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 в Type I Borosilicate Glass Vials
Сайт 13mm and 20mm Butyl Rubber Stopper with Self-Healing Injection Port с сайта PharGlass is engineered to deliver superior seal integrity, low extractables, и 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, и 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 и EP 3.1.9 стандарты.
Manufactured under ISO 9001:2015 и GMP-compliant conditions in Henan, China, every stopper undergoes rigorous quality control, including extractables testing, visual inspection, и bioburden analysis, ensuring full compliance with global pharmaceutical regulations.
✅ Основные характеристики:
| Характеристика | Описание |
|---|---|
| Материал | Медицинский 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 |
| Низкое содержание экстрактивных веществ | Minimizes leachables that could affect drug stability or safety |
| Moisture Barrier | Excellent protection against humidity ingress |
| Настраиваемые размеры | Доступно в 13 мм, 20 мм, 26 мм, 28 мм, 32 мм |
| Варианты цвета | Серый, красный или по желанию заказчика |
| Поддержка OEM/ODM | Yes – custom size, color, logo printing, surface treatment |
| Политика бесплатных образцов | Free samples available for compatibility testing |
Technical Specifications: 13mm & 20mm Self-Healing Rubber Stopper
| Параметр | Технические характеристики |
|---|---|
| Название продукта | 13mm 20mm Butyl Rubber Stopper with Self-Healing Injection Port |
| Номер модели | 03 |
| Название бренда | PharGlass |
| Материал | Butyl Rubber, Bromobutyl Rubber, Chlorobutyl Rubber |
| Цвет | Gray, Red, or Custom |
| Sizes Available | 13 мм, 20 мм, 26mm, 28mm, 32mm |
| Место происхождения | Хэнань, Китай |
| Использование | Primary closure for glass vials (injectables, vaccines, biologics) |
| Служба обработки | Precision compression molding |
| Упаковка | Plastic Bag + Export Carton |
| MOQ | 10 000 шт. |
| Наличие образцов | Бесплатные образцы |
| Поддержка OEM/ODM | Приемлемый |
| Характеристика | Medical Grade, Self-Healing, Solid Seal, Низкое содержание экстрактивных веществ |
| Размер одного пакета | 10×20×15 см |
| Вес брутто | 1.000 кг за единицу |
| Сертификаты | ISO 9001:2015, ISO 14001, OHSAS 18001 |
| Соответствие нормативным требованиям | USP, EP 3.1.9, JP XVII, FDA 21 CFR 177.1520 |
Why This Design Matters: The Science Behind the Dual-Lip Structure
Сайт 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 и vaccines, where even minor leakage can lead to waste or contamination.
According to a study published in Журнал фармацевтических наук (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 | Вакцины, biologics, multi-dose vials | Enhanced chemical resistance, better adhesion to aluminum seals |
| Chlorobutyl Rubber | Лиофилизированные (сублимированные) продукты | Superior барьер от влаги, lowest extractables profile |
Примечание: Для сублимированный (лиофилизированный) продукты, мы рекомендуем хлорбутилкаучук due to its excellent moisture barrier properties и 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) и Cell & Gene Therapies
- 💉 mRNA & Viral Vector Vaccines (requires ultra-low leachables)
- ❄️ Lyophilized Powders (requires high moisture barrier)
- 🧪 Упаковка для клинических испытаний & 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, и 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 или посетите https://www.pharglass.com to explore our full range of фармацевтические резиновые пробки, glass vials, и custom packaging solutions.
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