Seals for Life Sciences and Medical Devices

Our focus is making sure your seal meets not only your performance and regulatory goal, but also keeps your product development timeline on track. Fast prototyping USP Class VI silicones, and quick iterative adjustments can be the difference between success and project delay.

Ultrasonic Cavitation

We have spent several years working with Darcoid on a full suite of components used in one of our ophthalmic surgery devices.  Darcoid has supported us with a significant number of prototypes …their technical team and program manager have kept in constant communication … We’re confident we’ve found a long-term partner

Life Sciences and Medical Devices

Urgent need?

If you’re reading this because you have a PMA stage seal performance problem please contact us now to troubleshoot and find the best solution. Quickly. We can ship prototype compression molded seals in two weeks, LSR molded parts in 4-6 weeks, and cut elastomer shapes, plastics in hours or days.  FDA and USP Class VI stock seals ship same day. 

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A seal for every medical device use case

Whether your product is a predicate improvement or a novel Class II or Class III device we can help you find the best seal or media manifold/separator design. If you are in the prototype phase we can quickly help iterate when your seal element layout needs to change. We have strong relationships with fast turn LSR molding houses and access to premium USP Class VI silicone elastomer formulations. We’ve got you covered. From well-established profiles like o-rings, x-rings, quad rings, thru lip seals, check valves and complex molded shapes. When you’re ready to ramp, our molders can scale quickly too, giving you plenty of time to validate parts from higher cavity count tooling.

Seals are important no matter the application. Putting in the wrong size and type of seal will negatively impact your application. An incorrectly sized seal will introduce a leak path, which could affect sterility of the product or waste of material if product is coming out of the application.

The wrong type of seal can also influence how robust the application is. If a product requires low press sealing, but a high-pressure seal is chosen, the seal will not be able to provide the necessary seal. This in turn would lead to a leak path and would affect the application's performance.

Seals in Medical Devices in Surgery

Seals for surgical tools and diagnostic equipment

Medical pumps, feeding devices, syringes, surgical robots

Seals prevent ingress of contaminants and/or leaking of product outside of equipment/tools
Seals could be static or dynamic, which could be friction sensitive
Seals in these devices may needing to go through cleaning/autoclave process and material should be spec’ed accordingly

iv components, implants,

Static seals – prevent ingress of contaminants into body
Biocompatibility
Non-toxic

Seals for bioprocessing and laboratory equipment

Vial seals, blood analyzers

Static seals (to my knowledge, not sure if there’s any moving parts internally)
Prevent egress of biofluids out into the environment
Possibly need to be cleaning rated for rubbing alcohol or other sanitation solution

Seals for pharmaceutical manufacturing

Chemical compatibility
Heat compatibility requirements
Cleanliness requirements
Static and/or dynamic seal dependent on equipment

life-sciences

O-rings

Material: Commonly made from silicone, EPDM, and FKM.
Usage: Used in syringes, pumps, and valves.

Gaskets

Material: Made from PTFE, silicone, and other medical-grade elastomers.
Usage: Used in medical device housings and enclosures.

Diaphragms

Material: Often constructed from medical-grade silicone and rubber.
Usage: Used in pumps and valves to control fluid flow.

Materials used for life science and medical seals

Platinum-cured silicone is the most commonly used material in life science applications. The process of making platinum-cured silicone prevents leaching and outgassing, while also staying odorless and tasteless. Silicone is also compatible with autoclave.

EPDM and NBR are good for applications that will be in a water environment.

FKM, along with EPDM and NBR, are good to be used in salt water (saline).

FKM and NBR do outgas when they degrade, while EPDM does not outgas and is resistant to degradation.

Performance and design considerations

Chemical compatibility and resistance

Seals need to be compatible with the working fluid. Otherwise, the seal material could swell or shrink, which would weaken the seal and could cause contamination of chemicals or medicine. Swelling and shrinking is one of the signs of fluid incompatibility. Fluid soak tests and heat aging are some tests that can verify chemical compatibility.

Temperature resistance and sterilization

Because sterilizing with an autoclave involves exposure to steam at 121°C and 134°C, any rubber going through this process will need to be compatible with steam at these temperature ranges. EPMD, silicone, and FFKM are some rubber families that are compatible with the autoclave sterilization process.

FFKM and silicone are the only two materials that are recommended for gamma radiation sterilization. Gamma radiation typically causes chain scission and cross-linking reaction in rubber, but silicone and FFKM are able to resist this.

Low particle generation and outgassing

Topics to cover:

Why is low particle generation and outgassing important for seals in life science and medical applications? How is this achieved and measured?
What are the potential consequences of particle contamination?

Low particle generation and outgassing could contaminate specimen or fluids that require high purity and cleanliness. Particle contamination and outgassing could affect measuring equipment due to the presence of foreign material in samples.

Curing process and post curing can reduce/eliminate these forms of contamination, along with vacuuming baking.

Quality is at the heart of the company

Quality comes first with Darcoid. Nothing moves without Quality’s approval.  Our team is driven to assure zero defects with control plans aligned to your process and quality manual  - We secured ISO 9001 registration in 2002 and we continue to innovate, most recently achieved certification to the IATF 16949:2016 standard in 2021.  We recognize specific QA and regulatory requirements for medical device industry applications including ISO 13485.    

  If you’re visiting this page because you are dealing with recurring quality escapes please contact us and book time with our QA experts..  Our QA team has developed a wealth of seal quality and specifications expertise over the years. When molded features on elastomer components are the same size as standard flash allowances you need a good understanding of process controls to assure critical dimension CpK / PpK is maintained. We know where and how escapes can happen at every step of the manufacturing process and what controls need to be in place and verified.

Seals for Medical Devices

Which is the best seal for my medical device / process type?

In new product design processes the integration of the sealing element(s) are frequently overlooked or considered an afterthought. Our technical team at Darcoid is driven to help you develop the best possible seal for your unique application.  Best success comes with close collaboration, so engage with a Darcoid applications engineer as early in your project as possible to assure your project timeline and budget stay on track.

Risk management: recognizing and preventing “Performance Creep”

A critical part of your program’s success is making sure the seal that gets assembled in your device 4 or 5 years from now performs the same as the seal you qualify for production release.  Small omissions or assumptions in your control specs can create major headaches in the future..  Darcoid Applications Engineers will teach you how to control  Seal Performance Creep so you can rest easy and focus on developing your next revolutionary medical device.

Advanced Specification Support

Medical device seals on time – wherever in the world you need it

Our fulfilment and supply chain teams’ mantra is “wherever and whenever you need it, your shipment will be there”. With inventory forward positioned in the USA, Europe and Asia we keep your lines running wherever in the world your product is assembled.  Being easy to do business with is critical and everyone in our customer experience team is motivated and empowered to align with your business model to make that happen.

Why Darcoid?

Darcoid has been in business for over 75 years and over that time we have come to recognize one simple truth: The performance of your product is directly related to the quality and reliability of the seal. With those words in mind we continue to innovate and collaborate with customers whose products change the world for the better. To deliver meaningful and measurable value to your entire organization we have built and deployed the powerful Next Level® strategy - by deliberately integrating with your teams in quality, seal technology, fulfillment services and growth strategy. True Partnership. 

We’re looking forward to earning your trust and becoming your go-to seal solutions provider.

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You need to get your best product designed, validated, specified, ramped and released. We’ve got your back, from concept through zero defect supply programs. It starts with understanding what you need the seal to do. We’re ready to get started.

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