26 minute read
Anticounterfeiting and serialisation
from MPN EU Issue 66
by MPN Magazine
RICH QUELCH, GLOBAL HEAD OF MARKETING AT ORIGIN, SHARES THE CHALLENGES WITH THE ‘FAKE’ PHARMA MARKET.
PHONEY PHARMA
Pharmaceuticals are the world’s most counterfeited consumer product, with the latest fi gures from the World Customs Organisation estimating the global ‘fake’ pharma market to be worth upwards of $200 billion.
The global trade in counterfeit and falsifi ed medicines has always been a very large and real threat to public health – and pharma companies’ reputation. But the COVID-19 pandemic heightened this risk, creating a ‘perfect storm’ which made it easier and quicker for counterfeiters to circulate and sell fake products, thanks to supply chain disruption and complexities.
In the early emergency phase of the pandemic, it was clear that criminals would take advantage of the situation and put profi t over safety. In fact, by March 2020, Interpol’s Operation Pangea XIII seized counterfeit pharmaceuticals worth more than $14 million worldwide, just months after the COVID-19 virus was fi rst discovered.
So, what are the latest anti-counterfeiting strategies being actioned by the industry, regulators and governments? And how are packaging technologies aiding the fi ght against the fakes?
THE DIFFERENCE BETWEEN ‘COUNTERFEIT’ AND ‘FALSIFIED’ To understand the scope of the challenge facing the pharmaceutical market and the threat to public health, it’s important to distinguish between the terms ‘counterfeit’ and ‘falsifi ed’ medicines.
The European Medicines Agency defi nes counterfeit medicine as being “made by someone other than the genuine manufacturer, by copying or imitating an original product without authority or rights and [infringing] trademark law”.
These products are disguised as legitimate branded medicines, putting their reputations at risk.
There is also the challenge of falsifi ed medicines – the fake, unauthorised medical products that make their way into the market. These may be mislabelled or produced in fake packaging and, most dangerously, there is no regulation around their manufacturing. Falsifi ed medicines may contain the wrong ingredients or low levels of the active ingredient.
Both counterfeit and falsifi ed medicines pose risks to public health and threaten to undermine the healthcare system and pharmaceutical industry. A CAT AND MOUSE GAME Anti-counterfeiting is a cat and mouse game, with criminals usually cracking today’s systems in two to three years. This means continuous improvements and advancements are needed to stay one step ahead.
Packaging technologies remain the fi rst line of defence against counterfeit and falsifi ed medicines.
For pharmaceutical manufacturers, the primary solution has long been to build anti-counterfeiting technology directly into medical packaging – providing a convenient method for tracking products across supply chains as well as visual authenticity for the consumer. A signifi cant advancement in worldwide standards for mass serialisation on packaging came in 2019 when two important regulations came into force – the EU’s False Medicines Directive and the US’ anti-counterfeiting protocol, ‘The Drug Quality and Security Act’.
Both regulations focus on connected approaches to authentication, with all agents across
These products are disguised as legitimate branded There is also the challenge of falsifi ed medicines – the fake, unauthorised medical products that make their way into the market. These may be mislabelled dangerously, there is no regulation around their manufacturing. Falsifi ed medicines may contain authentication, with all agents across
the supply chain expected to contribute to the tracking of legitimate products. The EU’s FMD requires complete product traceability from manufacturing to decommissioning, rather than placing the burden of authentication on any single stage of the process. The Drug Quality and Security Act also requires authentication at every supply chain juncture, including wholesalers.
The challenge, however, is that criminals are only ever one step behind. And each new development in product-level coding only remains a barrier for a few years before fraudulent manufacturers produce counterfeit copies and bypass security protocols.
As a result, the development of advanced packaging-level tokens has led to watermarking techniques – invisible, encoded data that requires specialist verifi cation software. This technology proves diffi cult to replicate as it is invisible to the human eye, and its unique data is required throughout tracing and decommission to verify against interference.
SUPPLY CHAIN 4.0 Pharmaceutical supply chains are increasingly complex, introducing a greater risk of exploitation and making it harder for stakeholders to monitor the fl ow of products.
Enhanced anti-counterfeiting methods, including cloudbased tracking and perennial encryption technologies, are extending the lifecycle of protection for manufacturers so frequent and costly overhauls are avoided. They are also making it easier to spot and eliminate weak links in supply chains that criminals are quick to exploit.
They have the added benefi t of creating value in other ways too, helping to increase end-to-end visibility and effi ciencies across the pharma supply chain by gathering data that can be analysed and acted upon, often in real-time.
Big data, provided by smart packaging in part, will be key to giving pharma companies a more granular, real-time picture of events taking place along the supply chain, from manufacture to healthcare settings.
Advanced tracking systems, built into primary and secondary packaging, are an exciting area of innovation. By managing and recording all the typical activities that occur in the supply chain or designed to cover special requirements, tracking chips can log events or raise queries that occur across a product’s lifespan remotely.
This is invaluable information for anti-tampering and wider commercial strategies, allowing companies to locate and interrogate a product anywhere in the supply chain. For example, the geographical location of a product and the route it took to arrive there can all be captured and stored, thus revealing any unauthorised journey routes, interventions or delays.
Collected data can also highlight ineffi ciencies and bottlenecks, which can be addressed to streamline processes and drive cost-savings.
Drug companies won’t necessarily have to build their own anticounterfeiting ecosystems, either. Manufacturers can avoid the high up-front costs of developing an anti-counterfeiting system by handing off all or part of the work to external providers.
Anti-counterfeiting solutions are becoming smarter every year. But so are criminal networks. There is a real opportunity here for pharma companies with the foresight to invest in Supply Chain 4.0, and for governments to remove any red tape holding back its development, to set the stage for new business models that can create value in many ways – and limit counterfeit activity in the process, too.
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Developed to cope with the most demanding applications, Vyon PTFE is extremely durable off ering superior chemical resistance to most aggressive media and corrosive solvents. In addition, Vyon PTFE components are temperature resistant up to 260°C, naturally hydrophobic, exhibit minimal fl ex fatigue and contaminants do not easily adhere to components made from this advanced engineering plastic.
Sheets of advanced Vyon PTFE plastic materials can be manufactured into a variety of shapes and sizes to suit your specifi c application. Tightly controlled manufacturing processes ensure that Vyon PTFE porous plastic components for your product are produced with consistent, reproducible, and controlled critical properties such as thickness, diameter, and porosity.
Vyon PFTE is a naturally hydrophobic porous plastic that is ideal for applications such as chromatographic separations where longer term solvent impermeability (e.g., acetonitrile can be held up for 24hrs) is important. FOR FURTHER INFORMATION ABOUT VYON PTFE PLEASE VISIT https://www.vyonporousplastics.com/draft/vyonpolytetrafl uoroethylene-ptfe/ or contact Porvair Sciences Ltd on +44-1978-661144 / enquiries@porvairsciences.com.
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before after
PAULO CAVACAS, BUSINESS DEVELOPMENT MANAGER, HEALTHCARE, BOREALIS HIGHLIGHTS THE TRENDS IN MEDICAL GRADE PLASTICS FOR IN-VITRO DIAGNOSTIC APPLICATIONS.
Grade A A
An increasingly important trend in the healthcare industry in recent years has been the stringent regulatory demands on the entire value chain with the end goal to ensure patient safety. High level of quality, protection and health for the end users as well as supporting innovation and making sure that the new innovative medical and diagnostic devices reach patients in a timely manner have been at the heart of the transition to Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) in Europe.
WHAT ROLE DOES THE RAW MATERIAL PLAY? Along with the changes in classifi cation system for IVDs, the IVDR requires clinical studies and evidence in many IVD applications where previously self-assessment was accepted. In practice, this highlights the need for assurance that the material and the IVD that you qualify for today remains unchanged so that the validity of the clinical study is intact. This also safeguards the investment in material qualifi cation and ensures that any fi nal item testing maintains its relevance.
On top, project timelines during new healthcare product developments are critical; often a quick access to advanced raw material technical data that goes beyond the product data sheet is needed. Additionally, a rapid confi rmation from the supplier on substances of concern or even a composition disclosure and extractable data may be crucial for accelerating time-to-market. Fast technical and regulatory reaction globally and peace of mind for the healthcare value chain is at the heart of the Borealis Bormed medical grades service package. Choosing the right material for IVDs, consumables and labware often turns out to be crucial for the end performance of the product itself. Polyolefi ns are frequently being selected due to their combination of good property profi les and value in use as well as often off ering a better sustainability profi le by being lighter, easier or safer to use, chemically inert and recyclable.
VALUE CHAIN COOPERATION The validation of the recently developed Bormed BJ868MO is the result of close cooperation among Premix Oy (a leading manufacturer of electrically conductive and high frequency plastics), and a leading provider of in-vitro diagnostic solutions. These electrically conductive compounds enable extremely accurate liquid level detection and are widely used in in-vitro diagnostic consumables to ensure precise measurement. Bormed BJ868MO functions as a base for such an electrically conductive compound used in the production of high precision pipette tips.
WHY IS THE CHOICE OF STERILISATION SO IMPORTANT? Sterilising IVD and consumables is a common requirement in the industry and can be carried out by several diff erent approaches with chemicals e.g. ethylene oxide (EtO) and irradiation (e-beam or gamma) being the most common ones for such applications.
Gamma rays have high energy and penetration capability and as such are frequently used for items that are bulk packaged. Extensive safety measures are required for both operators and additionally the radioactive isotopes from where the gamma rays originate. Some polymers, especially PP, are sensitive to degradation (formation of radicals) due to the high energy used. As a result of the radiation the fi nal product can become brittle and/or yellow either directly after radiation or after a certain undefi ned time. Additionally, it is important to consider the ‘delivered’ dosage of irradiation, rather than the ‘emitted’ level as bulk irradiation will mean full dosage is not delivered to every part. In order to mitigate the eff ects of the irradiation, PP resins can be specially added.
common ones for such applications. Gamma rays have high energy and penetration capability and as such are frequently used for items that are bulk packaged. Extensive safety measures are required for both operators and additionally the radioactive isotopes from where the gamma rays originate. Some polymers, especially PP, are sensitive to degradation (formation of radicals) due to the high energy used. As a result of the radiation the fi nal product can become brittle and/or yellow either directly after radiation or after a certain undefi ned time. Additionally, it is important to consider the ‘delivered’ dosage of irradiation, rather than the ‘emitted’ level as bulk irradiation will mean full dosage is not delivered to every part. In order to mitigate the eff ects of the irradiation, PP resins can be specially added.
THIS IS GOLD
MEGAN MUROSKI, PHD, SENIOR PRODUCT MANAGER, LIFE SCIENCE BUSINESS OF MERCK, SHARES HOW GOLD NANOPARTICLES CONTINUE TO OFFER PROMISE IN DIAGNOSTIC INNOVATION.
Nanoparticles off er great promise for applications in biomedical research and clinical therapies. Nanoparticles, characterised as under 100nm in size, have unique physicochemical properties, including high surface area to volume ratio, strong signal intensities, and tuneable surface chemistries. Due to their large surface areas, nanomaterials can load a variety of molecules, such as antibodies, DNAs, and organic dyes, making them useful to detect low concentrations of analytes. They are also easily functionalised, allowing for multiple targets to be measured simultaneously.
The use of materials, such as iron oxide and gold, has been extensively explored for the fi eld of nanomedicine as they off er desirable and unparalleled characteristics for chemical and biological detection methods. Gold nanoparticles are easy to synthesise, are commercially available, and considered biocompatible, which make them ideal reagents for use in many applications, including bioimaging, nanomedicine, and diagnostics. In addition, gold nanoparticles have a localised surface plasmon resonance that results in their characteristic ruby red colour, that can shift purple, depending on the size of the particle; this makes them particularly suitable for colourimetric readouts, such as lateral fl ow assays (LFAs). In addition, gold nanoparticles have excellent biocompatibility and stability which is crucial for diagnostic testing. Due to the rise in demand for rapid testing during the COVID-19 pandemic, gold nanoparticles were catapulted into the mainstream of testing materials. The use of gold nanoparticle (GNP)-based lateral fl ow assays for detection of diseases like COVID-19 has demonstrated a fi ne balance of complexity and high sensitivity. In lateral fl ow development, the sensitivity of the reporter in the assay is dependent on the visual readout. There are many factors to consider during development, as reporters need to generate the largest possible signal, but also be small enough to travel through the membrane and bind to molecular targets. Other limitations of rapid testing include low sensitivity and cross-reactivity. Gold nanoparticles can overcome these limitations, as they can be made to be approximately the same size as antibodies, allowing for a 1:1 readout with a large signal with an easily visible testing line. Furthermore, gold nanoparticles can be easily modifi ed, allowing for a host of applications based on their surface chemistry, such as the detection of the host antibody (serological) or antigen. Their suitability and stability provide additional value for often price-sensitive point-of-care diagnostics. Rapid testing diagnostics need to be inexpensive, easy to operate, and instrument-free.
The extensive research in gold nanoparticle lateral fl ow tests has resulted in signifi cant improvements to their sensitivity, specifi city, and overall performance. Despite the signifi cant progress, further challenges remain for GNP-LFAs, including improving the reproducibility of gold nanoparticle synthesis and the lack of regulatory protocols for the development and characterisation of nanomaterials, which has limited mainstream integration of assays. This is a tremendously challenging task, as global regulations can vary, and the number of diverse nanomaterials is constantly expanding. However, it is important to understand, assess, and manage risks to ensure quality and regulatory standards are met. Companies, such as Merck, have developed the M-Clarity system to help industry researchers choose materials with the correct compliance to standards. Despite these challenges, gold nanoparticles are becoming increasingly commercially available with strict characterisation and quality controls. This may pave the way for a universal rapid testing solution that is readily available and accepted worldwide.
MARFRAN, PRODUCER OF TPE/TPO COMPOUNDS FOR FOOD CONTACT AND MEDICAL USE, SHARES ITS FOCUS FOR THE PRESENT AS WELL AS FOR THE FUTURE.
IN T NE with the times
Since their fi rst appearance on the market, TPEs have mainly been used in injection moulding and have experienced some diffi culties gaining ground in the extrusion world, as this has traditionally been dominated by vulcanised rubber and plasticised PVC. However, in recent years there has been a strong tendency to reconsider TPEs as suitable candidates for several extrusion applications - a trend favoured mainly in the fi elds of drinking water and medicine because of more stringent hygienic requirements.
In the medical fi eld, the dominant position of plasticised PVC as a raw material to produce medical devices stands as a point of reference to all market newcomers like TPEs, which must conform to many common processing techniques applicable to PVC or enable new applications/alternative processes to be created to carve out their own market space. Marfran is committed to develop and produce new TPE solutions for strongly regulated applications for both present and future challenges.
The company’s most recent developments have been focused on extrusion grades for many applications in the medical fi eld, for drinking water and other relevant industrial applications. Our current projects are dedicated fi rst and foremost to Marfran TPEs for drinking water applications and to medical compounds, with a particularly strong focus on solvent-bonding products - a complete revolutionary solution for a TPE that until only recently could not be bonded with a solvent.
By working closely with raw material suppliers and investing in new process technologies, Marfran uses the latest innovations to identify new material combinations and develop new possibilities.
MEDICAL COMPOUNDS Medical applications are a high-growth TPE sector with major applications in tubing, catheters, intravenous systems, resealable membranes and fi lms.
In the medical industry, the demand for safe and halogen-free polymers such as Styrenic block copolymer-based materials is currently on the rise. The safe and non-toxic properties of TPEs make them an ideal component in the design of medical products, for which superior performance levels and safety are required. TPEs combine fl exibility with high performance, while also complying with many food and skin contact regulations due to their inherent low toxicity.
When selecting TPE for medical applications, manufacturers can either choose food contact or medical grades. The current trend seems to be swinging towards medical grades, but awareness about the similarities and diff erences between both grades is necessary to make the right choices.
times
Food contact raw materials must be cleared by Regulation (EU) 10-2011, stating whether they are a substance with specifi c migration limits (SML) or a dual use substance. Medical raw materials have to be compliant with European Pharmacopeia and have their biocompatibility certifi ed according to ISO 10993 and USP class VI. With rapidly advancing technologies and increasing regulatory requirements, today’s customers are asking for more material knowledge and consistent processes in order to minimise variation and improve performance.
The transformation processes for Marfran.Med are carried out in a dedicated cleanroom, which is compliant with ISO 13485; ISO 7 class, according to ISO 14644-1, and Class 10,000 equivalent, according to US FEL STD 209E. The Cleanroom is highly automated, subject to strict cleaning procedures and optical checks for quality control. That means more extensive clean down and line clearance procedures, with the guarantee of process change control and that production only takes place on dedicated lines.
As a leader in the production of compounds based on thermoplastic elastomer compounds (TPE/TPO based on SBS and SEBS), Marfran has a full range of TPE Marfran.Med solutions for medical applications.
TPEs do not easily bond to other materials, such as the substrates polycarbonate (PC) or ABS connectors that are used in standard intravenous tubing sets. Recent developments allow Marfran to propose Marfran.Med grades suitable for both moulding and extrusion, that allow solvent bonding with cyclohexanone or THF.
The challenge of the pandemic and the sanitation of TPE surfaces. The pandemic has forced all health authorities to reconsider all the criteria for sanitising the environments and therefore the surfaces of all the artifacts used in the medical fi eld. The most stringent requirements relating to sanitation and sterilisation force us to reconsider the materials and identify new solutions to allow a more effi cient and safer sterilisation of the products.
In 2015 Marfran registered a patent on the use of usnic acid in TPE compounds as an antibacterial (WO 2016/020774 A1). The eff ectiveness of usnic acid has been proven by numerous tests conducted on various compounds, however its organic nature makes it “sustainable” but it also introduces limits on temperatures both for processing and operation.
The increase in the temperatures of the sterilisation cycles requires the use of TPE based on polymers with an average higher molecular weight which, therefore, requires an average higher processing temperature. Thanks to the collaboration with some suppliers, Marfran has developed solutions based on bacteriostatic substances which, due to their inorganic nature, can be used at higher processing temperatures more suitable for TPE compounds with higher molecular weight. The bacteriostatic eff ect prevents the formation of bacterial biofi lm on the surface of the artifacts, facilitating sanitation even with common detergents and making autoclaving more eff ective and lasting.
The “bacteriostatic” solution can be applied both on materials in contact with food and in the medical fi eld, having no eff ect of cytotoxicity, unlike other bactericidal substances. The eff ectiveness of the bacteriostatic treatment of TE compounds was confi rmed by evaluating the antibacterial activity conducted according to ISO 22196: 2011. The results obtained on a Marfran.Med 40A M compound are quite positive, considering the hardness of the chosen compound.
Numerous studies have highlighted the ability of COVID-19 to survive on the surfaces of various materials, even for several days. An antiviral activity measurement test, conducted in accordance with the ISO 21702:2019, highlights a signifi cant improvement in the reduction of COVID-19 on the surface of the Marfran.Med 40A M when treated with bacteriostatic treatments.
Design for the Real World
PHILIP REMEDIOS, PRINCIPAL AND DIRECTOR OF DESIGN AND DEVELOPMENT, BLACKHÄGEN DESIGN, DISCUSSES THE DEVELOPMENT PROCESS FOR CONNECTED DEVICE DESIGN.
Systems design, wireless design, cloud architecture, usability engineering, integrated artificial intelligence (AI) and machine learning (ML), cybersecurity - the list of technical requirements to consider seems endless when it comes to designing a connected medical device.
While an existing product might look the same as a connected device, the product design is fundamentally more complicated. Connectivity requirements launch the design process into a larger network of associated products and processes in a wider and interdependent ecosystem.
ACCELERATION OF DISTANCE CARE PRACTICES COVID certainly is an accelerant to instigate more focus on the needs of patient-operated healthcare. In fact, the practice of in-home monitoring and drug delivery has become so widespread that “distance care” is now a common term that includes everything from wearables to in-home devices for real-time monitoring, therapy, and chronic drug delivery applications.
Secure data collection and transfer to professional healthcare providers for oversight and interaction are powerful features in these new devices. Many also include sophisticated embedded intelligence that not only provides optimised performance but also feeds vital data into remote databanks for analysis and AI advancement.
The development of more sophisticated and even smarter devices for patient self-care is expected to continue. But, in the design and development processes, manufacturers must be particularly cognisant of the added usability requirements for the patient. Just the demographic and psychographic variations among patients present numerous design challenges to overcome comorbidity-driven limitations such as strength, vision, dexterity, and social/cultural variabilities to assure predictable operability and user safety.
USABILITY ENGINEERING PROVIDES THE PLATFORM FOR DESIGN Usability engineering requires several steps – discovery research, design confirmation, and risk-based validation through user studies. This approach provides an opportunity to identify and mitigate potential end-user challenges, which may be demographic. It also considers patient safety if potential or actual comorbidities are involved. The environment in which the device will be used is also identified if, for instance, hygiene or hazardous situations cannot be predicted. The usability approach also looks at how the device can be designed to blend inconspicuously into a home setting or, if wearable, can be non-intrusive or perhaps worn comfortably under a patient’s clothing. It also considers regulatory requirements upfront so that specific issues can be adequately addressed during the design process.
OVERCOMING CHALLENGES WITH TECHNOLOGY STANDARDS Further complicating device design and development for connected devices is that wireless telemetry protocols and hardware are not standardised internationally, making it virtually impossible to develop a single device that will be able to operate globally. Regional differences in radio standards and institutional infrastructure require multiple design versions or duplicated components, further complicating R&D for device manufacturers. And various design versions need to not only meet regional standards but also must be created to meet specific global regulatory requirements.
THE FUTURE PROMISES INNOVATION As AI and ML technologies continue to mature from consumer to medical platforms, corporate partnerships and incentive subsidies will be desirable to share in the substantial design/development overhead necessary to build, test, and validate robust and reliable software algorithms required to guide and control medical devices. Additionally, support is needed from governments, related industries, and clinical and insurance communities. Without this support, the return on investment (ROI) for manufacturers is difficult to predict and may stall the pace of new technology integration into the design process.
With appropriate concurrent commitments from all these entities, the advancement of this new and exciting medtech paradigm can absolutely elevate opportunities for patients to interact with their clinicians to improve healthcare at reduced operating costs.
JAY TOURIGNY, SENIOR VICE PRESIDENT AT MICROCARE MEDICAL, EXPLAINS WHY SILICONE SWELLING FLUIDS HELP MEDICAL DESIGNERS TO MAKE A CONNECTION.
Silicone has been widely used in the medical sector for decades. Thanks to its unique chemical and physical properties, highly-versatile medical-grade silicone can be found in everything from diagnostic and monitoring implements to surgical implants and device tubing.
With developing countries undergoing rapid changes and rising ageing populations, the need for silicone medical tubing in the healthcare and medical device industries is increasing. However, as medical devices become smaller and more complex, the use of this biocompatible material becomes more problematic.
Advanced swelling fl uids assist with this challenge by providing greater design fl exibility. They are an eff ective way to easily and successfully incorporate silicone tubing in today’s cutting-edge devices.
DESIGN FLEXIBILITY Medical device manufacturers require small, light and fl exible tubing that meets tight tolerances. This often means reduced inner and outer diameters, thinner wall thickness, and multi-lumen tube construction.
Although medical-grade silicone is a popular material choice for tubing, due to its high level of biocompatibility, durability and fl exible structure, it generally does not expand or stretch without assistance.
Silicone also has a high coeffi cient of friction, or a tacky surface. Therefore, sliding a silicone tube onto a barbed or textured fi tting often requires some force which can result in stress-cracks, splitting and ultimately scrapped materials. A CLOSE FIT Assisting medical device manufacturers in this assembly challenge are fl uids that allow silicone tubes to slide and fi t more quickly and easily. Oil, alcohol, and elastomer swelling agents are the three most common types.
Ultra-pure isopropyl alcohol (IPA) is another popular fl uid when assembling devices that use silicone tubing. Although IPA is cost-eff ective and easy to obtain, it does have problems.
Because IPA dries very slowly, the assembly cycle time increases while manufacturers wait to move to the next stage of production. Just like oil, IPA can negatively aff ect the rigidity of thin-structured tubing, making it diffi cult to work with.
ENGINEERED SWELLING FLUIDS A better option is an engineered silicone swelling fl uid. It quickly and evenly swells tubing simply by soaking one end of the tube in the fl uid. Depending on how much expansion is required, the longer tubing stays immersed in the fl uid allowing it to increase to the desired dimension. For example, if the tubing only needs to expand by 1–2% for assembly, the entire swelling process is often completed in less than a minute.
After the tube is fi tted to the connector, the engineered swelling fl uid evaporates quickly. The tubing returns to its original size, shape, durometer, compression and strength to form a tight, sealed fi t over the fi xture, regardless of its geometry. This makes it particularly useful when using multi-lumen tubes.
Unlike hexane or toluene, swelling fl uids are specifi cally engineered for the job. They do not change the physical properties of the tubing. It is not aggressive, so it has excellent materials capability and is safe to use on most elastomers and plastics including neoprene, EDPM, polyethylene and polypropylene. It is especially useful for swelling tubing with thin, soft walls or those with larger diameters.
The swelling fl uid does not cause long-term change to the mechanical properties of the tubing material. Furthermore, it will not weld or bond the tubing onto the fi tting, so it can be easily removed later, if needed.
A TIGHT FIT Engineered silicone-based swelling fl uids are helping advance the design and production of complex medical devices. Tubing that was once diffi cult or impossible to join to other components can now be securely fi tted with ease to ensure the safety and reliability of the medical device. Thanks to their specifi c properties, swelling agents make medical device assembly effi cient and eff ective and do so in the safest, most sustainable way.
The swelling fl uid does not cause long-term change to the mechanical properties of the tubing material. Furthermore, it will not weld or bond the tubing onto the fi tting, so it can be easily removed later, if needed. design and production of complex medical devices. Tubing that was once diffi cult or impossible to join to other components can now be device assembly effi cient and eff ective and do so in the safest, most sustainable way.
