STICK to the process
Process speed and control are two of the many benefits that UV curing adhesives can bring to manufacturers bonding medical plastics. To build an accurate and repeatable new process, all process variables need to be understood, so they can be eliminated or kept within acceptable tolerances.
In a UV curing adhesive process, the two key areas of focus are making sure the adhesive has fully cured, and that it has been applied in the correct quantity and location. For both areas, medical device manufacturers can identify the process variables, and either eliminate them or keep them within acceptable tolerances. This must be done using actual production parts, including the specified substrates, adhesive, and manufacturing tolerances.
ENSURING AN OPTIMAL CURE
The adhesive data sheet will guide the manufacturer on an appropriate curing lamp, which could be a mercury arc or LED-based technology. Once a lamp type and wavelength has been specified, it should not be changed without requalification.
For the adhesive to cure completely, it is important to ensure that it receives the correct “dose” of UV curing energy. The “dose” means the total energy arriving at the surface per unit area — the intensity of the light combined with the time duration of exposure.
Every application is different. Factors like the substrate, bondline topography, and differing light transmission characteristics impact the amount of UV energy getting into the bondline, which makes it essential to establish the dose for an optimum cure using practical tests on production parts.
Full cure is the point at which additional cure time/intensity no longer improves the physical
performance of the cured material. Medical device manufacturers can choose a measurable parameter to determine the amount of cure. Additionally, some materials offer features that visibly demonstrate when cure is complete, such as Dymax See-Cure color change technology.
KNOW YOUR LIMITS
A safety factor helps build a robust process that is capable of withstanding unavoidable variation. It is added to the minimum intensity, creating a minimum intensity limit. For example, if the minimum intensity for full cure in five seconds is determined to be 75 mW/cm2, a safety factor of 50% would make the minimum intensity limit 113 mW/cm2. While we recommend a 25% safety factor, it is highly application dependent, so we advise consulting an expert.
CHECKING THE INTENSITY
Once the limits are defined, it is important to develop a process that stays within them. To assess the health of the system and ensure it is within the process testing limits, manufacturers can check and document the output intensity of their curing lamps. The intensity of mercury arc broad spectrum lamps decreases over time, and should be checked regularly.
Mercury arc lamps have a warm-up and cool down period, typically taking up to five minutes to reach full intensity. In many cases, we recommend that mercury arc lamps are left on all day to avoid variation and save time. LED UV lamps, however, are instant on/off and have no warm-up or cool down time. LED UV lamps have minimal intensity degradation over time, and introduce less process variability, so are a good choice if they are a viable option to cure the specified adhesive.
ENSURING THE CORRECT DEPOSITION OF ADHESIVE
Dispensing UV curing adhesives is relatively straightforward, especially as they are single part materials. Process qualification requires the manufacturer to establish the minimum and maximum quantities of adhesive needed for the desired bond strength. Based on this, the choice of application technology can vary from simple time/pressure dispensing controllers with lower accuracy, up to volumetric dispensing equipment that can dispense small quantities with an accuracy of ±1%, >99% of the time.
The more variation that can be eliminated, the better. Adhesives applications are complex, and so the best approach is to work with an adhesives partner who understands all the details of the process.
ADHESIVES
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HANNAH MULLANE, CONTENT EXECUTIVE, BIOCOTE, DISCUSSES THE DEMAND, REGULATIONS AND SUCCESSFUL INTEGRATION OF ANTIMICROBIAL TECHNOLOGY.
In the ever-evolving landscape of healthcare, product innovation is constantly evolving with challenges that demand creativity, adaptability, and resilience from industry innovators. The journey from concept to end-product is filled with obstacles from navigating regulations to keeping up with technological advancements. It is this shared experience among innovators that invites the potential solution of antimicrobial technology, offering a promising response to the demands of the transformative landscape.
IDENTIFYING INNOVATION HURDLES WITHIN HEALTHCARE
Innovation in healthcare products is an intricate balance between creativity and practicality. Regulatory complexities pose a significant obstacle, requiring innovators to navigate a great deal of guidelines. Marešová et al. (2020) elaborate on the comprehensive medical device development life cycle outlining five phases: opportunity and risk analysis, concept and feasibility, verification and validation, product launch preparation, and product launch assessment. This study emphasizes the need for a comprehensive understanding of regulatory landscapes for successful product development.
MARKET DEMANDS AND CONSUMER EXPECTATIONS
Understanding the needs of healthcare consumers and meeting market demands is an ongoing challenge. Consumer behavior is increasingly being influenced by health aspects. From the consumers standpoint, the importance of a product extends beyond its price, the quality of the products is equally important (Czeczotko, 2022).
To actively respond to this changing landscape, product developers must gain insights into the mindset of the consumer, understanding their preferences and priorities to create healthcare items that hold significance for the end-user and aligns with the healthcare settings’ willingness to invest in providing optimal care for their patients.
REGULATORY COMPLIANCE
Healthcare products, especially those designed for patient use, must meet regulatory standards. BioCote streamlines the approval process with antimicrobial technology compliant with global regulations, ensuring a smoother entry into healthcare supply chains. BioCote holds key regulatory registrations, including the Biocidal Products Regulation (BPR), Environmental Protection Agency (EPA), Food and Drug Administration (FDA), and Federal Insecticide, and Rodenticide Act (FIFRA). BioCote is proven safe for direct contact with food and water, given its Hazard Analysis and Critical Control Points (HACCP) approval. BioCote antimicrobial additives are globally recognized for its effective additives and regulatory compliance. With substantial reports proving they are not toxic to the environment. For example, they do not need to be registered under the Toxic Substance Control Act in the USA.
Hospital bed with an untreated surface vs with a BioCote treated surface
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ANTIMICROBIALS
REGULATORY UPDATES
BioCote prioritizes adherence to regulations and stay vigilant about legal updates. BioCote have proactively addressed the challenges posed by the UK’s departure from the EU and the subsequent update on navigating UK REACH regulations post-Brexit, which introduced complexities for product innovators across the UK. BioCote partners benefit from regulatory and chemical support from our technical team, ensuring that their products, compounds, or applications comply with suitable regulations.
PRODUCT INNOVATION WITH BIOCOTE ANTIMICROBIAL TECHNOLOGY
As innovation takes center stage, the integration of antimicrobial technology emerges as a potential game-changer. Antimicrobial technology refers to a range of solutions designed to continuously inhibit the growth of microorganisms. This technology encompasses silver ions that can be integrated into products and surfaces throughout healthcare settings.
ENHANCING PRODUCT LONGEVITY
Antimicrobial solutions play a pivotal role in extending the lifespan of healthcare products. Silver ions break down microorganisms responsible for premature material degradation, also known as biodeterioration. This process prevents compromised structural integrity, leading to the creation of products that surpass the expectations of the end-user.
COMBATING STAINING AND UNPLEASANT ODORS
Beyond product protection, antimicrobial technology continuously combats both gram positive and negative bacteria, fungi, and other microbes, which are responsible for staining and odors. Microbial degradation or decomposition of organic matter results in alterations to color, texture, and odor development. BioCote assists businesses in creating products that not only last longer, but significantly contribute to the visual and aromatic aspects surfaces and items. By integrating this technology, developers have the opportunity to elevate the overall user experience, creating products that stand out in terms of both performance and sensory appeal.
SUCCESSFUL INTEGRATION OF ANTIMICROBIAL TECHNOLOGY
Examining real-world examples of healthcare products and surfaces that have successfully incorporated antimicrobial technology provides insights that confirm their effectiveness. BioCote has led practical case studies that showcase improved durability, performance, and positive outcomes that offer valuable insights for product developers. BioCote technology has been proven to reduce microorganisms by 96% in a hospital, and 95% in a nursing home.
ANTIMICROBIALS
The 2021 NHS National Standards of Healthcare Cleanliness update places responsibility for cleanliness on employees adhering to a strict schedule. However, insights from cleaning professionals reveal potential oversights, stating that patient-related equipment may “fall through the gaps”. This highlights the shift in modern cleaning methods. Through antimicrobial technology integration, developers can assure healthcare settings of elevated cleaning standards, as the technology is designed to reduce microbial counts on surfaces from within the product itself.
WHY COLLABORATE?
Navigating the balance between innovation and compliance requires thoughtful consideration. According to Harvard Business Review, managers often view compliance restrictions and resource constraints as primary barriers to innovation (Acar et al., 2019). This discussion underscores the importance of successful innovators harmonizing their concepts with a keen understanding of regulatory landscapes.
Innovation thrives within collaborative environments where expertise addresses challenges. The cooperation between product developers and antimicrobial experts propels success through the exchange of insights with innovators and product manufacturers, creating unique solutions. While the benefits of antimicrobial technology are evident, developers must carefully consider integration factors.
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Korpinen antimicrobial accessible bathroom fixtures with BioCote
Lojer antimicrobial hospital equipment with BioCote
The Home of Multi-Action Coatings | https://biointeractions.com
DR. MATIN MOHSENI, CTO AND FOUNDER, CODIKOAT, DELVES INTO THE ISSUES ADDRESSED BY ANTIMICROBIAL TECHNOLOGIES, SHEDDING LIGHT ON THE DEFINING CHARACTERISTICS OF IDEAL ANTIMICROBIAL MATERIALS.
BEYOND THE SURFACE
The importance of using coatings for the prevention and protection of medical devices against infections is growing as the number of healthcare-associated infections (HCAI’s) rises. While researchers have been able to pinpoint some causes of hospital-acquired infections, 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, 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, improves the longevity of the implanted device in turn improving the well-being for patients.
New developments are now bringing to light state-of-the-art 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 gramnegative bacteria as well as enveloped and non-enveloped viruses, including E.Coli, MRSA, Influenza, Norovirus and SARS-Cov-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 other technologies. The coating is able to kill enveloped and non-enveloped viruses and gram-positive as well as gram-negative bacteria which prevents the formation of biofilms for long-periods 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 2024 medical device innovations and trends look like?
There have been many 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 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), ventricular assist devices (VADs), vascular grafts, and prosthetic mechanical heart valves are examples of technologies used to assist vital organs in functioning normally. However, they share a common constraint: hemocompatibility.
Surface modification is one way of providing blood compatibility. BioInteractions have developed Astute, which is 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
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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 on to the device surface. This multifaceted 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. Also, this improves movement in joint locations without the risk of wear and tear. 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 features that improve the functionality must be reliable.
At BioInteractions, we have sought to meet this challenge by developing a Hydrophilic Coating called Assist, which is lubricious and flexible resulting in reduced friction, and has no particulate formation and delamination in high-stress and high-movement applications such as joints. 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. Assist is instantly activated through wetting, eliminating the need for pre-soaking the surface. This not only saves preparation time but also allows increased usage of the device.
At BioInteractions, we can achieve high-performance without utilizing cytotoxic and toxic components.
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. Our 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 an organization’s commercial manufacturing partner. We provide 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 our Product Pathway Partnership is to enable customers to get to market in the most efficient way possible.
Alongside the expanded Product Pathway Partnership, our integrated service streamlines the research and development of new innovative coating materials using its 30 years of expertise and a range of novel analytical resources to determine the optimal coating for your device. BioInteractions’ 30 years of experience and broad range of products allows us to create bespoke coatings for a wide range of applications building on the innovative solutions provided today. This unique aspect of the service draws on our expertise and knowledge in applying innovative solutions to a wide variety of devices and enables us to provide revolutionary and state-of-the-art solutions for our partners.
For further information about BioInteractions’ solutions, click here: https://biointeractions.com/.
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CRAIG ZWILLING, VICE PRESIDENT OF MARKETING AT JAMESTOWN PLASTICS DISCUSSES STREAMLINING A COMPLETE MEDICAL PACKAGING SUPPLY CHAIN.
In the fast-paced world of healthcare, where precision and speed are paramount, the medical packaging supply chain plays a crucial role in ensuring the safe and timely delivery of pharmaceuticals and medical devices. As the demand for healthcare products continues to rise globally, the need for a streamlined and efficient supply chain becomes increasingly evident. What challenges are faced by the medical packaging industry? What strategies can be implemented to enhance efficiency in the medical packaging supply chain?
THE CURRENT LANDSCAPE
For any given medical package, several components need to be sourced once a product is ready for packaging. Trays, inserts, lids, clamshells and pouches are oftentimes used to package medical devices. In many cases, these components are sourced from different manufacturers, suppliers, and distributors.
Additionally, the diversity of medical products, ranging from temperaturesensitive pharmaceuticals to delicate medical devices, increases complexity of the supply chain. The need for specialized packaging solutions further complicates matters, with many products requiring a customized approach to ensure safety.
Various regulatory bodies are then layered on top of this supply chain, creating a complex network that often results in bottlenecks, delays, and increased costs.
Coordinating logistics of these many moving parts can be time consuming for
internal teams that are typically managing several projects at once. With multiple points of contact throughout the supply chain, a delay at one point can cause a delay throughout the entire process.
TURNING CHALLENGES INTO OPPORTUNITIES
The current challenges in the medical packaging supply chain present opportunities for innovation and optimization. Here are some key areas on which companies can focus to streamline operations:
1. Localise sourcing: While the massive shipment delays experienced during the global pandemic have somewhat subsided, we must not forget the lessons learned during that time. Relying on distant suppliers can be problematic; moving to more localized suppliers with the ability to quickly react to your needs can help stabilize your supply chain. Jamestown Plastics is part of the global MedTech Network, a group of suppliers that serve global customers on a local scale.
2. Broaden material specifications: Historically when companies created their packaging, the base material was defined very specifically. In many cases, it may list a specific material from one specific supplier. Painting yourself into a corner this way can cause problems when that one supplier faces issues affecting their ability to deliver. Specifications can be broadened to provide flexibility, while still maintaining package integrity.
3. Collaborative partnerships: Building strong partnerships between manufacturers, suppliers, and logistics providers helps foster cooperation and communication. By creating an integrated network, companies can share information, identify potential issues, and collectively work towards optimizing the supply chain. Cross-industry collaborations can also lead to innovative solutions and cost-effective strategies.
4. Sustainable packaging solutions: As the global focus on sustainability grows, the medical packaging industry has an opportunity to incorporate eco-friendly materials and practices. Streamlining the supply chain can include adopting sustainable packaging solutions that reduce waste, lower transportation costs, and align with environmental regulations. Jamestown Plastics is working with our suppliers to identify medical-grade sustainable materials that can be successfully used for medical device packaging.
5. Data analytics for demand forecasting: Leveraging advanced analysis tools can enhance demand forecasting accuracy. By evaluating historical data, market trends, and product demand, companies can optimize inventory levels, reduce excess stock, and minimize the risk of product shortages. This approach assists in building a more responsive and efficient supply chain.
MOVING FORWARD
Streamlining the medical packaging supply chain is vital for meeting the growing demands of the healthcare industry. As the medical packaging landscape continues to evolve, those who proactively address these challenges and implement improvements have an opportunity to enhance their operational efficiency and help overall healthcare delivery worldwide. The prescription for success lies in a holistic approach that integrates innovation, collaboration, and sustainability into the very fabric of the medical packaging supply chain.
PACKAGING
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KATIE KELLOGG, GLOBAL PRODUCT LINE MANAGER, MILLIKEN & COMPANY DISCUSSES STRATEGY TO ENHANCE THE SUSTAINABILITY OF PLASTIC PACKAGING.
Medical plastics serve a critical use that is highly regulated—and rightly so.
The landscape of medical packaging, specifically plastics, often contradicts our vision of a circular economy. What is acceptable for plastic packaging in other industries doesn’t translate for medical plastics: Packaging integrity must be ensured and must perform to exacting specifications. The bar is set high to ensure patient safety, and few tradeoffs are available to the medical plastics industry.
Single-use plastics offer the most consistent way to adhere to the essential use needs of the medical industry, yet the concept of singleuse plastics comes with its own drawbacks. As plastic manufacturers and brand owners prioritize sustainability for their downstream customers, recyclable plastics are becoming the standard in many industries. Circularity would be the ultimate goal for medical plastics, too, but incorporating recycled resin or recycled content leads to critical product issues.
HOW TO SOLVE SUSTAINABILITY IN MEDICAL PLASTICS
Remember the formative lesson we learned in school: Reduce, reuse, recycle. The “three Rs” offer different solutions that work collaboratively to decrease waste across our planet. The emphasis on recycling and reusing is foremost in today’s conversations because it helps further the goals of a circular economy for plastics. But we can’t overlook the value that reduction brings to the table.
A more managed plastic economy for the medical field is possible if we are willing to consider the opportunities presented by reduction strategies.
Decreasing the amount of plastic used in pharma bottles, for example, is one illustration of material reductions. These bottles are not recyclable, given quality and cross-contamination concerns. But pharma bottles are critical to protecting and delivering patient medication, so they will always be needed. Consider the impact if the bottle were redesigned with reduction in mind. By intentionally sourcing novel plastic additives, like Milliken’s UltraGuard Solutions, bottle manufacturers can slow the transmission of oxygen and moisture in these high-density polyethylene (HDPE) bottles to improve barrier performance by up to 50% without the traditional layering necessary for prior iterations of pharma bottles. Using this technology reduces the overall weight of thick-walled HDPE bottles by up to 20%. Light and moisture performance remain intact, with less overall plastic needed.
LOWERING GREENHOUSE GAS EMISSIONS
Material reductions can be felt beyond its intended use case. The transition from glass syringes to plastic syringes meets patient-centric care needs with added supply chain benefits. Using plastic packaging over glass helps elevate the storage, transportation, and dispersal of vials and syringes because plastics are less breakable and weigh less than glass
counterparts. Finding weight savings in the transportation and storage of syringes helps contribute to lower greenhouse gas (GHG) emissions within the value chain.
There are significant benefits in manufacturing resource reductions. Focusing on sustainable manufacturing strategies that encourage responsible resource utilization can have impacts across the value chain. Considering new sources of power—Milliken harnessed cogeneration at manufacturing sites to eliminate the use of coal-powered energy at those facilities—translate to both GHG emission savings and waste reductions. These types of cuts create a sustainable currency that is passed along to brand owners and lessens the environmental implications that contribute to climate change. Exploring reduction strategies across the medical plastics value chain can increase industry sustainability by supporting vital patient outcomes with functional, performative—and most importantly, purposeful— plastic products.
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MIKE LUDLOW, MARKET DEVELOPMENT MANAGER FOR E&L AT ELEMENT LIFE SCIENCES SHARES HOW TO ENSURE THE SAFETY OF MEDICAL RESPIRATORY DEVICES AND THE IMPORTANCE OF THE CORRECT IMPLEMENTATION OF THE ISO 18562 TESTING GUIDELINES.
The recent recall of an estimated 5 million ventilators and BiPAP / CPAP sleep apnea devices by Philips Respironics, due to the reported failure of a polyurethane foam sound insulating material, has highlighted how critical rigorous analytical testing can be in ensuring the safety of medical devices and componentry used in the provision of respiratory care or in the supply of substances directly to the respiratory tract.
The ISO 18562 international standard addresses the need to assess the major potential risks of solid particulate matter, volatile organic extractable compounds and condensate related leachable materials from medical respiratory devices on the patient’s breathing pathway.
This article describes the key considerations in the implementation of ISO 18562, including an overview of the testing requirements, the product device types and components which are impacted by the standard and a discussion around associated challenges including some recent case studies.
BIOCOMPATIBILITY EVALUATION
A number of recent global product recalls of medical breathing devices have highlighted the importance of the biocompatibility evaluation of
breathing gas pathways in devices such as ventilators, breathing systems and respiratory monitors.
In July 2023, Dräger issued a worldwide voluntary recall for its Carina Sub-Acute Care Ventilator devices due to the presence of an acutely toxic and potentially carcinogenic contaminant in the device’s airpath. The contaminant, 1,3-Dichloropropan-2-ol, was derived from a polyurethane foam component used for sound insulation.
The FDA recall of more than 5 million Philips’ BiPAP and CPAP sleep apnea devices in 2022 is reported to have cost the manufacturer an estimated $1.3 billion. The breakdown of another polyurethane foam component, used for sound proofing the devices, gave rise to particulate matter in the gas pathway which could potentially be delivered directly to the respiratory tract during patient treatment.
The ISO 18562 guidelines have been developed to ensure that respiratory devices and associated accessories used in primary care applications do not pose any undue health risks to patients. These types of devices are medical products designed to aid or regulate the breathing process. Manufacturers of this equipment utilize these standards to demonstrate compliance with regulatory requirements concerning biocompatibility.
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The guidelines propose methodologies suitable for the assessment of the potential risks of device componentry that may come into contact with breathing gases and considers these risks in terms of patient toxicity, sensitization, and irritation.
The standard comprises of four sections which each address different aspects of the biocompatibility evaluation of respiratory devices and provides a framework for the risk assessment of these products.
The proposed methodology is similar to the approach used for the chemical assessment of extractables and leachables from pharmaceutical drug container and delivery systems but, due to the specific mode of use of these types of devices, includes additional physical testing of particulate matter.
a. Risk evaluation
The opening part of the standard outlines the overall risk management process to be used for the evaluation of respiratory products and defines the information required to complete the biocompatibility evaluation plan.
This plan includes an initial paper-based assessment of all existing data, identifies any information gaps, and confirms any requirements for additional data and testing, with the general goal of reducing the need for animal testing where possible.
b. Particulate matter
Particulate matter can potentially impact on both respiratory health and on the cardiovascular system. The smaller the particle, the deeper into the lungs it can penetrate and the longer the body takes to eliminate it.
In order to ensure that the components in contact with the breathing gas pathway in respiratory devices do not release particulate matter that could pose a risk in terms of patient safety dry air is passed through the device and sampled using either gravimetric or particle counting techniques. The level of particulate matter is monitored and the minimum, maximum, and average particulate concentration are assessed and compared against defined threshold limits.
c. Volatile Organic Compounds (VOCs)
VOCs such as residual solvents which can be derived from the production process of plastic components present a high risk in terms of irritation of the
mucous membranes, skin sensitization and toxicity which can result in long term effects on the nervous system. It is therefore vital to confirm that these compounds are not present in the gas pathway of respiratory products.
Gas samples are collected through the device and analyzed using gas chromatography-mass spectrometry (GC-MS) which provides a quantitative characterization of the VOCs. These results are then converted to patient exposure levels and assessed, based on contact exposure, against defined thresholds of toxicological concern (TTCs).
d. Leachables in condensate
The final part of ISO 18562 applies to any devices which may form a condensate during clinical use. Potential leachables deriving from components within the breathing pathway include salts and metals and are characterized by performing a simulated use extraction study of the device, using a combination of inductively coupled plasma-mass spectrometry (ICP-MS) and gas chromatography-mass spectrometry (GC-MS) techniques to identify inorganic and organic leachable species respectively.
The results from the various test procedures are then assessed in terms of patient toxicity in order to complete the biocompatibility assessment for the device.
SUMMARY
The ISO 18562 standard provides a comprehensive framework for ensuring the safety of gas pathway respiratory devices in terms of the risks associated with particulate matter, volatile organic compounds, and condensate leachables and the potential for any adverse impact on a patient’s health during the use of these devices.
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ANNA MALORI, HEAD OF PRODUCT MANAGEMENT, BORMIOLI PHARMA EXPLORES HOW THE PHARMA PACKAGING MANUFACTURER’S ROLE IS EVOLVING TOWARDS SCIENTIFIC CONSULTANCY.
According to the U.S. Food and Drug Administration, extractables are compounds that can be extracted from the container closure system when in the presence of a solvent. A concentration of such substances, together with other elements, might compromise drug stability, modifying the chemical and physical integrity of the dosage unit.
As the pharmaceutical industry continues to grow and evolve, extractables testing is a critical component of the pharmaceutical industry’s efforts to prioritize quality and safety, ensuring one of the key functions pharma containers are designed for.
THE ROLE OF THE PHARMA PACKAGING MANUFACTURER
While extractables analysis is usually run by pharmaceutical companies, pharma packaging manufacturers are increasingly called upon to provide data-based, scientific consulting services to their partners. That’s what Bormioli Pharma has been doing, starting to offer testing of their own products through third-party certified laboratories as an additional, high value-added service.
Indeed, pharma packaging manufacturers are uniquely positioned to provide data-based, scientific consulting services to their partners throughout the value chain. By conducting extractables testing on specific, delicate components of the packaging integrated systems, manufacturers can help identify potential risks and develop solutions that meet the industry’s most rigorous regulatory standards, allowing clients to streamline production processes and ensuring thus adherence to the industry’s most rigorous regulatory standards.
EXTRACTABLES TESTING
Moreover, for Bormioli Pharma extractables tests are a primary tool used in R&D to evaluate different options when it comes to specific solutions, coming back to the client with a proposal that is well grounded and supported by scientific data. Clients can then rely on such analysis – as a footprint or as a full report – to further orientate product-related decisions.
Extractables testing results can be also used as a tool to facilitate the adoption of innovative solutions that combine quality and safety requirements with other industry concerns, such as sustainability.
Bormioli Pharma’s decision to commission third-party certified analysis of their sustainable primary packaging solutions prioritize quality, safety, and sustainability. By providing data-based evidence of the safety of their containers manufactured with post-consumer recycled plastics, the company is promoting environmentally responsible product ranges.
IS SUSTAINABLE PACKAGING LESS SAFE REGARDING EXTRACTABLES?
Indeed, Bormioli Pharma has chosen to expose a prejudice still standing in the industry, by sharing with their partners scientific evidence and data validated by certified third-parties: the safety of sustainable primary packaging in plastics in terms of extractables.
A comparative analysis between bottles made from recycled PET and conventional solutions has been run by the specialized laboratory Lab Analysis, and then certified by the Istituto Tecnopolo Mario Veronesi, investigating the level of extractables in sustainable packaging solutions, comparing them with a risk index, a safe amount that is tolerated in pharmaceutical formulations.
The analysis consisted in chemical analysis with the bottles being tested with five different solvents, such as water solutions with different pH (2.5 and 9.0), alcoholic solutions with ethanol and isopropanol, and methanol to investigate the presence of nitrosamines. After the chemical analysis had run, a subsequent toxicological assessment of the solvents has been undertaken to analyze the inertness of the containers.
The outcome showed that these solutions can meet the industry’s most stringent requirements in terms of quality and safety, but it also revealed that these values are up to 150 times lower than the hazard index, calculated on ISO regulation on biocompatibility. In some cases, sustainable primary packaging has proved to be more performant and safer than conventional plastic primary packaging.
IN CONCLUSION
Looking ahead, pharma packaging manufacturers must continue to evolve their role from suppliers to strategic partners who can provide data-driven insights and support their partners’ business decisions. By doing so, they can help drive innovation and improve patient outcomes. Ultimately, this approach will benefit not only the pharmaceutical industry but also patients, and the environment.
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WGRAHAM KERSHAW, MANAGING DIRECTOR, MACPAC DISCUSSES THE BENEFITS OF THERMOFORMED PET PACKAGING SOLUTIONS FOR THE MEDICAL DEVICE AND DRUG DELIVERY INDUSTRY.
hen a healthcare professional or patient reaches for a pack containing vital medical devices or pharmaceutical products, it must be perfectly designed to give the most efficient access to the contents - whether in surgery, pharmacy, care facility or home environment. It needs to be safe, clean, hygienic, and meet sterility requirements whilst also easy to produce, pack, transport, and store.
Manufacturers of medical devices and pharmaceutical products are increasingly looking for scalable thermoformed PET packaging solutions that accelerate product development, simplify production processes, and help bring products to market as quickly as possible.
Thermoforming has become a popular way of creating bespoke medical device packaging. Due to its versatility, plastic packs can be specially designed for small units or larger, more complex items.
Thermoformed packaging is durable, resilient, and tamper-resistant, and can incorporate several seal options that offer security yet allow easy access.
WHAT IS THERMOFORMING?
Thermoforming is a fully automated process which involves heating a sheet of thermoplastic until it is pliable and by the use of vacuum and pressure can be formed into different shapes using bespoke tooling molds. Formed products are then cut and stacked inline without the aid of human contact before being packed ready to ship. The special requirements for medical packaging have led to increased
adoption of thermoforming as a more cost-effective solution due to tooling costs being lower than alternative solutions.
Fully automated thermoforming machinery offers high levels of precision and control for high quality solutions with consistent repeatability of high cutting tolerances and material distribution, all while generating less waste.
MONITORED DOSAGE SYSTEMS
An example of high-volume thermoformed solutions is Monitored Dosage Systems (MDS); where patient safety is essential, such packs offer enhanced protection for medication whilst being easy to use for elderly or infirm patients. They allow nurses or carers to instantly assess that medication has been correctly taken typically over a period of a week or a month whilst dramatically minimizing drug wastage, which offers huge cost savings.
Creating designs and taking them from initial concept to high volume production is the flexibility that thermoforming offers to the medical industry. Unlike pouches, bags or boxes, custom-designed thermoformed trays offer product protection during transport, handling and point of use. Packs can be designed in various sizes and with different cavity shapes and compartments, helping to keep them separate and stable.
THERMOFORMING APPLICATIONS
A common application which illustrates thermoforming’s greatest strengths are trays to hold specific items designed to permit a medical intervention in hospital
THERMOFORMING WWW.MEDICALPLASTICSNEWS.COM 20
quickly at hand which
easily be used in a specific sequence and then replaced so that no steps are missed or overlooked.
Multiple
typically
in specifically designed cavities which hold them in exact positions to permit the surgeon to pick up with minimum effort whilst completely protecting the product during transit before it arrives at its critical use. Such trays often require sterilization at the production manufacturers before arriving in theatre. The choice of the correct materials to use is essential to good design so that goods can be gamma irradiated or EO sterilized.
THERMOFORMING DEVELOPMENT
Thermoforming development typically starts by clients submitting a design brief which is taken on by CAD designers to visualize the requirement before moving to initial prototyping for form and fit of products. Once this stage has been passed and tolerances have been agreed, then development can move towards small scale production trials for production verification and
automation trials, before scaling up to full scale production.
It is essential that, during the early stages of product development, critical design choices are made to choose packaging solutions that will optimize the manufacturing processes and appeal to consumers.
THINKING GREEN
Thermoforming can be highly sustainable both in terms of production and materials. Thermoformed packaging manufacturers should follow environmentally friendly practices like recycling and incorporate sustainable materials such as r-PET (recycled PET) into designs.
As part of its sustainability commitment, Macpac optimizes pack size, incorporates r-PET in 97% of its products, uses clamshell instead of lidding film, uses detectable colors that can be recycled and reduces weight by downgauging the material used by clever design at the front end of the development.
THERMOFORMING qosina.com Parts shown at 50% ISO 13485:2016 certified Full medical compliance Cleanroom facility 3 year min change control Elevate your medical compounding in 2024 ISO 13485:2016 certified Full medical compliance Cleanroom facility 3 year min change control Elevate your medical compounding in 2024 Pentagon delivers a full turnkey solution for plastic injection moulding from one site of UK Manufacture pentagonplastics.co.uk +44 (0) 1403 264 397 MPN BUYERS’ GUIDE TO ADVERTISE IN THIS SPACE CONTACT CAROLINE JACKSON 01244 952358 TO ADVERTISE IN THIS SPACE CONTACT CAROLINE JACKSON 01244 952358 TO ADVERTISE IN THIS SPACE CONTACT CAROLINE JACKSON 01244 952358 TO ADVERTISE IN THIS SPACE CONTACT CAROLINE JACKSON 01244 952358 TO ADVERTISE IN THIS SPACE CONTACT CAROLINE JACKSON 01244 952358 TO ADVERTISE IN THIS SPACE CONTACT CAROLINE JACKSON 01244 952358 Components Supplier Masterbatch Raw Material Suppliers Plastic Injection Molding 21 WWW.MEDICALPLASTICSNEWS.COM operating theatres. It is essential that a surgeon has all the necessary devices
can
devices are
held
JOE MUMBY, TECHNICAL SALES MANAGER, ROBOSHOT, FANUC UK, EXPLAINS HOW MANUFACTURERS CAN FUTUREPROOF THEIR OPERATIONS BY WORKING WITH A SINGLE SUPPLIER FOR BOTH THEIR INJECTION MOLDING AND ROBOTICS SOLUTIONS.
Within the medical sector, automated injection molding machines can produce plastic parts to the highest industry standards accurately and consistently, helping to alleviate the burden of a shrinking labor pool. And if they are combined with robotics, they can deliver even greater benefits –increased output, improved health and safety standards, greater production capacity, and reduced energy bills, to name just a few.
Choosing one supplier for both your robotics and automated molding solutions can pay even further dividends. From ease of integration and a single point of contact for installation and after-sales support, to access to the latest smart innovations and superior AI technology, this approach is one way that firms in the plastics sector can fast track their way to greater success.
SEAMLESS INTEGRATION
One of the main barriers to robotics is the belief that it is too complicated. Injection molding companies may feel they lack the in-house capabilities to program or integrate robotics into their existing line, but working with a company that manufactures both robotics and injection molding machines can help to relieve this pressure.
As a robotics company that also makes automated injection molding machines, compatibility between our product ranges is assured. Manufactured to the same high standards and containing the same proprietary components, such as CNC controls, motors and drives, the FANUC ROBOSHOT injection molding machine can be integrated with our industrial robots.
SPECIALIST SECTOR KNOWLEDGE
Another potential barrier to automation is knowing how best to integrate it into your existing production line. Working with a supplier that understands your sector, your products and your customers is therefore essential to ensure you get the best value from any investment. FANUC’s specialist in-house team can design and manufacture custom water, air and hydraulic systems to user required specifications (URS), combining our 35-year history of making molding machines with the experience of manufacturing over one million robots.
SMART AI FEATURES
A further benefit of working with the same supplier for both robotics and injection molding technology is the advanced intelligent functionality that comes as standard with a global automation leader like FANUC. The ROBOSHOT incorporates smart AI features that can monitor the molding parameters and adjust the motor accordingly, to ensure it is always working at the correct tolerance for the part being produced. Delivering a consistent quality output without any drop in performance can help firms to maintain their brand reputation and win and retain business. In addition, the volume of scrap parts and waste being generated in the factory will be reduced, boosting a company’s sustainability credentials as well as its profit margins.
MEASURING LONG-TERM BENEFITS
It is important to consider potential savings and costs such as these when specifying any new technology. When it comes to automation, purchase price typically accounts for just 15% of the cost of ownership. Energy costs can be a major drain, so ensure you question any potential supplier about their system’s sustainability credentials.
Electric injection molding machines consume considerably less energy than their traditional hydraulic counterparts – up to as much as 70% – largely due to their higher base load. The ROBOSHOT’s power regeneration enables intelligent energy recovery. This means that, overall, it uses 10-15% less energy than other all-electric machines.
AGILE SOLUTIONS
A final point to mention is that manufacturing is not static, and it is highly likely that your production needs will alter over time. Ensuring that your injection molding automation system can flex with your company’s evolving needs is therefore essential. FANUC robots and ROBOSHOT are both highly flexible; they can either be redeployed to a new task as one cell with only the mold tool and end-of-arm tooling requiring a change, or they can be split up and moved onto different tasks entirely. Make sure that any solution you specify is as flexible as this to ensure the best return on investment.
AND AUTOMATION WWW.MEDICALPLASTICSNEWS.COM 22
ROBOTICS
JESSICA HAMBIDGE, HEAD OF REGULATORY AFFAIRS, LFH REGULATORY, SHARES INSIGHT ON DIGITAL HEALTH TECHNOLOGIES FOR THE US MARKET AND WHERE WE ARE TODAY.
There is a broad scope when we think about digital health, categories include mobile health (mHealth), health information technology (IT), wearable devices, telehealth and telemedicine and personalized medicine. The technology available is revolutionizing healthcare to accurately monitor, diagnose, and treat disease.
The FDA states that by using digital health tools, they can empower consumers to make better-informed decisions about their own health as well as providing new options for facilitating prevention and early diagnosis of life-threatening diseases, and management of chronic conditions outside of traditional healthcare settings.
THE REGULATORY PERSPECTIVE
These advances have led the FDA to putting more focus and resources into Digital Health, including the creation of the Digital Health Centre of Excellence (DHCoE) which was formed in 2020. Digital Health Technologies (DHTs) have been creating a revolution in healthcare for many years, with the potential to benefit patients in ways that we are only just beginning to understand, one of which is the use of DHTs in drug development.
In March of 2023, the FDA released a Framework for the use of DHTs in Drug and Biological product development which intends to address the challenges related to the use of DHTs in regulatory decision-making for drugs, such as data accuracy and reliability.
DHTs used in drug development have not always fallen within the definition of a medical device, or the device is a low classification and hasn’t had thorough clinical testing, which can mean the appropriate evidence needed to prove effectiveness may not be available, resulting in the data collected from them cannot be used in any meaningful way.
The new FDA Framework details the activities that the FDA will do in the coming years to provide clear guidance on the requirements for DHTs when they are intended to be used in regulatory decision making of drug development.
DHTs can be used for remote data collection purposes in drug clinical studies with goals to continuously collect data from study participants and reduce the burden of study visits and increase recruitment rates, study population diversity and more. However, in order to use the data collected by the DHTs as endpoints in clinical studies, there needs to be appropriate evidence for the DHTs, proving the clinical effectiveness of the DHT and their measure, as well as how the DHT is maintained throughout the duration of the study. Currently DHTs are mostly used for exploratory endpoints only, DHT data has yet to be used for secondary or primary endpoints in more than a few successful clinical studies.
The Framework lists several draft guidance’s that the FDA has released in recent years, including, ‘Digital Health Technologies for Remote Data Acquisition in Clinical Investigations’. This guidance places the responsibility on the sponsor of the clinical study to ensure that the DHT is fit-for-purpose, which includes a large number of topics to review, including design and validation.
WHAT DOES THIS MEAN FOR MANUFACTURERS OF DHTS?
This is where the manufacturers of the DHT can provide the highest benefit to the sponsors of the clinical study. If manufacturers of DHTs design and manage their DHTs in a similar way to high classification medical device development, even if their DHT isn’t a medical device, they will be able to provide the sponsor with most, if not all of the information required for the fit-forpurpose assessment, including a full validation package, processes and records of design, development and maintenance.
The industry still has a long way to go before it becomes standard practice to use DHTs for regulatory decision making in drug development, but that doesn’t mean that it isn’t possible for manufacturers of DHTs to get a head start. The Framework and the guidance’s that will be developed in the next few years will provide further clarifications on how to develop DHTs moving forward and the work needed to be done for older products to be used for secondary and primary endpoints in clinical studies.
23 REGULATORY UPDATE
WWW.MEDICALPLASTICSNEWS.COM
TOM HOOVER, BUSINESS DEVELOPMENT MANAGER, MEDICAL, EMERSON AUTOMATION SOLUTIONS DISCUSSES THE BASICS OF ISO CLEANROOMS FOR MEDICAL MANUFACTURING.
Generally, cleanroom performance specifications or contamination limits are based upon the products being developed or manufactured. For example, cleanroom specifications for manufacturing semiconductors differ in being several orders of magnitude “cleaner” than, for example, a cleanroom used to manufacture disposable surgical instruments such as a scalpels or hemostat clamps.
Cleanrooms typically are rated by cleanliness levels, which establish quantitative limits on the number of particles and their size per cubic meter volume of air. The International Standards Organization (ISO) has developed standards dedicated to cleanrooms, outlining the practices and procedures required to manage the risk of contamination.
Levels of permissible particulate concentrations for manufacturing in cleanrooms have been established
by the International Standards Organization in the ISO 14644-1 standard. This standard defines nine levels, or classes, of cleanrooms — ISO Class 1 through Class 9 — based on permissible particulate contaminant levels, with ISO Class 1 being the “cleanest” and Class 9 being essentially equal to ambient room air. The most used ISO cleanroom classifications for medical device or consumer electronics manufacturing are ISO 7 and ISO 8. Generally, each class has 10x fewer permissible particles than the class above it. So, for example, while a Class 8 cleanroom can have 100,000 particles per cubic meter volume of air, Class 7 cleanrooms only allow 10,000 particles per cubic meter.
Cleanrooms at ISO Class 7 or cleaner require double pass-through entrances. These special entrances provide a controlled environment — essentially an airlock — that is positively pressurized to help prevent particle transmission into the cleanroom. The outermost pass-through door leads into a gowning room where workers don smocks, booties, headwear, masks and gloves usually made of non-shedding, nonwoven fabrics, as well as specialized gloves. Gowning rooms often feature special gowning procedures, “air showers” to remove passive particulates on clothing or personal protective equipment (PPE), and “sticky” floor mats to help remove and capture particles carried in on the soles of shoes. After proper gowning, personnel may pass through the inner door to the cleanroom space.
MANAGING CLEANROOM AIRFLOWS
Laminar airflow analysis is used to visualize the flow of air in a cleanroom and how that flow is affected by people, objects or process equipment. Ideal laminar airflow is uniform in direction and velocity, like a smooth-flowing river that consistently sweeps particles down toward the floor before flowing them horizontally to low-wall air returns.
Disruptions in laminar airflow cause turbulence — a rapid or uncontrolled movement of contaminating particles — while inadequate laminar airflow can result in “dead zones” where no air is moving at all. Both of these are problems: Turbulent airflows can suspend particles in the air, while dead zones can allow for particles to settle on exposed surfaces. In either case, particulate contamination tends to build
WWW.MEDICALPLASTICSNEWS.COM 24
REGULATORY UPDATE
up over time and circulate within the cleanroom, rather than being swept down to the air returns and filtered away.
Airflow problems can also result from surface irregularities, such as cracks or joints, because they can trap particles. Sharp edges can also be troublesome, since they can snag and retain fine strands of PPE garments or the cleaning cloths used during periodic wipe-down procedures. Even sharply angled surfaces, such as the 90-degree corner on a table, can create turbulent airflows that hold particulates in suspension and prevent their efficient movement toward the air returns.
As the cleanroom class, or cleanliness level, increases so does the level of required filtration and air turnover. The air supply for a cleanroom is typically filtered through HEPA (high-efficiency particulate air) or ULPA (ultra-low particulate air) filters. These filter requirements, as well as the air volumes cycled through them, are calculated to enable the cleanroom to manage and overcome the particulate loads generated by human activity, process equipment and manufacturing operations.
HEPA filters are often constructed with corrugated internal structure and aluminum support, using dense nonwoven fiber material designed for the appropriate filtration levels. HEPA filters also have an ISO rating corresponding to a specific level of filtration and particulate removal or reduction, defined by the requirements of the ISO 29463 standard.
CLEANROOM COST FACTORS
Manufacturing in cleanroom environments adds significant operational costs to the manufacturing process. The ISO operating class is a primary driver of the clean space operational costs because each class mandates specific levels of filtration and room-air cycling. However, particulates generated by processing equipment, which can represent as much as 35% of all particulates generated during production operations, also contribute significantly to cleanroom operational costs. Careful selection and specification of processing equipment, specific to the process requirements, should consider the known levels of potential shedding of particulate, and be quantified to effectively manage and minimize clean space operational costs.
MANAGING ACTIVE AND PASSIVE PARTICULATE GENERATION
Particulates and contaminants can be generated actively or passively. Two significant sources of active particulate contamination are human activity and process equipment. Therefore, it is essential that process equipment be specified and selected based not only on production needs but also on
the level of particulate generated when in use. For example, process equipment or positioning stages that have moving or sliding surfaces, such as linear bearings or ball screws, can generate airborne particulates. Some lubricants used on these moving surfaces can also contribute particulates. As a best practice, manufacturing process equipment should be designed to reduce both active and passive particulate generation, so that the cleanroom environment can operate within ISO specifications while minimizing operational costs.
Best practices to reduce active particulate generation include:
• Use synthetic lubricants and greases instead of hydrocarbonbased products.
• Use sealed bearings whenever possible.
• Use laminar flow analysis to analyze design of process equipment surfaces and maximize smooth airflow across those surfaces.
• Ensure air-filtration and room-air turnover capacity is sufficient to overcome particulate generation from people, process and equipment.
Best practices for reducing passive particulate generation include:
• Use stainless steel or anodized aluminum for all exposed surfaces and fasteners.
• Design and construct cleanroom equipment with smooth surfaces that minimize or eliminate joints or cracks.
• Use low-VOC (volatile organic compound) paints to minimize outgassing from any painted surfaces.
Successful design and operation of a cleanroom for manufacturing medical devices or components begin with attention to the basics. Consult with your cleanroom supplier, as well as your assembly equipment supplier, for the information you will need to make wise decisions that ensure the most productive and cost-efficient operation possible.
25 REGULATORY UPDATE WWW.MEDICALPLASTICSNEWS.COM
LUKE SMOOTHY, FOUNDER AND DIRECTOR, GET IT MADE, DELVES INTO WHY INJECTION MOLDING STILL HOLDS THE SCEPTER IN THE MEDICAL INDUSTRY AND HIGHLIGHTS THE KEY BENEFITS IT BRINGS.
In the realm of medical device manufacturing, the tussle between traditional injection molding and modern 3D printing technologies continues. However, injection molding has held its ground firmly, especially when high-volume production, costeffectiveness, and precision are all paramount.
molding delivers unrivalled precision and finish quality. For medical applications such as moving machine parts or implantable devices, the procedure gives a vital smoother finish.
VERSATILITY IN MATERIAL AND DESIGN
An expansive range of materials are available with injection molding, making it easier to produce medical equipment that adheres to the strict biosafety and chemical stability criteria of the medical sector. Techniques such as thin wall molding and gas-assisted injection molding enable the production of both practical and aesthetically appealing parts.
REAL-WORLD APPLICATIONS
Below are examples of various types of injection molding which are employed to create a myriad of medical devices:
Thin wall molding: A specialized form of conventional injection molding that focuses on the mass production of ultra-thin (less than 1mm) and light plastic parts to make material cost savings. This is used to create portable medical devices enabling clinicians and patients to transport and operate them more easily - such as wearable devices, micro surgical tools, and invasive equipment like catheter ablation tools and endoscopes.
EFFICIENCY AND SCALABILITY
Since the need for devices and components in the medical sector is always increasing, injection molding stands out for its effectiveness and capacity to handle large-scale orders. The method is best suited for highvolume production, making it the preferred method for mass-producing medical components. That said, even though 3D printing is hailed for having cheaper initial costs in smallscale production, its cost advantage diminishes as production volume rises.
PRECISION AND FINISH QUALITY
Well-suited for products with straightforward shapes, injection
Gas-assisted injection molding: In certain medical device applications, gas-assist molding can provide solutions that conventional injection molding can’t. The process consists of injecting a pressurized gas into the mold cavity after the initial plastic injection, expelling the molten plastic and forming hollow areas within the final product. It is suited to the manufacturing of complex parts without visual blemishes, for instance, tube- or rod-shaped parts which typically include handles and foot pedals, as well as large, cover-shaped structural parts e.g. side panels and covers for medical devices.
Liquid silicone injection molding: This produces pliable, durable parts in high volume, and is used in fabricating tubes and respiratory masks requiring high levels of hygiene and chemical resistance.
BRIDGING WITH 3D PRINTING
Perhaps intriguingly is the fact that 3D printing and injection molding are not exclusive of one another. Injection molding is frequently preceded by 3D printing, which assists with prototyping and even helps create molds for the injection molding process.
THE FUTURE ROLE OF INJECTION MOLDING
The indelible imprint of injection molding in medical manufacturing underscores its pivotal role in delivering efficient, high-quality, and cost-effective solutions to the industry. As the medical field continues to evolve, the synergy between injection molding and emerging technologies like 3D printing is poised to drive innovation further, ensuring the continual enhancement of patient care and medical advancements.
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OLIVIA SIMPSON, CEO & CO-FOUNDER OF SYMBIOTEX – A COMPANY THAT USES SEAWEED AS A PLASTICS REPLACEMENT, SHARES WHY THEY CHOSE SEAWEED AND GIVES ADVICE TO START-UP COMPANIES.
