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Optimized design
CVC from special urethane material

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Pharmaceuticals, Trade shows
In the U.S., more than 5 million central venous catheters (CVCs) are inserted every year, which corresponds to 15 million days of treatment with CVCs. In Germany, this figure is 4.8 million in intensive care units alone. (Picture: Flexan)
In the U.S., more than 5 million central venous catheters (CVCs) are inserted every year, which corresponds to 15 million days of treatment with CVCs. In Germany, this figure is 4.8 million in intensive care units alone. (Picture: Flexan)

In the U.S., more than 5 million central venous catheters (CVCs) are inserted every year, which corresponds to 15 million days of treatment with CVCs. In Germany, this figure is 4.8 million in intensive care units alone. The use of these catheters is associated with some risks for the patient: the possible complications range from injured vessels and nerves to infections to pneumothoraxes, air embolisms and catheter sepsis, which can be fatal. In addition, these secondary diseases drastically increase health care costs. For this reason, efforts have long been made in medical technology to use new manufacturing methods to realize catheter designs that allow minimizing these dangers. For example, an international medical device company commissioned the experienced medical technology manufacturer Flexan to design catheters that facilitate insertion and positioning. To achieve this goal, the company chose a special urethane material that enters the body rigid but then becomes softer. This polymer was subsequently used to overmold thin-walled 5FR triple-lumen, 4FR double-lumen, and 3FR single-lumen small diameter PICCs. Flexan also designed and manufactured a 4FR catheter that has the same lumen as conventional 5FR catheters but a 14 percent smaller diameter. An overview of Flexan’s manufacturing services and processes available for the manufacture of catheters will be presented at this year’s Medica/Compamed.

Central venous catheters are catheters that are inserted into the upper or lower vena cava – just before the right atrium of the heart – via a large vein near the heart. The application of a CVC is actually a minimally invasive procedure, but it is still possible, among other things, to perform a malpunction, perforate a vein or damage nerves in the vicinity. This can cause complications that endanger the patient’s health and consequently cause an increase in treatment costs. With new manufacturing technologies for central venous catheters, standardization of insertion techniques, and the use of ultrasound guidance, however, complication rates in the U.S. have already been reduced from 11.8 to 4 – 7 percent in recent years.

Special material and newly designed catheter tip reduce risk of complications

In order to further minimize these risks with its own products, an international medical device company has commissioned Flexan’s experts to develop the critical manufacturing processes for a CVC with an optimized design that will significantly facilitate the insertion and correct positioning of its products. In support of the project, the U.S. contract manufacturer leveraged over two decades of specific PICC catheter design and manufacturing experience. For example, Flexan used a polyurethane material technology to fulfill the customer’s requirements: “We were able to mold with a urethane material that is inserted into the body in a rigid state, but immediately becomes softer there due to the body temperature,” says Eric King, V.P. and General Manager at Flexan. “This plays an important role in reducing complications in catheter positioning.”

 For this project, Flexan was able to draw on a broad portfolio of processes, with which biomedical components made of polymer can be adapted to the desired application. For example, Flexan is able to design and manufacture thin-walled 4FR catheters that are 14 percent smaller in diameter than conventional 5FR catheters but still have the same lumen. The company has also been able to manufacture a 4FR thin-walled catheter that has a kink resistance comparable to that of a standard 5FR catheter with the same lumen size. Moreover, the company has extensive experience in shaping catheter tips. It employs the latest high frequency technology to design the tips in a way that reduces complications during insertion.

 Market growth opens up high future potential for new design

“Thanks to our previous experience and a very good cooperation with the client, we were able to achieve the specified project goal together,” says King. “Within a project time of six to nine months, we succeeded in developing an optimized micro-catheter design, which significantly improves the functional performance of peripherally inserted central venous catheters.” In addition, the Flexan team designed an efficient process control plan and inspection methods to ensure reliable binding between all vital catheter components. “This successful project for the development of a thin-walled catheter has paved the way for using the changed design for future orders. The potential is high as the global market for vascular access devices is expected to grow at an average annual rate of nearly 6.5 percent by 2023,” concludes King.

Flexan at the Medica/Compamed 2019: Hall 8b, Stand F20-1

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Multivac cooperates with Bell-Mark

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High-precision piezo inkjet technology for chal-lenging printing requirements
Picture: Multivac

With immediate effect Multivac has the exclusive rights to market the Inteli Jet HD series of printing solutions from the US manufacturer Bell-Mark Sales Co. The inkjet printers are based on the piezo technology, and their main features include a large print area and excellent print quality on a wide range of materials. They can either be integrated into new packaging lines or retrofitted to existing ones.

“Bell-Mark is a leading manufacturer of digital printing systems for packaging machines, and the company has established itself as a reliable partner with many of our customers,” says Luc van de Vel, Vice President of the MCP (Medical, Cosmetics and Pharmaceuticals) Business Unit, explaining the reasons behind this strategic step. “Thanks to this cooperation, we can now offer high-performance digital printers for challenging requirements within the packaging process, particularly in the sectors of medical products, pharmaceuticals and cosmetics.”

The Inteli Jet HD series of printers are drop-on-demand digital printers, which can be configured for either one or two colours or even the full CMYK colour scale. In contrast to CIJ (Continuous Ink Jet) printers, which produce a continuous jet of ink, the nozzles of DoD printers only supply the ink drops that are actually required for the print. This is very efficient and therefore particularly cost-effective.

Thanks to its print resolution of up to 600 x 600 dpi and a printing speed of up to 150 metres per minute, the technology enables texts, logos, variable data and various codes to be printed precisely and cost-effectively on a wide range of materials such as paper, Tyvek, film or aluminium. The high-quality UV inks dry very quickly with state-of-the-art UV LED lights, and the ink spread remains very small even with the coarse-fibred Tyvek material, so that even small icons and text can be reproduced perfectly. The Inteli Jet HD printers are designed for a large print area and can print films either completely or partially with a high level of accuracy. The modules can be fitted with up to twelve printing heads, so that a complete blank film with a width of up to 630 millimetres can be printed.

Companies in the medical and pharmaceutical industries in particular benefit from the printing system’s high degree of flexibility, which is becoming increasingly important in view of the requirements of the UDI Regulations as well as serialisation.

All Bell-Mark models can be integrated into Multivac packaging lines. Customers also have the opportunity of having their existing lines retrofitted with the printing system by Multivac.

The printers and the corresponding consumable materials will be marketed by the more than 80 subsidiaries within the Multivac Group. Multivac is the exclusive sales partner of Bell-Mark for all regions worldwide – with the exception of the USA, Canada, Mexico, Puerto Rico and the Dominican Republic. The specialists at Multivac Marking & Inspection will undertake the complete after-sales service as well as the supply of spare parts, consumables and user training. Thanks to their many years of experience in printing with a wide range of technologies, they can ensure that the maximum reliability and durability of all installed solutions is achieved.

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Biotechnology News Pharmaceuticals

Peripheral somatosensory neurons
Scientist Wins Eppendorf & Science Prize 2019

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The American scientist Lauren Orefice, Ph.D., Assistant Professor at Massachusetts General Hospital and Harvard Medical School has won the 2019 Eppendorf & Science Prize for Neurobiology for her work on the causes and potential therapies for autism spectrum disorders (ASD). Dr. Orefice found that peripheral somatosensory neurons – neurons outside the brain that control the sense of touch – are key areas where autism-associated gene mutations have a critical impact. She showed how abnormal function of peripheral somatosensory neurons causes touch over-reactivity and how this over-reactivity during development contributes to altered brain function and some autism-related behaviors in mice. Dr. Orefice’s work changes how we think about the causes of ASD, providing a surprising revision of widely-held views that link ASD exclusively to brain function. She highlights peripheral somatosensory neurons as a possible novel therapeutic target for improving some ASD-related symptoms.

The annual US$25,000 Eppendorf & Science Prize for Neurobiology honors scientists, like Dr. Orefice, for their ground-breaking research. Lauren Orefice is the 18th recipient of this international prize which is awarded jointly by Eppendorf and the journal Science. Researchers who are 35 years of age or younger and have made outstanding contributions to neurobiological research based on methods of molecular and cell biology are invited to apply. The next deadline for applications is June 15, 2020.

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Pharmaceuticals Trade shows

Compamed 2019
Plastic examples in medical device competence

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Spang & Brands GmbH shows plastic examples in medical device competence
Picture: Spang & Brands

During Compamed Spang & Brands , Friedrichsdorf, Germany, will exhibit a variety of different plastics engineering solutions for applications in medical technology, such as connectors, caps and closures with piercing membranes, implant components, and parts for minimally invasive medicine, plus components for infusions and blood reserves, as well as transition and connection systems (for instance with precisely defined predetermined breaking points or linking points). Visitors can see assembled systems and in-house produced complete systems with high-precision geometries and features ready-to-use.

Spang & Brands reacts consistently and quickly to the current demands of the market. Competence under one roof: Three years ago, medical device competence was bundled in the technology centre. Flat hierarchy: it improves the interdisciplinary communication, transparency, cooperation and efficiency of the individual divisions, i.e. development, sales, order processing, construction, materials management, quality assurance/certification, toolmaking, injection moulding, assembly/clean room, dispatch and after-sales service. This was accompanied by the restructuring on the basis of three focal points: Strengthening the range of market services from product development to validation, driving forward the development of proprietary products and expanding core competencies. The family business in the third generation builds its success on the advantage of medium-sized businesses and an organically grown network, in which partners in raw material producing companies, in special mechanical engineering firms, in IMM manufacturers’ and IT companies play a target-oriented role in the exchange of complementary knowledge.

In view of high initial costs of medical devices customers expect speedy product development from an all-inclusive provider in order to reach validation, clinical trials, and introduction to market. Validation is one of the overriding topics in the medical device value chain of a company such as Spang & Brands that is certified according to DIN ISO 13485. Mould making for medical devices in plastic differs fundamentally here from toolmaking in automotive and white goods sectors, for example. An injection mould has to comply with typical regulations that are common in medical technology. “Process optimisation and traceability are essential. Looking at the patient, it is important to be able to prove the origin of the individual components and the various stable process stages on the way to fault-free medical devices”, explains Friedrich Echterdiek, CEO of Spang & Brands GmbH. It is for this purpose that Spang & Brands appointed a validation officer in 2016 to work seamlessly with quality assurance and report directly to the company management. “Starting with the initial 3-D prototype or 3-D printed trial mould inserts, analysis of the prototype status leads to quicker and more flexible optimisation of the individual parts, components and assemblies – in respect of design to value and design for manufacturing and assembly”, adds Friedrich Echterdiek.

Across the entire value-added chain of a medical devices specialist, Spang & Brands demonstrates ground-breaking R&D technology and, supported by a state-of-the-art tooling facility and machine park, i.e. the entire diversity of optimized plastics technological product ranges. Consequently, special plastics compounds, such as TPU, TPE, TPV, resomere materials, and polylactides are used. ‘Employing multi-component injection moulding technology our starting point is to embrace increased comfort enhanced with innovative functions and benefits based on the very latest moulding technologies’, emphasizes the CEO of Spang & Brands.

Spang & Brands has specialised in precision and cleanroom injection moulding technology for the medical and pharmaceutical industry for over 35 years. In addition to its own products, the company sees itself above all as a competent contract partner for customer projects. Product innovations at Spang & Brands go through all process stages – from the idea to the finished product, ready-to-use. The company ensures consistency of CAD tool data and maximum precision in CAM production of moulds for medical and pharmaceutical devices in its own technology centre. Spang & Brands has at its disposal latest equipment, as well as a team with a high level of competence and experience, which masters the technology: part development, mould design and construction, injection moulding with 70 mainly all-electric single and multi-component IMM, as well as the importance of cleanroom production. Fully automatic and manual assembly and packaging of parts and assemblies are located in cleanrooms – from pre-series or just-in-time batch sizes, extremely small series, and right up to full production running into millions of products. Strategically positioned control points and 3D measuring technology support quality assurance. The company is certified e.g. according to DIN ISO 13.485.

Spang & Brands at the Compamed 2019: stand 8a M33

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