13mm & 20mm Butyl Rubber Stopper with Self-Healing Injection Port – Medical-Grade Solid Seal for Glass Vials
Premium Self-Healing Rubber Stopper with Dual-Lip Design – Ideal for Injectables, Vaccines, and Biologics in Type I Borosilicate Glass Vials
The 13mm and 20mm Butyl Rubber Stopper with Self-Healing Injection Port from PharGlass is engineered to deliver superior seal integrity, low extractables, and reliable resealing performance after needle penetration. Designed specifically for use in pharmaceutical glass vials, this medical-grade rubber closure features a dual-lip (U-shaped) structure that ensures tight sealing against moisture, oxygen, and microbial ingress — making it ideal for sterile injectable drugs, mRNA vaccines, and lyophilized biologics.
This solid seal stopper is widely used in multi-dose vials where repeated access via syringe is required. Its self-healing property allows the rubber to close automatically after needle withdrawal, minimizing product leakage and contamination risk — a critical feature supported by USP <661> et EP 3.1.9 standards.
Manufactured under ISO 9001:2015 et GMP-compliant conditions in Henan, China, every stopper undergoes rigorous quality control, including extractables testing, visual inspection, and bioburden analysis, ensuring full compliance with global pharmaceutical regulations.
✅ Key Features:
| Feature | Description |
|---|---|
| Matériau | Medical-grade Butyl Rubber, Bromobutyl, or Chlorobutyl (optional) |
| Design Type | Dual-lip / U-shaped injection port – enhances puncture resistance and self-sealing |
| Self-Healing Technology | Automatically reseals after needle removal; prevents leakage |
| Low Extractables | Minimizes leachables that could affect drug stability or safety |
| Moisture Barrier | Excellent protection against humidity ingress |
| Customizable Sizes | Available in 13mm, 20mm, 26mm, 28mm, 32mm |
| Options de couleur | Gray, Red, or Customer Request |
| Support OEM/ODM | Yes – custom size, color, logo printing, surface treatment |
| Free Sample Policy | Free samples available for compatibility testing |
Technical Specifications: 13mm & 20mm Self-Healing Rubber Stopper
| Parameter | Spécifications |
|---|---|
| Nom du produit | 13mm 20mm Butyl Rubber Stopper with Self-Healing Injection Port |
| Numéro de modèle | 03 |
| Nom de la marque | PharGlass |
| Matériau | Butyl Rubber, Bromobutyl Rubber, Chlorobutyl Rubber |
| Color | Gray, Red, or Custom |
| Sizes Available | 13mm, 20mm, 26mm, 28mm, 32mm |
| Lieu d'origine | Henan, Chine |
| Utilisation | Primary closure for glass vials (injectables, vaccines, biologics) |
| Processing Service | Precision compression molding |
| Packaging | Plastic Bag + Export Carton |
| MOQ | 10,000 pcs |
| Sample Availability | Free Samples |
| Support OEM/ODM | Acceptable |
| Feature | Medical Grade, Self-Healing, Solid Seal, Low Extractables |
| Single Package Size | 10×20×15 cm |
| Gross Weight | 1.000 kg per unit |
| Certifications | ISO 9001:2015, ISO 14001, OHSAS 18001 |
| Regulatory Compliance | USP <661>, EP 3.1.9, JP XVII, FDA 21 CFR 177.1520 |
Why This Design Matters: The Science Behind the Dual-Lip Structure
The U-shaped (or dual-lip) design of this rubber stopper is not just aesthetic — it’s a functional innovation that improves performance in several key areas:
🔹 Enhanced Puncture Resistance: The two raised lips distribute needle pressure evenly, reducing deformation and improving durability during multiple withdrawals.
🔹 Improved Re-Sealability: After needle withdrawal, the elastic rubber returns to its original shape, forming a tight seal without gaps.
🔹 Reduced Risk of Product Loss: Critical for high-cost biologics et vaccines, where even minor leakage can lead to waste or contamination.
According to a study published in Journal of Pharmaceutical Sciences (2021), U-shaped stoppers reduce leakage rates by up to 40% compared to flat-faced designs in multi-dose applications.
Material Comparison: Which Rubber Is Right for Your Formulation?
| Rubber Type | Best For | Key Advantages |
|---|---|---|
| Butyl Rubber | General injectables, liquid formulations | Cost-effective, good elasticity, low gas permeability |
| Bromobutyl Rubber | Vaccines, biologics, multi-dose vials | Enhanced chemical resistance, better adhesion to aluminum seals |
| Chlorobutyl Rubber | Lyophilized (freeze-dried) products | Superior moisture barrier, lowest extractables profile |
Note: For freeze-dried (lyophilized) products, we recommend chlorobutyl rubber due to its excellent moisture barrier properties et low extractables, as confirmed by studies in European Journal of Pharmaceutics.
Top Applications in Pharma & Biotech
- 💉 Sterile Injectable Medications (e.g., insulin, antibiotics)
- 🧬 Monoclonal Antibodies (mAbs) et Cell & Gene Therapies
- 💉 mRNA & Viral Vector Vaccines (requires ultra-low leachables)
- ❄️ Lyophilized Powders (requires high moisture barrier)
- 🧪 Clinical Trial Packaging & Reference Standards
Why Global Pharma Brands Choose PharGlass
As a leading OEM supplier of pharmaceutical closures, PharGlass provides end-to-end support including:
- Full Drug Master File (DMF) documentation
- Extractables & Leachables (E&L) study support
- COA, TDS, and batch traceability
- Custom tooling for unique geometries
- Fast prototyping (samples in 3–5 days)
- Global shipping with DDP/DAP options
All products are manufactured in a cleanroom environment and can be supplied pre-sterilized (gamma or autoclave).
📞 Request a Quote or Free Sample Today!
Email us at sales@pharglass.com or visit https://www.pharglass.com to explore our full range of pharmaceutical rubber stoppers, glass vials, and custom packaging solutions.
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