Editorial Technical Reference

Pharmaceutical Vial Rubber Stopper

This page explains how Pharmaceutical Vial Rubber Stopper is classified within Pharmaceutical Preparation Manufacturing. Technical values and manufacturer relationships are research references; confirm the current specification and supplier evidence for each order.

Technical Definition & Core Assembly

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. The stopper is typically made from bromobutyl or chlorobutyl rubber, often with a silicone or ETFE coating to enhance performance. Key parameters include outer diameter (13–32 mm), flange thickness (2.0–3.5 mm), Shore hardness (45–55 Shore A), and gray color. It operates over a temperature range of -40°C to 150°C, with a penetration force of 5–10 N and resealability of at least 5 punctures. Extractable metals are limited to ≤1 ppm per ISO 8871-3, and it withstands autoclave cycles at 121°C for 30 minutes. Weight varies from 1.5 to 5.0 g depending on size and formulation. The stopper complies with ISO 8362-5 for dimensions and ISO 7619-1 for hardness. Always verify model-specific values and standards with the legal manufacturer or supplier before use.
Working Principle
The stopper works by compression sealing. When inserted into the vial neck, it is held in place by an aluminum crimp cap. The elastic deformation of the rubber creates a hermetic seal, preventing gas or liquid exchange. The needle can penetrate the rubber multiple times, and the material's elasticity allows it to reseal after withdrawal, maintaining sterility. The silicone or ETFE coating reduces friction and aids in resealing. The stopper's hardness and dimensions are optimized to balance penetration force and sealing integrity.
Common Materials
bromobutyl rubber, chlorobutyl rubber, silicone coating
Technical Parameters
ParameterTypical rangeNotes & selection driver
DiameterRequired13–32 mmOuter diameter of stopperISO 8362-5
Flange ThicknessRequired2.0–3.5 mmThickness of sealing flangeISO 8362-5
Shore HardnessRequired45–55 Shore ARubber hardness measurementISO 7619-1
ColorGrayStopper color for identification
Coating TypeETFE-coatedSurface coating material
Operating Temperature-40–150 °CSterilization compatibility (autoclave, dry heat)
Penetration Force5–10 NLow enough for syringe needles, high enough for resealISO 8871-5
Resealability≥5 timesNumber of punctures without leakageISO 8871-5
Extractable Metals≤1 ppmComplies with USP <381>ISO 8871-3
Sterilization Compatibility121°C, 30 minAutoclave cycles without degradationISO 11133
Weight1.5–5.0 gDepends on size and formulation

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

Components / BOM
  • Sealing Flange
    Primary sealing surface against vial neck
    Material: Butyl Rubber
  • Penetration Zone Part
    Area designed for needle insertion and resealing
    Material: Butyl Rubber
  • Surface Coating Optional Part
    Reduces friction and improves lubricity
    Material: Silicone

Industry Taxonomies & Aliases

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

vial stopper pharmaceutical stopper injection vial stopper

Industrial Ecosystem & Supply Chain Structure

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

Indicative industry ranges for design and RFQ preparation. Confirm the exact figures and applicable standard with the manufacturer before specifying.

Compliance & Manufacturing Standards

Applicable 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

Quoted from the published standard.

Manufacturing Precision
  • Bore diameter: +/-0.05mm
  • Thickness uniformity: +/-0.1mm
Quality Inspection
  • Extractable/Leachable Testing
  • Compression Set Test

Manufacturers of Pharmaceutical Vial Rubber Stopper

Manufacturer profiles associated with Pharmaceutical Vial Rubber Stopper.

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Frequently Asked Questions

What materials are used for this stopper?

The stopper is typically made from bromobutyl or chlorobutyl rubber, with optional silicone or ETFE coating. These materials provide elasticity and chemical resistance.

What are the key dimensions?

Outer diameter ranges from 13 to 32 mm, and flange thickness from 2.0 to 3.5 mm, per ISO 8362-5. Always confirm exact dimensions for your vial size.

Can it withstand sterilization?

Yes, it is compatible with autoclave sterilization at 121°C for 30 minutes and can operate from -40°C to 150°C. Verify compatibility with your specific sterilization method.

How many times can it be punctured?

It is designed for at least 5 punctures without leakage, per ISO 8871-5. Actual performance depends on needle gauge and usage conditions.
Data basis: editorial classification, named public sources where available, and source-reviewed manufacturer records. See the editorial policy.

Data Basis

Editorial classification, named public sources where available, and source-reviewed manufacturer records.

Preliminary Technical Classification
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