GEMÜ GmbH

Short description

GEMÜ Medical - Plastic system solutions for medical technology GEMÜ Medical was founded in 2003. As a supplier for medical technology companies and pharmaceutical manufacturers, GEMÜ Medical produces tailor-made plastic solutions using injection molding from the clean room.

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Range of products

  • D Contract development
  • D Prototyping
  • D Process development
  • M Treated/processed material
  • M Valves
  • M Other components
  • P Plastics processing
  • P Robot systems
  • P Laser processing
  • P Mold making
  • P Toolproduction
  • P Sterilization
  • P Clean room
  • P Contract manufacturing
  • P Packaging technology
  • M Inspections and approvals
  • M Analyses
  • M Testing equipment
  • M Testing systems
  • M Validation
  • S Regulatory affairs
  • S Documentation
  • S Consulting
  • S Approval
  • S Certification
  • S Quality assurance, quality control
  • S Other services

About us

GEMÜ Medical - Plastic system solutions for medical technology

GEMÜ Medical was founded in 2003. As a supplier for medical technology companies and pharmaceutical manufacturers, GEMÜ Medical produces customized plastic solutions using injection moulding. International medical technology customers receive everything from a single source, from individual components and packaged and tested assemblies to sterile finished products for ready-to-use applications. In September 2012, GEMÜ Medical opened the new clean room production plant in Emmen to ensure growth and to meet the high demands placed on the production environment. GEMÜ Emmen is one of the leading medical technology companies in Switzerland - shining a light on the world.

About us

The GEMÜ Group is a leading manufacturer of valves, measurement and control systems as well as plastic system solutions for medical technology. GEMÜ employs over 2500 people worldwide. With six production companies and 27 subsidiaries as well as a dense network of trading partners, GEMÜ is now active in more than 50 countries on all continents. GEMÜ is the world market leader in solutions for sterile processes.

www.gemu-group.com

Plastics engineering
GEMÜ deals with its customers' wishes regarding injection molded parts in medical technology as early as possible in order to provide optimum support for product development in all areas. GEMÜ offers the necessary expertise from a single source: from concept design to toolmaking, material consulting and regulatory support. Simulations, rapid prototyping and pre-series samples support the development - for a seamless transition to series production.

Range of cleanroom services
GEMÜ uses modern technologies for sought-after complete medical technology solutions. In addition to our core competence in plastic injection molding, we integrate laser welding or ultrasonic welding, printing technologies and assembly stations for tested and packaged system solutions. We implement our customers' sterilization processes with the same holistic approach. We have the expertise to control, integrate and implement all associated processes.

Clean room capacity
Our production areas meet the highest clean room standards (ISO 6 to 9). They allow the processing of various part sizes and specific materials. ISO 13485-certified cleanroom production is carried out using partially or fully automated injection molding machines (35 to 450 t clamping force). Thanks to our plastic injection molding expertise, we are able to meet every customer requirement in cleanroom medical technology - right up to the assembly of complete system solutions.

Toolmaking
Our in-house toolmaking department enables short response times. We develop, design and build tools in-house or together with long-standing partners who can draw on specific expertise in medical technology. In addition, we ensure tool maintenance as well as desired modifications.

Ready to Sterilize (RTS) – Ready to Use (RTU)

Our modern cleanroom concept in combination with our certification (ISO 13485) enables us to manufacture

- sterilizable (RTS) medical devices
- ready-to-use (RTU) medical devices

In accordance with customer requirements, we develop a concept that fully meets their specifications and expectations.

Logistics
In cooperation with our customers, we develop specifically defined packaging and logistics concepts. GEMÜ offers individually adaptable logistics solutions tailored to their needs.

Regulatory affairs
GEMÜ supports its customers with regard to national and international regulatory requirements right from the development phase. Our own Regulatory Affairs department guarantees that your products comply with current regulatory requirements at all times.

You can find more information at gemue-medical.com

Luer Vial by GEMÜ - simpler, more versatile, more economical

Luer Vial by GEMÜ with comprehensive benefits
GEMÜ has developed the Luer Vial as a highly beneficial, modular packaging and application system. It allows the administration of active ingredients with a longer shelf life at lower process costs in the simplest possible way. The standardized, aseptically fillable Luer vial container optimizes shelf life. The application-specific variable applicator increases safety and user-friendliness. And the one-handed operation enables precise administration. Thanks to the adaptability of the spray head, the device can administer active ingredients orally/mucosally and intranasally. It is also possible to use the Luer vial for topical applications (e.g. as a tissue adhesive). In addition, the standard Luer connection makes it possible to deliver active ingredients into bags via standard connectors and valves.

Vials made from perfectly suitable materials
The active ingredient containers (vials) are made of COC polymer. Tests in the "extractables and leachables" area showed excellent results: the high-performance COC plastic used has outstanding barrier properties. The vials are comparable to primary packaging made of glass - with the advantage that COC is practically unbreakable. If required, the material can be sterilized using various methods (EtO and gamma). COC polymers are often used in medical technology, for example for syringes, microplates or vials and containers. The Luer Vial by GEMÜ has a capacity of 0.2 - 0.6 ml. The standardized and GMP-compliant filling and sealing process is carried out by existing partners. Hermetic sealing is achieved using a film with different layers of COC and aluminum.

Body and spray head made from proven plastics
GEMÜ manufactures the Luer vial body and the standard spray head from polypropylene (PP) and polyethylene (PE). Due to the very short contact time of the active pharmaceutical ingredients during application, residues within the system are harmless or non-existent. GEMÜ selected the PP/PE materials due to their excellent processability. At the same time, we opted for a raw material that is used as standard in medical technology and in the administration of active ingredients, such as syringes, catheters and blood collection systems. The polymers can be sterilized up to 25 kGy.

You can find more information about the Luer Vial here: Luer Vial by GEMÜ