NORTH AMERIC AN EDITION
MEDICAL PLASTICS news + ASEPTIC CONNECTORS VS TUBE WELDING THE IMPACT OF THE AIA ON INNOVATIONS
DATA MANAGEMENT FOR SMART MANUFACTURING
CAPITALIZING ON LOCAL ISSUE 19
Oct/Nov/Dec 2021
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ADVANCING MEDICAL PLASTICS
CONTENTS MPN North America | Issue 19 | Oct/Nov/Dec 2021
Regulars 3 Comment Corrine Lawrence reflects on 2021. 4 Digital spy 10 Cover story As new opportunities emerge, medical injection molding can turn to local production and integrated systems says Thomas Bontempi of Husky Injection Molding Systems. 20 Back to the future
Features 6 Q&A: Reducing the cost of long-term manufacturing Trelleborg’s Chris Telling talks to MPN about how the company’s Rapid Development Center is helping customers to accelerate the time-tomarket cost effectively. 8 Joining technologies: The end of the weld? Troy Ostreng of CPC assesses the advantages of aseptic connectors compared with tube welding in small volume biopharma processing.
12 Regulatory update: Prioritized examination — patently clear? Robert J. Roby of Knobbe Martens discusses the impact the America Invests Act has had on prospective and existing innovations. 14 Regulatory update: Stronger together Adam Price of Rimsys explains how evolving regulations are forging a closer relationship between plastics suppliers and medtech manufacturers. 16 Sustainability: Prioritize, manage, reduce Clean Earth’s Holly Gamage advises how sustainability measures can also improve brand protection. 18 Smart manufacturing: Smart works Martin Gadsby of Optimal Industrial Automation explains how medical plastics producers can benefit from a well-designed data management strategy.
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CREDITS editor | corrine lawrence corrine.lawrence@rapidnews.com advertising | caroline jackson caroline.jackson@rapidnews.com | david geltman david.geltman@rapidnews.com
Editor’s Comment C O R R I N E L AW R E N C E
head of media sales plastics & life sciences | lisa montgomery head of studio & production | sam hamlyn graphic design | matt clarke publisher | duncan wood Medical Plastics News NA Print subscription - qualifying criteria US/Canada – Free UK & Europe – £249 ROW – £249 Medical Plastics News Europe Print subscription - qualifying criteria UK & Europe – Free US/Canada – £249 ROW – £249 FREE on iOS and Android devices Subscription enquiries to subscriptions@rapidnews.com Medical Plastics News is published by: Rapid Life Sciences Ltd, Carlton House, Sandpiper Way, Chester Business Park, Chester, CH4 9QE T: +44(0)1244 680222 F: +44(0)1244 671074 © 2020 Rapid Life Sciences Ltd While every attempt has been made to ensure that the information contained within this publication is accurate the publisher accepts no liability for information published in error, or for views expressed. All rights for Medical Plastics News are reserved. Reproduction in whole or in part without prior written permission from the publisher is strictly prohibited.
ISSN No: 2632 - 3818 (Print) 2632 - 3826 (Digital)
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A SHOT IN THE ARM
020 was a year many of us would care to forget for obvious reasons. It was a year during which many businesses found themselves digging deep to come up with workable solutions to satisfy financial and supply chain challenges ... because there was no official road map to recovery. The medical industry however, along with countless others, became adept to working differently. Quite simply, it had to. But it was far from ideal. Face-to-face interactions, or specifically the lack of them, was a particularly hard blow — not only did this gaping hole affect organizations’ daily dealings with customers and prospects, it also hammered trade fairs — a sector we rely on to showcase our technologies, innovations, and expertise, as well as the opportunities they afford to reconnect with established acquaintances or forge new connections. ‘Virtual’ has its place, and we’ve been thankful for its ability to bail us out of a few tight spots, but it can never fully substitute being physically in front of people: how many business deals have been secured not just because of impressive technologies or competitive pricing, but rather because of rapport and intuition gained only through physical interaction?
There’s nothing quite like a crisis to highlight weak spots … and the pandemic certainly achieved that. The international just-in-time supply chains relied on by many proved to be organizations’ Achilles’ heel. But where there’s a cloud, there’s (usually) a silver lining, and the silver lining here is that many businesses are now choosing to work with local partners — a move that keeps industrial cogs turning while benefiting local economies. To keep pace with this trend, companies have, therefore, chosen to invest in additional capacity either through expanding current facilities or through acquisitions. And yet, despite all of this — or, perhaps because of all of this — the industry has continued to innovate, particularly in the sustainability arena: another major theme of 2021. Many medical plastics companies have already signed up to net zero initiatives or are developing environmentally friendly alternatives to their main product portfolios. Regardless of what comes out of COP26, companies have a duty of care to assume responsibility for their own facilities, processes and products. We’re all keen to return to normal, but pollution? Well, that’s one ‘normal’ we don’t want back.
As we ushered in 2021, the weak light flickering at the end of the tunnel took on a new, brighter glow as vaccination programs began to roll out across the land. As the days passed, optimism grew. Businesses that learnt new ‘survival’ tricks in 2020 became more efficient, which in turn has attracted more customers in 2021. Others have now established a ‘medical’ arm to their business after realizing they can adapt their capabilities and know-how to help redress the industry’s high demand/low supply issue.
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DIGITAL
spy
www.guill.com
ACQUISITION UPDATE
https://tekni-plex.com Tekni-Plex acquires Mexico-based extrusion manufacturer
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aterial science and manufacturing technologies specialist Tekni-Plex Healthcare has acquired precision extrusion manufacturer Johnson Plastic Group (JPG) as part of a strategy to expand the company’s patient care solutions platform. Located in Mexicali, Mexico, JPG provides complete extrusion solutions into a variety of medical device applications for interventional and therapeutic procedures. The acquisition expands Tekni-Plex Healthcare’s medical device
TOOLING UPDATE
capabilities and broadens the division’s global footprint. The transaction also brings the company closer to its key customer base in Mexico and the Baja region, as well as leveraging JPG’s expertise across TeknoPlex Healthcare’s entire global customer base and healthcare end markets. Chris Qualters, CEO of Tekni-Plex Healthcare noted: “The addition of JPG continues to build upon our innovative patient care solutions platform centered on material science and process technologies.”
New extrusion crosshead features patented single-point concentricity adjustment
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uill Tool & Engineering has introduced a new extrusion crosshead that uses micro-fine adjustment screws for precise concentricity adjustment. The precision of concentricity reaches 0.008” or finer per revolution. This single point concentricity adjustment is a unique Guill innovation for the extrusion of thin-walled and precision ID/OD medical tubing. One adjustment bolt controls 360° of adjustment. Features of the Micro Medical crosshead include a patented cam-lock deflector for quick changeovers, with a residence time of one minute at .5 lb/hr material flow, optimized usage
with extruders measuring ½” and ¾”, and a max die ID of .250”. In addition, the new crosshead offers great flexibility to its users — it accepts both vacuum and micro-air accessories and is ideal for pressure and sleeving applications. Fluoropolymer designs are also available.
EXPANSION UPDATE
www.raumedic.com
Cleanroom manufacturing expansion on the cards for Raumedic
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edical technology company Raumedic has announced plans to expand the cleanroom manufacturing facilities at its US headquarters in Mills River, NC, by February 2022. The additional state-of-the-art cleanroom will be used for new product lines, bringing in new techniques and creating further job opportunities at the North American headquarters and production
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facilities. “Growth is the key word for describing our five years in Mills River,” said, summing up the current situation. In 2016, the ISO Class 7 cleanroom production facilities covering 13,000 sq. ft. were built on an empty field in the Asheville area. Now it is occupied with the business the company has developed. Raumedic serves international medical device
companies distributing insulin pumps, surgical equipment, or catheters, for example. “The advanced equipment and processes that will go into the new space will help us to remain ahead of the curve. With automated assembly cells and robotically augmented molding presses, we are able to produce high-quality medical technology solutions in the mainland US and remain competitive,” explained Martin Bayer, president and CEO of Raumedic.
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DIGITAL SPY
ADHESIVE UPDATE
www.dymax.com
Autoclave-resistant adhesive that also protects electrical components
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apid curing materials and equipment specialist Dymax has extended its MD line of adhesives for medical device assembly applications with 1040-M. Designed to be autoclave resistant for more than 100 cycles, the new adhesive offers extremely low water absorption (0.5%) making it ideal for surgical tools and devices that are subjected to numerous instances of sterilization, including autoclave or STERRAD (plasma). This 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 is LED curable at 365 nm wavelength. 1040-M successfully bonds to a variety of substrates including stainless steel, aluminum, glass, PP/PE, and PCB, and is especially suited for
encapsulating RFID chips, sensors, and other electronic components found on medical devices, tools, and vials. 1040-M meets the requirements for ISO 10993-5 cytotoxicity, is formulated without IBOA, has a durometer hardness of D60, and viscosity of 775 cP. The product is a solvent free, RoHS-compliant material, making it a “greener” choice compared with oneand two-part solvent-based epoxies currently on the market.
Mark Gomulka, CEO, Westfall Technik
www.csptechnologies.com US GOVERNMENT AWARDS APTAR $19-MILLION CONTRACT FOR DOMESTIC PRODUCTION CAPACITY ptar CSP Technologies, part of AptarGroup, has been awarded a $19 million contract from the US government to support expanded domestic production capacity for the company’s proprietary Activ-Film technology, which is used to protect and ensure COVID-19 test kit integrity and accuracy.
POINT
www.westfalltechnik.com
PRODUCTION UPDATE
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talking
The company’s Activ-Film technology is seamlessly integrated into diagnostic dipsticks and lateral flow cassettes to protect diagnostic tests from moisture or other environmental degradants that can affect test integrity and result accuracy. The material leverages Aptar’s proprietary 3-Phase ActivPolymer platform technology to provide broad spectrum, custom-engineered protection delivered in a variety of configurations. The technology is formulated to adsorb a specific amount of moisture and other compounds at a customized rate, creating a consistent microclimate throughout the supply chain. The contract provides for procurement of equipment and machinery needed to increase production of Activ-Film material at Aptar CSP’s Auburn, Alabama plant. Completion of this effort is expected in early 2023.
As the company’s new CEO, what is your vision for Westfall? To be the premier contract manufacturer in the medical and packaging space. Four years ago, no one had heard of Westfall Technik. Today some of the world’s largest OEMs take advantage of our fully integrated solutions from design and prototyping through Westfall’s IDG Design Group, to tooling and automation, molding and micromolding, to assembly and kitting. Our passion for this business will continue to drive us forward, and our vertically integrated model will allow for speed-to-market on some of the most complex programs that our customers demand. What’s new at the company regarding the medical plastics space? During the past 12 months, we’ve installed over 40,000 sq. ft of medical cleanroom manufacturing space and more than 40 new electric injection molding machines. We’re seeing many more requests for wearable drug-delivery devices — from insulin pumps and insulin monitors to auto-injectors for immunotherapies. Westfall is ready with capacity to meet that demand as our medical customers drive technology into their devices. How do Industry 4.0 concepts feature at Westfall? From our ERP to quality systems, we use our cloud infrastructure to manage our business as a whole. From predictive maintenance using smart sensor technologies to a cloud-based quality management system that spans our entire manufacturing eco system, we have developed and connected all the components of our manufacturing operations. We capture the critical points of our processes to make real-time decisions across the entire enterprise.
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Q&A
MPN SPOKE WITH CHRIS TELLERS, RAPID DEVELOPMENT CENTER DIRECTOR, TRELLEBORG HEALTHCARE & MEDICAL TO LEARN ABOUT THE COMPANY’S RECENTLY LAUNCHED RAPID DEVELOPMENT CENTER IN DELANO, MINNESOTA.
REDUCING
THE OF LONG-TERM MANUFACTURING
samples in as little as 24 hours. This enables multiple design iterations, as well as superior performance and quality, while ensuring effective and rapid scaleup to production.
Why has Trelleborg just launched its Rapid Development Center? We created the Rapid Development Center (RDC) to enable customers to accelerate the time-to-market and reduce the production cost of parts for healthcare and medical devices. The desire to launch products faster is not a huge surprise, but we saw a disconnect between the cost of parts designed by development or design houses and our customers’ desire to reduce the cost of longterm manufacturing. Generally, as much as 80–90% of the manufacturing cost is designed into the product. When customers engage the Trelleborg RDC early in the development process, we can minimize the built-in costs, ensure high-quality parts, and deliver a smooth transition from the design phase to long-term, serial production. What exactly does the Trelleborg RDC offer customers? For healthcare and medical customers who want to be the first to market with innovative technologies, the team creates
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Trelleborg’s primary experience is in high volume manufacturing, which allows us to employ Design for Manufacturing (DfM) principles from previous lessons learned. As a result, we can develop manufacturing processes that are efficient and cost-effective and can successfully transition from design to full-scale production. We partner with our customers’ development teams, creating a relational environment and consulting with them to develop designs and processes to best realize their objectives. What technologies does Trelleborg use to help expedite development? Trelleborg has decades of experience in manufacturing silicones, thermoplastics and metals. Our experts leverage their knowledge of processes, materials and tooling to quickly convert complex designs into prototypes that can be manufactured at scale and at the lowest possible cost. The RDC offers several core competencies critical to medical device and pharmaceutical component development, including design consultation, toolmaking, high-precision machining, silicone and thermoplastic molding, assembly, and other secondary operations. When partnering with the Trelleborg RDC, our medical device customers have access to manufacturing facilities with raw material traceability and Class 7 cleanrooms. These facilities are ISO 13485:2016 and ISO 9001-certified and meet requirements from the Food and Drug Administration and European Medical Device Regulation. What’s next for Trelleborg? As we continue to work with our customers at the RDC, we will adapt our processes and offerings to best serve their needs. We are already looking to add additional materials, capabilities and services in the near future. Since beginning operations in early 2021, the RDC has already completed 11 unique solutions, built nine tools, and shipped 1,259 parts, with some parts being delivered within four business days. We were able to achieve this because we are not limited by machine availability, and our processes are streamlined for speed to help our customers receive parts in hand quickly. For example, we invested in two presses for the RDC to aid in our quick turn capability. Looking to the future, we will continue to support our customers with their rapid development projects, review and invest in new technologies, and train our team to improve the diversity of our skills. We plan to add additional experts to the RDC team in 2022.
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So clear it’s like it’s not even here: highly transparent CYROLITE® for diagnostic applications.
We invented CYROLITE® over 40 years ago – and we’ve used the time ever since to perfect its properties. The result is highly advanced acrylic polymers that boast outstanding optical properties such as superior UV transmittance. At the same time, CYROLITE® offers excellent flow properties, thus enabling them to be molded into extremely thin-walled components. It goes without saying that CYROLITE® meets all the relevant USP Class VI, ISO 10993-1, and REACH standards. For more reasons why CYROLITE® is the clear choice, visit www.cyrolite.com.
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JOINING TECHNOLOGIES
TROY OSTRENG, SENIOR PRODUCT MANAGER FOR CPC’S BIOPHARMACEUTICAL BUSINESS, ASSESSES THE ADVANTAGES OF ASEPTIC CONNECTORS COMPARED WITH TUBE WELDING IN SMALL VOLUME BIOPHARMA PROCESSING.
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istorically, tube welding has been the only option for biopharma system designers and processors to make closed sterile connections in small volumes using small-bore tubing. As the industry continues to evolve, we are seeing unprecedented demand for new therapies, efficiencies, and improved speedto-market. The drive to process optimization has led manufacturers to evaluate all steps in their workflows to determine whether they can make improvements. One such area is the use of aseptic connections to create closed sterile systems. Today, manufacturers can move away from the cumbersome tube welding process towards singleuse connectors which are quick and easy-to-use, require almost no space in a cleanroom and provide efficient, seamless, and sterile fluid transfer.
SPACE AND TIME Cleanroom space is extremely valuable; the ability to remove welding equipment in favor of single-use connectors is, therefore, attractive to those looking to optimize the space they have when compared with the expensive and time-consuming process of validating new space. Single-use connectors are ready to use and have been validated for material biocompatibility, extractables, sterility, and leakage (Figure 1). From a practical perspective, once validated, welders also need to be moved into position and the correct size tubing holder must be obtained and inserted. They must then be initialized, the tubing loaded, welded, and then cured — a process that can take an average of 4–7 minutes in total; multiply the setup time by hundreds of welds each week, operator time stacks up considerably. One hundred welds, for example, would require 6.67 hours of welding time at the lower end of the timescale at four minutes, whereas aseptic
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f o d n e e h T ? d l e the w connectors are presterilized and ready to go in a tubing/bag assembly and require mere seconds to connect and actuate. LENGTH AND MATERIAL Aseptic connectors can also be applied to any tubing length with no minimum requirement, and to any type of tubing, including silicone (Figure 2). Different types can also be connected; for example, silicone to C-Flex, and different hose barb sizes can be used at opposite sides of the connector. Genderless options eliminate the need to carry male/female components, and connectors of the same family can be interconnected. For welding, minimum tubing lengths are often required to fit into the welder, and only the same kinds of tubing materials can be fused together. In addition, welding cannot be used on silicone as the material burns during the process. Welders must also be set up for a specific tubing size and material, adding a further stage to the process. RISK OF CONTAMINATION Using aseptic connectors also reduces the risk of contamination as the margin for error is far narrower. For example, not following manufacturers’ recommendations in tube welding can lead to placing tubing with the incorrect diameter in the tube holder. This can cause small pinholes in the weld, due to pinching or squeezing the tubing out of the holder during the weld process. Welding different tubing types together — whether knowingly or unknowingly — can also lead to weld failure. With aseptic connectors there is little to no contamination risk because validated aseptic connectors maintain a sterile boundary between two adjoining single-use systems.
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JOINING TECHNOLOGIES
COST Finally, there is the question of cost. There is a common misconception that tube welding is more affordable than single-use aseptic connectors, but when the cost of the welder and its upkeep, blade costs and operator hours are taken into consideration, aseptic connectors are clearly an economical alternative. In tube welding, capital equipment and ancillary equipment costs range from a few thousand dollars to tens of thousands per welder in each cleanroom. Aseptic connectors eliminate capital expenditures associated with primary and backup welding equipment as well as maintenance costs. CONCLUSION When properly applied, both sterile tube welders and single-use aseptic connectors can create reliable connections. Factors such as ease of use, downtime potential, operator error risk, cost, and supply management, however, are important factors for system designers and processors. Aseptic connectors — particularly genderless models — deliver the flexibility, ease of use, reliability and cost efficiencies that are highly sought after in state-of-the-art biopharma manufacturing. They also address the challenges to design and operate processes that are robust, reliable, and repeatable. In this respect, the ‘end of the weld’ may be here, and the benefits are clear to see.
Single-use connectors are ready to use and have been validated for material biocompatibility, extractables, sterility, and leakage Image below: Figure 1: Single-use connectors are ready to use and have been validated for material biocompatibility, extractables, sterility, and leakage. Image top right: Figure 2: Aseptic connectors can be applied to any tubing length with no minimum requirement, and to any type of tubing, including silicone.
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As easy as 1-2-3 Testing indicates that making a sterile connection with a MicroCNX connector is up to four times faster than an operator using a tube welder: in the time required to create one weld, up to four MicroCNX connections could be completed. Multiply those numbers over the course of a year, and the operational efficiencies are clear. The easy, three-step process for using aseptic connectors requires minimal training. Users simply “Pinch-Click-Pull”: 1) pinch to remove the protective cover; 2) click together the connector halves; and 3) pull out the protective membranes so flow can start. In comparison, tube welding involves a dozen or more steps, with challenges including maneuvering the tube welder into position, dealing with equipment maintenance, and requiring precise technique to create a successful weld. With aseptic connectors there is no risk of faulty welds, welder breakdowns, or production delays due to weld equipment downtime.
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COVER STORY
AS NEW OPPORTUNITIES EMERGE, MEDICAL INJECTION MOLDING CAN TURN TO LOCAL PRODUCTION AND INTEGRATED SYSTEMS SAYS THOMAS BONTEMPI HEAD OF MEDICAL BUSINESS DEVELOPMENT AT HUSKY INJECTION MOLDING SYSTEMS
CAPITALIZING ON LOCAL
MANUFACTURING OPPORTUNITIES
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Integrated molding systems deliver major benefits
edical injection molding continues to enjoy strong growth as worldwide demand increases for medical devices, according to industry observers. New business opportunities are emerging globally as the industry expects medical device sectors to see compounded annual growth of greater than 10%. The rising prevalence of chronic disease and the aging population are the key market drivers. In addition, emerging economies with higher GDPs are seeing increasing expenditures for healthcare. Another major influence has been the COVID-19 pandemic, which has spurred the explosive growth of lab consumables for testing, vaccinations, and other diagnostics. Among the growing business opportunities are pipette tips and blood collection tubes, utilizing integrated manufacturing approaches which assure the highest levels of certainty, scalability, and fastest time-to-market.
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LOCALIZED PRODUCTION IS A TOP PRIORITY Skyrocketing demand for medical devices during the pandemic resulted in major supply disruptions. One issue that resurfaced during the COVID-19 outbreak was the realization that 85% of the world’s countries rely on imports of medical devices and components.1 The imbalanced supply situation existed previously but the pandemic accelerated demand and raised concerns about worldwide shortages of medical products — many essential in the fight against the virus. To counteract future uncertainty and ensure supply, many political and governmental initiatives have made the creation of local supply chains a top priority. According to McKinsey & Co. more than 90% of medtech multinational companies (MNCs) expect greater localization in the industry after the outbreak.2 Meanwhile, about 60% of medtech MNCs believe that local manufacturing will be favorable for business success. The scenario presents lucrative opportunities for both existing players and new entrants. The looming question is whether manufacturers will be prepared to capture these new business opportunities. IDENTIFYING THE HIGH-GROWTH OPPORTUNITIES Clearly, processors and end users are poised to capitalize on potential growth applications. Selecting the right application means balancing the risk and opportunity. Making a risk/rewards evaluation is important in selecting business opportunities that present a reasonable risk and complexity level, combined with high volume for fast payback. Amidst the pandemic, the production of pipette tips, blood collection tubes, and prefilled syringes have emerged as high-growth tracts that are ripe for expanded penetration. Pipette tips — which dispense medical fluids and liquids — are a highvolume application which are predicted to see a 9.7% compounded annual growth rate (CAGR) through 2025.3 Growth opportunities are fueled by COVID-19, nationalization, and demand for quality parts. Pipette tip design has several critical quality criteria including dimensional tolerances, part filling (especially below 0.5-mm wall thickness), concentricity (run-off or run-out), inside and outside flash, and insert split lines positioning. Another promising application is blood collection tubes which have seen dramatic growth due to the need for pandemicrelated products. They consist of a PET tube, an HDPE closure, and a rubber stopper. Tubes are delivered ready-to-use to the end user for specific sample analysis with features such as labels, vacuum sealed to draw a specific volume, and prefilled with reagent. Key design requirements include dimensional accuracy, no brittleness, transparency, oxygen permeability, vacuum maintenance, water vapor permeability, and gate quality. A further growth area is prefilled syringes, which have emerged as one of WWW.MEDICALPLASTICSNEWS.COM
COVER STORY variation down to the subsystem and hardware components. This capability is enabled by the intimate understanding of all the building blocks of the integrated solution since they are all delivered from Husky as a single-source supplier.
the fastest-growing choices for unit dose medication, driven by the increasing adoption of self-care devices and the high demand for improved safety in injectables. Increasingly, prefilled syringes are manufactured using plastics as they are more break-resistant than glass, and can be manufactured for specific sizes, inner diameters, and finger flange designs while maintaining tight tolerances during production. INTEGRATED MOLDING SYSTEMS DELIVER MAJOR BENEFITS To meet the requirements of these high-volume applications, processors and OEMs are moving increasingly to integrated manufacturing systems that provide better quality, eliminate artificial barriers between suppliers, and provide faster time-to-market. Medical device manufacturing can be highly complex, and the process of self-aggregating different pieces of equipment can be time-consuming, costly, and inefficient. Integrated solutions offer maximum part performance and precision and repeatability in high-cavitation manufacturing processes, bringing validated medical parts to the market at unimaginable speeds and volumes. This is accomplished while minimizing waste and increasing the bottom line. The goal is to bring together the subcomponents of the injection molding system so they’re not simply integrated but designed and operating as a system. Husky has translated its extensive experience and expertise in turnkey PET systems for packaging to the medical segment. Along with its subsidiary Schöttli a leading medical moldmaker, the company delivers integrated systems for high-volume medical applications like pipette tips, blood collection tubes, and prefilled syringes. Husky brings injection machines, hot runners, controllers, and auxiliaries whereas Schöttli provides medical mold design and moldmaking expertise. Together, they deliver a total system solution which has single-source responsibility and is specifically configured for an application. For pipette tips, a typical fully integrated work cell for a two- to 128-cavity application, incorporates Husky’s injection machinery and Schöttli’s mold components. It also includes automation equipment such as racking, vision control, filter assembly, packing, and sterilization, from third-party suppliers. The system delivers reduced complexity, less risk, and faster time-to-market. The Schöttli mold solution features a compact design for high cavitation, built around the eight-cavity cluster concept. It also includes star nozzle hot runner technology, component accessibility from main parting lines, and highly efficient cooling for faster cycles. Concentricity and quality are achieved through adjustable cores and mold design concept. A cycle time of 4.9 seconds is estimated for a 200 μL pipette tip. For blood collection tubes, Husky’s Ichor integrated system is based on a proven PET platform, and provides high performance, low risk, and fast timeto-market. The work cell includes the injection machine, hot runner, auxiliaries, controller, and cold half mold. It delivers a 5.4-second cycle time and 97% overall system efficiency. Various levels of IMM integration are possible with downstream automation including takeout devices, inspection, labeling, and packing. Typical integrated systems run in ISO Class 8-9 Cleanrooms and incorporate downstream automation from third-party suppliers. Husky’s integrated systems also feature Advantage+Elite, a remote monitoring service with proactive troubleshooting capability which allows for early detection and traceability. It analyzes the operating system and traces WWW.MEDICALPLASTICSNEWS.COM
SYRINGE START-UP SCALES UP QUICKLY IN RUSSIA A successful case study involving a Russian manufacturer illustrates how integrated production systems can deliver business success. Husky helped Moscow-based Pascal Medical, one of Russia’s leading medical device suppliers, to scaleup fast to produce a high-quality product, and quickly become an industry leader. Pascal Medical wanted to reverse import trends by setting up local production of disposable PET syringes to meet local and international standards in a short time, starting from scratch. Pascal Medical was looking for technology to enable them to produce the highest quality syringes in Russia. They lacked upfront capabilities to set up such an operation, so they enlisted Husky to develop a turnkey system. Pascal Medical relied on Husky to guide them towards the right approach for setting up their injection molding capabilities. In this case, Husky supplied multiple integrated injection systems including molds, injection machines, and hot runners to mold high-volume quantities of disposable syringes. The company is now the largest Russian supplier for these products, producing 450 million disposable syringes per year. As processors and end users look to capitalize on these future business opportunities, they are acutely aware of the challenges coming out of COVID-19. They see the vital need to create local manufacturing to avoid being hamstrung by a reliance on imports. Integrated or turnkey production is expected to play a key role as processors and OEMs aim to collaborate with partners that can deliver the necessary technical expertise and know-how to efficiently scale up operations and quickly bring end products to market. REFERENCES 1. McKinsey & Co., New York, NY 2. McKinsey & Co., New York, NY 3. GlobalData, London, UK
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REGULATORY UPDATE
TEN YEARS AFTER PRESIDENT OBAMA SIGNED THE AMERICA INVENTS ACT (AIA) TO MODERNIZE THE US PATENT SYSTEM, ROBERT J. ROBY, PARTNER, KNOBBE MARTENS, DISCUSSES THE IMPACT THE AIA HAS HAD ON PROSPECTIVE AND EXISTING INNOVATIONS IN THE MEDICAL PLASTICS AND MEDICAL DEVICE INDUSTRIES.
Prioritized examination — PATENTLY LEAR?
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hen the Leahy-Smith America Invents Act (AIA) was enacted on September 16, 2011, it was proclaimed to be one of the most significant changes to the US patent system since the Patent Act of 1952. Most widely discussed at the time of enactment was the change of the US patent system from a ‘first to invent’ system to a ‘first inventor to file’ system — a change that sought to better align the US patent system with most other countries. Enacted in 2011, the change to ‘first inventor to file’ did not take effect until March 16, 2013. As with the changes resulting from the signing into law of the General Agreement on Tariffs and Trade (GATT) on December 8, 1994, the AIA resulted in a crush of patent filings just prior to the March 16, 2013 effective date, which affected priority rules and certain bases for prior art rejection. The bulk of these filings were a result of applicants trying to remain in the pre-AIA regime, which allowed inventors to rely upon inventive activities to remove certain prior art references and which also were not subject to certain post-grant validity challenges at the Patent Office. By and large, however, most applicants in the medical plastics and medical device industries already focused upon being the first inventor to file. Moreover, many of the new forms of prior art in the US could affect foreign applications; applicants were careful in filing before such events could be used against them. Accordingly, the changes that transformed the US patent system
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to the ‘first inventor to file’ system had limited impact in the medical plastics and the medical device industries. PRACTICAL CHANGES In contrast, one of the more practical changes facilitated by the AIA has wide ranging impacts on the medical plastics and medical devices industries: Track One or Prioritized Examination. The ecosystem of the medical plastics and medical device industries includes companies ranging from start-up ventures to multinational corporations, and Track One or Prioritized Examination has something for everyone. The AIA provided for the establishment of a program to allow the expedited examination of patent applications. The US Patent Office interchangeably calls this program “Track One” and “Prioritized Examination”. Entry into Prioritized Examination simply requires a certification and request for prioritized examination, the filing of the oath or declaration by the inventors or an Application Data Sheet (ADS) with the application, and payment of the applicable fees, including a special fee of $4200 ($2100 for a small entity and $1050 for a micro entity). With regard to application preparation, prioritized examination also limits an applicant to four independent claims and up to 30 total claims. Because it is intended to speed initial examination, receipt of a ‘final’ office action from the Patent Office terminates the expedited program, but the applicant is free to opt back into the program when filing a Request for Continued Examination if all requirements for the program are met. Although there is a limit to the number of Prioritized Examination requests allowed in any given year, effective September 24, 2021, the Patent Office increased the maximum annual number of Prioritized Examination requests it would accept from 12,000 to 15,000.1 PENDENCY The practical effect of Prioritized Examination is that the program allows a patent applicant to get a final disposition (that is, an allowance or a final rejection) within about 12 months. According to the US Patent Office’s most recent data for non-prioritized cases, the US Patent Office currently has a pendency of 16.8 months before the issuance of a first office action and a traditional total pendency of 23.2 months.2 Conversely, Prioritized Examination applications are, on average, pending for merely 1.4 months between grant of a petition for Prioritized Examination and receipt of a first Office Action.3 Under Prioritized Examination, average total pendency from grant of the petition to final disposal is 5.6 months, and average total pendency from petition grant to allowance is 4.4 months.3 Currently, the Prioritized Examination application pendency from filing to petition grant is 1.4 months.3 Thus, a Prioritized Examination application can expect a first action on the merits in about 2.8 months and a final disposition in about 7 months, which is significantly quicker than the traditional route.
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SilcoTek CVD Coatings for Medical Devices and Molding ALLOWANCE RATE Another significant advantage of Prioritized Examination is the allowance rate. During the past 12 months, 7,245 applications were allowed, and 6,561 applications were finally rejected, abandoned, or had rejections appealed.3 Thus, the rate of allowance exceeds 50% for prioritized examination applications, whereas the general population rate of allowance is lower. Speed to allowance is crucial for at least two distinct scenarios: • a start-up company attempting to demonstrate defensible intellectual property while seeking funding • any company facing a competitive threat to the bottom line. Through focused use of the Prioritized Examination program, companies can better address both issues. For example, filing on the core features of a start-up company’s technology can quickly yield one or more patents that can comfort would-be investors that the technology is not only addressing a marketplace demand, but also doing so in a patentable way. In addition, as competitors begin to pop up in the marketplace, patent claims that are supported by a pending application can be quickly obtained and used to address those competitive challenges. In fact, the Kenan Institute of Private Enterprise found just last year that small firms with limited patent portfolios are the most likely to expedite their patent applications and that accelerated patents are cited and litigated at higher rates than other patents.4 For this reason, while much of the press has been focused upon the change to first-inventor-tofile and the post-grant proceedings before the Patent Trial and Appeal Board, the change that has had the most impact on the US patent system under the AIA just may have been the creation of the prioritized examination program. REFERENCES
1. https://www.uspto.gov/patents/ initiatives/usptos-prioritized-patentexamination-program 2. https://www.uspto.gov/dashboard/ patents/ 3. https://www.uspto.gov/dashboard/ patents/special.html 4. https://kenaninstitute.unc.edu/ publication/the-track-one-pilot-programwho-benefits-from-prioritized-patentexamination/
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Increase Surface Release Improve corrosion resistance Prevent contamination Eliminate frequent maintenance Excellent adhesion properties SilcoTek Corporation Game-Changing Coatings www.SilcoTek.com TechService@SilcoTek.com +1(814) 353-1778
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REGULATORY UPDATE
EVOLVING REGULATIONS ARE FORGING A CLOSER RELATIONSHIP BETWEEN PLASTICS SUPPLIERS AND MEDTECH MANUFACTURERS SAYS ADAM PRICE, DIRECTOR OF PRODUCT, RIMSYS.
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anufacturers of medicalgrade plastics continue to play a critical role supplying high-grade materials to the medtech industry for medical and drug delivery devices, their components and diagnostics. Medtech manufacturers rely on purchasing controls within their quality management system to identify, assess, classify, and apply appropriate controls to each supplier partner. As the industry works to accommodate evolving standards, regulations, and certification processes and manufacturers adjust quality management systems as a result, partners within the supply chain are often affected by these changes. Medtech manufacturers must take steps to identify and best equip businesses playing the role of a critical supplier to be prepared to respond to changing requirements; they must also acknowledge the role critical supplier partners play in maintaining Notified Body (NB) certifications, and take action to ensure audit success. Regulatory Authorities responsible for ensuring the safety and efficacy of medical devices in the market are increasingly reliant on NBs — independent, non-governmental organizations accredited to evaluate devices and medtech manufacturers’ quality management systems for conformance to applicable standards and regulations. NBs play a key role conducting certification and surveillance audits to establish this conformance and are especially prevalent in the application of the new European Medical Device Regulation (MDR), In Vitro Diagnostic Regulation (IVDR), and corresponding CE certification for sale of devices into the European Union (EU). NB jurisdiction had been largely limited to legal manufacturers of the sellable medical devices with the responsibility to demonstrate purchasing controls lying solely within that manufacturer’s quality system. As Regulatory Authorities continue to expand the usage of NBs under MDR and IVDR to assess the medtech
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industry, these organizations have undertaken expanded roles and corresponding increased scope of responsibility. As a component of this new responsibility, an NB now expects audit access to all critical suppliers and to all sites where devices or critical materials and components are produced. Medtech manufacturers must identify and understand this exposure to ensure critical supplier partners are prepared and capable to manage an NB inspection should that need arise. It’s important to note that NBs may notify medtech manufacturers and their critical suppliers of an upcoming audit, but are within their power to arrive onsite unannounced for an audit. Regulatory Authorities require NBs to conduct unannounced inspections at some frequency as part of the certification process. Medtech manufacturers placing devices into the EU should determine critical suppliers in partnership with their NB. The contracts put in place between the manufacturer and the critical supplier should clearly acknowledge this role when appropriate and anticipate the need for both announced and unannounced NB inspections at the manufacturer as well as critical supplier facilities. Although there is no requirement for manufacturers to notify supply chain partners of their status as a critical supplier, the communication of this role and ensuring that critical suppliers have sound understanding of how to best support an onsite NB audit are key. The support is especially important in guiding those critical suppliers who have minimal experience managing an audit of this fashion. Communication and awareness are the first steps in aligning for this partnership, along with shared regulatory insight and information. Medtech manufacturers should consider shared access to regulatory information management or other systems where product and manufacturing information is consolidated. They can provide this access to critical suppliers to develop the capabilities and confidence to manage NB audits on their behalf. Medtech manufacturers can plan for success by opening lines of communication with supply chain partners identified as critical suppliers. With an aligned understanding of this relationship and appropriate preparation, partners can be prepared and confident in their capability as a critical supplier to the medtech industry.
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SUSTAINABILITY
HOLLY GAMAGE, SENIOR DIRECTOR OF CLEAN EARTH’S FULLCIRCLE BUSINESS ADVISES HOW MEDICAL PLASTICS COMPANIES CAN BECOME MORE SUSTAINABLE AND IMPROVE BRAND PROTECTION.
Prioritize, manage, and reduce
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onsumers are prioritizing sustainability when considering their purchase choices now more than ever, according to a recent survey that highlights how the pandemic has shifted consumer decisions to be more environmentally driven.1 Another recent consumer study revealed 70% think it is important for a brand to be ecofriendly.2 Similarly, medical plastics companies are looking for ways to reduce and recycle materials as much as possible.
however, beneficial for all parties involved, as well as the environment and consumers. Traditionally, certain unused items and those deemed unfit for sale, along with contaminated packaging, plastics and other medical industry waste streams were sent to a landfill or a disposal facility for incineration. In 2018, for example, nearly 50% of all waste in the US was sent to a landfill.3 Whether you are a manufacturer, distributor, or upstream supplier of reusable medical plastics, there are several important factors to consider when adapting to methods of effectively eliminating or reducing waste, while also maintaining a positive brand presence.
Waste reduction can mean reducing large quantities of waste at the source, meaning focusing on the initial production and design and selection of materials. Leading consumer goods manufacturers are honing in on the types of materials, such as plastics, that go into making the bottle or container that holds the goods consumers buy. By evaluating the design of historical packaging, which includes looking into the types of plastic used for the lid, bottle, pump, and so on, medical plastic manufacturers can best identify how to design products that align with sustainability goals.
AVOIDING BRAND RISK The ‘cradle to grave’ concept states that a generator is responsible for its waste at every stage, including the generation, transportation, treatment, storage, and disposal of waste. This means that if an incident happens at any point during the waste’s lifecycle, the generator will be held liable, potentially resulting in financial penalties, poor brand reputation and harm to human health and the environment. Leaders in the waste management space have a keen focus on brand protection and brand integrity, ensuring that medical devices and other byproducts that are not viable for business or consumer use avoid ending up in the wrong hands. When updated technology replaces older versions there is an overstock of supply, or materials are considered defective;
Medical plastics companies should prioritize recycling and reusing plastics and other nonviable, or unworkable, byproducts of manufacturing and distribution, meaning a secondary product resulting from a production process. When talking about byproducts, usually this means the various components of the unworkable inbound packaging and production waste. Recycling as much material as possible and building scalable, innovative programs can be a daunting undertaking. It is,
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SUSTAINABILITY
manufacturers of the updated technology must ensure that outdated items are recycled or properly destroyed. A reputable sustainability partner should develop programs that comply with all local and environmental regulations, while focusing on the future to protect brands from risk and expensive costs further down the line and putting the organization’s best interest first. In the medical plastics industry specifically, a partner must prioritize security and risk avoidance. A partner should closely track all branded material from pick up to final destruction to ensure it is rendered unusable and does not end up on the black market. A Certificate of Destruction (COD) should always be provided, documenting the receipt and destruction of nonviable waste. A partner who is knowledgeable of the company’s internal requirements, as well as local, state, and federal regulations, will ensure the entire process is seamless. SUPPORTING SUSTAINABILITY GOALS Beyond risk avoidance, a partner can drive the organization towards its sustainability goals. Many medical devices have recyclable materials and components, such as packaging, batteries, and cords, which a waste solutions partner may be able to segregate and consolidate for recycling. The same can be applied to components made entirely of plastic. A recycling plan should include driving higher levels of sustainability by increasing the percentage of recycled materials, as well as evaluations of upstream source generation. Medical technology providers must understand their sustainability footprint and how all technology and related materials are being reduced, reused and/or recycled, from glucose meters to surgical devices, pregnancy test kits and large pieces of diagnostic equipment. Another way to add value to a medical device company’s complete distribution plan is for the sustainability partner to evolve as the company evolves and continuously evaluate ways to improve sustainability efforts. SELECTING A PARTNER When looking for the right sustainability partner to minimize waste and/ or achieve zero waste, identify one that emphasizes the need to listen to and understand the company’s visions — this will inform them of how the company can take steps to becoming more sustainable. The right partner will consider the entire operation to customize waste solutions to fit the customer’s needs. A partner should be able to adapt and find solutions for an organization’s particular waste problems. As there are four types of medical waste (hazardous, infectious, radioactive, and general), the right partner will take a dedicated, personalized approach to recycling and beneficially reusing waste. They can also apply their expertise across industry boundaries and may replicate a solution to bring value to a particular client.
An experienced partner in the medical plastics industry is important. Although some waste management vendors do not consider sustainability goals as a top priority, it is critical that sustainability goals are a part of the complete journey as they will affect the future of any company or industry. Another important quality of a partner is their ability to offer enhanced data tracking and reporting of waste streams and how they align with financial and corporate goals, providing intricate insight on areas of improvement and trending. REALIZING THE BENEFITS Although complying with regulations and protecting the environment and consumers is the priority, also keep brand protection top of mind. There are major risks and negative outcomes that can result when organizations handle materials and products in a manner that does not ensure brand protection. By reducing waste where possible and properly managing the rest, medical plastics companies can unlock immense value. A particularly valuable asset on this journey is a waste solutions partner that builds a comprehensive, long-term and compliant program to address sustainability goals, while remaining sensitive to brand protection. REFERENCES 1. https://www.bcg.com/ publications/2020/sustainabilitymatters-now-more-than-ever-forconsumer-companies 2. https://www.ibm.com/downloads/ cas/EXK4XKX8 3. https://www.epav/sites/default/ files/2021-01/documents/2018_ff_ fact_sheet_dec_2020_fnl_508.pdf
By reducing waste where possible and properly managing the rest, medical plastics companies can unlock immense value
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SMART MANUFACTURING
MARTIN GADSBY, DIRECTOR AT OPTIMAL INDUSTRIAL AUTOMATION, ADVISES HOW A WELLDESIGNED DATA MANAGEMENT STRATEGY CAN HELP PRODUCERS OF MEDICAL PLASTICS SUCCEED IN SMART MANUFACTURING.
Smart WORKS
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he creation of Smart Factories can bring massive competitive benefits to businesses in the medical plastic manufacturing sector. These facilities leverage data generated throughout the manufacturing process to maximize responsiveness on the factory floor and optimize production. To unlock this potential and turn their plants into Smart Factories, medical plastic manufacturers need a knowledge management system to effectively gather, store, visualize and process data. By deploying a digital manufacturing strategy, companies can improve the capacity and productivity without increasing their footprint.
By turning existing facilities into Smart Factories, medical plastic manufacturers can take advantage of extensive benefits offered by a PAT-enabled process 18
IDENTIFY THE RIGHT TECHNOLOGY State-of-the-art technology is needed to set up Smart Factories for medical plastic production. Key elements include real-time, in-line and on-line probes, sensors, and spectral instruments to gather information, as well as data mining solutions to generate actionable insight and predictions about processes and operations. In addition, factory and process automation solutions, as well as digital twins (or cyber-physical systems), use the knowledge generated by instrumentation to optimize production and maintenance. A Process Analytical Technology (PAT) framework is essential to set up and interconnect these elements for responsive smart manufacturing applications. This is a quality-driven approach that relies on the relationship between critical process parameters and critical quality attributes of raw and in-process materials to optimize manufacturing activities. For example, this type of setup can be used to control hot melt extrusion of polyethylene oxide films by leveraging the multivariate data provided by near-infrared and Raman spectroscopy. IMPLEMENTING PAT SOLUTIONS The system used to link all the PAT systems together to create a Smart Factory is known as a data or knowledge management platform. In addition to automatically optimizing production process, this also acts as a key visualization tool that helps businesses have an immediate understanding of their processes and product quality predictions. When embarking on digital transformation projects, medical plastic manufacturers should select an automation specialist that can implement a comprehensive solution that includes, and seamlessly integrates, all the necessary technologies. By doing so, producers can create a truly intelligent, interconnected facility that result in significant reductions in
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SMART MANUFACTURING
production costs as well as substantial improvements in productivity, product quality and business sustainability. TURNING DATA INTO KNOWLEDGE Although it is relatively easy to generate large volumes of production data, medical plastic manufacturers need to identify which datasets should be stored, assessed, and rationalized into actionable knowledge. Without this filtering and analytics process, production facilities could resemble data warehouses, rather than agile, future-oriented plants, preventing businesses from achieving an in-depth process understanding that can enhance their shop floors. A PAT knowledge management platform, such as synTQ, is essential to this process. Instead of storing all the data from every single device along a production line, businesses can use a PAT knowledge manager to filter production data; for example, to only show key process parameters affecting a product’s quality attributes. This ensures that plant operators can instantly access actionable knowledge, without having to sift through large amounts of information. Historical data can also be profiled by experts, helping with the development of process-related mechanistic knowledge that can then be fed back into the process for further improvements. This can help manufacturers avoid overprocessing, thus reducing cycle times, energy usage and the risk of polymer thermal degradation, while ensuring the materials are well homogenized. In addition to scrutinizing data, the PAT data management platform also plays a crucial role in the delivery of highly automated Industrial Internet of Things (IIoT) applications. To identify the most suitable software, businesses need to consider some key elements, the first being what can the solution communicate with. MAXIMIZE INTERCONNECTIVITY A fundamental function that a PAT knowledge manager should support for smart manufacturing applications is data fusion. This is a process aimed at associating, correlating, and combining data as well as information from single and multiple sensors or other devices, including spectral instruments. The results of which can produce otherwise unobtainable, real-time, product quality attributes and process characteristics. By utilizing this capability, the software can maximize the use of accurate and precise predictive models and offer a key tool for process visualization. Also, this enables effective manual or automated process control and orchestration across the manufacturing line. To effectively support the fusion of data and information, the data management platform should connect to all different elements of a PAT system. For example, synTQ can be linked to multiple sensors and analyzers on the production line as well as industrial automation devices, such as programmable logic controllers, distributed control systems and supervisory control and data acquisition platforms. In addition, the software interfaces with higher level systems, such as historians, laboratory information management systems, manufacturing execution systems up to business platforms such as enterprise resource planning. Finally, to create a futureproof, IIoT-driven set-up, the synTQ PAT knowledge manager can connect to the Cloud to perform Big Data analytics. CONCLUSIONS By turning existing facilities into Smart Factories, medical plastic manufacturers can take advantage of extensive benefits offered by a PATenabled process and meet the needs of an increasingly demanding market. In effect, one of the biggest advantages is the substantial optimization of plant operations, which reduces OPEX while increasing overall productivity and profitability.
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Manufacturers who deploy effective PAT systems for real-time process control and monitoring, obtain an interconnected and responsive manufacturing line that can always maintain optimal process conditions to deliver high-quality products cost-effectively. When implementing PAT and automation solutions, manufacturers should look for a comprehensive system, where the different technologies are well integrated to ensure effective operations. An advanced knowledge management system, such as synTQ, must be incorporated into a PAT strategy as it is fundamental to enabling the interconnectivity of multiple disparate systems, data fusion and real-time quality predictions, which in turn enables qualitycentric real-time control. In addition, the software can streamline and simplify reporting, auditing, and data verification, enhancing quality management strategies and minimizing data integrity issues. To address these aspects and create a Smart Factory, businesses need to find a partner who knows their industry and specializes in automation and PAT. They need to be able to support every stage of a factory automation and PAT implementation project, providing all the necessary tools. By choosing a highly skilled partner, such as Optimal, companies can succeed in the digital transformation of their factories and organizations.
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CE Mark given for Cepheid’s ‘plus’ COVID and flu diagnostic test 1
The Xpert Xpress CoV-2/Flu/RSV plus is a rapid diagnostic test for detecting the viruses causing COVID-19, Flu and respiratory syncytial virus (RSV).
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The plus version provides a third gene target for SARS-CoV-2 detection to deliver broader coverage.
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The test is designed for use on any of Cepheid’s GeneXpert Systems placed worldwide, with results delivered in approximately 36 minutes.
Henkel launches novel ‘healthcare’ 3D printing resins
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new class of 3D printing resins for healthcare applications expands Henkel’s Loctite brand. The broad portfolio of high-performance photopolymers offers a range of biocompatibility standards from safe-to-touch parts to medical devices. In addition to the established portfolio of Loctite 3D printing resins, the company innovates
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to deliver tailored formulations to fit the specific application requirements and market demands for optimised production. Recently, the Henkel 3D printing facilities in Concord (laboratory) and Dixon (production) in California, have achieved the ISO 13485:2016 certification for medical applications. Henkel 3D printing resins are designed and manufactured in accordance with ISO 13485 quality management standards to ensure uniformity in design, development, production, and delivery of medical devices. In Henkel’s case specifically, it covers the design and manufacturing of biocompatible resins and other materials used to produce non-implantable medical devices.
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Only one sample is required to run a single, highly sensitive multiplexed test that detects and differentiates all four viruses.
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Shipping to countries accepting CE-marked products began in October.
Argon Medical launches innovations for portal vein access procedures
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lobal manufacturer of specialty devices for interventional radiology, vascular surgery, and interventional cardiology Argon Medical Devices has launched two unique portal vein access sets intended for transjugular liver access in diagnostic and interventional procedures. The SCORPION Portal Vein Access Series addresses the common challenges physicians encounter when placing a transjugular intrahepatic portosystemic shunt or conducting other portal vein access procedures. The series includes Scorpion and ScorpionX, which offer improved visualization, revolutionary navigation control, and enhanced
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durability to augment existing procedural techniques. Using a patented curve-incurve system the series offers physicians 360° range of motion with the needle or stylet used to access the portal vein. Each curved component can work together or independently to accurately steer the device through the liver to the intended target. Existing systems utilize only a single curve limiting the steerability of the needle or stylet. The Scorpion Series’ novel design was created by Dr Lowell Kahn, a vascular and diagnostic interventional radiologist located in Springfield, MA, in conjunction with Hatch Medical.
MEET MEDICAL REGULATIONS AND
MITIGATE RISK With MEVOPUR™ Compliant Colors When it comes to plastics used in medical applications, the need for compliant and consistent colorants and additives has never been more important. With robust raw material pre-testing and an unparalleled global change control process, MEVOPUR medical-grade concentrates offer peace of mind and help you deliver safe, reliable treatments.
For more idea inspiration, visit avient.com COV3
