Extrusion Molding Assembly

RAUMEDIC Your development partner and system supplier for the medical and pharmaceutical industry

Quality management

RAUMEDIC is your development partner and system supplier for the medical and pharmaceutical industry.

An understanding of quality and compliance with regulations – RAUMEDIC offers you highly qualified support.

C O M PA N Y

The company

RAUMEDIC is a leading developer and manufacturer

From initial idea to mass production, we stand

Customer satisfaction and compliance with all relevant statutory, normative and official requirements are the focus

of polymer systems and components. We partner

alongside our customers. With over 60 years of

of our quality concept. In order to meet high demand, RAUMEDIC has established a comprehensive and certified

with medical and pharmaceutical industries world-

manufacturing expertise in the areas of extrusion,

quality management system.

wide. In close cooperation with our customers, we are

injection molding, and assembly, RAUMEDIC is

making our contribution to innovative diagnostic and

optimally equipped to transform its customers’

acute therapeutic systems.

ideas into mature product solutions.

ÆÆ Certified QM system according to ISO 13485 Com pl ia

products)

e nc

(Primary packaging materials for medical

Quality

ÆÆ Certified according to ISO 15378

Customer Satisfaction

ÆÆ Clean room production according to ISO 14644, Class 7 (=10,000) ÆÆ Manufacturing according to GMP standards

s ou t C o n ti n u en Im pr o v e m

ÆÆ CE approvals for RAUMEDIC medical devices

RAUMEDIC headquarters in Helmbrechts

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C O M PA N Y

Development process Research

Product

Product idea

Our product designers follow the development process from concept to production.

Production RAUMEDIC is constantly researching new materials,

Often, the road is long between the initial idea and

formulations and products. We use our own in-house

the final product. Efficient prototype construction

laboratory skills for our research and development

helps to save on time and costs. With its prototype

activities.

development, RAUMEDIC offers a quick and

Product concept

From Research to the finished Product

economical solution for sample preparation and Our engineers will be happy to advise you on design,

short production runs.

the selection of materials and production of the first prototypes, through to the finished product and

Thanks to modern production equipment and

manufacturing concept.

precision work consistent with “Made in Germany and in the USA” products, we set the highest

Individual products require different approaches. Depending on the respective requirements,

standards for quality and safety.

Product design

Manufacturing concept

RAUMEDIC achieves the best possible functionality of the product through an operation that is both intuitive and user-friendly. Hereby we attach great

Prototyping

importance to the best possible ready-to-manufacture design and cost-effective manufacturing processes.

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Material formulation

You know the requirements on your product – we know the appropriate material.

RAUMEDIC develops its own material formulations based on customer requirements for processing in extrusion and injection molding.

Material research and development have been our

Due to this knowledge, we are able to choose the

By setting high standards, RAUMEDIC ensures

core capabilities for more than 60 years. By working

right material for your product while taking into

consistent quality from the selection of raw materials

closely with leading research institutions, we are

account interactions with the contact medium, such

and compounding through to the final product.

steadily expanding our material-specific expertise in

as blood or infusion solutions. Aspects of further

And we leave nothing to chance. We perform all

the fields of thermoplastic and silicone materials.

processing and assembly are also factored into the

manufacturing processes in a closed material flow

selection of materials.

using qualified equipment. Preparation and processing take place under conditions that cause extremely

RAUMEDIC processes all thermoplastic polymers and silicones at medical grade quality.

Customized PVC formulations ÆÆ Specific sterilization methods ÆÆ Good resilience ÆÆ Customized shore hardness and color ÆÆ Suitable for contrast X-rays ÆÆ Adapted to all available plasticizers ÆÆ Only tested raw materials

low levels of material wear and tear.

Raw materials

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M AT E R I A L

Material expertise

Formulation

Processing

Production

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From compounding to a comprehensive PVC solution

We provide comprehensive and competent consulting in the selection of raw materials and the right plasticizer for your products.

Pure-grade compounds – an important step towards a safe PVC product.

The quality of a medical product begins with its raw materials

Not all plasticizers are the same

M AT E R I A L

PVC raw materials and plasticizers

Correct processing is the basis for a customized PVC solution

Tested, documented and certified quality for more product safety

The choice of the right plasticizer for your application The quality and suitability of a product depend, to

is an important cornerstone. We are happy to make

Within the context of compounding, our raw

A great deal of experience, expertise and technical

a large extent, on the quality of its ingredients. This

our knowledge of the following plasticizers available

materials are processed on dedicated production

resources are needed to develop a medical device

is why we only use raw materials with certified

for you:

lines without contact with the environment, in a

from concept to completion. As a leading provider

process that minimizes wear and tear on the materials.

of medical plastic products, we develop reliable

Thus we are able to produce our own customized

and customized complete PVC solutions in close

compounds for medical-technical applications.

cooperation with our customers.

ÆÆ Processing in accordance with current state-of-

In order to fulfill our responsibilities, each of our

chemical, biological and toxicological properties in our formulations.

ÆÆ noDOP® (TEHTM) ÆÆ DEHT

Through decades of experience in the field of formulating and preparing soft PVC, we have succeeded in setting new standards for the

ÆÆ Di-IsoNonyl-CycloHexane-1,2-dicarboxylate ÆÆ ATBC ÆÆ DEHP

ÆÆ Ensuring quality by means of validated, fully

preparation of our own compounds. The phthalatefree plasticizer, noDOP, which has since become established worldwide, is just one example. It is characterized by extremely low migration and excellent biocompatibility.

the-art process engineering

Additional information on our plasticizers can be found on our website.

automated process control ÆÆ Lot-based quality testing ÆÆ Purity ensured by closed material flow from raw material delivery to the finished product ÆÆ Several processing systems at two sites ensure

products undergoes a variety of external and internal tests. We are thereby able to ensure maximum raw material and product safety. Our quality is continuously monitored, documented and confirmed via batch-related test certificates throughout production.

supply security, punctuality and customer-oriented flexibility

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Silicone expertise

Fluoropolymers are used when the product must possess special sliding properties.

Scarcely any other material is as versatile in its use or offers such a wide range of beneficial properties.

Fluoropolymers, such as FEP and PTFE, are very resis-

PTFE Moldflon™

tant to almost all chemical compounds and solvents.

M AT E R I A L

Fluoropolymers

Silicone is an excellent material for medical applications. Due to its elastomeric nature, it offers unique properties that cannot be achieved with thermoplastic materials.

Distinguishing characteristics include their excellent

One special fluoropolymer is PTFE Moldflon™. It

sliding properties and outstanding biocompatibility.

provides the perfect combination of PTFE material

Advantages of silicone

Possible areas of application

ÆÆ Constant material properties within a wide

ÆÆ Pharma Fluid Handling

properties and thermoplastic processing. In collabo‑ Optimally adjusted for the specific application, we

ration with ElringKlinger, RAUMEDIC has expanded its

produce both spools and cut lengths in your desired

material competencies to include this unique material.

dimensions. In addition, we can incorporate X-ray

PTFE Moldflon™ opens up entirely new possibilities

ÆÆ Excellent pump performance

contrast stripes – variable in number and shape – or

for a variety of medical devices.

ÆÆ High degree of biocompatibility

ÆÆ Nearly universal chemical resistance

fluoropolymers are also ideal for wire coating.

250°C (482°F)

ÆÆ ECC ÆÆ Infusion and nutrition ÆÆ Drainage ÆÆ Pharmaceutical packaging

ÆÆ Particularly low extractable profile

offer full contrast tubing.

With good coating and lubricating properties,

temperature range from -70°C (-94°F) to

ÆÆ All common sterilization methods are possible

ÆÆ Very good sliding properties ÆÆ Capacity for further thermoplastic processing ÆÆ High temperature resistance

Tipping and flaring without splits or cracks common with traditional PTFE.

Moldflon™ is a Trademark of ElringKlinger Kunststofftechnik GmbH – exclusive clean room extrusion by RAUMEDIC Extrusion

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Injection molding

Assembly

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Multilumen tubing

Our range of materials for tubing extrusion includes all common thermoplastics and elastomers. Our products can be adjusted to accommodate the respective requirements.

Multilumen tubing can be variably configured and thus used for different applications.

Smallest dimensions for RAUMEDIC extruded tubing

Thin walled PUR tubing

Diameter, lumen geometry, material and number of

Typical applications include catheters and endoscopes

lumen are tailored to the respective requirements.

in such fields as:

to the thickness of a human hair. The tubing is very suit‑

ÆÆ Achieving maximum flow rates

ÆÆ Nutrition

able for balloon applications and is employed, among

ÆÆ Administering different drugs through one access

ÆÆ Drainage

other uses, in endotracheal intubation for airway

ÆÆ Optional stabilizing through the use of guide wires

ÆÆ Urology

The wall thickness of thin walled tubing is comparable ÆÆ Internal diameters starting at 0.004" (0.1 mm) ÆÆ Wall thicknesses starting at 0.002" (0.05 mm) ÆÆ Micro layers with thicknesses up to 0.0002" (0.005 mm), can be combined up to four layers ÆÆ All common thermoplastics up to high temperature materials can be selected

management in anesthesia and emergency medicine.

ÆÆ Dialysis

ÆÆ Internal diameters from 0.079" (2 mm) to 0.394" (10 mm) ÆÆ Wall thicknesses from 0.002" (0.05 mm) to 0.006" (0.15 mm) ÆÆ Surface from high-gloss to micro-rough

Micro extrusion 12

Thin walled tubing 13

EXTRUSION

Single lumen tubing

Filling tubing for welding into film bags

Multilayer tubing is used when a single layer of material is no longer sufficient. This is the case when the inner and outer layer must exhibit different properties.

Filling tubing from RAUMEDIC is used, for example, as connector tubing for infusion and dialysis bag applications.

Multilayer tubing provides modern, effective and

Minimally invasive surgeries require increasingly

A combination of up to three specially formulated

practical solutions for wide-ranging medical

complex catheters to treat patients gently. Even in

polymers enables specific adjustments to be made for

applications. Especially in cases when standards and

diagnostics, miniature tubing are used more and more

manual or automated assembly processes to further

production technology of a medical system require

frequently due to sample quantities becoming

optimize your production processing.

the use of several materials.

continually smaller. Up to four different materials

EXTRUSION

Multilayer tubing

ÆÆ Secure adhesion of press-fit connectors made of various materials such as PC and PP ÆÆ Optimal weldability using all common types of films ÆÆ Processable on different types of machines ÆÆ No delamination of individual layers

can be combined in our multilayer tubing. The

ÆÆ Adhering connectors not required

smallest inner diameter ever achieved is approximately 0.012" (0.3 mm).

2 Materials

3 Materials

4 Materials

Application: Insulin treatment

Application: Percutaneous transluminal angioplasty (PTCA)

Application: Regional anesthesia

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2-layer tubing

3-layer tubing

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High pressure tubing

The range of RAUMEDIC tubing for light-sensitive solutions and preventing drug degradation.

Safety and flexibility in angiography through the use of RAUMEDIC high pressure tubing.

RAUSORB

RAUMEDIC offers two variants in its product portfolio specifically for high pressure applications – reinforced and

EXTRUSION

Light protection and drug compatibility

coextruded high pressure tubing.

Light-sensitive pharmaceuticals, which are destroyed in a photochemical reaction, are playing an increasing role in therapeutic medicine. Coloring the outer layer creates a filter, which counteracts this reaction. For light-sensitive solutions

Reinforced high pressure tubing

Coextruded high pressure tubing

ÆÆ Outstanding flexibility and optimal kink resistance

ÆÆ Flexibility can be adapted to customer

ÆÆ Adjustable transparency ÆÆ High pressure resistance (> 83 bar / 1,200 psi)

specifications ÆÆ Good transparency due to the non-reinforced design

RAUINERT

Make-up: Spools and cut lengths

The low dosing rates of modern drugs have resulted

ÆÆ High pressure resistance (> 83 bar / 1,200 psi) Make-up: Cut lengths

in prolonged retention in the tubing system. RAUINERT tubing minimizes the risk of unwanted interactions between the drugs and tubing. For preventing drug degradation

RAUSONERT Low-dose, light-sensitive preparations place high demands on the transport tubing. RAUMEDIC RAUSONERT combines the advantages of RAUSORB and RAUINERT in one tubing. For preventing degradation of light-sensitive solutions 16

Reinforced high pressure tubing

Coextruded high pressure tubing 17

Intravenous catheters

Tubing with wire inlays and coated micro cables play an important role in medical products.

Examples of RAUMEDIC extrusion expertise include peripheral intravenous catheters, which are available as spools or in cut lengths. PTFE Moldflon™, FEP and PUR are the materials used.

When it comes to extrusion, RAUMEDIC is your skilled development partner for coated micro cables and wire

As a system supplier, in addition to catheter tubing,

inlays based on customer requirements. For example, we combine nitinol, platinum alloys or copper and stainless

RAUMEDIC also has the production know-how for

steel wires with a variety of polymers. Furthermore, RAUMEDIC has implemented the use of high temperature

almost all other plastic components needed for

thermoplastics such as FEP, PEEK and PTFE Moldflon™.

peripheral intravenous catheters.

Coated micro cables and wires

Wire inlay

nitinol ÆÆ Selection of a polymer suited to your requirements ÆÆ Layer thicknesses starting at 0.0008" (0.02 mm) ÆÆ Wire diameters from 0.002" (0.05 mm) to 0.039" (1 mm)

Features and benefits ÆÆ Good processability when forming the tip and flaring the cannula end ÆÆ Further processing possible in a wide process window

ÆÆ Cannula protection as an extruded tubing or injection molded cap

ÆÆ Customized wire materials such as 304V and

EXTRUSION

Polymer and wire coextrusion

ÆÆ Customized wire materials are possible

ÆÆ Butterfly

ÆÆ Selection of a polymer suited to your requirements

ÆÆ Tubing for silicone valve sealing

ÆÆ Wall thicknesses starting at 0.024" (0.6 mm) and

ÆÆ Intravenous cannula

ÆÆ Excellent blood- and biocompatibility ÆÆ Quality tests according to customer requirements

ID 0.059" (1.5 mm) ÆÆ Wire diameters from 0.008" (0.2 mm) to 0.039" (1 mm)

Intravenous cannula for drug administration

Coated micro cables and wires 18

Wire inlay 19

Gas supply tubing

RAUMEDIC lay flat tubing for enteral and parenteral nutrition.

Optimal equipment for your artificial respiration, anesthesia and emergency devices with RAUMEDIC tubing for medical gas supply.

Naturally non-PVC materials are explicitly used in

Micro lay flat tubing

manufacturing our lay flat tubing. As such, these

The RAUMEDIC tubing for medical gas supply in the

Our gas supply tubing is made of inner tubing,

Shore 87A hardness setting corresponds in terms of

thread reinforcement made of polymeric materials

materials are very well suited for use as pharma‑

The micro lay flat tubing manufactured by RAUMEDIC

tubing relevant aspects to DIN EN ISO 5359 (low

and an outer layer. Upon request, we can make

ceutical packaging.

in the clean room is used, for instance, in medical

pressure tubing assemblies for use with medical

special adjustments to the formulation such as

engineering as protective tubing.

gases). The formulations used are physiologically

anti-static versions.

ÆÆ Excellent process capability on high-speed assembly lines ÆÆ Flexible film widths from 3.94" (100 mm) to 19.69" (500 mm)

EXTRUSION

Lay flat tubing

harmless and are adapted for the gases that are ÆÆ Flat width max. 0.984" (25 mm) ÆÆ Wall thickness starting at 0.002" (0.05 mm) ÆÆ Material: Polyethylene

ÆÆ Burst pressure up to 70 bar (1,015 psi)

normally used such as nitrous oxide, nitrogen,

ÆÆ Adhesive force of the tubing layers min. 1.5 kN/m

compressed air, oxygen or carbon dioxide.

ÆÆ Electrical resistance 3 x 103 to 3 x 106 Ω/m (for

ÆÆ Variable wall thicknesses from 0.004" (0.1 mm)

types modified to be electrically conductive)

to 0.016" (0.4 mm) ÆÆ Inner surface options include a textured design, longitudinal ribbing or smooth ÆÆ Very good transparency due to a special manufacturing process

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Vac

Air

O2

N2O

CO2

neutral

yellow

black & white

white

blue

gray

black

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Extra-CorporealCirculation (ECC)

RAUMEDIC silicone is the proven tubing for the use in pharmaceuticals and medicine.

RAUMEDIC ECC products have proven themselves for over 50 years in many countries. As a medical device they are provided with CE marking.

ECC tubing made of noDop®

ECC connectors

has a particularly low extractable content. This ensures outstanding biocompatibility. In addition, RAUMEDIC can

DEHP-free RAUMEDIC ECC noDOP tubing is

RAUMEDIC ECC connectors are deliberately designed

offer extensive validation documents for selected types of materials for a quick and easy customer-specific

characterized by a particularly smooth inner surface.

with a compact shape in order to prevent, as much

implementation.

This is one reason for its outstanding blood

as possible, the surface of the connector coming

compatibility (comparable to PUR).

into contact with the blood. They are made of poly-

RAUMEDIC silicone tubing is made of highly resistant, high-quality silicone, which is exceptionally suited for the use in pharmaceutical and medical engineering. Thanks to our years of expertise in production, our silicone tubing

Product portfolio

Patented surface treatment

ÆÆ Silicone, platinum or peroxide cross-linked

ÆÆ Low-Tack

carbonate and manufactured from a single casting. Therefore, they meet strictest mechanical

ÆÆ Shore hardness A 30-80 ÆÆ Reinforced for high pressure applications ÆÆ Also available as multilumen tubing ÆÆ Full contrast or with X-ray contrast stripes

Reduced tackiness of the surface ÆÆ Antimicrobial surfaces Protection against a variety of clinical germs

ECC silicone tubing

requirements.

Particularly in the ECC-roller pump, maximum reliability and safety as well as tight tolerances are what matter. Our RAUMEDIC pump tubing has been setting the bar for decades.

RAUMEDIC adhesive and dispersion – safety and protection for your medical devices.

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EXTRUSION

Silicone tubing

Precision injection molding

Micro injection molding

Our strengths include customized design and manufacturing, from complex parts and assemblies to complete systems.

Injection molding in its smallest size – RAUMEDIC produces customized system solutions.

We manufacture high-precision injection molded

We process all thermoplastic polymers up to and

The miniaturization of molded parts and complete

parts with part weights from 1 g to 200 g under

including high temperature thermoplastics as well as

groups of components is becoming increasingly

clean room conditions. Our manufacturing processes

silicone. A team of specialized engineers and tech-

important in the medical and pharmaceutical sectors.

have been validated and are guaranteed through

nicians is at your side from the initial idea to series

application of appropriate statistical methods.

production. Our services include the development

In order to be able to meet strict customer

and production of molded parts and the assembly of

requirements, all phases and processes must be

complex groups of components, including customized

specifically geared toward micro injection molding.

Complete groups of components and systems from one source ÆÆ Micro injection molding ÆÆ Micro extrusion ÆÆ Micro assembly

packaging and sterilization.

MOLDING

In micro injection molding, we produce products with part weights of 0.004 g to 1 g. Here too, we use a variety of thermoplastics up to and including high temperature thermoplastics such as PEEK and PSU, as well as silicone. PEEK tubing with overmolded tip for stent catheter

Application system for liquid drugs

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Customized dental application in sterile packaging

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Multi-component injection molding

Insert molding and overmolding

Multi-component technology makes it possible to combine different product features with economical assembly options.

Insert molding and overmolding of molded parts – the alternative to gluing.

With multi-component injection molding, a large number of polymeric materials can be combined and processed.

In the cases of insert molding and overmolding, we

The technology thus provides the opportunity to turn ideas into medical and pharmaceutical products.

bundle our expertise in extrusion and injection molding into a single group of components. Even

Combining hard and soft components to make one single component

Multi-component injection molding makes it possible

materials, where bonding is not possible, can thereby be optimally combined. High tensile loads

ÆÆ Manual, semi- and fully automated handling of insert parts during the injection molding process ÆÆ Optimal bond between the individual components ÆÆ Strict requirements on leak tightness

and pressure sealing characteristics can be achieved

to integrate additional functionality into individual

We combine a rigid thermoplastic component with

components. In sandwich injection molding, the use

a soft, elastic component. This opens up doors for

of two materials with different barrier properties

completely new angles, for example, medical sealing

makes it possible to reduce both water vapor and

elements or pharmaceutical dosing systems.

by insert molding of molded parts onto cannulas made of metal and plastic.

MOLDING

Sandwich injection molding

Benefits to you

oxygen permeation.

Luer cannula for eye surgery

Drug container with barrier function

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Overmolded connector to a PVC tubing for inhaler applications

Catheter coupling for regional anesthesia

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Silicone injection molding

Components and systems for the pharmaceutical industry

Silicone injection molding at RAUMEDIC – true added value. Combine your ideas with our passion for silicone.

Together with our customers, we have specialized in the field of pharmaceuticals in the following product groups:

We are specialists in the processing of liquid (LSR / LIM) and high consistency silicone rubber (HCR / HTV). Even

Drug delivery systems

With years of experience in medical engineering, we support our customers throughout the entire value chain.

Competencies

Possible areas of application

ÆÆ Sophisticated product and tool design

ÆÆ Pump segments for food and drug pumps

ÆÆ Optimal material formulation for your

ÆÆ Silicone plugs for syringe systems

application ÆÆ Customized tool technology for your medical and pharmaceutical products ÆÆ Qualified and validated processes for maximum process reliability

ÆÆ Insert molded connectors for feeding tubing and catheters ÆÆ Seals for the medical and pharmaceutical industry ÆÆ Thin walled molded parts for inhalation

Drugs can be fully effective only when their doses are correct. Using our customized solutions, we ensure that drugs are properly dosed.

Disposable patch pump for the treatment of heart failure

Injection systems MOLDING

2-component applications in the silicone/silicone or silicone/thermoplastic variants are included in our repertoire.

RAUMEDIC develops intelligent injection systems together with you. In this way, we ensure the quality and safety of your drugs.

systems Different injection and safety systems

Primary and secondary packaging Due to our wide range of manufacturing methods we are able to find innovative and customized packaging solutions for your drugs. Thus, your active pharmaceutical ingredient is optimally packaged. Primary packaging for liquid drugs 28

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Catheter assembly

Tubing sets

RAUMEDIC’s broad assembly repertoire combines tubing and components for customized, CE certified systems in sterile packaging.

Tubing sets assembled by RAUMEDIC are used, among other purposes, in the areas of ophthalmology, radiology, dialysis and arthroscopy.

Different manufacturing options at RAUMEDIC

Manufacturing technologies

Manufacturing technologies

Thereby we assemble specially extruded tubing, ÆÆ Micro extrusion of multilumen tubing

ÆÆ Punching

ÆÆ Precision injection molding of the connector

ÆÆ Printing (including high temperature materials)

ÆÆ Overall assembly of delicate components into the

ÆÆ Tip forming

We combine up to 100 components in one set.

standard components and customized molded parts.

ÆÆ Application-specific and cost-effective design of the sets ÆÆ Semi-automated assembly lines in the clean room

final product

ÆÆ 100% control of critical characteristics such as leak tightness

ÆÆ Thermoforming

ÆÆ Non-sterile or sterile delivery of the sets

ÆÆ Microchip technology ÆÆ Integration of electronic components ÆÆ Packaging ÆÆ Sterilization ÆÆ Certification

Customized tubing set

A S S E M B LY

Catheter for microdialysis

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Automation

Integration of electronic components

In whatever quantities you may be planning, RAUMEDIC offers manual, semi-automated or fully automated assembly processes to meet your needs.

Due to the continuous development of new technologies, RAUMEDIC is able to integrate even the smallest electronic components and cameras into catheter systems.

RAUMEDIC has efficient and reliable process solutions, ranging from manual, semi-automated

Micro cannula – an example for RAUMEDIC automation

tailored to your requirements and capacity needs.

ÆÆ Micro extrusion ÆÆ Fully automated assembly with tip forming and flaring of the cannula end ÆÆ 100% integrated camera inspection of defined quality characteristics

Manufacturing technologies

systems make minimally invasive procedures possible and can be precisely navigated to the origin of the

to fully automated assembly and production lines. The technical design and system concepts are

Due to their generally miniscule size, our catheter

disease. They are therefore useful in clinical diagnostics as well as in therapy, and reduce the time needed for interventions and, as a consequence, the stress for the patient.

ÆÆ Micro assembly ÆÆ Soldering e.g. of wires, cables ÆÆ Bonding of microchips ÆÆ Assembly of cameras, memory chips, etc. ÆÆ Electronic calibration ÆÆ Testing of mechanical and optical properties ÆÆ Testing of measurement function ÆÆ Packaging and sterilization ÆÆ Support for CE certification

© NanEye by AWAIBA/CMOSIS

Flexible micro cannula for insulin dosing

Disposable camera for use in the field of medical endoscopy, among other fields

A S S E M B LY

Fully automated UV bonding

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Implants

Your system supplier

RAUMEDIC processes implant-tested materials in conjunction with highly qualified assembly and precision molded parts.

Together with you, we will develop your product – from the customer’s initial idea to series production.

Implants are used in a wide variety of medical

Manufacturing technologies

disciplines. One example is drainage catheters in urology.

ÆÆ Silicone and polyurethane extrusion ÆÆ Silicone injection molding

As such, a distinction is made between short-term applications that remain in the body for less than 29 days and long-term implants. These are utilized over a longer period (> 29 days) and need to meet particularly strict regulatory requirements.

ÆÆ Printing ÆÆ Introducing perforations (punching, drilling) ÆÆ Assembly of connectors and cuffs ÆÆ Biological and toxicological tests and tests according to ISO 10933 ÆÆ Customized packaging and sterilization

Sophisticated products such as long-term implants,

Our experts will advise you on materials and raw

catheter systems, complex tubing sets or other

material selection, via our production technologies for

medical devices require many years of experience and

extrusion and injection molding through to the

extensive knowledge. RAUMEDIC combines these

assembly of complex systems. We are happy to

core capabilities and offers system solutions from a

handle customized packaging and subsequent

single source.

sterilization.

RAUMEDIC is your development partner for customized and high quality product systems in the medical and pharmaceuticals industry!

ÆÆ Support for CE certification In these cases, only certified materials such as silicone and polyurethane are used. These materials, in particular, possess a high level of purity. They are

A S S E M B LY

therefore ideal for implants.

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Global service! What can we do for you? Thanks to an extensive sales network, you can receive personal support, directly on-site, throughout the world.

Headquarters in Europe

Headquarters in America

RAUMEDIC AG Hermann-Staudinger-Str. 2 95233 Helmbrechts Germany Phone: +49 9252 359 0 E-mail: [email protected]

RAUMEDIC INC. 235 Broadpointe Drive Mills River, NC 28759 USA Phone: +1 828 684 8870 E-mail: [email protected]

Sales offices worldwide Asia/Australia

Southern Europe

RAUMEDIC Singapore Pte Ltd 140 Paya Lebar Road #05-09 A-Z Building Singapore 409015 Singapore Phone: +65 6702 2001 E-mail: [email protected]

RAUMEDIC SRL Via S. Maddalena 1 20900 Monza Italy Phone: +39 039 3900 816

RAUMEDIC AG Gallische Straße 2 63128 Dietzenbach Germany Phone: +49 6074 69651 0

North America RAUMEDIC INC. 235 Broadpointe Drive Mills River, NC 28759 USA Phone: +1 828 684 8870

Northern Europe RAUMEDIC UK LTD. C-TRIC Building Altnagelvin Hospital Complex Glenshane Road Derry/Londonderry BT47 6SB Northern Ireland Phone: +44 2871 611 345

RAUMEDIC AG Rte du Petit-Moncor 1 1752 Villars-sur-Glâne Switzerland Phone: +41 2640 970 40 RAUMEDIC AG 5 rue Alphonse Bouffard-Roupé Parc de l’Oppidum - Bât E 38500 Voiron France Phone: +33 476 935 220

Central and Eastern Europe RAUMEDIC AG Represented by REHAU Gesellschaft m.b.H. Industriestraße 17 2353 Guntramsdorf Austria Phone: +43 2236 2468 4317

C00N002 EN 10.2016 – Copyright by RAUMEDIC AG

Germany

Western Europe