MASTERFLEX – Technische Schläuche & Verbindungen

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MASTERFLEX – Technische Schläuche & Verbindungen

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MASTERFLEX – Technische Schläuche & Verbindungen
MASTERFLEX – Technische Schläuche & Verbindungen
Fleima-Plastic: Quality control of an injection molded part

Individual product development - precision, quality and complete service

We offer you development, production and quality management from a single source. Precisely, efficiently and to the highest medical standards.

 

 

Precision from a single source - from the idea to the finished product

For our customers, we are more than "just" a supplier. We are a technology partner, solution finder and development partner. We support you in all phases of your project.

With our full service - from development, design and prototyping to mold making, injection molding and assembly - we offer you everything from a single source.

As an ISO 13485 and ISO 9001 certified partner, we support you from the idea to the finished, labelled and packaged product and help you to efficiently optimize supply chain structures and costs. Modern 3D CAD, extensive material expertise and fast prototypes enable rapid and targeted development. Our in-house precision mold construction and state-of-the-art injection molding production - also in a clean room on request - ensure quality and flexibility.

Component assembly, further processing and system integration round off our range of services. This means you receive your complete product reliably from a single source.

Mood image: Developers in conversation during the Fleima-Plastic project planning

Developing together - Contact us

Do you have a special application or technical challenge? Fleima-Plastic will support you from the initial idea through to implementation and work with you to find the optimum solution.

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Holistic development and production process - flexible, precise, medically competent

No matter what phase of project development you are in - we will get involved exactly where you need our expertise. Particularly in medical technology, where products are often complex and individually designed, sound consulting expertise is crucial. Our structured approach accompanies you step by step through the entire development and production process.

Schematic diagram of the development and production process at Fleima-Plastic

1. development
We analyze your application, check the technical feasibility and integrate risk management right from the start. With many years of experience in medical technology, we develop viable concepts that optimally combine quality, cost-effectiveness and innovation.

2. component design
Your idea takes shape: We develop plastic-compatible, production-safe components, taking into account interfaces, joining processes and materials with medical approval. Modern CAx methods and an interdisciplinary team ensure precise results.

3. simulation
Through early moldflow analyses and strength calculations, we identify critical areas even before tool production. Simulation-supported optimizations save time, reduce costs and create a reliable basis for further development.

4. tool design
Our experienced designers develop cost-effective tool concepts and integrate proven technologies from almost 50 years of injection molding experience. In this way, we lay the foundation for efficient, stable and reproducible production processes.

5. toolmaking
Precise, durable and high-quality injection molds are produced in our in-house toolmaking department. Modern machining technologies, ISO-certified processes and an experienced team of specialists enable rapid implementation as well as flexible adjustments and repairs.

6. prototyping
Before a product goes into series production, we test functional and design aspects with near-series prototyping. With flexible master molds, contouring inserts and state-of-the-art 3D printing processes, we achieve short development cycles and a fast time-to-market.

7. production concepts
Whether single or multi-component injection molding, micro or insert technology: our production covers a wide range of technologies. Clean room production (ISO 6-8), digitalized processes and a wide range of joining and bonding methods guarantee maximum precision and process reliability.

8. validations
Indispensable for medical devices: we carry out comprehensive product and process validations, evaluate particulate and microbial contamination and ensure that all specifications are reliably met - for reproducible quality and regulatory safety.

9. measurement services
Modern measurement and testing technology enables the precise analysis of components and materials. From optical measurement and tensile testing to FTIR and DSC analyses, we offer all relevant methods for quality assurance and reverse engineering.

Modern measuring and testing technology enables the precise analysis of components and materials. From optical measurement and tensile testing to FTIR and DSC analyses, we offer all relevant methods for quality assurance and reverse engineering.

Hermann Kreyenschulte, Head of Injection Molding Development at Fleima-Plastic

Comprehensive services for quality, safety and technical excellence

We support you with comprehensive services along the entire value chain - from cleanroom production and technical support to validated quality and regulatory processes. We ensure the long-term quality and safety of your products through maximum precision, certified standards and in-depth material and manufacturing expertise.

Fleima-Plastic employees at work in the toolmaking department for injection molding

Quality you can rely on

Our certified management system in accordance with ISO 9001, ISO 13485 and ISO 14001 as well as digital solutions for quality management and safety guarantee the highest precision and reliability. By qualifying tools, systems and equipment and validating all manufacturing processes, we ensure consistently high product quality - especially for demanding applications in medical technology, diagnostics and pharmaceuticals. International customers from various industries have relied on our consistent focus on quality for many years.

Mood picture: Clean room at Fleima-Plastic

Clean room production for maximum product safety

We manufacture products for sensitive medical applications in class 6 to 8 cleanrooms in accordance with ISO 14644-1 at our Halberstadt and Wald-Michelbach sites. Continuous monitoring of cleanroom conditions, regular training and internal audits ensure maximum process and product safety. In this way, we guarantee consistently high quality - even for complex requirements.

Tool design and modulation in the Fleima-Plastic computer

Technical support & solutions for complex challenges

We support you with comprehensive technical support - from safe tool relocation and precise feasibility analyses to the optimization of your products. Whether metal-to-plastic substitution or the development of high-performance single-use articles: We offer in-depth expertise to realize economical, reliable and modern solutions. We accompany you every step of the way and create the basis for efficient and future-oriented production processes.

Mood picture: Injection molding machine in the Fleima-Plastic clean room

Regulatory support - security through clear guidelines

We support you with comprehensive expertise in all regulatory requirements - from the validation of critical manufacturing processes to secure documentation. We ensure standard-compliant, reproducible and safe production through precise process validation and individually created manufacturing and test instructions. This is how we create the basis for reliable medical products and transparent quality processes.