INDUSTRY COMPONENT

Silicone Plunger Tip

Medical-grade silicone plunger tip for precise fluid delivery in syringes

Component Specifications

Definition
A precision-engineered silicone component that forms the sealing interface between the plunger rod and syringe barrel in medical-grade polypropylene syringes. It ensures leak-proof operation, smooth movement, and accurate dosage delivery while maintaining biocompatibility with pharmaceutical formulations.
Working Principle
Creates a dynamic seal through elastic deformation against the syringe barrel's inner wall, allowing controlled fluid displacement while preventing backflow or leakage during injection or aspiration operations.
Materials
Medical-grade silicone (typically platinum-cured LSR) with hardness 40-60 Shore A, USP Class VI compliant, free from latex and animal-derived ingredients
Technical Parameters
ParameterTypical rangeNotes & selection driver
Hardness50±5 Shore A
Bioburden≤ 100 CFU/g
Tear Strength≥ 30 N/mm
Surface FinishRa ≤ 0.8 μm
Compression Set≤ 10%
Extraction Limits≤ 0.5%
Diameter Tolerance±0.05 mm

Ranges are indicative industry figures for RFQ preparation, not a supplier commitment. Confirm every value and standard with the legal manufacturer before ordering.

Standards
ISO 7886-1, ISO 10993, USP <381>, DIN 13097

Parent Products

This component is used in the following industrial products

Engineering Analysis

Risks & Mitigation
  • Material degradation from incompatible medications
  • Seal failure due to dimensional inaccuracies
  • Particulate generation from surface wear
  • Extractable/leachable contamination
  • Sterilization method incompatibility
FMEA Triads
Trigger: Material formulation deviation
Failure: Reduced elasticity leading to seal leakage
Mitigation: Implement raw material certification and batch testing per ISO 10993
Trigger: Manufacturing dimensional variation
Failure: Increased friction or fluid bypass
Mitigation: Statistical process control with Cpk ≥ 1.33 for critical dimensions
Trigger: Incompatible sterilization method
Failure: Material degradation and performance loss
Mitigation: Validate sterilization protocols (ETO, gamma, autoclave) for each material lot

Industrial Ecosystem

Compatible With

Typical Suppliers & Equivalents

Compliance & Inspection

Tolerance
Dimensional tolerances per ISO 11040-4, extractables per USP <1663>, biocompatibility per ISO 10993 series
Test Method
Dimensional verification via optical comparators, seal integrity testing per ASTM F2391, compression set per ASTM D395, extractables analysis via HPLC/GC-MS

Procurement Evaluation Criteria

A practical evidence checklist for RFQ preparation and supplier evaluation.

Technical documentation
Request current drawings, revision history, and a signed specification sheet.
Manufacturing capability
Verify equipment lists, process limits, capacity, and representative production evidence.
Inspection readiness
Confirm test methods, calibrated equipment, sampling plans, and traceable reports.
Supplier transparency
Check the legal entity, factory address, ownership, certifications, and direct contacts.

CNFX does not score or rank suppliers. Buyers must verify all claims and documents with the legal manufacturer before ordering.

Manufacturers of Silicone Plunger Tip

Manufacturer profiles associated with Silicone Plunger Tip.

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Frequently Asked Questions

Why is medical-grade silicone preferred for plunger tips?

Medical-grade silicone offers superior biocompatibility, chemical resistance to pharmaceuticals, consistent elasticity for reliable sealing, and meets stringent regulatory requirements for patient safety.

How does plunger tip design affect syringe performance?

Optimal tip design minimizes friction for smooth operation, maintains seal integrity across temperature variations, prevents medication adherence, and ensures accurate dosage delivery throughout the syringe's operational life.

Data Basis

Editorial classification, named public sources where available, and source-reviewed manufacturer records. See the editorial policy.

Preliminary Technical Classification
This page supports structured research, RFQ preparation, and supplier evaluation. It does not replace buyer-led supplier qualification, standards review, or technical approval.

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