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13mm, 15mm & 20mm Butyl Rubber Stopper for Lyophilization – Premium Freeze-Dried Product Closure with Low Extractables

Medical-Grade Lyophilization Closures Designed for Biologics, Vaccines, and High-Purity Pharmaceuticals in Type I Borosilicate Glass Vials

إن 13mm, 15mm, and 20mm Butyl Rubber Stopper for Lyophilization from فار جلاس is engineered specifically for freeze-dried (lyophilized) pharmaceuticals, offering superior moisture barrier performance, low extractables, و excellent resealability after vial sealing. These pharmaceutical lyophilization closures are ideal for biologic drugs, mRNA vaccines, monoclonal antibodies (mAbs), و sterile powder formulations that require long-term stability under controlled humidity conditions.

Unlike standard rubber stoppers, our lyophilization-grade butyl rubber stoppers are manufactured using high-purity raw materials and undergo rigorous extractables testing to ensure they meet the stringent requirements of USP <661>, EP 3.1.9, و FDA 21 CFR 177.1520 standards.

Manufactured under ISO 9001:2015 و GMP-compliant conditions in Henan, China, every stopper is tested for moisture permeability, visual defects, و bioburden control — ensuring consistent quality and regulatory compliance for global markets.

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✅ Key Features:

الميزة	Description
المواد	من الدرجة الطبية Butyl Rubber, Bromobutyl, or Chlorobutyl (recommended for freeze-dried applications)
Design Type	Flat-faced or dual-lip – optimized for vacuum sealing during lyophilization cycle
Moisture Barrier	Exceptional resistance to water vapor ingress – critical for dry powder stability
Low Extractables	Minimizes leachables that could compromise drug purity or safety
Customizable Sizes	Available in 13mm, 15mm, 20mm, 25mm, 28mm, 30mm, 32mm
خيارات الألوان	Gray, Red, White, Black, Blue, Yellow (customizable per request)
دعم مصنعي المعدات الأصلية/التصنيع حسب الطلب	Yes – custom size, color, logo printing, surface treatment
Free Sample Policy	Free samples available for compatibility testing

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Technical Specifications: 13mm, 15mm & 20mm Lyophilization Rubber Stopper

المعلمة	المواصفات
اسم المنتج	13mm 15mm 20mm Butyl Rubber Stopper for Pharmaceutical Lyophilization
رقم الموديل	03
اسم العلامة التجارية	فار جلاس
المواد	Butyl Rubber, Bromobutyl Rubber, Chlorobutyl Rubber
اللون	Gray, Red, White, Black, Blue, Yellow, or Customer Request
Sizes Available	13mm, 15 مم, 20 مم, 25mm, 28mm, 30mm, 32mm
مكان المنشأ	خنان، الصين
الاستخدام	Primary closure for freeze-dried glass vials
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, Lyophilization Grade, Low Moisture Permeability, Low Extractables
Single Package Size	10×20×15 cm
الوزن الإجمالي	1.000 kg per unit
الشهادات	ISO 9001:2015, ISO 14001, OHSAS 18001
Regulatory Compliance	USP <661>, EP 3.1.9, JP XVII, FDA 21 CFR 177.1520

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Why Chlorobutyl Rubber Is the Gold Standard for Freeze-Dried Products

For lyophilized (freeze-dried) pharmaceuticals, the choice of rubber material is critical. Here’s why chlorobutyl rubber is preferred over standard butyl:

🔹 Superior Moisture Barrier: Chlorobutyl reduces water vapor transmission by up to 30% compared to butyl rubber (Source: Journal of Pharmaceutical Sciences, 2022).
🔹 Lower Extractables Profile: Essential for sensitive biologics where even trace impurities can affect efficacy.
🔹 Better Chemical Resistance: Resists degradation from residual solvents and excipients used in formulation.
🔹 Enhanced Seal Integrity: Maintains tight closure under vacuum conditions during the lyophilization cycle.

According to the European Pharmacopoeia (EP 3.1.9), halogenated butyl rubbers (e.g., chlorobutyl) are recommended for high-purity biologics due to their low leachables و high chemical inertness.

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Top Applications in Pharma & Biotech

• ❄️ Lyophilized Biologics (e.g., insulin, interferons, growth factors)
• 💉 mRNA Vaccines (e.g., Pfizer, Moderna-style platforms)
• 🧬 Monoclonal Antibodies (mAbs) و Recombinant Proteins
• 🔬 Viral Vector Therapies و Gene Editing Tools
• 🧪 Clinical Trial Packaging & Reference Standards

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Why Global Pharma Brands Trust PharGlass

As a leading OEM supplier of pharmaceutical closures, فار جلاس provides end-to-end support including:

• Full Drug Master File (DMF) documentation
• Extractables & Leachables (E&L) study support
• COA, TDS, و 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).

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📞 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, و custom packaging solutions.