OEM Medical Silicone Seals & Gaskets | SynchroTech
Low Compression Set USP Class VI Material Class 100,000 Cleanroom Molding

OEM Medical Silicone Seals & Gaskets

Precision components engineered for water, dust, and fluid sealing in medical devices. Ensuring absolute reliability under repeated sterilization and long-term compression. Supplied non-sterile for further manufacturing.

Small seals are the bottom line for device safety. We understand material formulations, and your assembly tolerances.

Product Architecture

Comprehensive range including standard O-rings, flat gaskets, puncture self-sealing septa, and custom molded seals. Detailed dimensions and material reports are in the technical datasheet.

TypeDimension RangeMaterial / Feature
O-Rings (AS568 / Metric)ID 1~50mm × CS 1.0~3.0mmVMQ 50/70A (USP VI) / Water & Dust proof
Flat Gaskets (Die-cut/Molded)Custom (Thickness 0.5~3mm)VMQ 50~70A / Cushioning & Flange sealing
ApplicationDimensionsMaterial / Feature
IV Bags / Heparin CapsØ8~20mm (Custom to port)Silicone / Polyisoprene / Butyl (High-rebound)
Structure TypeTarget DeviceMaterial / Process
Cushion/Handle Seal SetsAnesthesia Mask / Phaco HandpieceLSR / VMQ 30~80A (Autoclavable)
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Technical Datasheet

Get the complete specification list, including dimensional drawings, durometer tolerances, and biocompatibility reports.

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Engineered for Critical Assembly & Clinical Requirements

Seal failures often occur in microns unseen by the naked eye. We design these risks out before they reach your production line.

Phaco Handpieces & Surgical Instruments

⚠️ Key Application Requirements:

Handpieces undergo thousands of autoclave cycles. Seals must not harden or become brittle due to thermal aging, which would allow irrigation fluid to seep in and destroy the expensive internal transducer.

🛡️ How Our Components Support You:

We supply high-temperature resistant VMQ. Our optimized cross-linking formulation ensures an extremely low compression set, maintaining softness and high resilience for long-lasting dynamic sealing after repeated 134°C sterilization.

IV Bags & Indwelling Needle Heparin Caps

⚠️ Key Application Requirements:

Nurses repeatedly puncture the same injection port with steel needles. The septum must absolutely not generate "coring" (particulate shedding), which could enter the fluid and cause severe medical accidents. It must also self-seal instantly upon withdrawal.

🛡️ How Our Components Support You:

Our puncture self-sealing septa use high tear-strength medical silicone or polyisoprene. Strict mold polishing and vulcanization processes ensure a flawless puncture surface, achieving zero coring and zero leakage after tens of thousands of punctures.

Monitor, Infusion Pump & IVD Device Housings

⚠️ Key Application Requirements:

Devices in hospital environments are frequently wiped with alcohol and disinfectants. Seals must not swell or deform upon contact with alcohol, and must not tear when over-compressed by tightened screws.

🛡️ How Our Components Support You:

We offer chemical-resistant flat gaskets and custom seals. By adjusting formulations, we enhance solvent resistance. We also provide ultra-high tear strength LSR materials to prevent rupture under extreme deformation during screw locking.

Common Pitfalls & Our Engineering Solutions

Seal issues usually don't explode on the production line immediately; they manifest months later in the field. We prevent these risks through process control.

⚠️ Leakage After Autoclaving (Compression Set)

The Challenge: Inferior silicone raw materials or insufficient vulcanization cause O-rings to fail to rebound to their original dimensions after prolonged compression and high-temperature steam sterilization, creating gaps and leaks.
Our Engineering Solution

We strictly select medical-grade precipitated or fumed silicone and execute post-curing processes. This completely eliminates volatiles, ensuring compression set far below industry standards (ASTM D395).

⚠️ Coring Leading to Particulate Contamination

The Challenge: Insufficient tear strength of the septum, or microscopic scratches and burrs on the mold surface, can cause a small piece of silicone to be cut off during needle puncture and fall into the IV bag.
Our Engineering Solution

We utilize high tear resistance formulations. For septum molds, we enforce mirror-grade polishing (SPI A-1) to ensure no microscopic burrs on the puncture surface, minimizing puncture resistance and coring risks.

⚠️ O-Ring Cut or Twisted During Assembly

The Challenge: During automated or manual assembly stretching, if the O-ring's surface friction is too high or its durometer too hard, it is highly prone to being cut on the groove edge, leaving a hidden leakage risk.
Our Engineering Solution

We can provide surface micro-coatings (e.g., silicone oil) to reduce assembly friction. We strictly control the O-ring cross-section (CS) tolerance to ensure it seats perfectly into your groove under 10%~20% stretch without damage.

Your OEM Component & Quality Partner

We bridge the gap between your assembly line and the strict compliance requirements of the medical device industry.

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Deep Mfg. Experience

Managed by a team with frontline medical device production backgrounds. We understand your assembly constraints and tolerance requirements.

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Traceability & Control

Strict batch record management and change control protocols. We prevent unauthorized material substitutions and ensure full traceability.

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Lab & Audit Ready

Backed by professionals with third-party lab management experience. We know exactly how to prepare documentation for ISO 13485 and USP Class VI audits.

Compliance Note: All components are supplied non-sterile, for further manufacturing use. We act as your OEM component partner.

Need Custom Tooling or Special Materials?

If standard seals cannot meet your groove design or chemical resistance requirements, send us your 2D/3D drawings. Our engineering team will evaluate custom formulations for you.

  • Custom molded seal tooling
  • High-temp / Solvent-resistant formulations
  • Surface coating / Cleanroom washing services
📎 Upload your 2D/3D Drawing (STEP, PDF, DWG)