Vaporized Hydrogen Peroxide (VHP), now FDA-recognized as an Established Category A sterilization technology, is an effective method for sterilization of temperature- and radiation-sensitive medical devices. The STERIS VHP LTS-V Low Temperature Sterilizer provides on premise sterilization using VHP technology and is part of our broad, technologyneutral sterilization product and service offerings.
For more information, visit sterislifesciences.com/VHP-LTS-V
3 Comment
Olivia Friett discusses the effect of AI in the medical industry
4 Digital Spy
Sharing some of the latest news in the medical plastics industry
12 Cover Story
Eastman highlights the importance of sustainability in the medical sector
28 Q&A
Xenco Medical explains the power of bridging digital health and materials science
8 Regulatory Update
LFH Regulatory shares how the new regulations can affect UK importers
10 Coatings
Microban delves into the sustainable impact of antimicrobials
16 Med-Tech Expo
Raumedic discusses the next generation of soft cannulas
23 Labeling
Arburg shares the benefits of in-mold labelling for packaging
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ith the rise of digital technology, not just in the medical industry, but in every industry, it’s hard not to think about the advancements in smart manufacturing and artificial intelligence (AI). While AI might not be directly relevant to medical plastics manufacturing, we can’t ignore the fact that it has changed the industry.
What exactly is AI? The BBC describes artificial intelligence as technology that enables a computer to think or act in a more ‘human’ way. It can take in the information from its surroundings and decide its response based on what it learns or senses.
So how can it benefit medical device manufacturers? For manufacturers, AI can be a game changer. The National Institute of Standard and Technology (NIST) states that AI can bring greater efficiencies, lower costs, improved quality and reduced downtime, as well as countless other benefits.
Other examples include when SyBridge showcased its AI-driven platform that puts manufacturing intelligence at every designer’s fingertips and AND Technology Research launched their TENTO+ AI compliance platform at Med-Tech Innovation Expo 2023. (You can still register for your free pass to Med-Tech Innovation Expo 2024 at med-techexpo.com).
It’s not just manufacturing medical devices, but the entire healthcare industry that needs these advancements. In the UK, for example, the strain on the NHS is excessive and the layout as it is cannot keep up with the demand. AI advancements can assist with the work of diagnostics, triage and diagnosis help, care delivery and many more examples – and this will only become more accurate and reliable as AI technology advances.
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AI isn’t just for large manufacturers, AI can be cost-effective and still high-quality, meaning smaller manufacturers can enjoy the benefits of the technology. BioMavericks, a life sciences start-up, was the wildcard winner at the Discovery Spark program with a prize of six months of free lab space at Discovery Park. The start-up company is focused on developing an in vitro diagnostic urine test for pancreatic cancer using AI-driven biotechnology.
In the past year alone, we’ve had AI generated diagnostic devices from companies such as femtech start-up Matrix Health and Care. Matrix is a digitally enabled, AI-supported pelvic assessment and diagnosis device, designed for holistic and data-driven gynecological applications. You can hear more about the device from my interview with Stiliyana Minkovska, the founder and CEO of Matrix on the FemTech Series on the MedTalk Podcast.
What is the future of AI in healthcare and life sciences? This is just the beginning for AI; AI’s full potential has not yet been explored – in fact, we’ve barely scratched the surface.
Front Line Medical Technologies, has announced that its COBRAOS (Control Of Bleeding, Resuscitation, Arterial Occlusion System) has officially been granted CE marking under the new European Medical Device Regulations.
EU medical providers now have full access to this aortic occlusion device, the first of its kind to be approved through the new MDR system.
“The CE marking of the COBRA-OS is momentous
for our company, as it reinforces our dedication to technological excellence and our unwavering commitment to better patient care,” said Dr. Asha Parekh, CEO of Front Line Medical Technologies. “Day in and day out, our pursuit of helping to save as many lives as we can is what drives our entire team, and this regulatory achievement means we are further on our way to accomplishing that goal.”
The COBRA-OS is most notable for its ultra-low profile. It also doesn’t require an over-the-wire technique, which speeds up deployment and buys valuable time until definitive care can be provided and is accompanied by a 4 French mini-access sheath kit and a 10 cc swordhandled syringe.
Tool recently announced EuroDev as their new European sales representative company. They will offer the full line of Guill products across Europe, excluding the UK.
Since its establishment in 1996, EuroDev has been the preferred business development partner of more than 500 North American firms. Their team consists of over 75 multilingual professionals whose aim is to help North American companies map out expansion strategies in an increasingly complex marketplace. The company’s sales outsourcing includes market research, entry strategy, lead generation and sales.
The company will offer sales support throughout Europe, while Padraic Lunn continues to represent Guill in the UK.
Padraic Lunn has worked since 1990 in the medical device extrusion
industry in Ireland. With more than 16 years in precision extrusion, Padraic Lunn Enterprises offers a full range of extrusion machinery and consultancy for all extrusion processes with a strong emphasis on tubing, wire, pipe and profile applications. The firm represents extrusion equipment companies in the UK, Ireland and other parts of Europe. Furthermore, Padraic provides customized extrusion training programs which are based on a customer’s specific process requirements.
Gerresheimer has entered into a partnership with the US digital health company RxCap and acquired a minority stake.
Under the terms of the agreement, Gerresheimer’s subsidiary Centor will receive the exclusive distribution rights for pharmacies in the US for adherence solutions by RxCap, consisting of connected prescription vial closure devices and complementary cloud-based software.
Patient adherence to medication is crucial for therapy outcome and can prevent cost-intensive hospitalizations. Digital therapy support is becoming increasingly important in this area, not only
through body-worn sensors and apps, but also through connected primary packaging and delivery systems and medication adherence monitoring.
Under the partnership agreement Centor will offer RxCap’s suite of connected prescription vial closure devices and complementary cloudbased software to pharmacies to help them monitor their patients’ prescription adherence.
This partnership will enable pharmacies to quickly launch adherence solutions that can support patient’s health journey more effectively, with minimal additional investments in their workflow, and create new revenue streams.
Ingenuity has developed a free online course on Thermoform Circularity as part of its new Good Information continuing education series. This course is designed to help industry insiders learn more about the principles of thermoformed packaging and how thermoforming can impact sustainability initiatives.
During the 90-minute course, students will complete lessons providing an overview of the thermoforming process, types of polymers used in thermoformed products, insights on mechanical recycling and advanced recycling, as well as progress being made toward a circular economy. A Thermoform Circularity certificate is available when the course is concluded.
Thermoform Circularity lessons are taught by Zach Muscato, corporate sustainability manager, and Sarah Webber, sustainable packaging engineer at Plastic Ingenuity. Packaging engineers, procurement officers, packaging development researchers, packaging buyers, sustainability managers and packaging students are all encouraged to register.
This is the first course offered in Plastic Ingenuity’s Good Information series. Future course topics will include Healthcare Packaging Sustainability, Sustainable Polymers, Advanced Recycling, Packaging Legislation and more.
The EcoVadis assessment evaluates 21 sustainability criteria across four core themes: Environment, Labour & Human Rights, Ethics and Sustainable Procurement. More than 85,000 companies globally have been rated by EcoVadis.
“We are immensely proud to have achieved a gold medal rating from EcoVadis, a testament to our unwavering commitment to sustainability and ethical business practices. It’s a milestone that energizes us to continue driving sustainable innovation and fostering responsible leadership in every aspect of our operations,” said Tessy president, Stafford Frearson.
Tessy Plastics has announced that it has achieved a Gold Medal from EcoVadis. The company submitted their first EcoVadis assessment in 2012 and has earned a rating nine times with the majority of them being silver up until this year.
Tessy Plastics scoring a gold medal places them in the 95th percentile globally.
EcoVadis’ business sustainability ratings are based on international sustainability standards such as the Ten Principles of the UN Global Compact, the International Labour Organization (ILO) conventions, the Global Reporting Initiative (GRI) standards and the ISO 26000 standard. The ratings provide an evidenced-based analysis on performance and an actionable roadmap for continuous improvement.
As a partner of Selenis, Resinex plays a role in bringing the new medical PETG range, Selcare, to the healthcare industry, specifically for medical devices.
Selcare offers a selection of three medical grade plastics for medical devices, with chemical resistance, impact strength and durability so that the medical value chain can exceed the expectations from customers. This partnership aims to introduce these medical grades to the industry.
Selcare HC 300 is an amorphous copolyester specifically developed for injection molding parts for medical devices and diagnostic applications, such as fluid Plastic
management components, dialyzers and injectable devices.
Safe grades are the ideal solution for thinwalled applications such as evacuated blood collection tubes, syringe caps and injectable devices. The use of polyester in this field has become well established due to its superior clinical performance.
Selenis’ quality inspection practices ensure the control of physical properties and the consistent provision of quality products Selcare product offering is complemented by a suite of supporting services, including biocompatibility statements, notification of change agreements, and regulatory support, among others.
Extractables and leachables (E&L) testing is critical for identifying and quantifying potentially harmful leachable impurities from pharmaceutical container closure systems (CCS) and drug delivery devices. A strong E&L strategy analyses the nature of all present substances and their toxicity, quantifying patient exposure to each chemical and the corresponding risk.
A 2019 study found that based on a sample of 85 patients, switching from dry powder inhalers (DPIs) to pMDIs was associated with decreased asthma exacerbations and improved asthma control. Despite alternatives such as DPIs being available, pMDIs still represent the foundation of asthma control in the UK.
pMDIs consist of a drug formulation with a closure that delivers the required dosage efficiently and consistently. A pMDI usually consists of a pressurized canister that contains the active substance and propellant and is capped with a metering valve, along with a plastic holder consisting of the actuator, expansion chamber, and mouthpiece.
When using a pMDI, patients administer a precise dose for inhalation into their lungs. Correct administration depends on several factors, including the drug formulation, the device design, and patient technique.
E&L studies provide a complete overview of any possible harmful substances that could leach from pMDI packaging. Compared with other pharmaceutical products, pMDIs have a much greater risk of the packaging impacting drug delivery. The formulation includes the API in a hydrofluorocarbon (HFC) liquified gas, which acts as an effective solvent for leaching. Furthermore, pMDIs often consist of multiple materials and plastic components with a range of polymerization catalysts, antioxidants, pigments, and slip agents used in their manufacture that may leach, all of which may carry varying toxicological risks.
Typically, an E&L assessment starts with a controlled extraction study using various solvents to identify compounds that can be extracted from the packaging. Information gleaned from this is vital for the design of the appropriate leachables studies.
Typically, E&L evaluation is performed during late-stage drug product development. However, it is recommended that manufacturers begin extractables studies early because it can take up to 18 months to be prepared for registration leachables stability assessments. Early assessment allows inappropriate materials to be replaced quicker, reduces risk by allowing time to react to extractables findings, and can help manufacturers accelerate the route to market for their product.
As soon as pMDI manufacturers have identified the material candidates, they can and should investigate their E&L implications. Early consideration of method development and validating bespoke methods for analyzing targeted leachables is essential. One key element of method development is ensuring that there is an effective means of ensuring the active pharmaceutical ingredient (API) is cleaned up during sample preparation. Doing so enables consistent and accurate trace analysis, free from interference. Collaborating with E&L specialists with knowledge in this field can help improve turnaround time.
The manufacturer can begin the stability studies after finalizing the container closure system design. These include an analysis of the targeted leachables to determine if the identified substances migrate from the container into the drug product and whether there is cause for concern. As well as the targeted leachables, it is best practice to include non-targeted screening methodologies since there is always the possibility that compounds additional to those targeted may arise in the drug product. These include leachable compounds not observed during extractable studies, degradants of identified leachables, and reaction products from the drug product formulation.
Study design can be challenging, so working with an E&L specialist is recommended. These experts can design streamlined, comprehensive studies to capture the necessary data and format it in a way that supports regulatory submissions.
E&L studies allow manufacturers to quantify and analyze harmful chemicals in their drug products and establish patient safety. With pMDIs a cornerstone of asthma and COPD treatment, designing and implementing an effective E&L regime is vital so that these products can reach the market and continue meeting patient needs.
Since the UK officially left the EU, importers in the UK have been subject to a new regulatory framework. Importers must comply with the UKCA marking requirements, which replace the CE marking previously used under EU regulations – although for the time being, medical device CE marking is still accepted. The MHRA (UK Medicines and Healthcare products Regulatory Agency) now oversees the approval and regulation of medical devices in the UK market.
Distributors, placing devices from the EU on the GB market, who are now importers, find themselves dealing with additional obligations. Understanding these obligations is crucial for companies operating in GB to ensure compliance and continued market access. Furthermore, if you are a manufacturer in GB wanting to market and distribute from an entity in the EU, someone needs to take care of the additional importer obligations of Article 13 in the EU Medical Device Regulation.
While the UK MDR 2002 does provide regulatory requirements for manufacturers, authorized representatives, and conformity
assessment bodies, it does not specifically outline the obligations of importers. The only obligations clearly outlined are listed on the MHRA website ‘Regulating medical devices in the UK’. This states that the importer is required to inform the relevant manufacturer or UKRP of their intention to import a device. Obligations on storage, transportation, and label checks also apply. The importer’s address does not need to be on the label unless acting as the UKRP.
The consultation on future medical device regulations back in 2021 proposed a list of obligations for importers which include requirements to:
• Keep records for the device for a specified time period.
• Ensure safe storage and transport of devices.
• Ensure devices are appropriately labelled and assigned a UDI.
• Cooperate with the MHRA during investigations of potentially unsafe devices.
• Ensure that the end user does not receive a medical device which has passed its expiry date.
• Inform the manufacturer or the manufacturer’s UKRP that they intend to import the device.
• Have an appropriate Quality Management System.
• Provide their details on the packaging or a document accompanying the device.
69% of respondents supported the introduction of these obligations. Therefore, it is likely that these will be published as part of the new UK Medical Device Regulations expected to be in place in 2025.
The introduction of the EU MDR 2017/745, combined with the UK’s departure from the EU, has induced confusion for some. It is important to distinguish the difference between the requirements of each territory.
The EU medical device importer is defined as any natural or legal person established within the Union that places a device from a third country on the Union market. Most of the proposed GB importer obligations align with the EU medical device importer obligations. The EU importer has to carry out checks on the conformity of the device, hold a copy of the Declaration of Conformity, and ensure they are identified on the product, its packaging, or accompanying documentation. However, these rules are listed out in the EU legislation specific to medical devices (EU MDR 2017/745), unlike the UK MDR 2002, making the EU medical device importer’s obligations much clearer.
It is important to remember that the legal manufacturer is responsible for the medical device. Therefore, the manufacturer should have an agreement with all economic operators, in writing, that lists out their responsibilities, wherever they are in the world. This puts a safeguard in place to maintain traceability and accountability, which is crucial during any adverse event.
A Global Technology led Contract Manufacturing business with ISO 13485 accredited facilities, and FDA 21CFR820 and MDR compliant.
Healthcare-associated infections (HCAIs) pose a serious and growing threat, putting staff and patients at risk and incurring significant costs. For example, 653,000 HCAIs were reported among 13.8 million adult in-patients in the NHS from 20162017, of which 22,800 patients died as a direct consequence.
In hospitals, the main sources of microorganisms are patients’ own microbiota, and the hands of healthcare workers, patients and visitors. Additionally, hightouch plastic surfaces – such as medical weighing scales, clinical workstations, hospital carts, dispensing cabinets and even chairs – can contribute to the chain of microbial transmission, by acting as reservoirs on which transferred bacteria can survive and multiply.
Similarly, waiting rooms and corridors are prone to contamination with dirt and debris, and microbes may also enter healthcare facilities on shoes, clothes, and even personal electronic devices. Policies that implement regimented hand washing and thorough, frequent disinfection of all surfaces are crucial to help prevent unwanted bacterial growth, but compliance tends to be suboptimal, and surfaces are quickly recontaminated by dirty hands.
Bacterial growth on plastic products in a medical setting can also cause staining, discoloration, structural damage or even odors, creating an unpleasant environment for patients and healthcare professionals. Deterioration causes items to be thrown away prematurely, adding to the environmental burden of the healthcare sector and incurring extra costs in terms of replacement goods.
Healthcare providers are therefore seeking out new ways to combat these issues, including implementing proactive measures to maintain a clean medical environment and reduce the volume of waste generated by the industry. Regular cleaning of high-touch surfaces is crucial to protect items from the growth of potentially harmful bacteria, however, standard disinfectants retain limited residual activity after application. Built-in antimicrobial technologies can be used in conjunction with regular cleaning practices to prevent the proliferation of damaging bacteria on plastic goods in healthcare settings, preserving their usability.
These antimicrobial formulations can be seamlessly engineered into polymer products during manufacture using standard coating processes – such as injection molding and extrusion – and into coatings and paints via spraying, rollto-roll or dip application methods. They therefore become an integral part of the molecular structure of the polymer, and work around the clock to help inhibit the growth of bacteria without the risk of washing off or wearing away.
This ‘always on’ technology has been shown to maintain a consistently lower bio-burden than would be expected on a product without builtin antimicrobial protection. In fact, studies have shown that built-in antimicrobial treatments can inhibit the growth of both Gram-negative and Gram-positive bacteria – including antibiotic-resistant MRSA, E.coli and VRE – by up to 99.9%.
Sustainability initiatives for antimicrobial technologies have stressed the importance of features like biocompatibility and biostability in recent years, making water-based antimicrobial coatings that contain fewer volatile organic compounds increasingly appealing to manufacturers.
These coatings, such as LapisShield by Microban, provide long-lasting protection for water-based coatings, and can be applied to a broad spectrum of substrates. The active ingredient in LapisShield works by disrupting the bacteria’s internal enzymes to block metabolic pathways and create an inhospitable environment that interrupts reproduction. Additionally, the technology is free from heavy metals, and is registered with the U.S. Environmental Protection Agency and the EU Biocidal Products Regulation, making sustainable antimicrobial water-based coatings more accessible to healthcare equipment manufacturers around the world.
Traditionally, in-can antimicrobial technologies have been employed to improve the shelf life of solvent-based coatings during storage, but the benefits of these formulations are minimal once the solution has dried, once again leaving the product vulnerable to attack by microbes. Therefore, long-lasting antimicrobial chemistries, such as Ascera, are vital to improve coating durability.
Ascera has been specifically designed for use in a range of molded polymers, solvent-based coatings and paints. Ascera interferes with bacterial cell membrane permeability, hindering nutrition absorption and conversion processes to inhibit cell proliferation and survival. The additive is completely free from heavy metals, and contains an ingredient inspired by nature, serving as an effective yet more ecofriendly antimicrobial solution than heavy metal-based options.
These well-established chemistries function as an adjunct to a regular cleaning schedule, providing a more comprehensive and proactive method of maintaining surface cleanliness for the entire lifetime of a product, even after extensive use. Both formulations help to prevent the accumulation of bacteria that could damage goods in healthcare environments, extending the usable lifespan of a range of items and preventing unnecessary disposal.
For instance, incorporating antimicrobial technologies into the base material of nebulizers, aspirators, and other breathing devices – or even on coatings covering these machines – can help to keep these essential plastic products cleaner and functional for longer. Adding these chemistries into toileting and bath safety products – including commodes, shower chairs, raised toilet seats, and grab rails – can help to protect them from degradation caused by mold and mildew, so that they can continue to provide users on a continuum of care with independence.
These technologies also reduce the need for aggressive deep cleaning with strong chemicals and copious water and energy, playing a substantial role in enhancing the sustainability of the healthcare sector as a whole.
Incorporating antimicrobial additives into plastic clinical surfaces and products at the point of manufacture is an integral part of ongoing plans to enhance cleanliness in healthcare environments. In fact, the healthcare segment accounted for 26% of the overall global revenue share of the antimicrobial additives market in 2021, and is expected to experience the fastest annual growth rate in the years leading up to 2030.
New antimicrobial technologies for polymers – which are easy to incorporate, aesthetically pleasing, highly functional and free from heavy metals – hold enormous potential for transforming the definition of clean in healthcare and provide much-needed peace of mind for staff and patients alike.
On top of this, built-in antimicrobials are valuable tools for promoting sustainability and building a circular economy in the medical sector, with technologies for polymers, solventbased coatings and paints paving the way for this industry-wide green transition.
In this Q&A, Eastman’s Katherine Hofmann explores the vital connection between sustainability and healthcare. She highlights the importance of medical plastics in achieving sustainability goals, discussing challenges, regulations, and emerging solutions. Her insights offer a comprehensive overview of ongoing efforts to advance sustainability in healthcare, with a focus on medical packaging and patient safety.
Why does sustainability matter in the context of healthcare?
The use of single-use plastics revolutionized healthcare, enabling better sterility and reducing potential infection or the spread of infection. However, the negative impact of climate change and environmental waste cannot be ignored. These sustainability issues are not only adversely affecting the environment but also place an additional burden on the healthcare system. Despite the healthcare industry’s commitment to “do no harm”, it inadvertently contributes toward climate change and waste through the use of singleuse plastics in medical packaging. While these plastics are essential for patient protection and optimal outcomes, it is crucial to recognize that environmental health is directly linked to human health. Therefore, it is imperative to develop solutions that protect both patients and the broader community.
What makes the examination of medical plastics crucial in the pursuit of sustainability?
Companies in the medical plastics industry are setting targets to reduce greenhouse gas emissions and collaborating on recycling programs led by organizations like the Healthcare Plastics Recycling Council (HPRC). These efforts are crucial in preventing medical plastics from being disposed of in landfills or incinerated, as they account for approximately 25% of waste from healthcare facilities
and contribute to greenhouse gas emissions. Surprisingly, a study by the World Health Organization (WHO) found that over 85% of plastic waste from healthcare facilities is uncontaminated and suitable for recycling, challenging previous perceptions. While single-use plastics in primary medical packaging are important for sterility and safety, there is a growing need to minimize their environmental impact.
What potential solutions do you see emerging to make medical plastics more sustainable?
While medical device reprocessing programs have been successful, it is anticipated that medical packaging plastics will continue to be used as singleuse due to their cost-effectiveness and ease of sterilization. To improve sustainability, efforts should be directed towards minimizing environmental impact through manufacturing, sterilization, and end-of-use practices. There are several solutions available, including hospitals reassessing the necessity of certain procedures and the adoption of advanced technologies like molecular recycling. This approach reduces greenhouse gas emissions and waste by converting materials into base molecules for the production of new plastics. It not only reduces manufacturing footprints but also promotes circularity by utilizing waste as feedstock. Pilot studies conducted by HPRC have demonstrated that medical plastic waste can be utilized effectively
across various technologies. Technologies like this encourage us to know that circularity is possible in the industry.
Can you provide insights into the ongoing efforts and projects in the industry that contribute to advancing sustainability in medical plastics?
Several significant initiatives are underway. The National Academy of Medicine has introduced a Sustainable Journey Map to assist healthcare facilities in reducing carbon emissions, including those associated with medical plastics. The Joint Commission has launched a voluntary certification program to recognize and promote decarbonization efforts within healthcare facilities. The HPRC is actively engaged in various projects, such as harmonizing sustainable procurement requirements, evaluating sortation technologies for mixed plastics waste, and collaborating with the Alliance to End Plastic Waste and Methodist Hospitals on a program called .e3TX to establish a scalable and economically viable hospital plastics recycling program. Kilmer Innovations in Packaging Sustainable End of Life (KiiP SEOL) is developing technical documentation to facilitate the regulatory acceptance of molecular recycling for medical packaging. Both HPRC and KiiP SEOL have created educational materials for stakeholders in the value chain, including HospiCycle, a plastics recycling blueprint for hospitals, and information on molecular recycling to enhance understanding of its utility for medical plastics.
What challenges, whether logistical, regulatory, or financial, is the medical plastics industry currently grappling with in the pursuit of sustainability?
Hospitals are under financial and resource pressure that hinder their ability to implement sustainability programs, including recycling initiatives. Limited financial resources and personnel make it challenging for hospitals to allocate additional funds and manpower towards sustainability efforts. Space constraints pose another obstacle, as most hospitals were not designed with plastics recycling in mind. The collection and pick-up of plastics require dedicated space, which may be lacking in many hospitals. This often necessitates the adoption of single-stream collection methods. Right now, municipal waste services do not typically accept hospital plastics, which adds to the logistical complexities that require the full value chain and come new actors to help.
At present, medical plastics are generally exempt from regulations targeting single-use plastics due to their critical role in safeguarding public health. However, the recent Packaging and Plastics Waste Regulation in Europe includes recyclability requirements for medical packaging by 2035. Eastman is
engaged in collaborative efforts across the industry to enable the recycling of PETG. By enabling recycling of PETG, the need for creation of new packaging can be reduced.
How can companies explore end-ofuse strategies for medical plastics, and what questions should they be asking to ensure both sustainability and financial viability?
HPRC recently published guiding principles related to molecular recycling, which align closely with the principles adopted by Eastman. These principles serve as an excellent starting point for engaging with end-of-use providers initiating discussions about the environmental and community impacts of their process, regardless of whether molecular recycling is involved. Key considerations include adherence to waste hierarchy, assessment of greenhouse gas emissions and other environmental impacts, identifying where the material will be processed, and determining potential applications it would go into. It is important to always ask about associated costs, as alternative solutions to landfilling and incineration often come with additional expenses. Determining how these costs will be distributed across the full value chain is important for developing a viable and sustainable strategy.
How can we guarantee that chemically recycled materials are not contaminated, and what criteria should companies consider in determining the safety of medical products made from these materials?
It is crucial to understand that the molecular recycling process effectively removes contaminants. This can be assessed through different analytical testing methods, such as infrared spectroscopy or nuclear magnetic resonance. Both techniques show the molecular make-up of a given material, allowing one to see any contaminants or differences between two products. Additional testing can be conducted to assess factors like biocompatibility, processing and mechanical properties including heat resistance, stiffness, and material flow. It is important to note that these properties will remain consistent as long as the molecular make-up remains the same.
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The recent move by the FDA to reclassify VHP sterilization as an Established Category A technology is a significant development for healthcare product manufacturers seeking to adopt VHP for terminal sterilization applications. VHP’s ongoing technology journey and the ever-increasing growth of innovative medical devices are well aligned for the benefit of the industry.
STERIS pioneered the development of Vaporized Hydrogen Peroxide (VHP) sterilization and biodecontamination technology in the mid 1980’s. The first commercial VHP product launch took place in 1991 for the biodecontamination of sterility test isolators. Since then, VHP has become a widely used method for biodecontamination of cleanrooms, isolators, and material transfer. In addition, VHP is used as a sterilization modality for reprocessing of medical devices in hospitals with increasing use in industrial sterilization applications. Beginning in the 2000’s, the medical device industry developed a demand for low temperature sterilization of sensitive medical devices. The pharmaceutical industry joined this increasing demand for the sterilization of packaged pre-filled syringes and other types of combination devices. Material compatibility, temperature, and radiation sensitivity of medical
device applications are key considerations for stakeholders. The increase of temperature sensitive ophthalmic drug products using pre-filled syringes, electronic implants and smaller batch customized orthopedics has created the need for a wider range of proven sterilization modalities.
In healthcare settings, VHP sterilizers used to reprocess heat sensitive hospital instruments have paved the way. VHP’s healthcare track record increased attention for industrial VHP sterilization applications. In 2014, chemical indicators for VHP sterilization processes were included in ISO 11140-1: Sterilization of health care products—Chemical indicators—Part 1: General requirements.
In 2015, the US Pharmacopoeia recognized VHP as a vapor phase sterilizing agent. The acceleration of regulatory developments for VHP industrial sterilization continued with the FDA’s 2019 Innovation Challenge. This challenge was to find sterilization modalities and optimize current sterilization processes.
STERIS was accepted for three applications within the program: AcceleratorBased Radiation Sterilization, Vaporized Hydrogen Peroxide Sterilization and Enhanced EtO Cycle Design and Processes for reducing EtO emissions.
Another important development has been the efforts by industry stakeholders in developing specific VHP sterilization standards. The first and most significant outcome as the publication of ISO 22441:2022 - 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. In 2023, the FDA announced the recognition of ISO 22441.
A notable milestone for VHP was achieved on January 8, 2024, when the FDA announced VHP as an Established Category A sterilization method. This puts VHP in the same category as dry heat, moist heat or steam, ethylene oxide, and radiation sterilization modalities. Best practices in regulatory guidelines and standards are often considered through PIC/S (Pharmaceutical Inspection Cooperation Scheme) and other regulatory collaborations and can strengthen the status of VHP globally since ISO 22441 is an international consensus standard.
The next step for VHP sterilization standards is the publication of EN 17180 - Sterilizers for medical purposes — Low temperature vaporized hydrogen peroxide sterilizers — Requirements and testing. This document is still currently in development. There is also consideration of work for the ISO 11138-6 standard for VHP biological indicators.
The industry is asking for new methods to meet the growing industry needs for sterilization capacity. VHP sterilization as an in-house process at the end of manufacturing line minimizes packaging and transport logistics. This is especially important around heat-sensitive biological products that often require cold chain management. The utility and energy requirements are also minimal compared to other sterilization methods. In house steam and large electricity energy use is not required for the process. VHP sterilizers come with qualified ready to use STERIS Vaprox sterilant and biological indicators conforming to ISO 11138-1.
The soft cannula market could experience a major disruption due to a manufacturing approach that could make production safer and more cost-effective: manufacturing soft cannulas as a single-piece injection molded part.
In the evolving landscape of drug delivery, wearable injectors stand at the forefront, combining medication administration with a high degree of precision and patient comfort. Among these advancements, patch pumps and belt pumps for subcutaneous injections have emerged as game changers.
These devices simplify the management of diseases such as diabetes, a growing ailment affecting more than half a billion people worldwide – a number that is expected to grow by 46% by 2045. In the case of diabetes, novel devices are delivering insulin directly beneath the skin, offering an efficient and less invasive alternative to traditional injections.
The role of soft cannulas in modern drug delivery devices Central to this revolution of drug delivery systems is the soft cannula, a critical component designed for subcutaneous (“beneath the skin”) injections. It serves as the critical final piece that connects the patient to the device. From an engineering standpoint, soft cannulas offer the upside of being versatile, catering to a wide range of drug delivery systems as an integral component of both patch pumps and belt pumps, enhancing patient comfort – and minimizing the risk of complications.
Classic soft cannulas vs. novel soft cannulas from a single cast RAUMEDIC, a German company specializing in customized polymeric solutions for medical and pharmaceutical applications, can produce soft cannulas the “classic” way - as an extruded tube that is finished when forming the tip and flaring the tube end. Additionally, the connection to the insertion system and the pump mechanism is done via overmolding with appropriate thermoplastic materials. But there’s a challenge to this approach; the assembly technique for connecting a soft cannula to a distributor system is currently costly.
To address these challenges, RAUMEDIC has filed a patent for a soft cannula manufactured in one piece. This development is designed to not only streamline the manufacturing process by reducing the complexity and number of parts, but also to minimize the risk of leakage.
A small selection of RAUMEDIC’s variety of customized soft cannulas – representing their capabilities and expertise in extrusion, molding, and assembly.
RAUMEDIC’s prototype of an injection molded soft cannula – made in one piece - offers a chance to enhance product safety and save costs.
As RAUMEDIC is one of the partners working to offer multiple manufacturing approaches for a fundamental cannula component, it is time to ask the most important question: will novel injection molded soft cannulas, molded in one piece, soon replace assembled and more complex “classic” soft cannulas? Answering this question requires a detailed look at the components, the manufacturing process, and the pros and cons of different soft cannulas.
The components
character, there’s no critical interface between the soft cannula and the housing. This is a major advantage as it further minimizes the risk of adverse effects such as leakage.
In addition, the aspect of enhanced safety, which is always the paramount criterion for medical and pharmaceutical applications, the economic aspect of cost minimization is an advantage not to be neglected. In a world of shifting demographics and economic uncertainty, public healthcare spending is under constant scrutiny, and the pressure on budgets is only set to grow. That’s one of the reasons why RAUMEDIC decided to develop a single-mold soft cannula - the unit price could be lowered in a meaningful and measurable way, compared to the classic approach. Is the classic soft cannula past its peak?
Classic soft cannulas typically consist of multiple components. In the case of RAUMEDIC’s needle insertion system: short pieces of an extruded tube, being formed to the soft cannula, thermoplastic overmolded housing, an integrated septum, and a closing clip, bringing it to a total of four components.
With RAUMEDIC’s development, a soft cannula manufactured in a single mold, the number of parts can be lowered to three components: the cannula from a single mold, a septum, and a clip. Thus, this approach allows the combination of two components and saves several steps in the process.
The manufacturing process
The manufacturing process of a classic soft cannula involves cutting the tubing into short sections, forming a tip according to customer requirements, and then tailoring the back end into various geometries for further processing. The method requires high precision to ensure a form fitting connection between the cannula head and the housing during the overmolding process.
The single-mold soft cannula on the other hand reduces the necessary process steps. All process steps prior to the overmolding such as tube extrusion, length cutting and the head forming of the tube can be eliminated.
Lower costs per unit and minimized risk of leakage
Besides eliminating costly and time-intensive production steps, there’s another striking benefit to the single-mold technique; due to its monolithic
Considering all the benefits of the approach of producing soft cannulas, this begs the question: will “classic” soft cannulas slowly but certainly disappear from the market, and become a museum piece to be examined with bewilderment by future MedTech professionals in the near future? The answer is a clear NO.
Certain designs, e.g. long versions of a soft cannula, cannot be realized through an injection molding process but require the usage of the existing process and extruded tubes. In addition, certain dimensions and materials are not suitable for a molding process, although the limitations are constantly changing.
With an assembled solution, the highest quality standards for materials, geometry and dimensions can be realized in the extrusion process. This approach offers far greater possibilities when post-processing extruded tubing to expand the assembly into customized soft cannulas. Thus, for many modern drug delivery systems, there is no viable alternative to a customized assembled version of a soft cannula.
NIC HUNT, HEAD OF SUSTAINABILITY, NELIPAK HEALTHCARE PACKAGING, SHARES HOW SIMULATION TESTING IS DRIVING SUSTAINABILITY IN MEDICAL PACKAGING.
In today’s rapidly evolving healthcare landscape, sustainability has emerged as a critical focal point. With billions of pounds of healthcare plastics being produced annually, the environmental impact of single-use plastics in the medical sector is undeniable. As the global community shifts towards more sustainable practices, the medical device and pharmaceutical sectors are facing increasing pressure to address their environmental footprint.
Medical device packaging manufacturers are stepping up their efforts to enhance sustainability throughout their operations. This includes a heightened emphasis on packaging design optimization, material selection, and waste reduction initiatives. By reimagining packaging solutions, these manufacturers aim to minimize environmental impact while maintaining the integrity and functionality of their products.
A key strategy in achieving these sustainability objectives lies in the adoption of simulation testing techniques. By leveraging advanced simulation technologies, such as in silico modelling, packaging engineers can evaluate the performance of various packaging designs without the need for extensive physical prototyping. This allows for faster iteration and optimization.
Simulation analysis offers an understanding of packaging dynamics, including factors such as material thickness, form factor, and failure points. Through virtual modelling, engineers can identify opportunities for lightweighting and material reduction, reducing the product’s environmental footprint. Additionally, simulation enables the exploration of alternative materials and design configurations, providing valuable insights into potential sustainability improvements.
One notable application of simulation in device packaging is the optimization of thermoformed plastics. By digitally modelling packaging designs and conducting virtual evaluations, stakeholders can assess the viability of sustainable packaging solutions before committing to physical production. This approach not only accelerates the design process but also minimizes resource consumption and waste generation associated with traditional trial-and-error methods.
Furthermore, simulation allows for scenario testing and sensitivity analysis, enabling manufacturers to anticipate and mitigate issues before they arise. By simulating real-world conditions, engineers can fine-tune packaging designs to ensure optimal performance and durability. This approach not only enhances sustainability but also improves product reliability and customer satisfaction.
Moreover, simulation-based optimization extends beyond the design phase to encompass the entire lifecycle of medical device packaging. By simulating transportation, storage, and end-of-life scenarios, manufacturers can identify opportunities for further waste reduction and environmental stewardship.
Ultimately, the integration of simulation testing into the packaging design process represents a paradigm shift in sustainability efforts within the medical device industry. By harnessing the power of virtual modelling, manufacturers can drive meaningful reductions in waste, energy consumption, and environmental impact. Simulation empowers stakeholders to make informed decisions based on quantifiable data, ensuring that sustainability objectives are achieved without compromising product quality or safety.
In conclusion, the incorporation of simulation testing is poised to revolutionize the way medical device packaging is designed and optimized for sustainability. By embracing innovative technologies and methodologies, manufacturers can pave the way for a more environmentally conscious future while delivering highperformance packaging solutions that meet the evolving needs of healthcare providers and patients alike.
As sustainability continues to take center stage in the medical industry, simulation offers a powerful tool for driving positive change and shaping a more sustainable tomorrow. With continued investment in simulation-based research and development, the medical device packaging sector can lead the charge towards a greener, more sustainable future for healthcare worldwide. The adoption of simulation testing represents not only a commitment to environmental stewardship but also a strategic investment in long-term competitiveness and resilience in an increasingly sustainability-focused marketplace.
Shortages in skilled labor, employee turnover, or high absence rates among workers due to illness are among the biggest challenges faced by laboratory or quality assurance managers. So, how can you take the necessary steps to guarantee optimal quality assurance with limited personnel resources?
Identify key positions – prioritize personnel tasks
Depending on the industry, a wide range of testing instruments can be used for quality assurance purposes. If we include pre-testing tasks such as specimen preparation, the number of machine and device options increases even further. For example, a typical testing laboratory in the plastics processing industry uses systems for various testing methods: mechanical testing, microscopic analysis, spectroscopy, thermal analysis, rheometric analysis and physical analysis.
Depending on the testing or analysis method and manufacturer, these instruments demand diverse levels of operator training. Machine operation can often be elaborate, and in addition an experienced specialist, must also be able to directly assess the test results. In such cases, it may be worthwhile investigating which machines or instruments operation can be simplified so that they can be easily used by less experienced personnel while also maintaining the highest level of safety.
Digitalize processes – save time and increase safety
Digitalization has taken on significant momentum in recent years, affecting the field of materials testing, where the use of digital technologies has greatly increased process efficiencies. The benefits of digitalization are clear when it comes to testing laboratory processes.
Save time: time-consuming manual tasks are replaced with digital solutions, leading to shorter test times. For example, 50% of the time required to manually measure specimens using calipers and entering the information into the system can be saved through automated transfer of the specimen dimensions.
Maximize accuracy: digitalized testing processes increase precision and accuracy by eliminating sources of human error. In the above-mentioned example, you not only save time, but the scatter of test results caused by incorrect measurements of the specimen dimensions is significantly reduced.
Automate data management: data is easily managed and evaluated. This makes it easier to monitor and analyze trends and possible errors or defects.
Take advantage of pre-configured analysis programs: you can have access to pre-designed analysis formats. It is no longer necessary to export data to Excel, merge it manually and subsequently analyze it.
Leverage automation for repeatable tasks
Today, many businesses are in a situation where consistent automation of a wide range of quality assurance processes is and remains the most important lever for counteracting the lack of qualified laboratory personnel. Materials testing with its strictly defined testing standards, offers an ideal business model for the automation of testing processes.
Increase accuracy and errors: automated systems are less susceptible to human error and can achieve a higher level of accuracy when monitoring processes and results. One example is the scatter of test results, which with the use of a fully automated testing system such as a universal testing machine with automated specimen feeding system, is reduced by approximately 5% when compared with a similar setup incorporating manual operation.
Increase efficiency: automated systems work faster and more efficiently than human testers, accelerating processes and increasing productivity. When performing a tensile test, it takes up to 35% less time with a semi-automated machine, when compared with a manual machine.
Increase monitor processes: automated systems can monitor processes as they occur, allowing you to quickly react to discrepancies or abnormalities and take appropriate corrective action. At the same time, large amounts of data can be analyzed quickly and efficiently to identify trends and patterns that are crucial for quality assurance purposes.
Project Management, with its emphasis on efficiency and value addition, demands meticulous planning and resource optimization. Nowhere is this more apparent than in the healthcare industry, where stringent regulations and exhaustive testing protocols dictate material choices, constraining flexibility and options for adaptation.
In this intricate landscape, the roles of plastic suppliers extend far beyond mere material provision. They serve as essential partners in innovation, design, and function, ensuring that every component aligns with project objectives and industry standards. Moreover, they can play a pivotal role in quality assurance, production optimization, cost management, and navigating the maze of regulatory compliance.
Plastic suppliers often have technical specialists that can advise options to meet design and function requirements. Whether that is living hinges, jointing options, materials for complex shapes or providing surface functions like laser marking or embossing, aesthetics and haptics. As well as in-use considerations like chemical resistance and sterilization. Engaging with suppliers early in the design process can avoid the complex task of solving issues down the road, saving time and money.
In the medical and pharmaceutical industries, stringent control is required over both materials and suppliers. Medical grade plastics come with support packages, including consistency of formulation, change notifications, single-site sourcing, medical compliance statements and Drug Master Files (DMFs). However, the specifics of these packages vary among polymer manufacturers. Some offer healthcare specific quality agreements that are not available with standard materials. While the VDI guideline helps standardize this process, it is not a prerequisite for using the term ‘medical grade’. Therefore, before delving too deeply into a project, it is advisable to discuss the support packages for the materials under consideration with the suppliers to ensure alignment with regulatory requirements and project objectives.
Sometimes a new medical application is difficult to transfer into production. Especially if molding is done by a different company to that of the design and development team. Suppliers usually have technical support functions that can assist converters with processing and help identify issues with materials or tool design to resolve any conversion problems. However, discussing earlier could potentially avoid the issues in the first place.
As commercialization is often years ahead, feasibility pricing is normally used at the start of the project. Healthcare projects are often small volumes, so it is worth discussing with suppliers options to minimize the cost – for example, looking at an available color to avoid development costs and the higher price of a small volume bespoke color.
COVID and global conflicts have shown how supply chains can be easily disrupted. It is worth considering at an early stage in material choice, where production could be now and in the future. Some materials are available globally, some have regional equivalents and some are only sold in specific regions. Discussion early on helps clarify this, thus assisting material selection.
Knowing the regulatory status of a material can be critical to a project. Food contact can assist with some pharma applications whilst European Pharmacopoeia would reduce testing. Grades with USP class VI, parts of ISO 10993 and DMF exist but statements are not always easily found. Upfront discussion with suppliers helps clarify material compliance and availability of supporting documentation.
Most plastics manufacturers have a medical policy that outlines accepted applications and those for which they do not wish their products to be used, or for which a decision will only be made after assessment. Initiating work on a material without discussing the manufacturer’s risk management policy could result in wasted time and effort on a material that the manufacturer does not support. Quality and regulatory information may be withheld until a risk assessment has been completed. ALBIS has observed an increase in requests from notified bodies for proof that the application has been approved by the supplier.
SUSTAINABILITY
While other industries have successfully integrated mechanically recycled products, the healthcare sector, faces unique challenges in doing so due to traceability, NIAS and lack of the medical support package. However biobased alternatives to fossil-based monomers are now widely used, with medical grades included in many producers’ portfolios. Although this doesn’t reduce the plastic waste it reduces carbon footprint and has no impact on the recyclability of the article or its end-of-life options (e.g. take back schemes). Additionally, these drop-in solutions relate to a “change” in how monomers are produced. This means there is no change in the polymers (specification or processing), which makes the type of change easier to get through regulatory barriers.
Chemical recycling of polymers is coming and will remove most of the obstacles of mechanical recycling whilst actively reducing plastics
heading for landfill or incineration. Where these options don’t suit, the choice of material will still influence the environmental impact of the finished product. Therefore, suppliers can help find the right materials for the task including consideration of the best LCA data whether virgin, mechanically recycled (rarely suitable), biobased or selecting a material that could later come from chemically recycled product.
Many companies manage extensive project teams navigating industry complexities. Often material selection begins before engaging a plastics supplier, bringing them in only when a sample is required. While preliminary research is beneficial, solely involving suppliers at a late stage overlooks their valuable resources, material expertise, and partnership potential. Collaborating from an early stage enables project teams to leverage supplier knowledge, ensuring the selection of the most appropriate polymer solution for the project’s specific requirements.
ISO: 13485: 2016
ISO: 9001: 2015
AIB Certified
• Sonic Welding
• Engineering Services
• 3D Printing
Products decorated using in-mold labeling (IML) are now standard in the packaging industry. For applications in the medical sector, on the other hand, it is not just the decor that is important, but above all precision and added value by integrating functions.
At the Fakuma 2023 trade fair, a newly designed application was on display that fulfils these requirements. Using the example of centrifuge tubes, the great potential of the IML process for use in medical technology and the pharmaceutical industry was demonstrated.
The partners involved in this project are Arburg (injection molding machine), Beck (automation), KEBO (mold), MCC/Verstraete (label) and Intravis (camera inspection).
1. Automation enables precise positioning
The narrow centrifuge tubes, each with a capacity of 15 milliliters, place high demands on the positioning of labels. While IML decors for packaging products are usually positioned with an accuracy of around 1 to 1.5 millimeters, the “print to cut” distance here is only around 0.2 millimeters. Arburg’s partner Beck played a large part in this, by utilizing the technical possibilities in automation to the full. An automated system with a label adjustment head is used to align and apply the labels precisely. Optical control is via an Intravis camera system integrated into the Beck automation system.
2. Integrated functions create added value
Labels for medical products are particularly interesting due to the possibility of integrating functions. The centrifuge tubes are fitted with a scale, for example, which indicates the exact fill level. Temperature-sensitive thermochromic printing, which changes color as soon as the temperature rises above seven degrees Celsius, can be applied to detect any interruption in the cold chain at a glance.
3. Monomer material is recyclable
The functional PP labels with a wall thickness of 57 micrometers are not only scratch-resistant, but also contribute to stability, so that the amount of material required for the PP tubes can be reduced accordingly. Downstream work steps such as conventional printing or gluing are no longer necessary. This enables time/cost-efficient production. In addition, the adhesive-free product made of monomer material can be recycled without any problems.
4. 100% traceability
Information on recycling and warehouse management can also be added to the product via an integrated code. Further added value of the clearly labeled IML labels: the process, quality and patient data can be traced back 100% for each individual part. Such intelligent linking of data is essential for smooth digital communication between patients and doctors or home care applications.
5. Efficient injection molding process
At Fakuma 2023, the 15-milliliter centrifuge tubes made of PP were injection molded with an 8-cavity mold from Kebo in a cycle time of around 10 seconds. At the center of the production cell is an electric injection molding machine with a clamping force of 1,500 kN in cleanroom design. The high-performance machine
in the “Ultimate” performance variant is designed for fast and demanding processes and fulfils the requirements for production in cleanroom class ISO 7. The finished products are discharged either as good parts, bad parts or test parts via three flaps.
6. Rejects reduced by a factor of 10 The production of the ready-to-use products and the application of the IML labels in just one injection molding process also made it possible to reduce rejects by a factor of 10. In a real application, the concept could be expanded further by integrating screwing of tubes and packaging in tubular bags into the production cell.
Conclusion
Due to the combined expertise of machine, tool and IML technology experts and automation, an IML application has been developed that is setting standards in the medical industry. It is designed to enable precise, space-saving and cost-efficient production of IML products - without any additional hygiene risk or work for staff and logistics.
Functional IML labels, in this case indicating the fill level of centrifuge tubes, place high demands on precision with regard to the injection molding process and automation.
In parenteral manufacturing, visual inspection of vials is crucial, as all units must be inspected to ensure the precision quality assurance the mission-critical format mandates. Visual inspection can be performed with the human eye by a trained inspector under controlled conditions, or via automation using advanced cameras and computer technology.
Since visual inspection is a vital function of any manufacturing process, keeping current with technological advancements and global regulations is necessary to meet increasing production demands. The first step is continuously validating an incorporated system with high confidence.
like statistical analysis, known particle size defect standards, and consistent inspection conditions. These capabilities were advanced further by the advent of AVI machines. AVI technology allowed a company to perform inspections faster and with more repeatable results that could be validated, substantiated, and reproduced. As with any new paradigm, vendors have continued to push the frontiers of technology in response to pharmaceutical manufacturers’ various (and increasingly discerning) requirements.
What we see today in the automated visual inspection field are deployments of advancements in processing time, artificial intelligence (AI), and deep learning that promise to revolutionize the product inspection space and free up human inspectors to pursue less retina-taxing monotony.
The notion of inspecting injectable compounds to maintain consistent quality is over a century old; the first mention dates back to 1915 when a document called USP IX insists such protocols must entail “true solutions”. Out of such vagueness have evolved methods and acceptance criteria that matured along with our understanding of risk and, just as significantly, advancements in inspection and manufacturing technologies. As more standards developed around what constituted “good or bad” inspection, attempts were made to fine-tune or supplement the human eye’s limitations via tools
The disadvantages of human inspection have long been understood. Manual visual inspection leads to frequent needs for breaks, and even then, human nature invariably leads to long-term difficulties maintaining consistency - a must-have for increasingly tight tolerances. In short, there are too many human variables to meet modern requirements.
By contrast, AVI systems have traditionally been hampered by one factor: speed. Promisingly, AVI machines have made tremendous strides toward meeting the escalated production throughput needs of 21st-century pharmaceutical manufacturing and packaging lines. Compared to cameras manufactured as recently as ten years ago, today’s AVI systems can employ line scan or gigabit ethernet (a.k.a. “GigE”) cameras with vastly superior processing speed and image acquisition capabilities. The relatively newfound ability to take multiple images per second and then compare them to preset standards allows several criteria to be computed instantly, and a determination made as to “good or bad product” in mere fractions of a second. Today’s machines can process several inspections of typical 10–20ml vials at a rate approaching 30,000 per hour. Well-designed AVI systems are as precise as they are rapid. They can inspect vials from multiple angles for more detailed analyses of vial bases, bottoms, necks, and heels. Combined with backlighting, these camera perspectives can reveal details regarding glass cracks or vial deformities so minute that the human eye would struggle to notice them. Further, employing rapid rotation of vials allows for 360-degree inspection by stitching together images into a continuous “panorama” view of liquid or even lyophilized (freeze-dried) products.
We define validation as a quantitative approach to prove the quality, functionality, and performance of a pharmaceutical/biotechnological manufacturing process. This approach is applied to individual pieces of equipment and the overall macro-level manufacturing process. While regulatory authorities set guidelines for validation, its specifics are too customized for comprehensive government oversight and must, therefore, be carefully compiled by the individual manufacturers. There is no one-size-fits-all handbook for validation, and AVI systems are certainly no exception to this notion.
Validation is broken down into three phases we call the three Q’s: Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). IQ and OQ are the foundation for Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT). The vendor of the automated inspection machine should supply pharma manufacturers with a protocol plan for the testing, as this takes several weeks before initiating the process. From here, it is the manufacturer’s responsibility to review and approve these proposals to ensure they align with their specific production and quality assurance needs.
Installation Qualification (IQ):
This protocol ensures that the AVI equipment and its various components are installed correctly and to the original manufacturer’s specifications. Calibration of major equipment, accessory components, and any adjacent utilities also should be performed in this step. In addition to ensuring proper electrical and compressed air supply setups, attention should be given to calibrating vacuum sensors, which perform not only vacuum leak checking but also help properly position vials on star-wheel conveyors. This is important, as these gauges tend to drift over time.
Operational Qualification (OQ): OQ commences following the IQ’s completion. Here, tests are performed on the critical parameters of the system and the more extensive process that it drives – in other words, functions and variables associated with system equipment. If the system is the hub, this step considers the hub and various spokes, examining how it impacts the larger manufacturing environment around it.
During OQ, all test data and measurements must be documented to set a baseline for the equipment’s performance. Here is where manufacturers should ensure that vials run smoothly through the inspection machine and that the intended operation and inspections work as intended.
Performance Qualification (PQ):
The third and final validation phase tests the ability of the process to perform over long periods within tolerances deemed acceptable. PQ is performed on the manufacturing process as a whole by the company and is usually devised and executed by the pharma company to conform to specific line requirements. Some vendors may help craft this protocol and offer assistance during PQ. However, at minimum, the company should always direct and perform a PQ wherever possible to avoid conflicts of interest.
Individual components of the system are not tested individually during PQ, but the overall synergy and performance are run through their paces and compared to anticipated results or desired manufacturing goals.
The demand for sustainable packaging is growing in every industry, but the challenges inherent in the protection and shipping of medical devices are assuredly greater than most. The first and most obvious reason is that medical devices significantly aid or even save lives, so their intact arrival is of paramount importance. The second hurdle is that many medical devices are delicate, high-precision apparatuses and require packaging that ensures instrumentation arrives completely free of damage or displacement. Neither of these prerequisites can be compromised when creating more sustainable packaging. What’s more, the overengineering of packaging that was done in the past is no longer acceptable as it typically required more materials to be used. Thankfully, the tension that exists between the demand for sustainable packaging and the need for that packaging to still perform has been met with innovative solutions in structural integrity. Solutions that have managed to reduce materials and incorporate more recycled materials for greater circularity and sustainability.
process of creating packaging that’s made to be recovered. The Healthcare Plastics Recycling Council (HPRC) has developed the Design Guidance for Healthcare Plastics Recycling, a resource to aid manufacturers in meeting circularity goals. Meanwhile, non-governmental organizations (NGOs) are helping to shape these efforts by managing overarching frameworks and resources to help keep the greater industry on track.
In addition, healthcare service providers (HSPs) are endeavoring to be zero or reduced-waste operations sooner rather than later. This requires responsible recycling of end-of-life medical device packaging. While international operations must abide by stringent global legislation, as well. What’s more, a high-level look is being taken of packaging systems in general. Holistic evaluations are assessing where material reductions make sense while still ensuring the structural integrity of the package.
Newly developed advanced recycling techniques and the mass balance process that tracks recycled content used in manufacturing have medical device makers excited about the possibilities.
Advanced recycling, sometimes called chemical recycling, is a collection of innovative methods designed to break down or remove the impurities in hard-to-recycle materials. Purification, depolymerization and conversion reduce a polymer to a precursor and/or remove colorants and additives.
The mass balance process provides chain-of-custody proof that records the recycled materials used throughout the manufacturing of a particular product. The recycled plastic is tracked and then balanced with certified recycled content in end products.
Some of the most significant influences in the healthcare industry are group purchasing organizations (GPOs) and the environmentally preferred procurement (EPP) policies they insist on. More and more, contract tenders are including EPPs, necessitating medtech manufacturers make the sustainability of their devices and packaging a primary goal. Organizations have also been established to help direct the
The following case study illustrates how a sophisticated medical device required an innovative solution to provide protection against handling damage while also reducing material usage and improving the packaging’s ability to be recycled. Beckman Coulter Diagnostics partnered with Plastic Ingenuity to engineer a custom thermoformed package to protect the consumables of their new automated diagnostic machine. An extremely sensitive pipette tip needed comprehensive protection for the device to function as intended.
Extensive research and development were required in a process that took several years. Beckman Coulter and Plastic Ingenuity collaborated on structural design features to both the base and the lid to withstand drop tests. Not only was the packaging strengthened and the user experience improved, but a reduction in the materials was accomplished. Ultimately, 58% less plastic was used, 255,735 pounds of material was saved per million parts, and 371 metric tons of carbon dioxide (CO2) equivalent was reduced per million parts.
Transitioning to a circular economy is particularly challenging for the healthcare industry. However, strategic design engineering fueled by continued innovation and combined with collaborative partnerships can help the sector realize its sustainability objectives in both the short and long term.
Netstal′s leading injection molding technology for high-performance medical applications.
In January of 2019, the Centers for Medicare & Medicaid Services brought a $60 billion program for Medicare and Medicaid patients, called the Connected Care Campaign.
Nearly 90% of hospital readmissions could be prevented by meeting patients where they were virtually, the Connected Care Campaign is used for healthcare innovators to improve patient outcomes by developing impactful, remote monitoring solutions.
After the paradigm shift that followed the Connected Care Campaign, Xenco Medical founder and CEO Jason Haider aimed to become the first spinal technology company to harmonize the postoperative episode of remote therapeutic monitoring with the intraoperative phase of biomaterial implantation.
Medical Plastics News asked Jason Haider about his company’s latest technology, the TrabeculeX Continuum.
Is there a focus in Xenco Medical’s technologies on lowering healthcare costs and patient outcomes?
Well, as an organization with an outcomes-oriented thrust optimized for the value-based era of healthcare, we’ve devoted ourselves to continually developing technologies that address the entire spectrum of a patient’s surgical experience. Whether it’s been the development of the first glasses-
free holographic surgical simulation platform in HoloMedX, our portfolio of disposable, composite polymer spinal implant and instrument systems, or our biomimetic, titanium foam spinal implants, all of our technologies share the common thread of value-based medicine. We have committed ourselves to addressing not just a single instance of intraoperative care but the entire longitudinal journey of every patient. That calling was instrumental in spurring us to develop a bridge that unified the surgical and postoperative phases of our patients’ journeys through the TrabeculeX Continuum.
Could you walk me through the process of developing the TrabeculeX Continuum?
When we began this development process, it was essential that the two technologies that would bridge the patient’s surgical journey were harmonious. It was for that reason that we began at the sub-micron scale when engineering the TrabeculeX Bioactive Matrix, ensuring that the biomaterial half of the continuum we were creating would be peerless in its orchestration of three-dimensional bone formation. Because the microscopic surface topographies of each granule embedded in Xenco Medical’s TrabeculeX Bioactive Matrix conduct both the dissolution of damaged bone by osteoclasts and its replacement with newly formed bone by osteoblasts, it was critical to evaluate our biomaterial’s microarchitecture with Fourier transform infrared spectroscopy, X-ray diffraction, and scanning electron microscopy. To allow for robust bone regeneration, calibrating the interplay between the bioactive glass, highly porous beta-tricalcium phosphate, and hydroxyapatite was a critical consideration as well. It was only after we were convinced that our regenerative biomaterial would be the most effective solution in its class that we set our sights on actualizing the full vision of the TrabeculeX Continuum.
Could you explain the digital health layer of this technology?
Treating our patients as partners rather than pathologies has been a guiding tenet for us as a company, and the promise of extending care to implantees long after their surgical procedure was completed was one that we worked tirelessly to fulfill. Developing an asynchronous care platform that directly addressed the postoperative journey of our patients was essential in making this a reality. Because physical therapy has been proven to impact the ultimate surgical success of a patient, anchoring our remote therapeutic platform in recovery exercises that could be monitored by treating surgeons was critical. Our ultimate mission in developing the TrabeculeX Continuum, however, was to create a seamless, uninterrupted link from surgery to full mobility that dissolved the otherwise siloed nature of modern surgical care. Because we resolved to make the greatest impact on public health within our power through the TrabeculeX Continuum, we decided to engineer our biomaterial to be effective not only in the spine but in a patient’s extremities as well.
5-6 JUNE 2024
