Linear Stepper Stages

The LSS-031-04-011-MEA stage

A series of single-axis linear stepper stages is available from H2W Technologies, Santa Clarita, CA. The LSS-031-04-011-MEA stages integrate a linear encoder into the single-axis linear stepper motor stage to operate the linear stepper motor as a 2-phase brush-less linear motor when coupled with an advanced motion control electronics package. The motors draw the current needed to hold the desired position or make the desired move. The integrated 1.0-μm resolution encoder works with the control package to operate the stepper motor as a 2-phase brushless linear motor, which generates higher speeds, also allows for precise positioning.

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Tubing and Bottle Closures

Liveo™ Silicone Pharma Tubing

DuPont, Wilmington, DE, has launched two new product lines in its DuPont™ Liveo™ biopharmaceutical processing series. Liveo Pharma TPE Tubing is a range of extruded thermoplastic elastomer (TPE) pharma tubing dedicated to fluid transport and single-use bioprocessing applications, produced under similar high-quality and high-purity principles as Liveo Silicone Pharma Tubing. Liveo™ Pharma Bottle Closures are specifically designed to seal threaded glass and plastic bottles and containers used for critical fluid transfer, media and buffer pooling and storage, and sample collection in bio-pharmaceutical and biotechnology processes.

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IoT Bluetooth Module

The new module is certified under Radio Law for multiple countries.

A radio law–certified Bluetooth® module from Renesas Electronics Corp., Tokyo, Japan, combines an MCU, an antenna, and peripheral circuits in a small package. The RX23W Module includes full Bluetooth 5.0 low energy support for system control and wireless communication on IoT endpoint devices. The module is equipped with an antenna, oscillator and custom-matched circuit. The new module is certified under Radio Law for multiple countries, including Japan and the United States and is Bluetooth SIG certified, which eliminates the need for additional RF design work, tuning, or specialized RF knowledge. The very small 6.1 × 9.5 mm, 83-pin LGA package makes it possible to design more compact devices with fewer external components. This improves the development efficiency of IoT endpoint devices such as healthcare equipment.

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PEEK Biomaterial

The polymer VESTAKEEP® Fusion

Evonik, Darmstadt, Germany, is partnering with Swiss plastics specialist Samaplast to develop an osteoconductive PEEK biomaterial for injection molding. As part of the collaboration, both partners are demonstrating and documenting the processing properties of the high-performance polymer VESTAKEEP® Fusion using the first prototypes of spinal implants. The functional BCP (biphasic calcium phosphate) additives are available on the surface of injection-molded components, which is ensured by the specially configured microparticles and their homogeneous distribution. The material was developed with a goal to process in different manufacturing technologies and is initially offered as granules and semi-finished products. It can be milled, compression molded, extruded, and injection molded.

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Circular Polycarbonate

The certified circular polycarbonate offers a potential carbon footprint reduction

SABIC, Houston, TX, has launched a certified circular polycarbonate (PC) resin and blends made from the upcycling of post-consumer mixed plastic — a first in the industry. According to an internal SABIC LCA study, the certified circular polycarbonate offers a potential carbon footprint reduction up to 23 percent in comparison to its incumbent. Part of the company’s TRUCIRCLE™ portfolio, the material is produced through the advanced recycling of postconsumer mixed plastic that could otherwise be destined for incineration or landfill. Through a process called pyrolysis, difficult-to-recycle used plastic is broken down into a liquid called pyrolysis oil and then used as a feedstock to create certified circular building blocks for high-performance plastics.

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Thermoplastic Gears

The Power-Core™ gears

Intech Power-Core, Closter, NJ, offers thermoplastic gears suitable for medical equipment such as mammography units and robotic surgery devices. The Power-Core™ gears, which combine a proprietary polymer gear material with a metal core, have a unique balance of properties that make them well-suited to medical equipment applications. In addition to absorbing shock and vibration, compared to metals, the gears reduce noise by up to 6 db. Because the gears are available with a stainless steel, nonmagnetic core, they are suitable for magnetic resonance imaging (MRI) machines. They provide precise control over the gear’s mesh engagement and backlash, maintaining high image quality over time. They also eliminate fuzzy imaging due to motion chatter.

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Autoclave-Resistant Adhesive

The materials protects critical medical devices.

Dymax, Torrington, CT, has released a line of adhesives for medical device assembly applications. Designed to be autoclave resistant for more than 100 cycles, MD® 1040-M offers extremely low water absorption (0.5 percent), making it ideal for surgical tools and devices that are subjected to numerous instances of sterilization, including autoclave or STERRAD (plasma). The material also works well as an encapsulant, protecting critical sensors and electronic components, where moisture ingression may be of concern. The material cures quickly upon exposure to broad-spectrum UV light and successfully bonds to a variety of substrates.

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Guide to Biological Equivalence

The new guide provides an overview of the EU MDR requirements.

To address manufacturer uncertainty around the acceptability of their biological equivalence strategies under the EU Medical Device Regulation (EU MDR), RQM+, Monroeville, PA, has produced a new guide providing insight into notified body expectations for biological equivalence, as well as a reference tool of potential methodologies. This guide provides an overview of the EU MDR requirements for biological safety evaluation and outlines practical approaches for establishing biological equivalence. It also presents a detailed table of potential methodologies to demonstrate equivalence. For each of the common material differences between a product and its equivalent device, the guide explains the likelihood of acceptance by notified bodies and suggests actions manufacturers can take to increase this likelihood.

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