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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 в Type I Borosilicate Glass Vials

Сайт 13mm, 15mm, and 20mm Butyl Rubber Stopper for Lyophilization с сайта PharGlass is engineered specifically for freeze-dried (lyophilized) pharmaceuticals, offering superior moisture barrier performance, low extractables, и excellent resealability after vial sealing. These pharmaceutical lyophilization closures are ideal for biologic drugs, mRNA vaccines, monoclonal antibodies (mAbs), и 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, EP 3.1.9, и FDA 21 CFR 177.1520 стандарты.

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

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✅ Основные характеристики:

Характеристика	Описание
Материал	Медицинский 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
Низкое содержание экстрактивных веществ	Minimizes leachables that could compromise drug purity or safety
Настраиваемые размеры	Available in 13mm, 15mm, 20mm, 25mm, 28mm, 30mm, 32mm
Варианты цвета	Gray, Red, White, Black, Blue, Yellow (customizable per request)
Поддержка OEM/ODM	Yes – custom size, color, logo printing, surface treatment
Политика бесплатных образцов	Free samples available for compatibility testing

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

Параметр	Технические характеристики
Название продукта	13mm 15mm 20mm Butyl Rubber Stopper for Pharmaceutical Lyophilization
Номер модели	03
Название бренда	PharGlass
Материал	Butyl Rubber, Bromobutyl Rubber, Chlorobutyl Rubber
Цвет	Gray, Red, White, Black, Blue, Yellow, or Customer Request
Sizes Available	13 мм, 15 мм, 20 мм, 25mm, 28mm, 30mm, 32mm
Место происхождения	Хэнань, Китай
Использование	Primary closure for freeze-dried glass vials
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, Lyophilization Grade, Low Moisture Permeability, 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

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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 хлорбутилкаучук is preferred over standard butyl:

🔹 Superior Moisture Barrier: Chlorobutyl reduces water vapor transmission by up to 30% compared to butyl rubber (Source: Журнал фармацевтических наук, 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 и 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) и Recombinant Proteins
• 🔬 Viral Vector Therapies и Gene Editing Tools
• 🧪 Упаковка для клинических испытаний & Reference Standards

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Why Global Pharma Brands Trust 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).

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📞 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.