Solvay’s Ixef Polyarylamide, or PARA, is a natural fit for single-use medical instruments, and it offers several advantages over stainless steel and other metals. It is now available in rod stock only from Genesis Medical Plastics. Our experience converting high performance polymers, as well as our commitment to quality and safety, means Genesis Medical Plastics is ready to handle Solvay’s unique medical polymer.
Ixef PARA’s role in medicine
Solvay’s Ixef stock shapes can be used for single-use medical instrumentation and prototyping. In other words, when medical device designers need to see and handle a new instrument before it is mass-marketed and produced, the Ixef PARA stock shapes are a perfect option for the job. It’s also an ideal biomaterial when incorporated into final instrument builds. There are a few reasons for this, including:
1. No soft tooling needed – Ixef PARA prototypes can be produced to extremely precise specifications, providing an accurate visual and tactile representation of the final instrument. Once a prototype is approved and production is given the green light, Ixef PARA can be converted using injection molding, and this greatly speeds up production runs. Injection molding is a perfect conversion process for high volume, single-use instrumentation, as it can be used to create components within tight tolerances, without compromising the scalability and efficiency that comes with injection molding.
With some polymers with high glass filler content, there’s a concern that injection molding could affect their properties. That’s not an issue with Ixef PARA, even with 50-percent glass fiber-reinforcement, it was developed specifically with injection molding in mind. As such, Ixef PARA retains its material properties following injection molding.
2. Proven biocompatibility – Ixef PARA has been assessed according to the ISO 10993 standard and has been deemed safe for use in limited-duration applications. The ISO 10993 standard is used to determine if a medical device requires biocompatibility testing and what that testing should include. Ixef PARA’s biocompatibility is also supported by an FDA Master Access File, or MAF.
3. Much lighter than metal – Devices and instruments manufactured with polymers, and particularly with Ixef PARA, can be ergonomically enhanced, reducing fatigue during longer procedures due to the major weight advantage over metal. In some cases, this material can be up to 450 percent lighter than metal, which makes a noticeable difference when the instrument is held. The polymer’s lighter nature also means more instruments can be included in a single surgical kit.
4. Offers excellent strength – The reduction in weight doesn’t come with a reduction in strength, as Ixef PARA is e modified with glass fiber to reinforce its structure. A standard choice is 50-percent glass fiber-reinforced Ixef PARA. This polymer grade offers superb rigidity and strength, along with added creep resistance. Put it all together, and glass fiber reinforced Ixef PARA can withstand constant mechanical stress and strain.
5. Many other advantages – There are many differences between metal and polymers, most of which indicate advantages in favor of Ixef PARA. For example, Ixef PARA can be converted while retaining a resin-dense, smooth surface. This reduces the likelihood of glove tears due to glass fiber and protects the wearer as a result.
Ixef PARA’s resin-heavy surface also keeps moisture absorption to a minimum, preserving the user’s grip during extended use.
Another Ixef PARA perk is its versatility during the design phase. The polymer can be augmented with additional ergonomic elements without a secondary process. For instance, the polymer can be textured to produce a tighter grip, and this can be done without more operations.
The Genesis Medical Plastics Advantage
A final reason for considering Ixef PARA is its cost. Genesis Medical Plastics and Solvay have worked together to create a more cost-efficient prototyping solution. While Ixef PARA is a compelling prototyping material on its own, now that we can produce machinable rod stock, prototyping costs can be reduced further.
Genesis Medical Plastics has experience with several conversion methods and is an expert at utilizing injection molding with high performance polymers. It is especially advantageous for device designers to procure their Ixef PARA stock through us as we can seamlessly transition from machining prototypes to scaling up to injection molding production.
In addition to our experience with leading edge conversion processes, we are ISO 9001:2015 certified and operates FDA-registered device manufacturing facilities. Our quality system is designed to satisfy ISO 13485 specifications, which means Genesis Medical Plastics is constantly monitoring and adjusting its processes to ensure top quality and safety.
Solvay’s Ixef PARA is a leap forward for single-use medical instrumentation and has the potential to supplant metal devices in short order. Even better, the polymer is available in a form that’s easy to machine.
