Combining 60 years' experience with the dynamism of a young and flexible company, RAUMEDIC provides the highest quality systems, components and services. Dr Thomas Jakob explains to Abi Millar how RAUMEDIC tailors its products to meet its clients' needs.
Injection moulding, extrusion, polymer compounding and product assembly; each of these technologies is offered by RAUMEDIC, a leading manufacturer of systems and components for the medical and pharmaceutical industries.
From polymer-based drug administration systems to catheter couplings for anaesthesia, the company is fully equipped to meet each customer's pharmaceutical needs.
"Our customers have the initial idea, and then we develop this into a product concept," says Dr Thomas Jakob, RAUMEDIC's director of business unit moulding and pharma solutions. "We already support our customers when choosing the right material, and then we build all the necessary equipment . we're talking about millions of products per year."
RAUMEDIC has a long industry pedigree, having been in operation for over 60 years. Originally part of REHAU AG + Co, which employs around 15,000 people worldwide, it split off from REHAU in 2004. The company thus combines the benefits of experience with the dynamism of a new and rapidly expanding team. The company has approximately 450 staff, with headquarters in Munchberg, Germany, and two further production facilities in Germany. All its capabilities and technologies are based in house.
"We are very fast-growing," says Jakob. "We took on 86 new employees last year alone."
Chief among its pharmaceutical solutions is the fluid-handling programme, which reflects RAUMEDIC's considerable expertise in the interactions of polymer with flow media.
Consisting of FluiSil (a silicon tubing range) and FluiSet (complete assembled sets), the programme is optimally designed for biopharmaceutical manufacturing and filling processes. RAUMEDIC also offers individually tailored sets and customised parts.
"The possible applications of our products are very broad," says Jakob. "For example, we develop and produce secondary and primary packaging, innovative drug delivery systems and injection systems."
Such applications fall under the remit of the company's Pharma Solutions programme, which creates high-quality polymer-based products according to customer specifications. A team of engineers, chemists and managers completes each project, processing a wide range of tailor-made plastics.
When it comes to drug delivery systems, RAUMEDIC is faced with the dual challenge of ensuring exact dosage while being user-friendly. Its solutions include dose-sipping devices and injection systems.
Perhaps most ingenious is the company's dose-sipping syringe, which has a double function: it can be used like a syringe or a straw. This method is particularly suited to children whose reluctance to take medicine is counterbalanced by their enjoyment of sucking straws. Here, as with all RAUMEDIC products, patient safety and comfort are paramount.
RAUMEDIC adheres to the highest standards of quality control: its quality management systems are in line with ISO 13485 and ISO 9001; its quality assurance systems conform to appendix II of the EC directives 93/24/EEC and 90/385/EEC; and its clean room manufacturing meets ISO 14644, class 7. In addition, the company excels in R&D.
"We have a very big R&D department with all kinds of capabilities," says Jakob. "There are engineers from a wide range of backgrounds, including biologists and chemists. We also have a medical advisory board, bringing us into contact with doctors and specialists in certain application fields. This gives us very detailed information about all kinds of different applications from our customers."
RAUMEDIC does not wish to supply one solution to all, but rather to find the correct solution in each individual case. The imperative, however, is always the same: to improve patients' quality of life.
"We are aiding people's recovery through the development of innovative application and acute therapy systems," says Jakob. As such, the company will settle for nothing less than the provision of the highest quality services and products.
Safety is essential in the pharmaceutical industry, so products that retain their structure and original qualities should be a specific focus for all manufacturers.
With multicomponent injection moulding technology as well as the combination of extrusion and injection moulding technologies, hard and soft thermoplastic polymers can be combined in one product without post-assembly. Combinations of different thermoplastics are especially used for applications such as sealing and connecting. The soft component reacts chemically with the hard component and can only be separated through destructive force. This makes the product perfectly safe - an important factor in the pharmaceutical industry. Furthermore, the reduction of individual parts contributes to reduced costs.
Innovative and complex ideas need a capable partner to succeed in realisation. Starting with a first idea through prototyping, design studies, risk analysis, research and development, engineering to mass serial production under clean room conditions, packaging and sterilisation, RAUMEDIC offers the whole value-added chain of a system supplier including all qualification and validation requirements. Through the application of a wide range of polymer technologies including innovative multicomponent technology, RAUMEDIC provides its customers with a whole host of possibilities to transform ideas into innovative products. Combined with a fully automated production process also available with 100% camera control systems, RAUMEDIC actively supports customers according to the highest quality standards.
The multi-component technologies can even be enriched by combining them with metal insert technology. Figure 1 shows a metal cannula directly moulded with two-component injection moulding technology, first with a soft polymer and subsequently with a hard polymer. In the two-component luer cannula, the soft component has an additional sealing function. In addition, the adhesion between the metal insert and the polymer is comparable with gluing processes. Applications can be found in all kinds of injection systems.
A further technology related to multi-component injection moulding is the so-called 'sandwich technology' for the improvement of barrier properties of polymer products for the pharmaceutical industry. Figure 2 shows a pharmaceutical drug container with cap, each made of two different hard polymers. With the systematic combination of two materials, RAUMEDIC accomplished a water vapour permeation improvement of more than 70% in comparison to existing drug containers in the market.
Multi-component technology is an example of the development and manufacturing expertise of RAUMEDIC and its customer-oriented conversion into high-quality medical and pharmaceutical products. RAUMEDIC meets all the requirements for generating tailormade solutions in the areas of rapid prototyping, material development, precision and multi-component injection moulding, injection of moulded parts onto tubes, extrusion, microextrusion, multi-layer extrusion, part assembly, end packaging, sterilisation and certification. The company creates complex concepts and developments for its customers and is consistently putting these into practice.
RAUMEDIC provides customer service worldwide through local subsidiaries and the development and processing competence centre in Münchberg. The company has established a comprehensive quality management system encompassing all processes throughout the organisation (marketing, research and development, production, quality and sales). The quality management system is process-oriented and certified in compliance with ISO 13485: 2003.
RAUMEDIC is a spin-off of REHAU AG + Co providing customerspecific polymer products and complete assembled systems on fully automated manufacturing machines, all manufactured from biologically suitable and approved materials under clean room conditions according to DIN EN ISO 14644 ISO class 7.