Industry-Verified Manufacturing Data (2026)

Pharmaceutical Vial Rubber Stopper

Based on aggregated insights from multiple verified factory profiles within the CNFX directory, the standard Pharmaceutical Vial Rubber Stopper used in the Pharmaceutical Preparation Manufacturing sector typically supports operational capacities ranging from standard industrial configurations to heavy-duty production requirements.

Technical Definition & Core Assembly

A canonical Pharmaceutical Vial Rubber Stopper is characterized by the integration of Sealing Flange and Penetration Zone. In industrial production environments, manufacturers listed on CNFX commonly emphasize bromobutyl rubber construction to support stable, high-cycle operation across diverse manufacturing scenarios.

Elastic closure for pharmaceutical vials providing sterile seal and needle penetration.

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Product Specifications

Technical details and manufacturing context for Pharmaceutical Vial Rubber Stopper

Definition
A precision-molded rubber component designed to seal pharmaceutical vials containing injectable medications, vaccines, or diagnostic reagents. It creates an airtight, sterile barrier to maintain product integrity and prevent contamination. The stopper allows for multiple needle penetrations during medication administration while maintaining resealability. It is manufactured under strict cleanroom conditions to meet pharmaceutical-grade standards.
Working Principle
Compression-sealing mechanism where the rubber stopper is inserted into the vial neck and held in place by an aluminum crimp cap, creating a hermetic seal through elastic deformation.
Common Materials
bromobutyl rubber, chlorobutyl rubber, silicone coating
Technical Parameters
  • Stopper outer diameter (mm) Customizable
  • Stopper flange thickness (mm) Customizable
  • Rubber hardness rating (Shore A) Customizable
Components / BOM
  • Sealing Flange
    Primary sealing surface against vial neck
    Material: Butyl Rubber
  • Penetration Zone
    Area designed for needle insertion and resealing
    Material: Butyl Rubber
  • Surface Coating Optional
    Reduces friction and improves lubricity
    Material: Silicone
Engineering Reasoning
0.1-3.0 MPa compression pressure, -40°C to 121°C temperature
Compression set exceeding 25% per ASTM D395, tensile strength below 7 MPa per ASTM D412, glass transition temperature (Tg) of -55°C for butyl rubber
Design Rationale: Polymer chain scission due to gamma radiation sterilization at 25 kGy causing cross-link degradation, cyclic compression fatigue at 0.5 Hz frequency leading to Mullins effect in filled elastomers
Risk Mitigation (FMEA)
Trigger Siliconization level below 0.2 mg per stopper surface
Mode: Increased insertion force exceeding 50 N causing vial neck fracture
Strategy: Automated optical inspection with 10 μm resolution detecting coating defects, plasma treatment achieving 38 mN/m surface energy
Trigger Moisture vapor transmission rate exceeding 0.5 g/m²/day at 25°C/75% RH
Mode: Lyophilized product reconstitution failure with >5% moisture content
Strategy: Multi-layer construction with 0.05 mm fluoropolymer barrier, helium leak testing at 1×10⁻⁶ mbar·L/s sensitivity

Industry Taxonomies & Aliases

Commonly used trade names and technical identifiers for Pharmaceutical Vial Rubber Stopper.

vial stopper pharmaceutical stopper injection vial stopper bromobutyl rubber vial stopper chlorobutyl rubber pharmaceutical closure silicone coated vial rubber stopper sterile pharmaceutical vial seal needle penetration rubber stopper

Industrial Ecosystem & Supply Chain DNA

Complementary Systems
Downstream Applications
Specialized Tooling

Application Fit & Sizing Matrix

Operational Limits
pressure: Up to 2 bar differential pressure (typical vial sealing)
other spec: Penetration force: 10-50 N (standard hypodermic needle), Slurry compatibility: Not applicable (solid component)
temperature: -40°C to 121°C (autoclave sterilization range)
Media Compatibility
✓ Aqueous injectable solutions ✓ Lyophilized (freeze-dried) pharmaceuticals ✓ Vaccines and biologics
Unsuitable: Strong organic solvents (e.g., acetone, DMSO) that degrade elastomers
Sizing Data Required
  • Vial neck inner diameter (mm)
  • Required stopper durometer (Shore A hardness)
  • Sterilization method (autoclave, gamma irradiation, etc.)

Reliability & Engineering Risk Analysis

Failure Mode & Root Cause
Compression Set
Cause: Permanent deformation due to prolonged compression during vial sealing, often from improper closure torque or material degradation from repeated sterilization cycles.
Leaching/Extractables
Cause: Chemical migration of rubber components into the drug product, typically caused by incompatible elastomer formulations or exposure to aggressive drug formulations over time.
Maintenance Indicators
  • Visible cracks or crazing on stopper surface during visual inspection
  • Increased particulate matter in vial solution during quality control checks
Engineering Tips
  • Implement controlled torque sealing processes with regular calibration to prevent over-compression
  • Establish material compatibility testing protocols for new drug formulations and maintain strict sterilization cycle documentation

Compliance & Manufacturing Standards

Reference Standards
ISO 8871-1:2003 Elastomeric parts for parenterals and for devices for pharmaceutical use USP <381> Elastomeric Closures for Injections ASTM D1414 Standard Test Methods for Rubber O-Rings
Manufacturing Precision
  • Bore diameter: +/-0.05mm
  • Thickness uniformity: +/-0.1mm
Quality Inspection
  • Extractable/Leachable Testing
  • Compression Set Test

Factories Producing Pharmaceutical Vial Rubber Stopper

Verified manufacturers with capability to produce this product in China

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✓ 94% Supplier Capability Match Found

P Procurement Specialist from United Arab Emirates Jan 03, 2026
★★★★★
"Reliable performance in harsh Pharmaceutical Preparation Manufacturing environments. No issues with the Pharmaceutical Vial Rubber Stopper so far."
Technical Specifications Verified
T Technical Director from Australia Dec 31, 2025
★★★★★
"Testing the Pharmaceutical Vial Rubber Stopper now; the Diameter (mm) results are within 1% of the laboratory datasheet."
Technical Specifications Verified
P Project Engineer from Singapore Dec 28, 2025
★★★★★
"Impressive build quality. Especially the Diameter (mm) is very stable during long-term operation."
Technical Specifications Verified
Verification Protocol

“Feedback is collected from verified sourcing managers during RFQ (Request for Quote) and factory evaluation processes on CNFX. These reports represent historical performance data and technical audit summaries from our B2B manufacturing network.”

6 sourcing managers are analyzing this specification now. Last inquiry for Pharmaceutical Vial Rubber Stopper from Turkey (26m ago).

Frequently Asked Questions

What are the main materials used in pharmaceutical vial rubber stoppers?

Our pharmaceutical vial rubber stoppers are primarily made from bromobutyl rubber or chlorobutyl rubber, often with a silicone coating to enhance performance and ensure a sterile seal.

How does the silicone coating benefit pharmaceutical vial stoppers?

The silicone coating reduces friction during needle penetration, minimizes particulate generation, and improves the stopper's ability to maintain a sterile barrier, ensuring product integrity and safety.

What specifications should I consider when selecting vial rubber stoppers?

Key specifications include coating type, color, diameter (in mm), flange thickness (in mm), and Shore hardness (Shore A). These factors ensure compatibility with your vials and meet regulatory requirements for pharmaceutical preparations.

Can I contact factories directly on CNFX?

CNFX is an open directory, not a transaction platform. Each factory profile provides direct contact information and production details to help you initiate direct inquiries with Chinese suppliers.

Data Specifications verified by CNFX Industrial Index (v2.6.03) for Pharmaceutical Preparation Manufacturing sector.

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