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  • Capabilities
    • Assembly
    • Catheter Design
    • High Purity Specialty Closures
      • Closure Assemblies
      • Liners
    • COVID-19 Rapid Manufacturing Capabilities
    • Custom Compounding
    • Custom Filtration
    • Medical Extrusion
    • Medical Molding
    • Prototyping and Tooling
    • Product Co-Development
  • Materials
    • Fluoropolymers
      • Basics 101: Fluoropolymers
    • Other Materials
    • Silicone
      • Basics of Silicone:101
    • Thermoplastics
      • Basics 101: Thermoplastics
      • PEEK page
  • Markets
    • Cardiology
    • Diabetic Care
    • Drug Delivery
    • Nephrology
    • Ophthalmology
    • Other Medical Markets
    • Surgery
  • Resources
    • Schedule a Lunch and Learn
    • Technical Data and Literature
    • White Papers
      • Extruded Silicone Tubing with Optimized Precision for medical device manufacturers
      • Two-Shot Silicone-Thermoplastic Medical Molding
      • The Impact of Gamma and Autoclave Sterilization on Silicone Tubing
      • Low Coefficient of Friction Materials: Tygon® LCF Offers the Ideal Combination
      • Liquid Silicone Rubber Injection Molding
      • Flow Rate Stability of Medical Peristaltic Pump Tubing Materials
      • Effect of Sterilization on the Mechanical Properties
    • Quality and Regulatory
      • Medical Product Disclaimer
      • ISO Certifications
    • FAQs
    • Videos
  • About Us
    • Events
    • Blog
    • News
    • Case Study
  • Contact Us
COVID-19 Rapid Manufacturing Capabilities – LEARN MORE

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To search the Frequently Asked Questions (FAQs), enter your search terms or questions in the box below. You can also select a Product Category using the dropdown menu below. If you are unable to find the answer to your question in the FAQs, please feel free to Contact Us here

What tolerances can you hold for extrusions/tubing?

Link to Datasheet page

Can you create custom Tygon® tubing?

Yes, we can custom compound Tygon® to create specialized durometers and colors.We can also create custom printing on the tubing, including logos.

Why is tooling so expensive with a cold deck?

Typically these molds are quoted with higher run potentials and are fully automated.These tools have a higher precision to allow for minimal operator influences.The cold decks are a necessary technology in these systems to ensure part repeatability.

How quickly can you turn around prototypes?

Extrusion prototypes can often be produced in 2 weeks or less. Molded prototypes typically range from 2-4 weeks for a production quality prototype. These lead times are dependent on the part design.

In two-shot molding, what do I need to take into account for shut –offs?

Typically flat shut-offs are the cleanest, using contoured or step parting lines adds to the complexity of the tool and shut-off and are less predictable.Other considerations are the function of the part, acceptable limits from a flash spec and thickness of the substrate that we are shutting off?  

How many shots can a mold get through?

Our standard hot runner molds would produce 500K shots, anything after this the mold would be inspected to determine if the mold needs any refurbishment.The cold deck fully automated molds would be 1MM shots, anything over this would have the tool inspected for possible refurbishment.

Are you capable of thermoplastic injection molding?

Yes, we have the industry experience to support our customer’s thermoplastic injection molding needs including with a wide variety of materials including but not limited to: ABS, PC, PP, PE, PEEK, CFlex® and PTFE.

Can silicone bond to metallic and plastic substrates?

Typically silicone by itself does not effectively bond to metals and plastics. There are some self-bonding grades of silicone available that are designed to bond to specific substrates. However, a primer may need to be applied to the surface or the surface may need to be modified through the use of some other method such as plasma, corona discharge, or UV treating. Even after surface treatment, you may see varying degrees of bond strength depending on which surface treatment method you are using and what type of substrate you are bonding it to. 

Will a cut or slit part “heal” or “reknit” over time?

It varies from grade to grade of silicone; however you may see the zero-gap features in silicone begin to reknit or heal over time.Exposures to additional heat cycling, pressure, and various sterilization techniques increase the rate of reknit.There are self-healing resistant grades of material and additives available to help prevent this. However this is something that should be considered in the material selection process and evaluated in the validation portion of product development.

Can you create custom Tygon®?

Yes, we can custom compound Tygon® to create specialized durometers and colors. We can also do custom printing on the tubing, including logos.

Can you recommend a material?

Yes we can. First we need to understand what type of product you are designing, its’ functionality and life.  We have worked with many raw material manufacturers and their different grades so we are able to recommend a good fit based on our material expertise and experience.

What are the effects of sterilization on Silicone?

Please check out our white paper. Link to White paper

What options do you have for Business Continuity Planning?

We have 19 medical component manufacturing facilities around the world, many of which have overlapping capabilities which can be leveraged for validating your product/process across multiple sites.  We can also look at validating multiple presses, multiple tools, spare cavities, secondary raw materials, etc. which are all efforts to mitigate risks to manufacturing.

Do you have cleanroom manufacturing?

Yes, we have certified ISO Class 7 and 8 cleanrooms at various manufacturing locations around the world.  Our facilities operate following ISO 9001 and/or ISO 13485 as well. We can discuss your project and see which facility best meets the needs of your project.

Does Saint-Gobain provide any validation services?

Yes, we have a standard validation package which consists of an Installation Qualification, Operational Qualification and Process Qualification (sometimes referred to as IQ/OQ/ PQ or IOQ/PQ) that satisfies most medical component validation requirements. We also have the ability to add services based upon your unique validation needs, upon request.  Our dedicated applications engineering team will work with you to prepare protocols, review, update and approve to ensure all of your needs and requirements are met.

What tolerances can you hold?

This is dependent on the part itself, materials and any specific geometric dimensioning and tolerancing that need to be held.   We do have the ability to hold very tight tolerances but this is really a discussion to be had with the customer to understand their goal from a functionality stand point.

What types of value-add operations are you capable of?

We have the experience and skill level to perform value-add operations such as cutting, punching, slitting, assembly, special packaging and more to meet our customer’s needs. 

If I am not an existing customer and have never done business with Saint-Gobain, what is the policy to set up a new account?

A new customer would need to fill out a confidential credit application with bank references and submit it with their PO to our customer service team who will help complete this process. 

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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