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Compamed 2019
Plastic examples in medical device competence

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Pharmaceuticals, Trade shows
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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Merck
Virtual Annual General Meeting On May 28

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Merck, a science and technology company, will hold its Annual General Meeting this year in virtual form on May 28. The company is thus making use of the possibilities afforded by the German legislator in view of the coronavirus pandemic. Within the scope of the Annual General Meeting, a resolution on the dividend proposal of € 1.30 per share will also be voted on. Payment is planned for June 3.

The Annual General Meeting will be publicly webcast in its entirety on the Internet. Physical participation is not possible. The invitation will be published by May 7, in keeping with the official deadline. Notes on exercising shareholder rights and further information on the virtual Annual General Meeting will be available as of May 7 on the website www.merckgroup.com/agm and in the invitation.

Merck had already announced back in March that it would postpone its Annual General Meeting originally planned for April 24 and hold it in virtual form as soon as possible in order to protect the health and safety of employees and shareholders.

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Pharmaceuticals Valves, Pipes & Fittings

Pharma and Medicine
Globe valves are granted USP Class VI certification

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Gemü
Picture: Gemü

The Gemü globe valves 507, 550 and 554 with stainless steel valve bodies and PTFE seals from the valve specialist Gemü have been awarded approval in accordance with USP Class VI. They now comply with the prerequisites for application in the medical and pharmaceutical industries.

The U.S. Food and Drug Administration (FDA) divides the plastics used in the medical and pharmaceutical industries into six biocompatibility classes in the American Drugs and Medicines Register (USP). The most stringent of the six categories is the USP Class VI classification. It is the prerequisite for use of the materials in the medical and pharmaceutical industries.

With immediate effect, the Gemü globe valves 507, 550 and 554 with PTFE gland packing (Gemü code 5P) and stainless steel valve bodies (Gemü code 37, 34 or C2) now have certification in accordance with USP Class VI and are therefore approved for use in the medical and pharmaceutical industries.

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Biotechnology Chemicals Pharmaceuticals

Lab Inventory, Safety and Compliance Management System
System to Improve Scientists’ Productivity in the Lab

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Lanexo System. (Picture: Merck)
Lanexo System. (Picture: Merck)

Merck, a science and technology company, today launched its Lanexo Lab Inventory, Safety and Compliance Management System, a new digital laboratory informatics solution designed to drastically reduce1 time in labs and improve data quality and traceability.

“Today, 85 percent of labs are using paper or Excel to manage consumables data, and 25 percent of time is spent managing these data — taking scientists away from bench research,” said Jean-Charles Wirth, head of Applied Solutions, Life Science at Merck. “Lab efficiency is critical as it gives scientists more time to focus on their research and analytics work and less on administrative tasks, which ultimately leads to faster drug development. Our Lanexo System — with first-to-market features — underscores Merck’s commitment to advancing and commercializing laboratory informatics.”

Laboratory informatics is the application of data using a platform of software, data management tools and equipment that allow scientific data to be captured and interpreted for immediate use, and then stored for future research and development purposes. The laboratory informatics market, which accounted for $2.4 billion in 2018, is expected to reach $5.45 billion by 2027, according to a recent Research and Markets global market outlook report.

Merck is the first to offer radio-frequency identification (RFID) labels which auto-register open dates and calculate expiry dates. Through this digital data capture, the Lanexo System rapidly documents lab reagent data in real time. Digitalized inventory, expiration and storage monitoring reduces human error and safety risks and improves the reliability and traceability of compliance documentation. Ultimately, each reagent, including in-house preparations, can be instantly matched to a full audit report. Within an experimental workflow, the system allows for easy reagent identity checks and provides automatic alerts, helping scientists to avoid using expired reagents and minimizing experimental error.

The cloud-based Lanexo System can be easily set up and rapidly integrated into existing lab workflows. It includes mobile (Android) and web applications and is designed for use in highly regulated analytical and research labs in pharmaceutical, quality assurance / quality control and industrial testing markets.

Merck last year launched Milli-Q Connect, a cloud-based service portal for its water purification systems, and also acquired BSSN Software, a lab informatics company that makes data more readily accessible for ease of integration, collaboration, analysis and long-term archiving.

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