply issue, Qosina assesses alternate resin selection when the original resin is unavailable. The team understands that a new resin is an unwelcome change control in regulated industries and take pains to simplify the change control process for customers through careful resin selection and thorough documentation. Being prepared for the unknown is an important part of any supply chain management program. Qosina offers delivery from our vast inventory, allowing you to reduce your stock levels and warehousing costs while taking advantage of volume pricing at the same time. The company works with clients to plan out their projected inventory needs and purchase components as they need them; clients can be confident in knowing that Qosina will fulfil their order.
■ Prototyping support: From prototype to production, Qosina will work with you throughout the design and development process and help you select the right components that match technical requirements, timing, cost, and regulatory support needs. It has a liberal sampling policy and offers low minimum order quantities to help get its components into the hands of designers quickly to help speed time to market.
Medical Device Developments /
www.nsmedicaldevices.com
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