MDDI Online is part of the Informa Markets Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

Supplier Stories for the Week of February 16

Here’s what was new in the world of medical device suppliers during the week of February 16.

  • Schott Primoceler has developed a new bonding process for hermetically sealing implantables at room temperature using its laser-based Glass Micro Bonding process. 

    “Our core philosophy at Schott Primoceler is to find ways we can use Glass Micro Bonding to enable improvement of existing products in the market or even open entirely new application possibilities," explained Ville Hevonkorpi, managing director of Schott Primoceler Oy, in a news release. "Innovation is at the heart of everything we do. We are particularly excited about the prospect of implantable devices that cooperate with miniaturization requirements and critical medical imaging processes thanks to an outstanding collaborative effort with IRD Glass and Geissler.”

    Typically, implants such as pacemakers, RFID tags, neurostimulators, and various other implants with wireless communication functions and electronic components are constructed with ferrous metals, the company explained. The resulting magnetic properties mean exposure to other magnetic fields must be minimized. 

    Room-temperature bonding allows for the use of heat-sensitive materials, opening up the possibility for non-magnetic materials to be used in implantable electronics that have heretofore used heat-resistant ferrous metals as part of their construction, the company explained. The process uses a laser to create a vacuum-tight bond between two or more glass interfaces, and the sealing procedure generates a heat-affected zone of just a few microns. 

    Added Jochen Herzberg, medical program manager of Schott’s Electronic Packaging business unit: “We are a ready and willing partner to take on the complex component design and quality challenges faced by top innovators in the medical industry. This exceptional collaboration from the teams at Schott Primoceler, Geissler, and IRD Glass on this project adds to the established custom-designed components and capabilities Schott offers for implantable and medical devices, including customized glass-to-metal sealed hermetic packages and feedthroughs as well as sterilizable connectors and LEDs for surgical devices.”

    [Image courtesy of SCHOTT] 

  • Watson-Marlow Fluid Technology Group (WMFTG) has launched BioPure silicone transfer tubing for a wide range of bioprocess fluid transfer applications. 

    “Tubing choice is an important consideration for any bioprocess engineer in order to ensure the entire process is compatible with regulations and maintains the quality of high-value products," explained Mark Lovallo, product manager at WMFTG, in a news release. "It is therefore essential that quality is not compromised for cost. Using our extensive experience in bioprocessing, we have designed the BioPure transfer tubing to provide a reliable, flexible and good-value solution for a wide range of applications.”

    The new BioPure new transfer tubing offers the following features:

    • Biocompatible materials– The tubing is USP Class VI compliant and animal derived component free.
    • Sterile–manufactured and packed in an ISO14644-1 Class 7 cleanroom in accordance with EP 3.1.9.
    • Withstands challenging conditions – BioPure silicone tubing is autoclavable and gamma stable up to 50kGY.
    • Product traceability– Lot numbering enables product traceability for confidence in the supply chain.

    [Image courtesy of WATSON-MARLOW FLUID TECHNOLOGY GROUP]

  • West Pharmaceutical Services Inc. introduced several new pharmaceutical containment and closure options at Pharmapack, February 5-6 in Paris. These include two AccelTRA component line extensions, a Flip-Off Seal container closure system (CCS) compatible with the 5mL Daikyo Crystal Zenith vial, and the new Ready Pack system with Schott's adaptiQ platform, resulting from West's recent partnership expansion with the packaging supplier.

    "West's priority is to help customers simplify their journey, whether through new products or by helping mitigate risks in the drug development process to accelerate speed to market in today's ever-evolving, complex industry and global regulatory environment," said Fran DeGrazio, Vice President, Scientific Affairs & Technical Services at West, in a news release. "We have deep knowledge of navigating the nuances of biologic drugs and delivery systems even at the earliest stages, including quality systems, design controls and risk management frameworks. By keeping a lens on the unique interface between a drug, its primary package and device, we support our customers with smart, integrated solutions from end to end that help them meet, if not exceed, industry standards." DeGrazio also spoke in the Pharmapack session, "Understanding the Complexities of Delivering a Biologic Drug to the Market" on February 6. 

    West described the new offerings as follows: 

    • AccelTRA components program: The AccelTRA Select EU configurations available in Ready-to-Sterilize (RS) and Ready-to- Use (RU) steam for customers needing a high-performing elastomer and regulatory support in North America and the AccelTRA ready-to-sterilize (RTS)/ready-to-use (RTU) components product line with the RTS option for customers needing support outside North America. Both product lines leverage the next-generation elastomer formula of 4031/45, which features 13-mm and 20-mm serum and lyo stoppers in eight configurations.  
    • Flip-Off CCS Seal: The Flip-Off CCS Seal offers a ready-to-use sterile, quality capping product for its 5-mL Daikyo Crystal Zenith vial. 
    • Ready Pack system (shown above): Ready-to-use combinations of West and Schott products will be available on a small quantity basis, including West's Ready Pack system with the Schott adaptiQ high-quality RTU glass vials. The ISO standard vial products are being offered in three sizes: 2R, 6R, and 10R. 

    [Image of the Ready Pack system courtesy of WEST PHARMACEUTICAL SERVICES INC.]

  • Victrex plc has formed a joint-venture between its subsidiary, Victrex Hong Kong Limited, and Yingkou Xingfu Chemical Company Limited, to build and operate a new PEEK polymer manufacturing facility in Liaoning, China.

    The agreement will enable Victrex to complement its portfolio of PEEK and PAEK grades, in anticipation of a range of significant long-term growth opportunities, it reported in a news release. Victrex had already worked with its joint-venture partner through its monomer supply chain, as Yingkou Xingfu developed and operated chemical facilities in China.

    “This investment is in line with our record of not only investing ahead of demand, but in complementing and further differentiating our range of PEEK and PAEK grades, as well as setting the stage for specific geographic growth, whereby we can capitalize on the significant opportunities in China and the Asia Pacific region by having a competitive manufacturing presence there,” stated Jakob Sigurdsson, chief executive of Victrex, in the release. “Alongside the ‘Made in China 2025’ initiative, some of our increasingly diverse application areas mean our customers require a quality and differentiated PEEK offering. While we already manufacture a range of PEEK and PAEK grades, this will enhance our portfolio, making us even better positioned in a region where we have seen strong growth in recent years and continue to see attractive opportunities, aligned to our know-how and strong technical and application development capabilities. Overall, we believe this is a good entry point to a China manufacturing operation, working with an established partner and offering an attractive returns profile.” Victrex will oversee process management and intellectual property during development of the polymerization process.

    Commissioning of the facility is expected in early 2022, and it will be eventually be capable of producing up to 1,500 tonnes per annum.

    The agreement is subject to certain performance conditions, including finalizing land purchase and permit applications, it was explained.

    [Logo courtesy of VICTREX PLC]

  • THine has introduced high-volume availability of its new GPIO / LVCMOS transceiver IC, THCS251. Suitable for use in medical equipment, robotics, printing machines,, and more, it allows engineers to aggregate up to 37 lines of different data rates into just 4 lines that can be received and transmitted in the same IC. In addition, manufacturers could lower cost, reduce size, and improve reliability by utilizing simplified and smaller hinges/slip rings in their product implementations, the company reported.

    The high-speed differential signal path of the THCS251 is supported by 8B10B encoding and built-in adaptive equalization, allowing a distance of greater than 15 meters with standard cables.

    “This IC can be a game changer for many applications,” explained Tak Iizuka, chief solution architect of THine, in a news release. “Hinges used in many devices cause product limitations. For example, even the wide hinges used in laptops limit the number of wires to 15 per hinge. As more sensor functions are being added to laptops, the laptop designers need to aggregate more functions into the wires, so they do not exceed the maximum number of wires constrained by the hinges. Another example is for devices that require slip rings such as those that deploy 360-degrees of rotation. These slip rings also constrain the number of wires through them. The THCS251 solves problems caused by the limitations of hinges and slip rings.”

    Added Yasuhiro Takada, CEO of THine: “We are excited to announce this new IC because this enables our customers to introduce new products with reduced sizes and costs thanks to this new extension of our technologies which we have provided for decades.”

    [Image courtesy of THINE, THINE ELECTRONICS INC.]

Filed Under
500 characters remaining