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
إن 13mm and 20mm Butyl Rubber Stopper with Self-Healing Injection Port من فار جلاس is engineered to deliver superior seal integrity, low extractables, و 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, و 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 و EP 3.1.9 المعايير.
صُنعت تحت ISO 9001:2015 و متوافق مع معايير ممارسات التصنيع الجيدة (GMP) conditions in Henan, China, every stopper undergoes rigorous quality control, including extractables testing, visual inspection, و bioburden analysis, ensuring full compliance with global pharmaceutical regulations.
✅ الميزات الرئيسية:
| الميزة | الوصف |
|---|---|
| المواد | من الدرجة الطبية 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 |
| خيارات الألوان | Gray, Red, or Customer Request |
| دعم مصنعي المعدات الأصلية/التصنيع حسب الطلب | نعم – أحجام مخصصة، ألوان، طباعة الشعار، معالجة الأسطح |
| سياسة العينات المجانية | تتوفر عينات مجانية لاختبار التوافق |
Technical Specifications: 13mm & 20mm Self-Healing Rubber Stopper
| المعلمة | المواصفات |
|---|---|
| اسم المنتج | 13mm 20mm Butyl Rubber Stopper with Self-Healing Injection Port |
| رقم الموديل | 03 |
| اسم العلامة التجارية | فار جلاس |
| المواد | Butyl Rubber, Bromobutyl Rubber, Chlorobutyl Rubber |
| اللون | Gray, Red, or Custom |
| Sizes Available | 13 مم, 20 مم, 26mm, 28mm, 32mm |
| مكان المنشأ | خنان، الصين |
| الاستخدام | Primary closure for glass vials (injectables, vaccines, biologics) |
| Processing Service | Precision compression molding |
| التعبئة والتغليف | Plastic Bag + Export Carton |
| موك | 10,000 pcs |
| Sample Availability | Free Samples |
| دعم مصنعي المعدات الأصلية/التصنيع حسب الطلب | مقبولة |
| الميزة | Medical Grade, Self-Healing, Solid Seal, Low Extractables |
| Single Package Size | 10×20×15 cm |
| الوزن الإجمالي | 1.000 kg per unit |
| الشهادات | ISO 9001:2015, ISO 14001, OHSAS 18001 |
| الامتثال التنظيمي | USP, EP 3.1.9, JP XVII, FDA 21 CFR 177.1520 |
Why This Design Matters: The Science Behind the Dual-Lip Structure
إن 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 و 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 | اللقاحات, 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 و low extractables, as confirmed by studies in European Journal of Pharmaceutics.
Top Applications in Pharma & Biotech
- 💉 الأدوية المعقمة القابلة للحقن (e.g., insulin, antibiotics)
- 🧬 الأجسام المضادة أحادية النسيلة (mAbs) و Cell & Gene Therapies
- 💉 mRNA & Viral Vector Vaccines (requires ultra-low leachables)
- ❄️ Lyophilized Powders (requires high moisture barrier)
- 🧪 تغليف منتجات التجارب السريرية & المعايير المرجعية
Why Global Pharma Brands Choose PharGlass
بصفتها شركة رائدة OEM supplier of pharmaceutical closures, فار جلاس تقدم دعمًا شاملاً يشمل:
- كامل ملف المرجع الدوائي (DMF) الوثائق
- دراسة المواد القابلة للاستخلاص والتسرب (E&L) الدعم
- COA, TDS, و تتبع الدُفعات
- الأدوات المصممة خصيصًا for unique geometries
- النماذج الأولية السريعة (العينات خلال 3–5 أيام)
- الشحن الدولي مع خيارات DDP/DAP
يتم تصنيع جميع المنتجات في بيئة غرفة الأبحاث ويمكن توفيرها معقم مسبقًا (جاما أو الأوتوكلاف).
📞 اطلب عرض أسعار أو عينة مجانية اليوم!
راسلنا عبر البريد الإلكتروني على sales@pharglass.com أو قم بزيارة https://www.pharglass.com لاستكشاف مجموعتنا الكاملة من سدادات مطاطية صيدلانية, glass vials, و حلول التغليف المخصصة.
AR 
EN 
FR 
DE 
ES 
PT 
FA 
RU