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Medical Molding

Medical Molding

From concept to prototypes to high volume manufacturing, Saint-Gobain is your trusted partner in producing custom molded medical device components.You will be paired with a dedicated applications engineer whom will provide feedback for design for manufacturability.We also provide a robust manufacturing plan including automation, full validation services, as well as regulatory expertise and advice to ensure you receive the quality medical device component you need.Our molding operations utilize ISO 7 and ISO 8 clean rooms (at rest) as well as use ISO 9001 and ISO 13485 certified quality systems.Contact us today to start your product realization journey.

Molding Capabilities:

  • Manufacturing and packaging in ISO 7 and ISO 8 clean rooms at rest. Device establishments registered according to FDA 21 CFR 807Quality Managements Systems compliant with FDA 21 CFR 820
  • In-house tool manufacturing and maintenance
  • Full IQ/OQ/PQ validation services
  • Fully automated manufacturing
  • High-speed robotics
  • Automated material handling systems
  • Dedicated applications engineer for each project
  • Dedicated manufacturing engineers each project
  • Utilize World Class Manufacturing methodologies (i.e. Six Sigma, LEAN, Kaizen, 5S)
  • Full range of value-added secondary services
  • Conventional, insert, and two-shot medical molding
  • Silicone, thermoplastic and thermoplastic elastomer molding
Silicone/LSR/Liquid Injection (LIM) Molding

Liquid silicone rubber (LSR) molding offers an efficient, cost-effective method for producing a higher volume of parts with faster cycle times.

Not sure if you should specify an LSR or an HCR silicone material?  Give Saint-Gobain a call! We can discuss your application, the functionality of the part, sterilization requirements and other details to give you advice on the best material for your custom molded medical component.

HCR/Transfer/Compression Molding

High consistency rubber (HCR) molding is an older technology but well suited for larger components, lower volumes and parts that demand certain material properties.

Overmolding/Insert Molding

Overmolding allows for two components of varying materials or durometers to be combined into a single component.Saint-Gobain is here to help with design tips for a mechanical bond as well as suggestions to help with a chemical bond, if necessary.

Silicone Micromolding

Our silicone micromolding capability allows us to create micro-sized parts with complex geometries and extremely tight tolerances. 

Two-Shot/2K/Multi-Shot Molding

With two-shot molding, Saint-Gobain combines what could be considered two parts into one part, in one press, in a single process.The parts are fully covalently bonded and ready for assembly straight out of the press.This process drives an excellent bond and removes variability inherent in an overmolding operation.This process can involve silicone-silicone molding or silicone-thermoplastic molding.

What’s the catch? Tooling for this process is a significant investment.Give us a call and we can help you with the analysis to see if two-shot or overmolding is the best process for your project and your budget.

Thermoplastic Injection Molding

From engineered polymers such as polycarbonate to high temperature polymers such as PEEK and PTFE,Saint-Gobain offers tight tolerance,high precision medical thermoplastic injection molding.

Prototyping

From quick 3D printed parts to parts made from single cavity steel tools,Saint-Gobain offers prototyping that fits your needs.While various prototype trails help you with fit, form and function, we are able to learn the best fill locations, gating methods, and more.It is a win-win and sets up both parties for success going into production.

About Saint-Gobain

Saint-Gobain designs, manufactures and distributes materials and solutions which are key ingredients in the wellbeing of each of us and the future of all. They can be found everywhere in our living places and our daily life: in buildings, transportation, infrastructure and in so many industrial applications.

 

Saint-Gobain Performance Plastics' group of businesses gather solutions to save energy, provide protection, improve comfort and sustain the environment for a variety of markets.

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Saint-Gobain’s medical products are distributed exclusively to medical device manufacturers for use in the manufacture, assembly or distribution of their medical devices. Saint-Gobain cannot authorize the sale of its medical products directly to device user facilities (e.g. hospitals, surgery centers, nursing home, clinics, etc.), nor directly to end users (e.g. patients, patients’ caregiver, prescribing physician, nurse, pharmacist, etc.), including distributors serving device user facilities and end users directly. In accordance with every jurisdiction globally, Saint-Gobain’s customers are responsible for determining that any medical device they manufacture and market that incorporates a Saint-Gobain’s medical product, is compliant with each country-specific medical device regulations and has received proper country-specific clearance, certification or registration authorizing the sale of this medical device.


Saint-Gobain’s medical products offer covers:
- Medical Components [21 CFR 820.3(c)], intended for processing or use in the manufacture or assembly of medical devices before the finished medical device is packaged/labeled; Medical Components are intended to be included as part of the finished, packaged, and labeled device [21CFR820.3(c)].
- Finished Devices [21CFR820.3(l)] made on behalf of medical device manufacturers [21 CFR 807.20(a)(2)] under contract-manufacturing agreement. In accordance with the United States’ jurisdiction, Saint-Gobain complies with the FDA’s requirements for contract manufacturers of finished devices.

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