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Borealis Expands Its Mechanically Recycled Plastic Compounding Capacity With Closing The Acquisition Of Rialti S.P.A

Borealis Expands Its Mechanically Recycled Plastic Compounding Capacity With Closing The Acquisition Of Rialti S.P.A

  • Borealis closes deal to acquire Rialti  S.p.A., an Italian polypropylene (PP) compounder of recyclates.
  • The acquisition will enhance Borealis’ portfolio of PP compounds based on mechanical recyclates by 50,000 tons per year, strengthening its ability to meet customer demand for an ever-wider range of sustainable, high-performance solutions.
  • The transaction represents a proof point of Borealis’ EverMinds commitment to accelerate the transition to a circular economy.

On June 30, 2023 Borealis announced that it had signed an agreement to acquire Rialti S.p.A., a polypropylene (PP) compounder of recyclates based in the Varese area of Italy, subject to regulatory approvals. Today, the parties announce the successful closing of the transaction.

Rialti is one of the European market leaders specialized in production of sustainable polypropylene (PP) compounds with a focus on mechanically recycled PP feedstock from post-industrial and post-consumer waste. Based in the area of Varese, Italy, Rialti has over thirty years of experience. The company utilizes its annual capacity of 50,000 tons to make injection moulding and extrusion PP compounds with applications in different industries, including automotive, appliances and construction.

The acquisition will bring significant expertise and capacity to Borealis, expanding its PP compounding business and, in particular, increasing its volume of PP compounds based on mechanical recyclates. The improved capacity will strengthen Borealis’ speciality and circular portfolios, enabling the company to meet customer demand for an ever-wider range of sustainable, high-performance solutions. By adding Rialti’s expertise in compounding of mechanically recycled PP to Borealis’ know-how and innovation leadership, we contribute to close the loop for a more circular economy. The move also represents a proof point of Borealis’ EverMinds™ commitment to accelerate the transition to a circular economy, and progress towards its ambitious targets.

“Mechanical recycling is a key component of our integrated circular cascade model, which is a cornerstone of our future-positive transformation and path to net zero. The acquisition of Rialti provides a vital expansion of our recyclate-based PP compound capacity, and marks another critical step on our path to reinventing essentials for sustainable living,” says Lucrèce Foufopoulos, Borealis Executive Vice President Polyolefins, Circularity and Innovation & Technology.

“Borealis is at the forefront of our industry’s mission to advance plastics circularity. With the closing of this transaction, I am pleased to see Rialti’s capacity and expertise contributing to this endeavour. I am convinced that Borealis and Rialti now look forward to a shared future of growth and innovation, ultimately enabling them to provide their customers with an even wider range of advanced PP compound solutions,” comments Massimo Dal Toso, CEO of Rialti.

https://www.borealisgroup.com/

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25 Years Technology Centre At Brückner – Expansion In Sight

25 Years Technology Centre At Brückner – Expansion In Sight

25 years ago in autumn, on the occasion of the leading international plastics trade fair “K 1998”, Brückner Maschinenbau inaugurated a technology centre at the Siegsdorf site. It was to house the laboratory equipment already in use as well as a completely new type of pilot line on which films could be stretched simultaneously for the first time with the aid of linear motors.

The aim of the technology centre was and is to research and further develop film stretching technologies as a prerequisite for innovative film applications, e.g. in food packaging as well as in solar modules, capacitors, flexible screens or membranes for lithium-ion batteries. The globally unique facility soon developed into a meeting place for raw material manufacturers, converters, film producers and even brand manufacturers, who can rent the technology centre for their test projects.

 For Brückner, this was an important milestone on the way to becoming the world market leader. Michael Baumeister, Managing Director CTO: “By bundling development and synchronising the various company divisions, we were able to identify technological trends as well as market opportunities at an early stage and often place our technologies as trendsetters in the global market.”

The equipment of the technology centre, which has been constantly expanded and modernised over the years, with a pilot plant, laboratory extrusion, laboratory stretching frames as well as a chemistry and film laboratory, enables almost all types of film stretching and the processing of a variety of polymers and biopolymers. All known stretching methods can be used: monoaxial in machine direction (MD) or transverse direction (TD), biaxial sequential or biaxial simultaneous.

In this way, raw materials can be tested for their stretchability, new film concepts developed, small series produced for sampling and entire production models run through. The films produced can be immediately tested in the film and chemistry laboratory – for prompt feedback on sample production.

Two customer testimonials as examples:

“It is always a great pleasure working with the full Brückner team in the technology center. We have had a strong collaboration for several years now and the high-quality, professional support, excellent pilot facilities and in-depth technical discussions have been key in advancing our developments in BOPE. We’ve come a long way from the initial trials we ran together and now it is great to see how this work is being implemented on the new, industrial lines”, says Martin Hill, Packaging and Specialty Plastics Technical Service and Development, Dow Chemical Ibérica S.L.

Tom & Cagla DeAngelo, owners Thomas Frank Associates, LLC, confirm: “It’s been our privilege to collaborate with the team at the Brückner Technology Center on many projects over the last 25 years. The team’s technical knowledge, experience and creativity have been invaluable inputs on every experiment run, and the efficiency of the lab has made working there a joy. We want to thank you all for your skills, cooperation, professional approach and for your hospitality. Congratulations on 25 years of excellence at Brückner Technology Center and our best wishes for the future.”

Expansion of the technology centre at the site planned

Changing framework conditions and ever new areas of application place high demands on the entire film industry. The legally required use of recycled materials and bio plastics, films for energy production and storage, or membrane technologies for water treatment are just a few examples. Brückner Maschinenbau intends to meet these challenges with a significant expansion of its technology centre. The most important innovation besides the modern infrastructure is an additional pilot plant to increase the availability of testing capacities and to reduce waiting times for customers quite significantly.

Senior Manager New Business Development Markus Wolfertstetter: “For some of the biggest challenges facing our industry, this expansion of the pilot plant will be of utmost importance. I am thinking, for example, of the linking of new film types with the requirements of digitalisation in the service of the circular economy or CO2-neutral and waste-free film production. Research and development will also become even more important for technical film applications – we are ideally equipped for the future with this expansion.”

https://www.brueckner.com/en

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Continuously Precise Linear Movements In The Mold

Continuously Precise Linear Movements In The Mold

New developments from Servomold are the servo linear actuators of the SLA series and (on the left side) the servo worm actuators of the SSA series. Top right, the associated servo control system SMC-Mini with control panel. Servomold.

Erbach/Germany, October 2023 – For long-term reliable, 100% precise and powerful execution of linear movements in injection mold tools, Servomold has developed the new servo linear actuators of the SLA series as well as the equally new compact servo worm actuators of the SSA series. They offer high-performance as well as clean, oil-free and thus optimally cleanroom-suitable alternatives to hydraulic and pneumatic cylinders traditionally used to perform translational slider, core or platen movements in injection mold tools. The actuators, which are suitable for both new molds and retrofit applications, are available at short notice in performance classes from 4 kN to 50 kN. Special solutions with thrust forces up to 150 kN and rust-proof versions are available on request. The market launch of the new actuators will take place at Fakuma 2023 at booth A2-2111 in hall A2.

The SLA types are available in five sizes. The three smaller actuators are equipped with ball screw spindles as standard, but can also be optionally supplied with roller screw spindles that can withstand higher loads over longer periods. The two larger versions are available solely with roller screw spindles. To achieve even higher forces or to equalize the force distribution, the SLA variants can be equipped with several spindles according to customer specifications. The SSA servo worm actuator, which is available in only one size, has a particularly flat design with a 90-degree arrangement of the drive unit. The specific ball screw and roller screw spindles can be configured with pitches of 2, 5 or 10 mm in any length for up to more than 1000 mm stroke. All versions offer high nominal thrust forces thanks to an integrated gear stage, which can be supplemented by an additional planetary gearbox.

In addition to precise positioning and repeat accuracy, their common advantages include permanently high forces and speeds, which are realized regardless of the process status. The movement profiles can be freely and individually defined and called up via the Servomold control units in order to optimize the sequences in the injection molding process. For the mold, controlled and gentle movements mean less wear, higher availability and significantly longer longevity. The easy interchangeability of the ball and roller screw spindles simplifies maintenance work.

Managing Director Thomas Meister comments: “Even before the official market launch, we have already won customers for pilot applications of our new linear actuators, which offer maximum flexibility with different spindle systems and individually configurable servo motors. Such systems are currently in continuous operation at Wild & Küpfer in Switzerland and at Avenue Mold Solutions in Ireland, which belongs to the Nolato Group. Thanks to the consistently positive experience gained there, and not least because of our reputation as a reliable, innovative specialist for the automation of injection mold tools, we have since been able to start projects with a number of further well-known companies from the medical technology sector.“

In addition to the new linear actuators, Servomold will be showcasing the SMC (Servo MoldControl) as a novelty at Fakuma 2023, a newly developed control unit generation for servo amplifiers that will be available on the market from 2024. Characteristics are the intuitive operability via the uniformly used touch panel as well as the automatic switching between different encoder systems. The trade show presentation will also focus on the portfolio of cost-efficient, standardized servo system components. In addition to servo-electric single to fourfold unscrewing units and worm unscrewing units for unscrewing threads, this also includes complete unscrewing halves ready for operation, high-performance servo drive units, space-saving indexing plates that can be integrated, thread core sets and rotating thread core cooling systems for unscrewing devices.

www.servomold.com

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Constantia Flexibles wins Green Packaging Star Award for Cutting-edge Mono-material Packaging

Constantia Flexibles wins Green Packaging Star Award for cutting-edge mono-material packaging

Constantia Flexibles scoops the Green Packaging Star Award for its mono-material packaging solution EcoLamHighPlus. The pioneering packaging solution from the Viennese packaging manufacturer is recyclable and has a high oxygen and water vapour barrier that is even comparable to multi-material solutions.

When it comes to packaging, sustainability and product safety often do not go hand in hand. That is why Constantia Flexibles is continuously investing in the development of environmentally friendly, recyclable materials that also provide maximum protection for the packaged goods. Mono-material solutions are the perfect way to combine the two, as they are easy and cost-effective to recycle (circular economy) and can also provide a high barrier function when processed professionally. With EcoLamHighPlus, the packaging company has developed a mono-material laminate that is not only recyclable but also has a barrier function comparable to multi-material laminates. For this innovation, Constantia Flexibles received the Green Packaging Star Award yesterday at the award event.

EcoLamHighPlus: The mono-material superstar
The mono-material packaging solution has a particularly high barrier to oxygen and water vapor, close to that of a PE-PET-aluminum (triplex) composite. This makes it a perfect fit as a sustainable alternative for various applications such as packaging for wet wipes, nuts, baby food, fruit juices, and coffee. Constantia Flexibles chose PE as the laminate base because it can be recycled in a well-established recycling stream and there is already a market for recycled material (PCR). It therefore remains part of the circular economy. To demonstrate recyclability, the laminate was certified according to the RecyClass validation process.

The Green Packaging Star Award
Launched in 2008, the Green Packaging Star Award is presented annually by Kompack magazine and the Austrian Research Institute for Chemistry. It recognizes companies for their sustainable packaging solutions and improved packaging processes. The best environmentally friendly products, corporate philosophies and production processes in the packaging industry are honored in four categories. By winning the Green Packaging Star Award, Constantia Flexibles also qualified for the WorldStar Award, presented by the World Packaging Organization (WPO).

“Sustainability is the core value that guides us in everything we do. We realized very early on that in the long run, multi-material laminates would have to be replaced by mono-material laminates to facilitate a circular economy. With EcoLamHighPlus, we have succeeded in developing a mono-material solution that meets all our customers’ requirements,” says Pim Vervaat, CEO of Constantia Flexibles. “We are particularly proud to receive the Green Packaging Star Award for this innovative packaging solution. It is an important contribution to reducing the carbon footprint of everyday consumer purchases,” says Vervaat.

https://www.cflex.com/

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Danimer Scientific and Chevron Phillips Chemical Expand Collaboration to Include Application Development for Rinnovo Polymers

Danimer Scientific and Chevron Phillips Chemical Expand Collaboration to Include Application Development for Rinnovo Polymers

BAINBRIDGE, Ga.–(BUSINESS WIRE)– Danimer Scientific, Inc. (NYSE: DNMR) (“Danimer” or the “Company”), a leading next-generation bioplastics company focused on the development and production of biodegradable materials, today announced it is expanding its collaboration with Chevron Phillips Chemical (“CPChem”) to explore development and commercialization of cast extrusion films, blown extrusion films, injection molded parts and rotational molded parts using Rinnovo polymers produced in a loop slurry reactor process.

Rinnovo is a type of polyhydroxyalkanoate (“PHA”) synthesized from lactones produced using Danimer’s proprietary Novo22 catalyst technology, which can be used in the production of biodegradable alternatives to traditional plastics. The collaboration expands on Danimer and CPChem’s previously announced agreement, in which Danimer is evaluating the use of CPChem’s loop slurry reactor design to develop a continuous reactor system in the manufacturing process for Rinnovo.

Stephen E. Croskrey, chief executive officer of Danimer, said, “Our business relationship with CPChem continues to yield results, and we’re excited for the further opportunities that lie ahead. CPChem’s Research and Technology lab in Bartlesville, Oklahoma, is a premier facility staffed with world-class talent that we believe will accelerate the path toward adoption of Rinnovo materials in high-volume applications that will assist in lowering the cost to serve key markets.”

Opened in 1950 by Phillips 66, CPChem’s Bartlesville facility contains first-class research equipment allowing for rapid testing of products across various processing conditions. Additionally, the facility’s testing and analytical capabilities provide a more rapid feedback loop, accelerating the development and optimization of resin formulations.

“We continue to be excited about the potential of our MarTECH process technology and related collaborations to advance Danimer’s Rinnovo, another CPChem initiative that can help accelerate change for a more sustainable future,” said Venki Chandrashekar, CPChem vice president of research and technology.

www.DanimerScientific.com.

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“Smart Nanocomposites” For Wearable Electronics, Vehicles, And Buildings: Thermoelectric Generators With Graphene Nanotubes

“Smart Nanocomposites” For Wearable Electronics, Vehicles, And Buildings: Thermoelectric Generators With Graphene Nanotubes

  • Small, lightweight, stretchable, cost-efficient thermoelectric devices signify a breakthrough in sustainable energy development and waste heat recovery.
  • Next-gen flexible energy harvesting systems will owe their efficiency to the integration of graphene nanotubes. They offer easy processability, stable thermoelectric performance, flexibility, and robust mechanical properties.
  • Nanocomposites have high market potential in manufacturing generators for medical and smart wearables, vehicles sensors, and efficient building management.

Around half of the world’s useful energy is wasted as heat due to the limited efficiency of energy conversion devices. For example, one-third of a vehicle’s energy dissipates as waste heat in exhaust gases. At the same time, vehicles contain more and more electronic devices requiring electrical energy. As another example, lightweight wearable sensors for health and environmental monitoring are also becoming increasingly demanding. The potential to convert waste heat or solar energy into useful electrical power has emerged as an opportunity for more sustainable energy management. Convenient thermoelectric generators (TEGs) currently have only low effectiveness and a relatively large size and weight. Based on expensive or corrosion-vulnerable materials, they are rigid and often contain toxic elements.

Recently developed, easy-to-process, self-supporting and flexible nonwoven nanocomposite sheets demonstrate excellent thermoelectric properties combined with good mechanical robustness. A recent paper in ACS Applied Nano Materials described how researches combined a thermoplastic polyurethane (TPU) with TUBALLTM graphene nanotubes to fabricate a nanocomposite material capable of harvesting electrical energy from sources of waste heat.

Thanks to their high aspect ratio and specific surface area, graphene nanotubes provide TPU with electrical conductivity, making it possible to achieve high thermoelectrical performance while maintaining or improving mechanical properties. “Stiffness, strength, and tensile toughness were improved by 7, 25, and 250 times compared to buckypapers, respectively. Nanocomposite sheet shows low electrical resistivity of 7.5*10-3 Ohm×cm, high Young’s modulus of 1.8 GPa, failure strength of 80 MPa, and elongation at break of 41%,” said Dr. Beate Krause, Group Leader, Leibniz-Institut für Polymerforschung Dresden e. V.

Graphene nanotubes, being a fundamentally new material, provide an opportunity to replace current TEG materials with more environmentally friendly ones. The sensors powered by such thermoelectric generators could act as a “smart skin” for vehicles and buildings, providing sensoring capabilities to monitor performance and prevent potential issues before they lead to breakdowns, ensuring optimal operational efficiency. In aircraft, no-wire nanocomposites could serve as stand-alone sensors for monitoring deicing systems, eliminating the need for an extensive network of electrical cables. The high flexibility, strength, and reliability of graphene nanotube-enabled thermoelectric materials also extend their applications into the realm of smart wearable and medical devices.

www.ipfdd.de

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Borealis Among First To Successfully Complete Operation Clean Sweep Certification

Borealis Among First To Successfully Complete Operation Clean Sweep Certification

  • Borealis is among the first plastics producers to achieve the Operation Clean Sweep Certification.
  • Third party external audits were successfully completed in two locations in Belgium.
  • European Industry stewardship certification program brings entire plastics value chain together to achieve zero pellet loss.

Borealis announces that two of its key sites in Belgium, Kallo and Antwerp, have been certified by Operation Clean Sweep, an international initiative aimed at preventing pellet loss. After extensive third-party audits according to the Operation Clean Sweep Standard in December 2023, both locations achieved the Operation Clean Sweep Certificate, a unified and equitable certification scheme for pellet handlers across the entire value chain. This recognition comes after contributing to the development of the Operation Clean Sweep Standard via a successful pilot audit in 2021 and underscores the company’s commitment to environmental sustainability and responsible business practices. and underscores the company’s commitment to environmental sustainability and responsible business practices.

The Operation Clean Sweep Standard is the next evolution of an international program dedicated to preventing the loss of plastic pellets during manufacturing, transportation and final conversion processes. Plastic pellets, also known as nurdles, are small pre-production plastic particles that, if improperly managed, can contribute to water pollution and harm aquatic/marine life. The program provides industry-specific guidelines and best practices to ensure the proper handling and containment of plastic pellets, ultimately minimizing the risk of environmental impact.

As part of its unwavering commitment to Operation Clean Sweep, Borealis has implemented all requirements to fully comply with the Operation Clean Sweep Standard and consequently put in place a comprehensive set of on-site measures aimed at preventing and responding to pellet spills, should they occur. Notable initiatives include the installation of big and small preventive measures to keep pellets in their designated systems as well as retention measures such as screens, pellet separators, and skimmers at various operating sites. These measures are consistent with the company’s commitment to environmental stewardship and ensure that plastic pellets are contained within the facilities. Borealis’ proactive approach is designed to test and refine processes to ensure that the company’s operations meet the highest standards of pellet containment and prevent any unintentional release into the environment. Borealis aims to have all of its polyolefin locations Operation Clean Sweep certified by the end of 2024.

“Receiving the Operation Clean Sweep Certificate is a testament to our ongoing commitment to environmental responsibility and emphasizes our purpose of re-inventing essentials for sustainable living. By actively participating in initiatives such as Operation Clean Sweep, Borealis continues to research and implement innovative solutions to reduce its environmental footprint across all its operations. The Operation Clean Sweep Certificate serves as a benchmark for our ongoing efforts to build a prosperous and sustainable future for all,” says Thomas Gangl, Borealis CEO.

www.borealisgroup.com

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Mondi Hosts First-Of-Its-Kind Round Table To Tackle Used Paper Bags From Construction

Mondi Hosts First-Of-Its-Kind Round Table To Tackle Used Paper Bags From Construction

  • On 16 November 2023, a group of industry leaders came together to a round table in Spain to talk about how to boost the circularity of paper bags in the construction industry.
  • The project aimed at finding solutions how to scale up the collection, sorting and recycling of used paper bags, and reduce waste.
  • The round table followed a pilot project in which Mondi has already been collaborating with partners in the construction industry in Spain to increase the circularity of used paper bags.
  • New circularity approach provides template for more collaborators and industry leaders to join or replicate across Europe.

16 January 2024 –Mondi, a global leader in packaging and paper, has brought together industry leaders in an expert round table to discuss how to improve the circularity of used paper bags in the construction industry. The event, which was held on 16 November 2023 in Madrid, looked at how to build systems that will prevent the disposal of used paper bags, working towards implementing a process of efficient collection, sorting, and recycling that can be managed on an industrial scale.

The partners attending were representatives from different parts of the value chain, namely Mondi, Envalora, Neinor Homes, OHLA, Arpada, Macotran, RCD Asociacion, S. Solís, Uder, Alier, Saint-Gobain and CoCircular. These like-minded industry leaders share a vision of boosting the circularity of paper bags used in the construction industry and see collaboration and stakeholder dialogue as a critical activity to achieve this.

The event follows a successful pilot project driven by Mondi, which set up a collection and recycling system for used paper bags in Spain. The project was initiated because paper bags used in the construction industry are currently not recycled at scale, resulting in valuable fibres being lost. In this pilot, different construction companies and specialised collectors for construction and demolition waste teamed up to manage the collection of used paper bags at construction sites, transportation, and the reprocessing of the used paper bags. This pilot provides a proof of concept to increase the circularity of used paper bags.

Carlos Martinez Ezquerra, Circular Economy Manager Flexible Packaging at Mondi says: “Improving the circularity of used paper bags in this industry is vital and our successful Spanish pilot project shows that it can become reality – but Mondi cannot do it alone. We need committed partners at every stage of the value chain to collaborate closely and create a successful model that can close the loop.

“This initiative – the first of its kind in Spain – is clear illustration of our commitment to working with industry partners across the value chain to increase recycling rates for used paper bags – and helps us set up an approach that can be scaled throughout Europe and across other industries.”

www.mondigroup.com

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FIRST CORPORATION SRL SELECTS SUSTAINABLE LURAN S ECO MATERIAL FROM INEOS STYROLUTION

FIRST CORPORATION SRL SELECTS SUSTAINABLE LURAN S ECO MATERIAL FROM INEOS STYROLUTION

INEOS Styrolution, the global leader in styrenics, today announced that EdilPlast SRL, part of First Corporation group, has chosen the company’s sustainable styrenics solutions for their latest generation of building products. First Corporation group, leader since 1966 in the production of plastic products for buildings, offers a wide range of solutions, from the ground to the roof, entirely made in Italy and distributed throughout the world. EdilPlast SRL, with the goal of constant innovation and development, has selected INEOS Styrolution’s Luran S ECO materials for Cover Innovation, a new roofing sheet solution.

Luran S is an ASA (acrylonitrile styrene acrylate) polymer that offers superior long-term performance when exposed to UV light and heat. Its low maintenance and high weather resistance make Luran S the best material for a wide range of outdoor applications. Mixing with PVC or covering over PVC makes it perfect for applications such as roof tiles, gutters or drain down pipes. Luran S ECO is INEOS Styrolution’s first sustainable ASA solution with up to 39% lower carbon footprint. The use of these materials will allow EdilPlast to use bio-attributed raw materials from 30% to 50%.

Giulio Mantelli, President of First Corporation Group and creator of Cover Innovation, states: “INEOS Styrolution has allowed us to reduce our ecological footprint by using sustainable materials in our production. Indeed, the new material has proven to be an optimal solution for products exposed to atmospheric agents. Cover Innovation products are a tangible result of First Corporation Group’s R&D to make 100% eco-sustainable and recyclable products.” Olivia Vigano, Key Account Manager at INEOS Styrolution, adds: “I am very excited that INEOS Styrolution is able to offer sustainable material that helps EdilPlast SRL reduce its own carbon footprint as well as that of the companies involved in the distribution process.”

www.ineos-styrolution.com

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MICROMETAL IS AWARDED ISO 13485 MEDICAL DEVICES ACCREDITATION

MICROMETAL IS AWARDED ISO 13485 MEDICAL DEVICES ACCREDITATION

Micrometal GmbH, a pioneer in the development of the photo chemical etching (PCE) process, is delighted to confirm that it has once again been awarded with the ISO 13485 accreditation, crucial in the company’s mission to bring its next-generation precision metal fabrication technology to all relevant sectors of industry micrometal’s years working in the medical device sector has demonstrated the imperative for flawless precision metal parts and components due to the critical nature of these devices. Even the slightest imperfections can lead to malfunctions, compromised patient safety, and regulatory non-compliance. Therefore, ensuring perfection is vital to maintain the reliability and efficacy of medical devices, supporting accurate diagnoses, treatments, and patient outcomes. micrometal’s PCE process stands out as an ideal technology for achieving this level of precision. Its intricacy allows for the production of highly detailed and complex parts with minimal material stress, preserving the integrity of the metal and eliminating the risk of burrs or distortions. Additionally, the process offers exceptional repeatability and tight tolerances, guaranteeing consistent quality across large-scale production. This makes PCE exceptionally well-suited for crafting intricate, burr-free, and dimensionally accurate parts that adhere to the stringent requirements of the medical device sector.

Jochen Kern, Head of Sales and Marketing at micrometal says, “ISO 13485 accreditation is of paramount importance for a subcontract precision metal part manufacturer like micrometal, as it signifies our compliance with rigorous quality management standards specific to the medical device industry. This accreditation demonstrates our commitment to producing components via our next generation PCE process that adhere to the highest levels of quality, safety, and traceability, critical for medical devices where precision, reliability, and consistency are non-negotiable. ISO 13485 not only enhances our credibility and marketability within the healthcare sector, but also ensures seamless collaboration with medical device companies by aligning their processes with industry best practices, ultimately contributing to the delivery of safe and effective medical products.”

ISO 13485 is a quality management standard specifically tailored for the medical device industry, and was developed to address the unique regulatory and safety demands of this sector. Medical devices directly impact human health and safety, necessitating a comprehensive framework that ensures consistent adherence to stringent quality controls. ISO 13485 was conceived to provide a standardized approach to quality management, encompassing design, development, production, and post-market activities, while considering the critical aspects of risk management, process validation, and traceability thatare paramount in healthcare applications. By establishing a clear and harmonized set of guidelines, ISO 13485 facilitates compliance with global regulatory requirements, streamlines communication across the supply chain, and instills confidence in the safety and reliability of medical devices.

Kern continues, “From our perspective at micrometal, ISO 13485 certification underscores a profound dedication to the medical device sector and signifies a superior level of service. By meeting the stringent requirements of this industry-specific quality management standard, we have demonstrated our unwavering commitment to delivering products and services of the highest quality, precision, and reliability. ISO 13485 not only ensures compliance with rigorous regulatory standards but also showcases a proactive approach to risk management, process optimization, and continuous improvement. This commitment enhances trust among medical device manufacturers and end-users, affirming our capability to contribute to the development and production of safe and effective medical devices, thereby solidifying our position as a valued partner in the healthcare ecosystem.”

www.micrometal.de

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