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Rubber Stopper Component – Rubber and Plastic Product Manufacturing

Component Specifications

Definition

A rubber stopper is a critical elastomeric closure component used in pharmaceutical vials to maintain sterility, prevent contamination, and ensure product integrity during storage and transportation. It forms a hermetic seal when compressed between the vial neck and aluminum crimp cap, protecting sensitive liquid or lyophilized drugs from environmental factors while allowing sterile needle penetration for administration.

Working Principle

The rubber stopper functions through elastic deformation and compression sealing. When inserted into the vial neck and secured with an aluminum crimp, it creates a tight barrier that prevents microbial ingress, maintains vacuum or inert gas headspace, and allows multiple punctures while resealing automatically due to its elastic memory properties.

Materials

Pharmaceutical-grade elastomers: Bromobutyl rubber (most common for chemical resistance), Chlorobutyl rubber (enhanced moisture barrier), Synthetic polyisoprene (high purity), Silicone rubber (for lyophilized products). All materials must meet USP Class VI and EP 3.1.9 standards for biocompatibility.

Technical Parameters

Diameter 13-32 mm (standard vial sizes)
Durometer 40-50 Shore A
Thickness 2.5-4.0 mm
Extractables < 5 μg/mL per USP <1663>
Sterilization Gamma irradiation (25-40 kGy) or autoclaving
Coring Resistance ≤ Category 2 per ISO 8871
Self-Sealing Capability ≥ 20 punctures with 16G needle

Standards

ISO 8871, ISO 8362, USP <381>, EP 3.2.9, FDA 21 CFR 211

Industry Taxonomies & Aliases

Commonly used trade names and technical identifiers for Rubber Stopper.

Parent Products

This component is used in the following industrial products

Pharmaceutical Vials

Sterile glass or plastic containers designed for storing and dispensing pharmaceutical products, vaccines, and injectable medications.

View Product Details

Engineering Analysis

Risks & Mitigation

Extractable/leachable contamination
Coring during needle insertion
Incomplete seal leading to sterility breach
Material-drug incompatibility
Particulate generation

FMEA Triads

Trigger: Inadequate compression during crimping
Failure: Leakage and loss of sterility
Mitigation: Implement torque-controlled crimping machines with regular calibration and visual inspection systems

Trigger: Material degradation from drug interaction
Failure: Extractable contamination and product recall
Mitigation: Conduct comprehensive compatibility studies per USP <1664> and maintain material certificates

Industrial Ecosystem

Compatible With

Interchangeable Parts

Compliance & Inspection

Tolerance

±0.2 mm diameter, ±0.1 mm thickness per ISO 8362

Test Method

USP <381> elastomeric closures, ISO 8871 extractables, ASTM D3577 compression set

Procurement Evaluation Criteria

Not customer reviews or live demand data. These dimensions support RFQ preparation and supplier evaluation.

Technical documentation

4/5

Manufacturing capability

4/5

Inspection readiness

5/5

Supplier transparency

3/5

These scores are example evaluation dimensions, not real customer ratings, country-specific buyer feedback, or live inquiry activity.

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Frequently Asked Questions

What is the difference between bromobutyl and chlorobutyl rubber stoppers?

Bromobutyl offers superior chemical resistance against aggressive drug formulations, while chlorobutyl provides better moisture barrier properties for hygroscopic products. Selection depends on drug compatibility testing.

How many times can a rubber stopper be punctured before leaking?

High-quality stoppers withstand 20+ punctures with 16G needles while maintaining seal integrity, though single-use is recommended for sterility. ISO 8871 defines coring resistance categories.

Can I contact factories directly?

Yes, each factory profile provides direct contact information.

Data Basis

CNFX manufacturer profiles, technical classification, publicly available product information, and ongoing plausibility checks.

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.

Rubber Stopper