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
En 13mm and 20mm Butyl Rubber Stopper with Self-Healing Injection Port from PharGlass is engineered to deliver superior seal integrity, low extractables, y 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, y 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 y EP 3.1.9 normas.
Manufactured under ISO 9001:2015 y GMP-compliant conditions in Henan, China, every stopper undergoes rigorous quality control, including extractables testing, visual inspection, y bioburden analysis, ensuring full compliance with global pharmaceutical regulations.
✅ Características principales:
| Característica | Descripción |
|---|---|
| Material | Calidad médica Caucho butílico, Bromobutyl, o 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 |
| Extraíbles bajos | Minimizes leachables that could affect drug stability or safety |
| Barrera antihumedad | Excelente protección contra la entrada de humedad |
| Tamaños personalizables | Disponible en 13mm, 20mm, 26mm, 28mm, 32mm |
| Opciones de color | Gray, Red, or Customer Request |
| Asistencia OEM/ODM | Yes – custom size, color, logo printing, surface treatment |
| Política de muestras gratuitas | Free samples available for compatibility testing |
Technical Specifications: 13mm & 20mm Self-Healing Rubber Stopper
| Parámetro | Especificación |
|---|---|
| Nombre del producto | 13mm 20mm Butyl Rubber Stopper with Self-Healing Injection Port |
| Número de modelo | 03 |
| Marca | PharGlass |
| Material | Caucho butílico, Bromobutyl Rubber, Chlorobutyl Rubber |
| Color | Gray, Red, or Custom |
| Sizes Available | 13 mm, 20 mm, 26mm, 28mm, 32mm |
| Lugar de origen | Henan, China |
| Utilización | Primary closure for glass vials (injectables, vaccines, biologics) |
| Processing Service | Precision compression molding |
| Packaging | Plastic Bag + Export Carton |
| MOQ | 10.000 unidades |
| Disponibilidad de muestras | Free Samples |
| Asistencia OEM/ODM | Aceptable |
| Característica | Medical Grade, Self-Healing, Solid Seal, Extraíbles bajos |
| Single Package Size | 10×20×15 cm |
| Peso bruto | 1.000 kg per unit |
| Certificaciones | ISO 9001:2015, ISO 14001, OHSAS 18001 |
| Regulatory Compliance | USP, EP 3.1.9, JP XVII, FDA 21 CFR 177.1520 |
Why This Design Matters: The Science Behind the Dual-Lip Structure
En 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 y vaccines, where even minor leakage can lead to waste or contamination.
According to a study published in Revista de Ciencias Farmacéuticas (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 | Lo mejor para | Principales ventajas |
|---|---|---|
| Caucho butílico | General injectables, liquid formulations | Cost-effective, good elasticity, low gas permeability |
| Bromobutyl Rubber | Vacunas, biologics, multi-dose vials | Enhanced chemical resistance, better adhesion to aluminum seals |
| Chlorobutyl Rubber | Lyophilized (freeze-dried) products | Superior moisture barrier, lowest extractables profile |
Nota: For freeze-dried (lyophilized) products, we recommend caucho clorobutílico debido a su excelentes propiedades de barrera contra la humedad y low extractables, como confirman los estudios realizados en Revista Europea de Farmacia.
Top Applications in Pharma & Biotech
- 💉 Sterile Injectable Medications (e.g., insulin, antibiotics)
- 🧬 Monoclonal Antibodies (mAbs) y 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, y 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 o visite https://www.pharglass.com to explore our full range of tapones de goma farmacéuticos, glass vials, y custom packaging solutions.
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