MPN NA Issue 27

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.

So clear it’s like it’s not even here: highly transparent CYROLITE® for diagnostic applications.

editor | olivia friett olivia.friett@rapidnews.com

group portfolio sales manager | caroline jackson caroline.jackson@rapidnews.com

advertising | helen hickey helen.hickey@rapidnews.com

vp, sales & sales talent | julie balmforth julie.balmforth@rapidnews.com

head of studio & production | sam hamlyn

Editor’s Comment

OLIVIA FRIETT

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Hello,

and welcome to Q4 of Medical Plastics News - the final issue of 2023. It feels as if this year has gone by in the blink of an eye yet we have seen so much happen.

The team has visited multiple shows around the world this year - Arab Health, MD&M West, Med-Tech Innovation Expo, MD&M East, Interplas and still has Compamed to visit in November. How is it possible to speak to so many companies and see so much innovation and yet there is still always something new around the corner?

At Arab Health, Diamedica shared how its portable systems can enable safe anaesthesia and respiratory support. The portable machine can function anywhere from in a hospital or in a rural clinic. Designed with some of the world’s most challenging environments in mind, it shows how far the industry has come with making technology accessible for all.

DuPont showcased its healthcare portfolio, including their soft elastomeric silicone adhesive at MD&M West (you can read more about this on page 6). In collaboration with Aevice Health, they shared their smart stethoscope, used for connected at-home monitoring and early detection of asthma attacks. To think that around 2,000 people around the world use an inhaler every second, how much must this stethoscope help avoid potential casualties?

Med-Tech Innovation Expo saw ZwickRoell showcase its testing machinery. Its therapy systems products include testing for autoinjectors, insulin pens, prefilled syringes, plus testing blister packaging to establish how much force is required for a tablet to be removed for consumption. Everything that is used on a patient needs a quality test and with regulatory standards rising, the requirement for testing needs to rise along with this.

Of course, one thing that everyone could have

predicted this year is the continuous regulation delays and numerous companies are using their expertise to aid others where they can; one of these companies is AND Technology. At Med-Tech Innovation Expo, the company launched TENTO+, an online platform that helps you manage design and risk compliance of medical devices across all major regulation.

Regulation is the focus of many companies in the industry, including BioInteractions who unveiled a new pathway. On page 19, you can read about how the company has utilised its 30 years of expertise to create its Product Pathway Partnership.

MD&M East in New York gave us the opportunity to meet ICP DAS, Asia’s first medical-grade thermoplastic polyurethane (TPU) manufacturers. The company produces three product series: Alithane, Durathane and Arothane – you can learn more about the company on page 31.

Our Rapid News sister show Interplas – the UK’s biggest show for the plastics industry – saw Ampacet showcase the ProVital and ProVital+ range of masterbatches for healthcare applications. The combination of raw materials and strict manufacturing conditions with the masterbatch means packaging can meet high industry requirements and regulations.

Last but not least is Medica/Compamed in November - one of the biggest medical shows in the world, with nearly 6000 exhibitors across 18 halls. We’re excited to meet new companies, see new innovations and catch up with familiar faces. If you have something to show us that we simply must see, please get in touch!

With more shows to visit and innovations to see, who knows what 2024 will bring? I’m looking forward to finding out.

https://discovery-park.co.uk/

Discovery Park selects 13 startups to join life science programme

Thirteen life science start-ups have been accepted onto Discovery Park’s new business support programme and competition, Discovery Spark. The eight-week Discovery Spark programme will equip the early-stage companies with the necessary skills to catalyze their business growth plans and gives them the chance to win a business support package worth over £100,000.

The start-ups span across the biotech, digital tech, engineering

biology, synthetic biology and medical technology sectors. Participants were chosen by a judging panel that scored the start-ups based on their product or service, opportunity and market, team management, programme fit and investment potential.

The programme will culminate with an investor pitching event sponsored by Discovery Park as part of the GIANT Health conference on 5th December 2023. The startup with the best pitch at the conference will win a business support package worth over £100,000. The package includes one free year of lab space at Discovery Park and £50,000 investment from Discovery Park Ventures, as well as comprehensive business support and mentoring.

EXPANSION UPDATE

https://www.junkosha.com/en

https://mayku.me/

Mayku’s custom mode to deliver injection mold quality parts

Mayku introduces its Multiplier Pressure Former, bringing the precision of injection molding to engineers’ benchtops for the first time. It now enables engineers and designers to capture sub-micron details, creating isotropic prototypes and end-use parts within 2 to 30-minute cycles.

With its new custom mode, users can now create custom profiles for any compatible thermoformable material. Custom mode also helps increase accuracy by giving engineers extended control over the machine’s pressure capacities.

The machine’s new reducing plate accessory also simplifies material sourcing and testing by condensing the forming area down to a more widely available A4 or US letter format and extends the range of thicknesses from as low as 0.1 mm to more than 5mm.

The Mayku Multiplier now produces consistent, repeatable parts with

material properties typically reserved for injection molding, such as high chemical resistance and optical clarity. It works with hundreds of hard-to-print thermoplastic materials, including PMMA, UHMW and polypropylene.

When used in conjunction with 3D printers or CNC milling machines, the Multiplier can scale up the production of end-use parts, aiming to achieve the same accuracy level every time.

Japanese fluoropolymer manufacturer, Junkosha, is delivering benefits to its customers ahead of schedule thanks to capacity gains resulting from its growth strategy.

A reduction in lead times down to 10-14 weeks for both the peelable heat shrink tubing and liners solutions is a benefit Junkosha can deliver as it works with customers worldwide to stabilize the supply chain. Junkosha is continuing to add more machines and resources with the expectation that it will have doubled capacity by the end of 2023, and tripled capacity by mid-2024.

In the medtech sector, Junkosha understands that customers need access to innovations that support their efforts in pushing the boundaries to develop new interventional products and therapies that lead to improved patient outcomes.

Mike Winterling, chief operating officer, Junkosha, explains: “We have worked hard as a company over the last 18 months to not only increase our capacity through new machines and products, but also on clear communication with customers as we work together to improve the robustness of the entire supply chain.”

https://www.bolle-safety.com/gb/

www.medovate.co.uk

MEDOVATE SIGNS DISTRIBUTOR AGREEMENT WITH FANNIN

Bollé Safety earns EcoVadis gold medal sustainability accreditation

Medovate has concluded a distribution agreement with Fannin Limited giving the Dublinbased company distribution rights for SAFIRA (SAFer Injection for Regional Anaesthesia) across the Island of Ireland.

The SAFIRA system has been developed by Medovate in collaboration with anesthetists in the UK National Health Service (NHS) and has been designed to help revolutionize standard regional anesthesia clinical practice and promote patient safety. Regional anesthesia is a widely used anesthetic practice to place peripheral nerve blocks to numb a specific part of the body prior to a surgical procedure so the patient remains awake but feels nothing.

With the appointment of Fannin as a further distributor for the SAFIRA technology, anesthetists across Ireland will be able to access and apply the SAFIRA system in their everyday practice and realize the benefits of the technology for both them and their patients.

Kieran O’Halloran, commercial director Fannin said: “Fannin is delighted to have partnered with Medovate to become the exclusive distributor across the island of Ireland for the SAFIRA (SAFer Injection for Regional Anaesthesia) system.”

Bo llé Safety has announced that its European division has been awarded a EcoVadis sustainability gold medal accreditation. This recognition places the company amongst the top 5% of companies assessed by EcoVadis in more than 175 countries worldwide, and underscores Bollé Safety’s dedication to sustainability and responsible business practices.

FACILITY UPDATE

https://www.turbofil.com/

TurboFil expands development and demonstration facility

TurboFil Packaging Machines, an equipment specialist dedicated solely to the design and development of liquid filling and assembly machines, has expanded the product development and demonstration space at its Mount Vernon, NY headquarters. The additional elbow room was necessary to accommodate double-digit year-over-year business growth, driven primarily by heightened demand for the company’s pharma syringe filling and capping solutions.

For TurboFil, the expansion provides the company with approximately 50% more square footage – valuable real estate for designing the type of complex solutions it

EcoVadis is a globally recognised and independent sustainability assessment platform that evaluates companies’ environmental, social, and ethical performance. Achieving this accreditation demonstrates Bollé Safety’s efforts in sustainability across various areas, including environmental impact reduction, ethical business conduct, and social responsibility.

Peter Smith, CEO of Bollé Brands Group and president of Bollé Safety, said: “We are delighted to receive the EcoVadis Gold Medal accreditation, which acknowledges the collective commitment of our team to sustainability. This accreditation is a testament to our dedication to making a positive impact and a significant step for many more exciting announcements to come.”

The EcoVadis Gold Medal accreditation adds to a growing list of initiatives and achievements from Bollé Safety. The new strategy underscores important commitments by the group such as reducing carbon emissions of each of its products by 35% by 2027, guaranteeing 100% of packaging will be eco-friendly by 2025, and ensuring 90% of its product ranges are eco-designed by 2027.

provides pharma customers in the US and beyond.

“The previous few years have seen the sort of consistent growth that requires an expanded physical footprint, particularly for the design, development, validation and demonstration teams,” said Deborah Smook, VP of marketing & business development for TurboFil Packaging Machines. “Needing more room to address rapid growth is perhaps the best ‘problem’ to have, and we’re excited for the expansion and the additional opportunities it will help accommodate.”

MAKING THINGS

Silicone SSAs offer gentle skin adhesion with low peel release force. They also are non-sensitising, non-irritating and non-cytotoxic. Consequently, they are ideal solutions to protect highly sensitive and fragile skin, allowing children, the elderly or patients with skin conditions to receive medical support outside of medical facilities

In addition, their repositionability enables greater ease of use, cost-effectiveness and sustainability by avoiding device consumption in case of misapplication or detachment, thereby reducing waste. This benefit can be of value particularly in the context of growing adoption of smart medical patches for patient monitoring to enable device repositionability and atraumatic removal.

BENEFITS OF SILICONE ADHESIVES

Silicone skin adhesives for wearable medical devices include soft skin adhesives (SSAs), pressure sensitive adhesives (PSAs) and next-generation hybrid adhesive systems that incorporate the best properties of both.

The silicone soft skin adhesive technologies pioneered in the 1990s by what is today known as DuPont Liveo have become adopted by the market in advanced wound care and scar therapies.

SILICONE ELASTOMER TECHNOLOGY

Silicone elastomers are made with a combination of polymers, reinforcing agents, a crosslinker and a catalyst; different combinations determine the type of elastomer produced: Heat Cured Rubber (HCR), Liquid Silicone Rubber (LSR), and Room Temperature Vulcanisation (RTV).

Silicone elastomers are used in highperformance applications, they ensure long durability and reliability, even when exposed to a wide range of temperatures (from -50 °C to 250 °C).

SOFT SKIN ADHESIVES

DuPont Liveo SSAs are based on platinum-catalyzed silicone elastomer technology – solventless and formulated to deliver suitable adhesion to skin. The physical properties of these adhesives lead to cohesive, self-adhering materials for biomedical applications.

Silicone technology has a more than 70-year history of safe, effective use in specialty medical and pharmaceutical applications with the strictest biocompatibility and quality requirements, such as drug delivery devices, monitoring and diagnostic devices, respiratory devices, urology and gynecology devices, and more.

Today, for skin contact applications, silicone skin adhesives are recognized for their quality and versatility, as well as for their ability to offer atraumatic removal, repositionability, reliable long-lasting adhesion and comfortable wear. These adhesives can be designed not only to provide suitable adhesion performance for the application, but also to encourage improved patient compliance.

EMPOWERING HEALTHCARE INNOVATION

Wearable medical device manufacturers around the world are partnering with specialists in silicone skin adhesive technology -- including DuPont Liveo – to develop innovative wearable devices for people of all ages. These include wireless vital-sign monitors for premature infants, devices to report pressure ulcers in bedridden patients, and devices for day-to-day tracking of health metrics in people managing chronic conditions such as diabetes – the kinds of devices that support the global push towards broader, more accessible healthcare for all.

Silicone soft skin adhesives have the power to help wearable medical technology innovators develop devices with the potential to improve overall health and wellbeing for all people at all ages.

Recently, DuPont Liveo partnered with Singapore-based Aevice Health Pte in the development of the AeviceMD, a smart AI wearable stethoscope that provides continuous, connected care for at-home monitoring and early detection of asthma exacerbation.

Most asthma-related deaths occur in low-income and lower-middle-income countries, where underdiagnosis and undertreatment are frequent issues. While asthma affects both children and adults, it is the most common chronic disease among children, so Aevice created its wearable stethoscope specifically for children ages 2 and up. This required serious consideration of the highly sensitive, fragile nature of children’s skin.

Standard acrylic double-sided tape attachment solutions proved too harsh. But a DuPont Liveo soft skin adhesive typically used in advanced wound care provided Aevice Health with an alternative suited to the sensitive skin of children. The resulting attachment was a safe, comfortable, long-lasting solution with the ability to improve children’s experience, comfort and compliance.

JENNIFER GEMO, XAVIER THOMAS, AUDREY WIPRET, JASON SIANG & ALEXIS BOBENRIETH, DUPONT LIVEO HEALTHCARE, SHARE THE BENEFITS OF SOFT SKIN ADHESIVES USING SILICONE ELASTOMER TECHNOLOGY.

GAUTAM GUPTA, PH.D., SENIOR VICE PRESIDENT AND GENERAL MANAGER, MEDICAL DEVICES, 3D SYSTEMS PINPOINTS

THE ADVANTAGES OF PEEK IN MEDICAL DEVICE IMPLANTS.

Peek PRECISION

Medical device manufacturers need innovative ways to bring high-quality, reliable products to market faster. 3D printing has rapidly gained traction as a technology that can produce intricately designed medical devices such as spine cages. With the release of faster, multi-laser systems, manufacturers can costeffectively expand applications to larger implants for the shoulder, hip, and knee. Additive manufacturing (AM) also enables the design and efficient production of patientspecific implants and instrumentation. Now, with the ability to 3D print implants in polyetheretherketone, more commonly known as PEEK, manufacturers are exploring the possible applications to capitalize on the tremendous advantages this high-performance polymer has to offer.

PEEK has mechanical properties such as high strength, durability, and fatigue resistance that are close to those of human bone, enabling enhanced load-bearing performance and reduced risk of stress shielding. PEEK is also radiolucent which helps improve visibility in medical imaging to determine how the bone is healing, for example, as part of tumor surgery.

The EXT 220 MED enables the processing of high-temperature materials, such as PEEK. A wide range of medical applications is conceivable.

HARNESSING THE VIRTUES OF PEEK WITH 3D PRINTING

While PEEK is well-known within the orthopedics market, most PEEK implants are still produced using conventional manufacturing methods like machining, turning, or injection molding due to misconceptions about the ability to 3D print PEEK. These likely arise from the early days of 3D-printed PEEK implants when the constructs often did not show the same mechanical properties exhibited by traditionally manufactured parts. 3D Systems has been able to change this perception due to the 3D printing technology. This printer’s integrated cleanroom and temperature controls with a laminar airflow make it ideal for the rapid manufacture of biocompatible, sterilizable medical devices. The combination of PEEK and 3D System’s extrusionbased platform enables design flexibility to create complex, patient-specific geometries.

REVEALING THE POTENTIAL OF PEEK IMPLANTS

The promise of implants that are additively manufactured using PEEK is already being realized. The solution has most notably seen successes in cranial implants, spinal cages, and bone plates for trauma.

Earlier this year, University Hospital of Salzburg (Austria) successfully applied 3D Systems’ portfolio of point-of-care additive manufacturing technologies to design and produce its first 3D-printed PEEK cranial implant as a custom device for a 55-year-old male suffering from a skull deformity. Brought together by the hospital’s in-house clinicians, the team used Oqton’s D2P software to create 3D models from the patient’s CT images and Geomagic Freeform to complete the design of the patient-specific occipital prosthesis. The cranial implant was printed using VESTAKEEP i4 3DF PEEK by Evonik on 3D Systems’ EXT 220 MED (formerly the Kumovis R1) extrusion platform.

Implants play a pivotal role in treating craniomaxillofacial trauma. In these situations, time is of the essence to get the patient into surgery and provide critical care. The ability to rapidly produce patient-specific cranial and orbital implants from PEEK has the potential to not only provide care as efficiently as possible but also can help enable a better outcome and healing for the patient. Producing these plates using PEEK enables lightweight plates yet perhaps not the durability required to facilitate healing. In these cases, carbon-fibre-reinforced (CFR) PEEK is showing promise. The modulus of CFR-PEEK is the closest to that of human bone, which enables strength and durability. CFR-PEEK also provides higher osteoconductivity and allows for better osseointegration and implant fixation. Additionally, CFR-PEEK’s radiolucency allows the ability to track bone healing while assessing the surrounding tissues and monitoring the implant’s performance.

PEEKING INTO THE FUTURE

Hospital-based printing with PEEK shows great promise as the material can be printed quickly, is biocompatible, requires minimal post-processing, and can be used for a broad range of both standard and personalized implants. Combining PEEK with an advanced extrusion platform can help facilitate this new frontier. As these technologies become more user-friendly for medical professionals, more hospitals will be able to implement additive manufacturing at the point of care as part of an end-to-end solution for personalized surgery.

EVONIK

INDUSTRIES DISCUSSES SMART BIOMATERIALS BASED ON PEEK AND HOW THEY OPEN UP POSSIBILITIES FOR PATIENT-SPECIFIC TREATMENT.

PEEK OF ITS POWERS

Among the many developments in today’s medical technology, three very exciting areas are offering a wide range of growth and potential in the polyetheretherketone (PEEK) biomaterials field: the need for more patient-specific and point of care treatment, digitalization and robotics, and metal-free solutions.

“Improved, patient-specific treatment at point of care is true reality. For example, it is already possible today to integrate bioactive additives with biomaterials, giving 3D printed implants a range of characteristics that promote faster bone-healing and thus better patient recovery,” said Marc Knebel, head of Evonik’s Medical Systems market segment. “Besides additive manufacturing of individual implants, patient-specific treatment also means to offer material solutions for people’s different natures. In this regard, metal-free solutions like polymer-based medical devices are in demand.”

DIGITALIZED TECHNOLOGY AND SMART BIOMATERIALS

The use of easy-to-handle implant grade, 3D printable PEEK filaments – such as VESTAKEEP i4 3DF – in combination with suitable dedicated medical printers and the integration hardware and software in digital workflows, has led to a positively disruptive step towards point of care treatment: such a combination of material and technology allows implants to be created directly in the hospital. Having been first achieved with VESTAKEEP i4 3DF at Skåne University Hospital, a Swedish hospital, in 2021, the potential benefits of 3D printing smart biomaterials on-site has become limitless.

Another breakthrough in patient-specific care with smart biomaterials is the use of the VESTAKEEP i4 3DF filament early in 2023, in the first US surgeries of a 3D printed spinal implant. Printed by Curiteva, the hightech implant was cleared by the US Food and Drug Administration (FDA) and was the world’s first 3D-printed, fully interconnected porous PEEKimplanted structure of its kind for commercial use.

Recently, the first patient at the University Hospital Basel received a 3D-printed implant based on Evonik’s PEEK filament from in-house production. A 46-year-old man suffered a stroke in 2019. During treatment, his skullcap was removed and replaced. But after a few months, the ceiling began to disintegrate, and the skull sank in. A team led by Raphael Guzman, head of neurosurgery, and Florian Thieringer, head of oral and maxillofacial surgery, succeeded in producing an artificial skullcap in the in-house 3D printer.

ADVANCED OSTEOCONDUCTIVE MEDICAL PLASTICS

For certain medical procedures, the ability for bone cells to adhere to implants, also known as osteoconductivity, is critical for good patient recovery. Specific ceramics and porous metals are traditional materials used for this purpose. Key to success is a material’s ability to be formed to mimic bone structure and chemistry.

Smart biomaterials combine multiple features in one material. The most prominent feature of VESTAKEEP Fusion smart biomaterials is its inclusion of a special additive - biphasic calcium phosphate (BCP). BCP can

positively influence osteointegration with the body’s existing natural bone. As a result, bone fusion is promoted, leading to accelerated patient recovery.

ONGOING DEVELOPMENTS IN SMART PEEK BIOMATERIALS

As the global needs in the medical industry continue towards more customization, digitalized and metal free solutions, the range of possibilities in high-tech medical plastics is boundless. This goes beyond human implants. In its future-oriented strategy for smart PEEK biomaterials, Evonik is also exploring uses for joint prostheses in veterinary as well as in human implants. Continued research and development in joint implants aims to reduce the need for revision surgery and long-term pain therapy.

Among other developments to come, Evonik is working on a carbon-fiber reinforced PEEK-based filament, which will come in different options that allow more customization towards the strength and flex requirements of the implant to be 3D printed.

In the future, as the medical industry grows, PEEK-based biomaterials will continue to be a boon for medical plastics manufacturers operating in this exciting, high-growth field.

PIERRE MOULINIÉ AND PAUL NOWATZKI, COVESTRO, DISCUSS HOW AGING STUDIES WITH POLYMERS ARE DONE, BOTH IN REAL TIME AND ACCELERATED.

Manufacturers of medical devices are expected to provide guidance on the service life of their products. Furthermore, devices are often stored for many months prior to use, and knowledge about a device’s shelf life is also necessary. How a material’s properties change over several years is therefore an important aspect of whether it is suitable to use in a medical device. For plastics, factors such as elevated usage temperatures, exposure to UV radiation or being under constant mechanical load can cause significant physical property changes over time. A more subtle, yet still relevant change that can occur at ambient conditions is termed physical aging.

Data for a medical grade polycarbonate collected in Covestro laboratories serves as an example of estimating the aging factor Q10.

WHAT ARE AGING AND ACCELERATED AGING?

Rigid plastics, i.e., those below their glass-transition temperatures (Tg), have polymer chains in a configuration that was frozenin during processing. Despite being below Tg and “frozen”, the polymer chains still undergo a slow densification process. Over time, the decrease in free volume between polymer chains can slightly alter polymer properties. Since storing samples for several years is not always feasible, accelerated aging studies apply the time-temperature superposition principle to use data from test samples stored at elevated temperatures for relatively short periods to

predict changes at ambient conditions after several years. In the case of polycarbonate, although the decrease in ductility from aging is sometimes measurable, the polymer remains overall ductile and tough. So-called Q10 factors estimate how the rate of aging changes with an increase in temperature of 10°C and are used to design accelerated aging experiments.

THE Q10 FACTORS FOR ACCELERATED AGING

The simplicity of the Q10 approach makes its use for aging studies of materials in medical equipment fairly common. Some researchers claim that Q10 factors are oversimplified and have proposed models that may more accurately reflect changes over time.

The following equations capture how Q10 factors are used:

Where TAA is the temperature for accelerated aging, and AAF, the accelerated aging factor, reflects the ratio of aging rates between TAA and ambient temperature (TRT). It follows that the accelerated aging time can be estimated by:

Complications in accelerated aging studies at high temperatures can arise from chemical or structural changes in the polymer. Degradation, oxidation, crystallization which can also occur in plastics, especially at elevated temperatures, or creep from prolonged mechanical stress can complicate the analysis and hamper extrapolations to ambient temperature. If the actual application entails conditions that may prompt chemical or structural changes, then real-time aging studies may be unavoidable.

Q10 DERIVATION EXAMPLE: POLYCARBONATE

For polycarbonate, the tensile stress at yield is a sensitive indicator of aging and is useful to construct the equations to estimate Q10. In the example that follows, a medical grade polycarbonate (Makrolon 2458 550115, from Covestro) was injection-molded into ASTM tensile bars according to recommended procedures. Accelerated aging was done by subjecting tensile bars to temperatures between 60°C and 100°C for various lengths of time, up to 100 hours. Using the time-temperature superposition principle, the tensile strengths at each temperature were shifted to form a master curve. The shift factors were plotted versus inverse absolute temperature to construct an Arrhenius plot. The slope of this plot represents the activation energy that describes how aging rate depends on temperature. The ratios of Arrhenius reaction rates at the TAA and TRT gives AAF, which is used with equation (1) to find Q10. For the polycarbonate studied in this article, a Q10 of roughly 7.6 was obtained in the 25-55°C range which is a common range for accelerated aging studies.

MODELS VS. REAL-TIME AGING

Tensile bars of an analogous polycarbonate grade were stored at ambient conditions for 3.6 years. The tensile yield strength was

Taking Taking

Biomaterials Biomaterials Further Further

measured immediately after molding and again 3.6 years later and was found to have increased by 0.7 MPa. To simulate years at ambient temperature, tensile bars of the same grade were aged at 55°C for intervals up to 168 h. A Q10 of 7.6 predicts that 3.6 years at ambient conditions (25°C) is like 72 hours at 55°C, and indeed the tensile yield strength increased from 0.6 ± 0.2 MPa over this interval. The predicted and actual results were deemed to be in excellent agreement.

Transformative biomedical solutions

Transformative advancing healthcare innovation advancing healthcare

As restorative healers who possess a true passion

As restorative healers who a true passion for improving patient outcomes, DSM Biomedical* for improving patient outcomes, DSM Biomedical* aspires to aspires to solve our world’s healthcare needs solve our world’s healthcare needs through sustainable science through sustainable

JUHA

MATTILA, DIRECTOR, STERILIZATION TECHNOLOGIES,

STERIS LIFE SCIENCES, DISCUSSES HOW THE COMPANY IS DEVELOPING TECHNOLOGIES THAT IMPROVE PATIENT CARE – INDEPENDENT MONITORING FOR INDUSTRIAL VH202 STERILIZER CYCLE CONTROL AND MONITORING.

Vaporised Hydrogen Peroxide (VHP) – or VH2O2, is playing an increasingly important role for today’s biopharmaceutical and medical device industry manufacturers. This is especially true when considering a sterilization modality, feasible for temperature and/or radiation sensitive, packaged single-use devices. Such products include hip and knee implants, stents, cardiovascular type implantable devices, subcutaneous patches, and combination devices such as a prefilled syringe designed to administer a sensitive drug, such as ophthalmic injectables for macular degeneration disease of the eye.

STERIS manufactures VH2O2 sterilizer equipment for the sterilization of reusable medical devices in healthcare settings, and industrial sterilizers for sterilization of single-use medical devices in biopharmaceutical and medical device manufacturing facilities. The first VH2O2 sterilizers for industrial use were introduced by STERIS over 20 years ago.

VH2O2 is compatible with most materials and applicable for surface sterilization at low temperatures of 2850 °C [82-122°F]. A benefit of VH2O2 sterilization is the absence of any toxic residuals or byproducts, as hydrogen peroxide sterilant breaks down into water vapor and oxygen.

A risk-based approach to the sterilization process is required. The recently published EU Annex 1:2022 adds emphasis to this and sets more specific requirements for manufacturing of medicinal products in Europe and globally.

Control over a sterilized production batch is achieved by routine monitoring. This includes monitoring the process and the inactivation of process challenge devices placed on the product load being sterilized. An applicationspecific external process challenge device (ePCD) is developed and validated for the process and then

used to verify successful sterilization of production batches. A process challenge device is a combination of a biological indicator of known high resistance (Geobacillus Stearothermophilus), and an item providing a defined resistance to a sterilization process that yields an equal or higher resistance than the product being sterilized.

The sterilization process is required to be controlled, monitored, and independently verified. Resulting in continuous risk-based evaluations to improve process safety in the industry, independent monitoring has been introduced in equipment standards such as EN 285 for steam sterilizers and EN 1422 for ethylene oxide sterilizers.

ISO/TS 22421 sets common requirements for sterilizer equipment and includes general guidance for independent monitoring. Having a specified and validated independent monitoring of process variables in place can be instrumental in considerations for parametric release of production batches.

VH2O2 sterilization is a well-recognised process as evidenced by the recently published VH2O2 specific standard ISO 22441 - Sterilization of health care products - Low temperature vaporized hydrogen peroxide - Requirements for the development, validation, and routine control of a sterilization process for medical devices. Currently, CEN is also developing the standard specific to VH2O2 equipment requirements (EN 17180). Currently it is estimated to be published in 2024.

A modality-specific industry standard results in the ability to be more specific with the requirements and risk mitigating approaches that enable continuous improvement of processes for the industry.

MONITORING THE SITUATION

ISO 22441 sets general requirements for the process but also calls out for control and monitoring and defines the main process variables:

• time (intervals and setpoints)

• temperature

• VH2O2 concentration (measured directly or indirectly)

• pressure

STERILIZATION PROCESS

An industrial VH2O2 sterilizer process is based on vaporizing liquid hydrogen peroxide sterilant (H2O2), typically of 35% concentration and delivering into the chamber by vacuum. Vaporized hydrogen peroxide is delivered in a noncondensing dry vapor state into a production scale chamber of up to 9,000-liter volume. Deep vacuum pulses of 4-10 mbar [3-7 Torr] and chamber fan circulation are used to ensure the hydrogen peroxide sterilizing agent reaches all locations within the load and devices to be sterilized. After sterilization, the hydrogen peroxide sterilizing agent is removed from the chamber and load by aeration, with in-line catalyzing of exhaust effluent to destroy remaining hydrogen peroxide.

TEMPERATURE

Achievable maximum VH2O2 concentration is dependent on chamber temperature. Cycle temperature is unidirectional only, meaning that the process has a minimum temperature to reach prior to cycle commencing to the sterilization phase. The cycle temperature typically increases during the entire cycle, and this results in slightly increasing the VH2O2 concentration during the sterilization phase to maintain the defined relative humidity (RH%) setpoint.

VH2O2

CONCENTRATION

Equally important as temperature is controlling the VH2O2 concentration to ensure consistent and repeatable sterilization efficacy, and optimal total cycle profile in general. The VH2O2 injections increase chamber humidity, and the process is controlled by the sterilizer via a relative humidity sensor (RH) that has a specified set point (RH%) resulting from cycle development and process validation. The purpose of the RH-sensor is to control reaching and maintaining VH2O2 concentration during the sterilization pulses.

PRESSURE AND TIME

The chamber pressure sensor is assigned to control the vacuum level to a defined set point (4-10 mbar level). The exact pressure and hold time parameters for each specific sterilization application are determined during validation activities.

INDEPENDENT MONITORING

The STERIS VHP LTS-V sterilizer independent control and monitoring design adds a reference load temperature sensor and a reference chamber pressure sensor to the chamber. Measurements from these devices are transferred to an independent recording device. The total consumption of hydrogen peroxide during the cycle is monitored by measuring the total injected volume

of VH2O2 per cycle from the liquid hydrogen peroxide reservoir that feeds the VH2O2 vaporizer. This value is transferred to the recording device for evaluation (see VH2O2 reference level sensor in Diagram 1).

The control sensor measurements are taken to the PLC that controls the chamber process and to the recorder. The reference sensor measurements are directly taken to the recorder. The recorder compares these measurements and their specified ranges and establishes if any deviations exist. These deviation values are sent to the PLC where all deviation alarms are recorded and printed in the batch report for batch evaluation.

Independent monitoring of a sterilization process is designed to improve process control reliability and confirm that required means are provided to ensure an effective cycle. Along with the long application history, regulatory approvals, and having the latest developments of industry standards in place, VH2O2 sterilization is proven to be a comprehensively established sterilization modality that can safely be implemented to a medical device sterilization application.

Diagram 1: Process instrumentation of the VHP LTS-V sterilizer cycle control

Diagram 2: VHP LTS-V sterilizer independent monitoring

Medical diagnostic equipment & biotech applications

ALBIS offers the medical industry an unparalleled choice of high performance polymers from renowned producers. This offering is complemented by customized polymer compound solutions tailored to customer’s needs and made by ALBIS’ sister company MOCOM.

We support numerous projects in the medical and pharmaceutical sector as well as for diagnostic equipment and biotechnology applications. Addressing the latest trend towards an increasing use of sustainable solutions our portfolio includes newest and state of the art sustainable polymers which are specifically developed to fulfil the strict regulatory and service needs of the healthcare industry.

albisuk@albis.com

albis.com

Weare witnessing an increase in supply-chain complexity and a shortage of raw materials. This leads to more and more illegal copies of original components, which threaten the integrity and safety of consumers and of the industry relying on them.

To mitigate these risks, savvy brands implement traceability and authentication of their products. Traceability identifies the path all the way to the place of production, while authentication ensures that the parts are original. The anticounterfeiting features must be identifiable as such by consumers, legal authorities, investigative teams or the brands themselves.

WHICH SOLUTIONS?

Typical solutions involve printing or laser etching. This can include batch and serial numbers, QR codes, special product features such as shapes, colors, or in-mold labels, security labels, material taggants and other additives. For molded products, a new solution solves both issues with zero consumables and no post-processing. It provides anticounterfeiting with instant authentication and tracing of the part to the original mold cavity. It is based on engraving parts of the mold (inserts or cavities) with nano-precise features. Such features were previously only available for flat designs such as passport security. For three-dimensional molds, the nano-features are created not with a laser, but by lithographical means. They are then transferred with a proprietary patented technology to hardened-steel inserts or cavities, from which they are replicated into the molded parts.

Due to their extraordinary precision of just tens of nanometers, the structures diffract light, similar to the visual effects of CDs. But the diffraction is now fully customized, with the logo or more complex design the brand chooses. Hidden security can be included via micro/nano-images and text, as well as laserreadable codes.

WHY NANO-ENGRAVING?

The nano-engraving is used in three main cases:

1. Difficulties for printing/ lasering/ labeling due to materials or shape.

2. Large volume production where any additional step and consumable becomes prohibitively expensive.

3. Secure product differentiation, where the brand value, IP and R&D efforts have to be protected in an intelligent way, easy for consumers as well as other stakeholders to identify.

This solution was developed by the Swiss company Morphotonix, and is securing products in the medical, packaging and technical industries. By confirming the legitimacy of the products, it prevents safety hazards, malfunctions, and failures caused by illegal copies. This protects brands from damage to their reputation and potential legal liabilities. It also protects the manufacturers of molded parts – they have an easy proof to identify an item produced on their molds and on their premises. Unlike labeling, printing or lasering parts, the nano-marking involves no consumables and no further part processing, while maintaining 100% of the original material composition. The Morphotonix solution was selected by the European Innovation Council (EIC) for its market potential and sustainable profile. A life cycle analysis proved that companies using this anticounterfeiting technology save 1.7 tons equivalent CO2 emissions for 1 million Morphotonix-marked products, compared to using labels.

The Swiss company is partnering with mold manufacturers and injection molding companies to increase market awareness about this low carbon footprint, instant authentication method.

With one of them, the nanoengraving behavior was analyzed in detail in long-term production. EMI Wissler, an Alsace-based company with expertise in processing of thermoplastic and composite materials, has been using the Morphotonix solution with a lifetime of over 1m cycles. Gautier Depiesse, the project manager, has verified that there is no change in molding parameters, and that tooling maintenance is as simple as previously for a mirrorpolished surface. Steel quality and surface finish are critical for the optical intensity of the diffractive security marking. Implementing it on ejector pins or inserts makes the refurbishing of the security marking easier, while minimizing the machine down-time by having a 2nd set of marked ejectors/ inserts ready to be mounted once the 1st set reaches its warranty.

In this rapidly evolving technology landscape, being on top of the game for brands means not only creating functional, “green” and aesthetic products, but also making sure that the consumers and users are safe and satisfied and can easily differentiate originals from counterfeits.

VERONICA SAVU, CEO, MORPHOTONIX, SHARES HOW TRACEABILITY AND AUTHENTICATION CAN BE INTEGRATED IN ANY MOLDED PRODUCT.

JOE ANDERSON, MARKETING MANAGER, HARLAND, HIGHLIGHTS THE DISTINCTION BETWEEN HYDROPHILIC AND HYDROPHOBIC MEDICAL DEVICE COATINGS.

In the realm of modern medicine, the development of innovative medical devices has revolutionized patient care and treatment outcomes. From intricate surgical instruments to life-sustaining implants, medical devices play a pivotal role in improving the quality of life for countless individuals. One crucial aspect that often goes unnoticed but is of paramount importance is the coatings applied to these devices. These coatings can significantly impact the performance and functionality of medical devices. Among the various types of coatings, hydrophilic and hydrophobic coatings stand out due to their distinct properties and applications. In this article, we delve into the difference between hydrophilic and hydrophobic medical device coatings, shedding light on their characteristics, benefits, and applications.

HYDROPHILIC COATINGS

The term “hydrophilic” originates from the Greek words “hydro,” meaning water, and “philos,” meaning loving. Hydrophilic coatings are designed to attract and absorb water molecules. These coatings are engineered to minimize the friction between the medical device and soft tissues such as the vascular system. They achieve this by creating a thin, lubricious layer that facilitates the easy passage of the device within the body.

One of the defining features of hydrophilic coatings is their ability to retain fluids within their surfaces. This property is particularly advantageous in medical applications where minimizing friction is critical. For instance, hydrophilic coatings are commonly used on catheters and guidewires. When these devices are coated with a hydrophilic layer, they can be easily inserted into the body without causing damage to delicate tissues. Moreover, the reduction in friction can significantly lower the risk of discomfort or injury to the patient during insertion and removal procedures. Additionally, hydrophobic coatings can have antimicrobial properties, inhibiting the growth of bacteria and reducing the risk of infections associated with medical interventions.

Hydrophilic coatings excel in the following areas:

Urology: Catheters and stents with hydrophilic coatings are utilized in urological procedures to ensure smooth navigation through the urinary tract. This reduces the chances of trauma to the urethra and other sensitive tissues.

Cardiology: In cardiovascular interventions, hydrophilic coatings aid in the insertion of catheters and guide wires, enabling precise positioning within blood vessels while minimizing the risk of vessel damage.

Endoscopy: Hydrophilic coatings are applied to endoscopic instruments, facilitating their passage through the gastrointestinal tract with ease and reducing patient discomfort.

Neurovascular: Hydrophilic coatings are critical in the neurovascular market, as they enhance the navigability of catheters and devices through intricate cerebral vasculature by reducing friction and promoting smooth, atraumatic insertion, ultimately improving the safety and efficacy of neurovascular procedures.

HYDROPHOBIC COATINGS

The term “hydrophobic” also stems from Greek roots, where “hydro” translates to water, and “phobos” means fear or aversion. Hydrophobic coatings are designed to repel water, forming a protective barrier against moisture and other liquids. These coatings prevent the absorption of water into the device surface, making them useful in various medical applications.

A key feature of hydrophobic coatings is their ability to resist the adhesion of biological fluids and other liquids. When applied to medical devices, these

coatings prevent the buildup of substances like blood, serum, or mucus, which could compromise the device’s functionality.

Hydrophobic coatings find application in the following areas:

Medical devices and instruments: Guide wires, scalpels, forceps, and other surgical instruments coated with hydrophobic layers remain free from blood and tissue residues, simplifying the cleaning process and maintaining their sharpness.

Implantable devices: Devices such as pacemakers and artificial joints benefit from hydrophobic coatings, which prevent the accumulation of bodily fluids that could lead to device malfunction or infections.

Diagnostic equipment: Optics and lenses used in medical imaging devices are often coated with hydrophobic layers to repel moisture, ensuring clear visibility and accurate diagnoses.

CHOOSING THE RIGHT COATING

Hydrophilic and hydrophobic coatings represent two ends of a spectrum in the world of medical device coatings. While hydrophilic coatings embrace water to reduce friction and aid in smooth insertion, hydrophobic coatings repel liquids, preventing buildup and potential contamination. These coatings play an essential role in enhancing the performance, safety, and longevity of medical devices across a range of applications.

POROUS PLASTIC SOLUTIONS enhancing medical and healthcare devices

Everycomponent or assembled product meticulously designed and rigorously tested, must adhere to stringent quality standards before being entrusted with patient care. Among these components, porous plastics stand out as versatile thermoplastics extensively utilized in various medical, healthcare, and pharmaceutical applications. From medical syringes to respiratory devices, porous plastics play a pivotal role in ensuring the functionality of the final product.

In this article, we look into some key applications that underscore the adaptability, robustness, and versatility of porous plastics, showcasing how they enhance key functionalities of medical and healthcare devices.

1. Filtration: ensuring purity and safety

Filtration, a fundamental application of sintered porous plastics, is instrumental in the medical device market. Their intricate porous structure and channels of interconnected pores offers exceptional depth filtration capabilities. This unique filtration method captures and traps particulates throughout the material, ensuring superior quality control, biocompatibility, and environmental sustainability. In applications like dialysis and respiratory equipment, filtration becomes a critical step in eliminating impurities and contaminants, ensuring the safety and efficiency of these devices. Porous plastics serve as ideal materials, adapting to deliver efficient filtration solutions while upholding the integrity of medical devices.

2. Venting: safeguarding pressure and sterility

Venting, a critical aspect of medical device design, employs porous plastics as pressure relief mechanisms in closed systems. The key properties of porous plastics, such as pore size, porosity, and permeability, enable controlled gas flow while preventing the escape of liquids, ensuring both safety and sterility. The versatility of porous plastic manufacturing allows for the incorporation of active components, enhancing functionality. For instance, catheter vents featuring compounds

that automatically seal upon contact with liquids ensure continuous airflow. This innovation proves invaluable when working with substances like blood, safeguarding clinicians from potential bloodborne pathogens and showcasing the adaptability of porous plastics in healthcare applications.

3. Absorption: controlled fluid dynamics

The porous structure of sintered porous plastics enables efficient absorption and retention of fluids, pharmaceutical compounds, or biological samples in a controlled and predictable manner. This precision in absorption proves crucial in applications like wound dressings, diagnostic devices, and drug delivery systems. Porous plastics not only absorb biological fluids but also facilitate capillary action, ideal for wicking applications. Through chemical modification of the surface, their properties can be enhanced to cater to specific applications, ensuring accurate diagnostic test results, sustained drug release, and effective wound management.

4. Media support: enabling precise exchange

In medical devices, porous plastics serve as invaluable media supports. Their interconnected pores and labyrinthine network create an ideal environment for supporting compounds, enhancing processes such as blood cleansing in dialysis machines or facilitating gas exchange in respiratory equipment. With unmatched versatility and reliability, porous plastics maintain low bacterial levels, making them a safe choice for direct contact with patients and bodily fluids.

5. Diffusion: controlling molecular transport

Porous plastics, with their precisely engineered porosity and tailored pore size distribution, play an important role in enhancing diffusion processes within medical devices. Diffusion, the movement of molecules from areas of high concentration to low concentration, is fundamental in various medical applications. In inhalation devices, porous plastics can support even distribution of airflow and facilitate molecular diffusion is pivotal in achieving accurate dosing and supporting the functionality of medical instruments.

Choose Vyon® for your porous plastic needs

Porvair Sciences stands as a global leader and expert in plastic manufacturing for medical, healthcare, pharmaceutical, and life science applications. Explore our leading porous plastic brand, Vyon, at www.vyonporousplastics.com or reach out to us at enquiries@porvairsciences.com to discover the ideal solution for your medical or healthcare device. Your patients deserve the best – choose porous plastics engineered for excellence, ensuring the highest standards of safety, functionality, and innovation in every application.

The importance of using coatings for the prevention and protection of medical devices against infections is growing as the number of healthcare-associated infections (HCAIs) rises. While researchers have been able to pinpoint some causes of HCAIs, there is still a need to protect complex surfaces including implants from device-related infections as well as surgical equipment and other invasive instruments to be protected from germs and microbes. The protection of all surfaces in healthcare is critical to evolving the infection prevention infrastructure for patients and professionals, as well as visitors. The specific need for medical device coatings is almost universal, with increasing demand for implantable devices to be included within the evolving infection prevention infrastructure. Medical implants protected with a non-leaching antimicrobial coating reduces the risk of device related infections to patients, improving the longevity of the implanted device in turn - improving the well-being for patients.

As such, new developments are bringing to light antimicrobial coatings, such as TridAnt, which offers a new way to combat infections more effectively, efficiently and for longer periods of time. These coatings are proven to provide monoclonal protection, which kills a broad spectrum of gram-positive and gram-negative bacteria as well as enveloped and nonenveloped viruses, including E.Coli, MRSA, Influenza, Norovirus and SARSCov-2. TridAnt, for example, is being utilized for enhanced skin protection as well as to prevent pathogens on most surfaces including woven and non-woven fabrics, hard materials such as metals (stainless steel and nitinol) and polymers (polyamides, polycarbonates and polyurethanes).

The new antimicrobial technology is non-leaching and therefore completely safe to use in all environments and even for class 3 implants which are implanted inside chronic areas of the human body. Its active components target microbes (prokaryotic cells) and have reduced risk to human cells

unlike previous technologies. The coating is able to kill enveloped and non-enveloped viruses and gram-positive as well as gramnegative bacteria which prevents the formation of biofilms for longperiods of time of up to 365 days (as well as safe enough to protect skin for up to 48 hours) without any noticeable reduction in efficacy. As a result, antimicrobial-coated medical devices are protected consistently with a highly effective and safe, non-leaching shield for the entire lifetime of the device.

What do near future medical device innovations and trends look like?

There have been impressive products released over the last few years in the areas of surgically implanted devices and many of them must remain in contact with blood. This has prompted medical device developers to introduce biocompatible coatings that can meet not only the clinical but also the engineering requirements for these devices. Devices such as total artificial hearts (TAHs),

ARJUN LUTHRA, COMMERCIAL DIRECTOR, BIOINTERACTIONS SHARES THE IMPORTANCE OF COATINGS IN DRIVING SURFACE TREATMENT INNOVATIONS.

ventricular assist devices (VADs), vascular grafts, and prosthetic mechanical heart valves are examples of devices used to assist vital organs function normally. However, they share a common constraint: hemocompatibility.

Surface modification is one way of providing blood compatibility. BioInteractions has developed Astute, an antithrombogenic coating which has been used successfully on chronic implants and on blood-contacting medical devices for over 25 years. Astute is a non-leaching coating that uses an active antithrombogenic component combined with additional passive components to mimic the natural endothelial layer. The active component gives the coating the ability to interrupt the blood cascade mechanism, preventing platelets from activating and hinders thrombus formation. The additional passive components prevent blood components from depositing onto the device surface. This multi-faceted approach provides superior hemocompatibility to the surface without any reduction in performance over long periods of implantation.

In addition, the burgeoning development of miniaturized and minimally invasive procedures includes a variety of challenges like reducing the amount of tissue trauma by way of smaller incisions, and that leads to a potential reduction in infection risk, less pain, and more comfort during recovery. Addressing the dynamically increasing needs for smaller medical devices demands several key qualities from the components used to produce them, for example size must be reduced without compromising quality and application-specific qualities that improve the functionality must be reliable.

BioInteractions has sought to meet this challenge by developing a Hydrophilic Coating, which is lubricious and flexible resulting in reducing friction, and has no particulate formation and delamination in high-stress and high-movement applications. Assist uses a two-factor approach to reduce friction at the device-body interface for long periods of time, hindering occlusion of the device and allows the device to remain in position for extensive use. This significantly reduces tissue damage and improves comfort when delivering or removing devices from the patient, improving the functionality and safety of therapeutics.

What are the most common challenges customers are facing today?

Universally, medical product developers and manufacturers navigate a highly regulated and particularly constrained environment. Under today’s European Union (EU) regulations, medical devices are considered medicines and are therefore tested by the European Medicines Agency (EMA) following the same tests and approval processes that drugs do. BioInteraction’s Product Pathway Partnership team closely work with customers to navigate all areas including optimization of the application process, fixture design and tooling, biocompatibility testing, regulatory compliance and providing services as the commercial manufacturing partner. The team provides guidance along a strategic pathway with a focus on offering a flexible approach to meeting all of the ever-revolving regulatory demands on a wide variety of devices with varying geometries and substrates. The aim of which is to get the customer to the market in the most effective way possible.

Your technical experts for plastic injection moulding

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Make Pentagon your UK supplier of choice for Mould Tool manufacture and Plastic Injection Moulding. Whether you need a supplier for a new injection moulding project or sourcing a new manufacturing partner for existing production, Pentagon will support you at every stage.

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We design advanced multi-cavity systems equipped with dedicated solutions to meet the most challenging needs of the medical device world: complex geometries, excellent part quality and maximum product safety.

High repetition accuracy

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Part to part consistency

Excellent quality parts

Experience with complex polymers

CAN RISE TO THE CHALLENGE OF MEDICAL GRADE POLYMERS.

“hard” whilst caprolactone, dioxanone and trimethyl carbonate are considered “soft”. The outlier to this trend is P4HB, which does not achieve the same tensile properties as PGA but is far more pliable and flexible than PGA and PLA. It is also capable of stretching up to 10 times its original length before breaking.

Regarding extrusion, care must be taken with each of these materials to prevent polymer degradation before/during processing. It is common practice to make sure that the polymer is carefully dried prior to extrusion as these products are very sensitive to degradation via hydrolysis – resulting in significant variation in the intrinsic viscosity (IV) of the polymer, making it unprocessable. Following polymer preparation, FET uses a specifically designed combination of extruder and screw to extrude the molten material under an inert atmosphere to achieve the desired product specifications. This really is the key to good quality product.

Thereis a vast array of polymers which are used for medical applications worldwide. FET has processed over 70 different polymer types in multifilament, monofilament and non-woven formats, with many of those being polymers from a sustainable source. This process has involved close collaboration with biomedical research establishments for testing and evaluation.

MONO & MULTIFILAMENT YARNS

Modern absorbable sutures are produced, mainly, from synthetic polymers. Most sutures are created as either monofilaments or multifilament yarns which undergo further processing to become sutures.

These are based on a homopolymer or combinations of various block copolymers. The materials used are PLA - Poly(lactic acid), PGA - Poly(glycolic acid), PCL - Polycaprolactone, P4HB - Poly(4-hydroxybutyrate), PDO - Poly(p-dioxanone) and PTMC - Poly(trimethyl carbonate). These polymers are used due to their high biocompatibility, low toxicity and tuneable absorption rates. Each building block is subdivided into two types, “hard” and “soft”. Glycolide and lactide blocks are considered

In addition to this, there is a great deal of know-how on the post-extruder processing of each absorbable suture polymer, which only comes with experience. For example, some of these polymers respond best to a large amount of melt drawing, whilst others achieve the best results through a more step-wise thermal drawing approach. Similarly, when working to produce very fine diameter yarn (10-0 sutures have a diameter of 20 µm) the choice of spin pack, spinneret materials and hole design are cornerstones of any successful production campaign.

BIOPOLYMER YARNS

Alongside synthetic polymer-based yarns, there are a number of examples of biopolymers being used as medical products. The market forces surrounding this use of the biopolymers are complex however, one reason for their use is that they are an inherently more sustainable polymer than fossil fuel-based alternatives. For example, P4HB, a recent addition to the absorbable suture market, is produced via bacterial fermentation from renewable sugars rather than chemicals synthesized from crude oil – which is the common method for most absorbable suture polymers.

Besides sutures, biopolymers are used in wound dressings, hemostatic agents and in regenerative medicine. The extrusion of these polymers can be challenging as chemical reactions need to take place to produce a fiber rather than a physical, thermal based system. This is where wet-spinning comes into play.

This technology extrudes dissolved solution (dope) through a metering pump into a coagulation bath. In some instances, the dope can become highly viscose and require high torque mixers and vessels capable of reaching high pressure to extrude this material. Historically, this has always been conducted by submersing the spinneret into the solution and conducting the extrusion horizontally.

However, FET has recently developed a vertical spinning system. This line utilizes the Venturi effect to allow for better exposure of coagulation media with the dope and easier threading up of the yarn. This is particularly useful when working with more challenging coagulation solutions such as concentrated sulphuric acid or highly basic solutions. FET also supplies spunbond systems for the scaled development of new nonwoven fabrics based on a wide range of fibers and polymers.

DR JONNY HUNTER, RESEARCH & DEVELOPMENT MANAGER OF FIBRE EXTRUSION TECHNOLOGY (FET) DISCUSSES HOW EXTRUSION TECHNOLOGY

MARIE SCHWAB, NPI MANAGER, OGM LOOKS AT HOW CHANGES TO THE MATERIAL USED IN THE MANUFACTURE OF PLASTIC COMPONENTS TRIGGERS THE NEED FOR REVALIDATION WITHIN THE CLEANROOM AND WHERE TIME AND COST SAVINGS CAN BE MADE.

The need for revalidation

Sometimes, your material supplier may decide to change the formulation of a polymer or discontinue it altogether. If this is the case, an alternative material will have to be urgently sought and the production process revalidated before starting full manufacture. Revalidation of a component for any reason is, in essence, a repeat of all or part of the original validation, it can be very expensive due to the number of processes involved in the IQ (Installation Qualification), OQ (Operational Qualification) and PQ (Performance Qualification) tests. The aim is to prove that the intended manufacturing process will repeatedly and consistently deliver products of the required quality.

There are also times when a change in materials is inevitable, due to new legislation, design updates or availability of an improved material. Here, the validation and revalidation services of an experienced injection molding partner will help you avoid having to repeat work that will incur additional and otherwise unnecessary time and cost.

By using medical grade materials, however, you can largely avoid having to revalidate under extreme

time pressure because any changes to medical grade plastics must be declared by suppliers in advance, the industry standard is two years. Medical device manufacturers who are specifying medical grade plastics for their components, can therefore enjoy relative security of material supply once the plastic injection molding process has gone through its original validation process.

CLEANROOM FACILITIES

When seeking an injection molding partner for plastic component manufacture, a fundamental consideration is the quality and capabilities of its cleanroom facilities and the ability to manage additional demand which may be required with limited notice.

First, the cleanroom’s ISO classification must meet or exceed the customer’s requirements for the types of products manufactured. For OGM this means ISO Class 7, which demands that particles with a diameter greater or equal to 5 microns should not exceed 10,000 per cubic foot of air.

Importantly, providing full cleanroom, validation and molding services inhouse brings customers significant economies in terms of time, cost and project complexity.

Considerations when partnering with an injection molding company for validating components include:

• The experience of the injection molder and the validation team on a range of validation and revalidation projects

• The range of injection molding machines, metrology and other equipment in the cleanroom

• How automated the processes within the cleanroom are

• The space and set-up in the cleanroom for injection molding and assembly

• The cleaning regime and sterility checks that are carried out

HOW TO RECOGNIZE A SUITABLE MOLDING PARTNER

The suitability of a molding company can be assessed by research and questioning. A meeting should be arranged to view its facilities – including cleanroom and metrology equipment – and to see examples of its validation work. Customers must satisfy themselves that the company has carried out a large number and wide variety of substantial validation projects.

The company’s technical expertise, including knowledge of what tolerances are feasible for each material, is crucial too. It should also demonstrate flexibility in tailoring validation packages according to available budgets as well as product specifications.

Good communication is fundamental to collaborative project success. OGM assigns a dedicated project manager to every project to oversee it from start to finish and provide a single, easily accessible contact point. Key milestones are agreed at the beginning, with regular updates and meetings to keep the project on track.

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Machine calibration according to ISO/IEC17025:2017 on-site at customer’s premises

Medical parts

Cleanroom manufacturing plays an important role in producing precise medical devices. To enhance efficiency, reduce costs, and maintain high-quality standards, it is critical to identify where there are practical solutions to eliminate waste. Below are five strategies to eliminate waste in cleanroom manufacturing and assembly, in order to make it a more streamlined and cost-effective process.

1. Streamlining material flow

We commonly see companies that want to manufacture parts in one facility, or country, and then ship those parts to another facility for final assembly. While in early stages of a project, this is less of a risk, but in volume, it adds unnecessary handling, inspecting, cleaning and transferring of parts. This wastes time, increases labor costs, and introduces complexity in the production process.

By keeping cleanroom manufacturing and assembly all in one space, companies avoid the time-consuming process of shipping materials from external suppliers and contamination risks during transportation.

2. Ensuring consistent quality and eliminating defects

Consistent product quality is key, and maintaining it can be challenging, particularly when different operators are involved in the manufacturing process. Manual handling and assembly introduces variations and product defects. A diagnostics client needed Natech to assemble a prototype device with a precise glue application to create a seal. The company introduced an automatic dispenser, guaranteeing uniform glue application. The dispenser allowed for higher control of the glue, ultimately reducing the risk of variation, scrap, inspection, defects, and physical labor. Ensuring consistent quality also means emphasizing documentation of

quality control processes, strict adherence to standardized procedures, and comprehensive training for all operators.

3. Upgrading process and fixtures

One goal during cleanroom manufacturing and assembly is reducing material waste and inefficiency. Long setup times get in the way and lead to increased labor and costs. Natech recently worked with a client whose assembly machine required 20 minutes of setup time between each assembly step.

To address this, the company upgraded fixtures and tooling to a universal solution tailored for the assembly process. After implementing fixtures for this machine, the operators were able to easily make quick and precise adjustments before starting assembly, reducing setup time to less than a minute. Efficiency improvements often go hand-in-hand with cost savings. By upgrading your process, you also enhance the overall manufacturing process, reducing errors and material waste – and ultimately reducing your costs.

4. Harnessing automation potential

When transitioning from prototypes to high-volume production, labor-intensive processes become less sustainable. Manual processes mean higher labor costs, longer production times, and more room for errors.

To combat time waste, consider automating specific manufacturing steps, particularly for larger quantities – and be sure to think about what scaled volume production will look like early in your product design process. When a process can be automated, you’re able to slash production times.

5. Minimizing environmental impact

Excessive cleaning and chemical use within cleanrooms can have negative environmental consequences, increase operational costs, and pose health risks to operators. Practices like using and disposing of excessive mold release or alcohol baths contribute to environmental harm and increased expenses.

To minimize environmental impact, consider conducting both manufacturing and assembly in a cleanroom environment that works best for your product’s requirements. With fewer cleaning chemicals and reduced waste from disposable supplies, cleanrooms become more eco-friendly.

NOOR LONE, DIGITAL MARKETING MANAGER, NATECH PLASTICS, SHARES FIVE WAYS TO ELIMINATE WASTE IN CLEANROOM MANUFACTURING AND ASSEMBLY.

COLLABORATION

Collaborate with us to provide a spark of innovation for your most demanding application needs.

At Saint-Gobain Medical, collaboration is at the heart of everything we do. Leveraging over 350 years of material expertise, our deep industry knowledge and global footprint, we work side by side with you to inspire breakthrough solutions that advance medical technology for better patient outcomes.

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APPROACHING INNOVATION

Medical and in-vitro diagnostics (IVD) devices help to save lives, diagnose and treat diseases, and offer pain relief. And because of their strength, versatility and durability, plastics have become the material of choice for such devices. But how do you keep up with all the innovation on the market? Which polymer is most suitable for a new medical device? And how do you get your device approved? The medical polymer experts at IMCD can help you navigate the entire process.

In 2021, the medical technology market in Europe – dominated by Germany, France, the UK and Italy – reached about €150 billion, having grown by an average of 4.8% per year over the past ten years. And in an increasingly complex environment with more sophisticated equipment every year, it continues to grow.

Moreover, there are upwards of 500,000 types of medical devices on the European market, according to the EU Commission. These range from low-risk devices like stethoscopes and tongue depressors, to medium-risk devices like syringes and catheters, to high-risk devices like pacemakers and stents. Meanwhile, IVD devices include blood sample tubes, pregnancy tests and HIV status tests. In other words, the potential applications for medical and IVD devices are vast and wide ranging.

FEEDING THE NEED FOR INNOVATION

The European population is an aging one, which means innovation in the medical industry is vital. But this development isn’t new: innovations in medical device technology have

been rising steeply for a few centuries already. Take the urinary catheter, for instance; the most primitive methods for draining urine from the bladder using reeds or straw go as far back as 3000 BC. In the 18th century, rubber came into use, making the treatment less painful. Then, in the 20th century, latex became the material of choice. Nowadays, catheters with complex balloons made of combinations of polymers like silicone, PVC, PEBA, PA, TPU, PET and PTFE are used, guaranteeing easy and safe treatment for patients.

IMCD’s focus has always been to help customers bring innovations to the medical technology market. For example, IMCD worked with a producer of membranes for monitoring fluid pressure in bloodlines. With our support they developed a silicone-free solution using thermoplastic elastomers to significantly improve the gas barrier. For patients, it means more efficient treatment while being assured of comfort and safety.

As a specialty distributor of raw materials, especially medical polymers, IMCD has established a broad network of customers from all stages of device development – from initial design through to market launch.

ACCELERATING DEVELOPMENT

The development of medical devices can be a long and complex process. Stringent testing, clinical studies and rigorous

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documentation are all factors that need to be taken into account. High upfront investments are often needed, and the lead time from initial design to final launch can be five to seven years or more. Once launched on the market, however, a device can be used to help patients for 20 years or even longer.

Pre-filled syringes, for example, are in contact with the drug inside for an extended period. Long-term studies need to confirm that the medium will not attack the polymer and the polymer will not migrate into the medium. IMCD is working on a number of pre-filled syringe projects, one of which is now in its eighth year.

All of this means that optimizing the time to market is key to the success and profitability of a product. Quick response times to requests for regulatory documents of the polymer material or for sample material are fundamental. IMCD’s medical polymer experts have decades of experience in helping customers’ projects through the various development phases – from technical knowledge of the materials themselves through to understanding regulatory requirements and application-specific details.

SECURING THE PROCESS

Where innovation meets development, protecting intellectual property while sharing all the necessary information with the various parties involved in developing a medical device, is crucial. That’s where a non-disclosure agreement (NDA) comes in. An NDA can be signed by the designer, development company, original equipment manufacturer (OEM) and IMCD. But it can also involve the polymer producer, if desired. At the same time, long-term, stable, sustainable supply of raw materials is central to the success of a project: signing a quality agreement ensures that supply and specification details are properly set upfront.

Medical polymer producers usually have their own policies relating to the applications that are supported for use: for example, the amount of time that a medical device can safely be in contact with bodily fluids. These policies often contain a warning that the polymer producer reserves the right to stop supply in case of non-compliance. IMCD can also help its customers navigate these various policies.

SMOOTHING THE WAY

Having developed an innovative product, attracted investment, protected the intellectual property and found the right polymer material and corresponding supplier, another step is to request approval from so-called notified bodies. A notified body is an organization designated to assess whether a medical device fulfills the legal requirements before it can be sold on the European market. And this can be a challenging process: any change to the polymer composition can be fatal for the validity of the approvals.

While change is undesirable, it’s sometimes unavoidable. In order to reduce risk, it’s essential to have a sound notification-of-change (NOC) process in place. IMCD has NOC agreements with all its medical polymer suppliers. These agreements include details about how far in advance a change needs to be notified, and whether a final buy option can be granted.

IMCD’s medical polymer experts know how to manage this process as smoothly as possible, by providing information well in advance and by understanding the options for reassessment and re-certification. For example, a recent change in production site by a supplier of polymers for medical extraction devices required close cooperation with customers to share the extensive data and samples required in a timely and fully transparent way.

TOGETHER FROM START TO FINISH

Teamwork – working closely with all stakeholders involved in medical device development, including design companies, start-ups, academia, contract manufacturing/ development organizations and OEMs – is imperative. IMCD has exclusive partnerships with market-leading producers of medical polymers, which means it can offer a broad portfolio of polymers as well as expertise in selecting the right polymer material for the specific medical application.

To get the most benefit from the partnership, it pays to involve IMCD’s medical polymer experts at the earliest stages of development. Because upfront knowledge translates into better advice later in the process.

Webinars o er a multi-layered marketing outcome, enabling you to tell your story to a global audience, define your organisation as a thoughtleader and simultaneously deliver a healthy number of leads for your sales team to get to work on.

To find out more contact Caroline Jackson | t: +44 (0) 1244 952 358 | e: caroline.jackson@rapidnews.com

www.medicalplasticsnews.com/medical-plastics-resources/webinars

You’ve heard it said time and time again: “We’re all in this together.” What does that mean amid mountainous challenges? The world has seen many hurdles over the last few years — a pandemic, supply chain challenges and inflation — all while the climate crisis continues to affect our daily lives. These issues can cause both people and companies to retreat into themselves rather than truly working together.

Like nurses and doctors in a hospital, companies throughout the medical packaging value chain rely on each other and their specialties to keep the healthcare industry going and to keep patients safe — regardless of the challenges.

Eastman and its partners are building a pathway to sustainability for the healthcare industry where it seemed impossible. The introduction of Eastar Renew 6763 copolyester to the marketplace and the value chain partners’ adoption of it have brought recycled material into a marketplace that’s traditionally tough to make sustainable while navigating extraordinary supply challenges, inflation and the demands of a healthcare system still recovering from COVID-19.

INDUSTRY-SHIFTING TECHNOLOGY

“Molecular recycling is a game-changing technology that has implications for the whole world, not just the medical industry,” said Heather Singler, commercial director for medical at Eastman. “With Eastar Renew 6763, companies can certify that plastic waste is being diverted from landfills while continuing to use a product with the same toughness, safety and product performance trusted for decades. Eastar copolyesters continue to be the gold standard for the industry.”

Eastar Renew is powered by Eastman’s molecular recycling. That sets it apart from traditional mechanical recycling methods. By breaking down plastic waste to the molecular level for purification, Eastman expands

sourcing opportunities and produces materials that are indistinguishable from virgin materials. This molecular recycling technology enables the use of Eastar Renew in even the most demanding medical applications, ensuring the highest standards of quality and performance.

Medical device sterile barrier packaging made from Eastar 6763 with 50% certified recycled content* offers the same puncture and chemical resistance and ease of processing as Eastar 6763 without compromising on quality. This chemically and structurally identical solution eliminates the need for extensive testing required for new medical products.

DRIVING A SHIFT TO SUSTAINABILITY

Much of Eastar Renew’s success is due to the enthusiasm of Eastman’s partners, who are educating their customers on the product’s benefits and encouraging them to try it.

Companies like Pacur and Klöckner Pentaplast (kp), long-standing partners of Eastman, have shown considerable interest in Eastar Renew due to the increasing demand for sustainable solutions from their customers. As good stewards of the environment, these companies recognize the importance of bringing recycled content to medical packaging without compromising quality, cleanliness and protective properties.

Ethicon, a Johnson & Johnson MedTech Company, became the first healthcare company to use medicalgrade Eastman Renew material in its packaging when it adopted Eastar Renew 6763 in the fall of 2022.

“Eastman, with the help of partners like Ethicon, Pacur, kp and Nelipak,

EASTMAN OUTLINES ITS PARTNERSHIPS WHEN IT COMES TO INNOVATING IN A SUSTAINABLE MANNER.

will leverage molecular recycling to enable the medical industry to divert plastic waste from landfills and catalyse circularity for its packaging,” said Scott Ballard, Eastman plastics division president.

“Renew has a lot of interest from our OEM partners,” said John Carlson, CEO of Pacur, a four-decade Eastman partner that has used Eastar 6763 since product launch. “Sustainability is of interest to them. Just as good stewards to the environment, they want to deliver better solutions to the market.”

This comes as no surprise as many hospitals, GPOs and IDNs are looking into sustainability as a part of their sourcing criteria due to ESG goals and even to avoid future tax burdens of virgin plastic use. Eastar Renew can help meet those needs right now, especially with Eastman starting up the largest molecular recycling facility in the world by the end of the year.

Pacur announced in late August that they are adopting Eastar Renew as part of their portfolio.

“Eastman and Pacur have been partners for over 40 years,” Carlson said. “Launching Eastar Renew is yet another way our companies have used our unique relationship and different expertise to innovate and create a more sustainable industry.”

“Our tagline at kp is, ‘The sustainable protection of everyday needs,’ which sums it up very well,” said Kirstin Hedin, kp vice president of product line and marketing. “We work with our business partners, like Eastman and others, to innovate industry-disrupting technologies that genuinely move the needle of sustainability.”

RESILIENCY AND INNOVATION

Eastman’s partnerships have not only facilitated innovation in production but also played a crucial role in mitigating potential incidents. In 2022, a steam line rupture at Eastman’s Kingsport site caused a delay in the production of Eastar, which coincided with the emerging effects of the COVID-19 pandemic and a volatile economic environment.

Through collaborative efforts and constant communication, Eastman

and partners managed to prevent any impact on patients. Despite the challenges faced during the pandemic and global supply chain disruptions, they found creative solutions to maintain a steady supply of essential medical materials.

Eastman produced Eastar at close to double its normal run rate for several months after manufacturing resumed. Much like a critical care team, consistent collaboration with supply chain partners, some of whom altered their shipping methods and made other changes to adapt, resulted in zero impacted patients.

“This was a high-stress situation for the value chain, but we were outpacing the market’s ability to make up for that lost time,” said Brad Potter, marketing director for Eastman. “We all leaned in according to our specific areas of expertise.”

That impact was further complicated by worldwide supply chain issues in 2022, forcing Eastman and its partners to get creative. Kp worked with Eastman to airfreight raw materials to Europe and other parts of the world and fill supply demands. For Pacur, this disruption involved daily talks about what products were needed when and prioritizing orders to keep the most essential items moving.

“There was some tension, but at the end of the day, we had a greater understanding of the full end-to-end supply chain and what our partners can do for each other,” Carlson said. “We stayed very, very close (with Eastman) through those months. That laid the groundwork of what we do today.”

ACHIEVING SUSTAINABILITY ONE CHALLENGE AT A TIME

Despite the challenges, Eastman and partners like Pacur and kp continue to tackle the world’s problems with products like Eastar Renew 6763 while ensuring the product arrives when and where it’s needed most.

When challenges abound, leave it to the specialty innovators who, instead of retreating into themselves, look to their partners and work together to make the industry more sustainable — one innovation at a time.

MAXIMILIAN SCHOBER, VP SALES GERMANY & MARKETING, POLYRACK TECHGROUP, SHARES HOW TO FACE THE CHALLENGES OF DESIGNING COMPONENTS.

In the global medical technology industry, patients worldwide rely on the functionality of medical technology components and systems. Companies in this sector are therefore faced with enormous challenges, as their products must not only be durable, but also provide lasting, reliable performance.

In this context, system and enclosure solutions play a central role, especially those that are characterized by their robustness, hygiene, electromagnetic compatibility (EMC) and long-term availability.

In the field of medical technology components, savvy suppliers with a broad performance spectrum benefit considerably, as they can meet the requirements of a long service life and maximum reliability, while at the same time offering customized adaptation options.

POLYRACK’S PORTFOLIO

Polyrack’s industrial enclosure series, the FrameTEC series for 19-inch racks, recently won the iF Design Award in

the “Product” discipline within the “Industry/Tools” category, due to its flexibility in design and dimensions.

The design is modern and simple, and yet it convinces with functionality. Due to its mechanical and cosmetic customization options, a FrameTEC enclosure opens up a wide range of applications in the field of medical technology.

Polyrack also has the EmbedTEC SFF (Small Form Factor) enclosures with a customized development platform. These enclosures have been developed as a flexible platform for various application areas, including powerful embedded computer systems and HMI solutions with compact integrated computers and displays. The special feature of these enclosures is the “Customize-Only” strategy, where customers can assemble their desired enclosures based on individual changeable components. The aim was to ensure a high degree of customizability with a low number of basic components to make specific adaptations as simple as possible. The basis of the EmbedTEC enclosures consists of a base plate, four design corner elements and a bonnet, with all elements available in different sizes.

FLEXIBILITY AND TRUST

Early communication of customer requirements is crucial to developing the optimal solution. This enables consideration of economic aspects such as distribution and service costs as well as the targeted unit price. Various internal technologies allow personalization in terms of appearance, coloring and printing to implement the customer’s corporate design. Innovative technologies enable the design of customized products from standard components that ideally meet the requirements.

CAN SECOND SOURCE BECOME FIRST CHOICE?

In the medical technology industry, innovation management plays a central role, and tight risk management is crucial. One of the challenging tasks is to ensure that alternative, already pre-certified components are also always available in order to prevent possible supply bottlenecks. In this context, the selection of single source suppliers gains particular importance. This strategy aims to ensure the highest quality and reliability of components and thus protect the heart of innovative medical devices.

In many cases, the decision for a second source represents a complex compromise. It requires careful qualification and testing to ensure that the final product offers the required quality and reliability. The costs associated with this decision, particularly for second source qualification, can be significant and acceptance of such changes can be a major hurdle in the industry. Polyrack has many years of experience and technological capabilities in the field of prototyping and second source planning, which as a complete package offer customers maximum relief and the highest level of planning security.

A New Medical-Grade TPU Series THAT ANSWERS YOUR NEEDS

ICP DAS – Biomedical Polymers, Asia’s first medical-grade TPU (thermoplastic polyurethane) manufacturer and supplier focused on TPU development and quality management, proudly presents the new Arothane™ ARP-W series loaded with 30-50% Tungsten as the radiopacifier. This series is specifically for small or thin-walled devices.

INDUSTRY-PROVEN DESIGN

The radiopaque filler is added in a one-step process instead of a secondary compounding process, allowing the TPU produced to exhibit superior physical properties and processability. Tungsten, renowned for its exceptional radiopacity, makes Tungsten-filled TPU particularly ideal for manufacturing small-dimension or thin-walled devices such as TPU coating for guidewires.

HOLISTIC PRODUCT SERIES & SERVICES

ICP DAS – BMP provides a diverse range of over 80 products that are USP Class VI and/or ISO 10993 certified, including Alithane™ (ALP series), Durathane™ (ALC series), and Arothane™ (ARP series). To meet customerspecific needs in the early stages of product development, we offer small order quantities with short delivery times enabled by smart manufacturing.

A WIDE SPECTRUM OF APPLICATIONS

ICP DAS – BMP high-quality medical-grade TPU, offering high reliability, has been selected by clients worldwide to manufacture electromedical devices, advanced catheters used in cardiovascular, urological, gastrointestinal, and cancer treatment procedures, as well as for coating of guidewires and

LUKE HIGGINS, MARKETING SPECIALIST, ATOMO DIAGNOSTICS, DELVES INTO THE UNPRECEDENTED RISE OF HOME-BASED DIAGNOSTIC TESTING AND ITS TRANSFORMATIVE IMPACT ON THE HEALTHCARE INDUSTRY.

In the wake of the unprecedented COVID-19 pandemic, the world has witnessed a remarkable shift in the way healthcare is delivered. Medical systems were put to the test, prompting the rise of innovative solutions to meet the growing demand for safer and more accessible diagnostics. One notable outcome of this healthcare revolution has been the surge in popularity of home-based diagnostic testing.

Once considered niche, the idea of conducting tests from the comfort of one’s own home without the need to queue up to see a healthcare practitioner, has now become an integral part of the healthcare landscape. The convenience and efficiency of new home-based testing has captured the attention of health authorities, medical professionals, and the general public alike. This paradigm shift has not only redefined healthcare accessibility but has also played a vital role in increasing the ability to regularly monitor wellness biomarkers.

From pregnancy tests and COVID-19 antigen tests to self-screening tests for HIV, the spectrum of home-based testing is expanding to cater to diverse medical needs and increased consumer demand.

PRE COVID-19

Prior to the COVID-19 pandemic, the prevalence of self-testing for various health conditions was relatively low, and there was limited data available on public willingness to conduct diagnostic self-tests at home. While self-testing for certain conditions like pregnancy or blood glucose levels was more common, the broader acceptance of self-testing for infectious diseases or complex health issues remained limited, in large part due to regulatory barriers to approve of ‘bits in a box’ test kits that were fiddly to use and delivered poor usability.

With the outbreak of COVID-19, there was a surge in the use of rapid testing at home. Studies and surveys conducted during the pandemic showed an increased acceptance and readiness among individuals to self-administer COVID-19 tests, especially when traditional testing facilities were overwhelmed and lab results were not being returned quickly enough to be of real use.

While the COVID-19 pandemic undoubtedly accelerated the acceptance and adoption of home-based testing, its benefits now extend far beyond that crisis. The potential to reach remote and underserved communities, support early detection of diseases, and reduce the strain on healthcare facilities are key advantages that make this an emerging trend in the delivery of healthcare.

AHEAD OF THE TIMES

Despite the concept of self-testing for infectious diseases being relatively new

in the consciousness of the general public, it is something that Atomo has been focused on for over a decade. After more than ten years of serving as a senior leader in the medical device industry, John Kelly, co-founder and CEO of Atomo Diagnostics, recognized several opportunities for a transformation in the field of diagnostics.

The early years of Atomo saw the company begin to develop its diagnostic testing solutions, integrating the various moving parts and functionality of traditional multicomponent lateral flow rapid diagnostic test kits into one integrated cassette to simplify the testing process and improve usability and accuracy.

MATERIAL CHOICE MATTERS

In order to achieve reliability and improved usability, the selection of plastics for Atomo’s cassettes was rooted in an evaluation of key criteria, namely dimensional stability, processing capability, and chemical resistance. Each chosen material is sourced as virgin plastic with their distinction underscored by UL and C-UL approvals.

For the unique blood collection unit, Atomo reviewed numerous materials and significant efforts in design and prototyping to find a suitable material that would meet requirements with stiffness, critical tolerances, and dielectric properties being key requirements.

A glass-reinforced polymer was selected and delivers hydrophilic properties well in excess of standard polymers typically used in medical devices. This material and special tube geometry improves blood collection from a fingerstick and proprietary design elements remove air bubble formation via venting.

DI A G N O S I S

Diagnostic tests inform 70-80% of healthcare decisions. They also account for a significant portion of the sector’s waste and carbon footprint. With the environmental impact of healthcare facing greater scrutiny, there’s a strong case for enhancing R&D with sustainability considerations. Handled well, this can have a positive impact across both environmental and commercial performance.

As the sector starts to consider sustainability alongside patient safety, there are new commercial opportunities for companies that can strike an effective balance.

SUSTAINABILITY IN THE DIAGNOSTIC PROCESS

Diagnostic waste accounts for a tenth of all medical waste, and since much of it is infectious or hazardous, reuse and recycling are challenging. At present, cost and performance are the main considerations shaping the development of diagnostic devices. How can we make sustainability integral to the process without undue compromise of these factors?

The first step is to consider the full lifecycle of a laboratory diagnostic test, identifying environmental impacts at each stage. For instance, the hazardous and/or infectious

nature of waste brings end of life complications. Disposal of sharps, patient specimens, contaminated equipment, and harmful chemicals needs to be handled with great care. Consequently, most diagnostic waste is incinerated, with 1g of waste generating up to 3g of CO2. In fact, greenhouse gasses are emitted at every stage of the diagnostic test lifecycle, so exploring ways to reduce these emissions is a good place to start.

INNOVATING AROUND BLOOD TESTING

An Australian study published in 2020 “The carbon footprint of pathology testing” focused on five common hospital pathology tests. It determined that sample collection and phlebotomy dominated the overall carbon footprint, and although CO2 emissions per test were small, the volume performed meant the cumulative carbon footprint was significant. We’ve used the findings from this study as a platform to demonstrate how R&D efforts can be directed towards the reduction of CO2 emissions.

For instance, equipment used for sample collection accounted for around half of the overall carbon dioxide equivalent (CO2e). Waste incineration represented a significant portion too. The CO2e of the diagnostic process itself varies according to the test and the amount or type of reagent required. Based on these insights, we identified four strategies to improve the sustainability position of blood testing.

COLLECT LESS BLOOD

In the main, blood tests involve a venous blood draw into vacutainer tubes. The volume collected is typically 4mL, yet many diagnostic

DR NICK COLLIER, CTO MEDICAL, SAGENTIA INNOVATION, EXPLAINS WHY DIAGNOSTIC TESTING IS RIPE FOR SUSTAINABLE DEVELOPMENT.

tests only require a small portion of this – a complete blood count can be performed using 100μL. If the volume of blood collected was reduced to 500μL it would still be possible to perform multiple tests, but a smaller vacutainer could be used. Based on the figures in the Australian study, this would immediately reduce carbon emissions linked to ‘needle holder and collection tube’ and ‘incineration of hazardous waste’, effecting a 27% reduction in CO2e for a whole blood count, and a 38% reduction for clinical chemistry. These wins could be taken further if the overall number of blood draws per patient was reduced, for instance by conducting multiplex testing on samples.

FOCUS ON REAGENTS

Manufacturing the reagents that play a critical role in many blood tests is expensive, and production must be closely monitored for quality control and consistency. Vendors tend to produce reagents centrally and distribute them globally, which makes a notable contribution to the CO2e of diagnostic tests which require them. According to the Australian study, reagents used in a whole blood count test account for around a third of the total CO2e.

A large portion of a reagent is ultrapure water, so the use of concentrated formulations for reconstitution in the laboratory could cut the carbon emissions linked to transportation. We calculated that a x10 concentrate shipped via sea from Singapore to Australia would deliver a 4.5x CO2e reduction. Dilution at point of use would add a new burden of responsibility to pathologists and introduce a potential failure point, but this could be addressed using an automated process.

It’s also worth exploring ways to reduce the amount of reagent used. At present, lab instruments typically require 100μL of blood per test while point of care technologies only need 5-30μL. If lab instruments were adapted or redesigned to operate with smaller volumes of blood, it would result in a corresponding reduction in the amount of reagent required.

CONSIDER SELF-COLLECTION

Swapping the venous blood collected by a phlebotomist for patients’ self-collected capillary blood could also offer carbon reduction benefits. Self-collection would negate the need for PPE which is

identified as a significant CO2e element in the Australian study. This approach may also reduce the need for patient/phlebotomist journeys, bringing further carbon savings.

Devices for the self-collection of blood on the market at present haven’t been designed with sustainability in mind. However, there is scope for innovation focused on optimizing the materials used, reducing the portion wetted by blood, and making devices safer to dismantle.

IMPROVE RECOVERY OF DEVICE COMPONENTS

Reducing the volume of blood collected has the potential to reduce CO2e quite significantly, but further improvements could be made if more components used in sample collection devices could be reused or recycled. At present, all components enter a single waste stream destined for incineration. However, an automated system for the separation and disinfection of waste could allow some of the plastics to be recovered. Use of well-characterized plastics could allow non-biological waste from laboratories to be disinfected, separated, and channeled into commercial recycling streams. As with the dilution of reagents, this could be facilitated with automation and high throughput analysers.

COLLABORATION ACROSS THE DIAGNOSTIC LIFECYCLE

Together, the four approaches outlined here could reduce the CO2e of blood tests by around 50%. Whilst these examples are theoretical, they are technically feasible. Given the complexity of healthcare systems, bringing approaches like this to life will require industry partnerships or vertical integration strategies. Like minded companies that understand and align with the need for environmental sustainability have opportunities to collaborate to win market share, derive cost savings, and deliver benefits for individual patients and wider public health.

MEDICAL PLASTICS NEWS SPOKE TO JARED O’CONNELL, GENERAL MANAGER, HEALTHCARE PACKAGING, HONEYWELL TO DISCUSS THE NEWS OF THE NEW ACLAR IMPACT ESTIMATOR.

MAKING

an impact

Could you please tell us about the new impact estimator tool?

Honeywell developed its Aclar Impact Estimator tool to help suppliers calculate the potential reduction in packaging material, weight, waste and carbon dioxide emissions they can achieve with a change in packaging material.

When it comes to selecting packaging materials, patient safety is the top priority for suppliers in the pharmaceutical and healthcare sectors, but sustainability is another factor being added on top of an existing list of requirements, which creates a challenge for companies trying to find packaging solutions that meet all of these needs.

According to a recent report from IQVIA, figures from the NHS in England and France suggest the contribution from the manufacturing of medicines ranges between 25–33% of their total healthcare system greenhouse gas emissions respectively. One way to decrease these effects is to minimize the impact of drug waste with the use of a high barrier packaging that can help extend shelf life and maintain the efficacy of medicines.

Furthermore, using an ultra-high moisture barrier blister packaging such as Honeywell Aclar films, versus cold form foil (CFF), can also help increase efficiency in the supply chain, because it offers the opportunity for smaller pack sizes and therefore reduces the amount of packaging material being used. With a smaller

pack size, reduction in material and weight will lead to smaller secondary packaging, smaller crate sizes and ultimately help reduce the environmental impact of transporting the medications.

Could you tell us more about Honeywell Aclar films?

Aclar is a premium, high-barrier packaging solution that is designed to protect drugs with high moisture sensitivity. It is used in combination with polymer substrates like polyethylene terephthalate (PET) and polypropylene (PP), which are polyvinyl chloride (PVC)-free materials. Aclar’s lamination and thermoforming properties allow for a high pill density in a package, reducing the total package size and therefore the total packaging material used.

Using thermoformed Aclar blisters can reduce pack size and secondary packaging by 50% on average compared to the same material packaged in CFF. With a higher density of pills per package, suppliers using Aclar can directly reduce raw material usage and waste, as well as total packaging weight, which can help lower transportation-related environmental impact.

How does the impact estimator tool work?

Honeywell’s Aclar Impact Estimator helps pharmaceutical companies understand the potential reductions in packaging waste and carbon footprint when switching to Aclar packaging materials.

The tool was validated by a third-party life cycle assessment expert and was developed using data on Aclar’s total cost of ownership, market data, as well as data provided by customers about the real uses of Aclar and CFF. Potential reductions are generated based on customizable elements including capsule size, annual packages per year and method of transport. Data from the tool can be used to calculate the potential cost savings, including warehousing expenses and transportation costs, as well as capital expenditures.

Honeywell experts are available to help pharmaceutical companies review their goals and determine how Aclar can help meet their needs.

What’s the importance of such an impact estimator tool?

The pharmaceutical and healthcare sectors are looking to advance their sustainability journeys without compromising patient safety or product efficacy. One aspect that can be put into focus now is reduction to help increase efficiency. Tools like Honeywell’s Aclar Impact Estimator can support the industry’s transition to more sustainable practices by demonstrating the tangible impact that waste reduction savings can provide. Packaging solutions like Aclar are ready-now to help.

The Aclar Portfolio carbon footprint has improved by 50% since 2012. Honeywell has active projects underway at our sites to reduce Aclar carbon footprint by an additional 20% by 2025.