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Model 03 – 20mm Pharmaceutical Butyl Rubber Stopper Coated with PE & PTFE (Medical Grade)

High-Performance, Sterile-Grade Rubber Stopper for Injectable Medications

Designed for demanding pharmaceutical applications, the Model 03 20mm Butyl Rubber Stopper features a dual-layer coating of Polietileno (PE) y Polytetrafluoroethylene (PTFE) to ensure optimal sealing performance, chemical compatibility, and minimal extractables. This medical-grade stopper is ideal for use in vials containing biologics, vaccines, monoclonal antibodies, and sterile injectable solutions, where integrity, stability, and patient safety are paramount.

Manufactured from high-purity natural butyl rubber in our ISO-certified facility in Henan, China, this stopper meets or exceeds international standards including USP <661>, EP 3.1.9, JP XVII, y ISO 9001:2008 / ISO 14001:2004. The gray color is customizable per customer request, ensuring consistency with brand identity and regulatory labeling requirements.

✅ Características principales:

• Dual Coating (PE + PTFE): Enhances lubricity, reduces friction during needle penetration, and prevents rubber migration into the drug product.
• Low Extractables: Minimizes risk of leachables that could compromise drug purity or efficacy.
• Excellent Seal Integrity: Ensures long-term protection against moisture ingress and microbial contamination.
• OEM/ODM Support: Customizable size, color, and surface treatment options available.
• Free Sample Policy: We offer free samples for quality evaluation and compatibility testing.

This stopper is widely used in combination with Type I borosilicate glass vials, forming a reliable primary packaging system for sensitive pharmaceutical formulations.

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Especificaciones del producto

Parámetro	Especificación
Nombre del producto	20mm Butyl Rubber Stopper Coated with PE & PTFE
Número de modelo	03
Material	Natural Butyl Rubber (Butyl Rubber)
Coating	Polyethylene (PE) + Polytetrafluoroethylene (PTFE)
Color	Gray (Customizable upon request)
Opciones de tamaño	13 mm, 15 mm, 20 mm, 25 mm, 28 mm, 30 mm
Lugar de origen	Henan, China
Marca	pg
Processing Service	Moulding
Utilización	Primary Packaging for Glass Vials (e.g., injection, vaccine, biologics)
MOQ	10.000 unidades
Packaging	Plastic Bag + Carton
Single Package Size	10×20×15 cm
Peso bruto	1.000 kg per unit
Unidad de venta	Single Item
Sample Policy	Free Samples Available
Asistencia OEM/ODM	Aceptable
Certificaciones	ISO 9001:2008, ISO 14001:2004, OHSAS 18001:1999
Regulatory Compliance	USP , EP 3.1.9, JP XVII, FDA 21 CFR 177.1520
Característica	Medical Grade, Low Extractables, High Chemical Resistance

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Technical Insights & Industry Applications

🔬 Why Choose PE+PTFE Coated Rubber Stoppers?

• PTFE Coating: Offers excellent non-stick properties and reduces syringe plunger drag, critical for pre-filled syringes y auto-injectors.
• PE Layer: Acts as a barrier to prevent rubber degradation and enhances compatibility with aqueous and lipid-based formulations.
• Reduced Protein Adsorption: Particularly beneficial in biologic drugs such as monoclonal antibodies, where protein loss at the interface can affect bioavailability.

According to studies published in Pharmaceutical Technology y Revista de Ciencias Farmacéuticas, coated rubber stoppers significantly reduce the risk of particulate formation y drug-product interaction, especially in high-dose or long-term storage scenarios.

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Ideal For Use With:

• Vacunas (including mRNA vaccines)
• Monoclonal Antibodies (mAbs)
• Insulin and Peptide Therapeutics
• Sterile Injectable Solutions
• Biologicals and Cell-Based Therapies

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¿Por qué elegir PharGlass?

En PharGlass, we specialize in providing customized, high-quality primary packaging solutions for the global pharmaceutical industry. Our team offers:

• Full support for COA, DMF, and pre-market validation
• Rapid prototyping and sample delivery within 3–5 days
• Technical consultation on compatibility testing, leachables study, y stability testing
• Global shipping with traceable logistics

We welcome OEM/ODM collaborations and are committed to helping you achieve regulatory approval y market success with reliable, compliant packaging components.

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📞 Póngase en contacto con nosotros
For pricing, technical data sheets (TDS), certificates of analysis (COA), or custom design requests — reach out to our sales team at sales@pharglass.com o visite https://www.pharglass.com.

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Nota: All products are manufactured under strict quality control systems and can be tested for extractables, bioburden, endotoxin levels, and visual inspection per client requirements.

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