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Viales de vidrio farmacéuticos conformes a las normas ISO y USP para mercados mundiales

PharGlass delivers ISO and USP-compliant pharmaceutical glass vials designed to meet the highest global standards in quality, safety, and regulatory compliance. These 10ml clear borosilicate glass vials are Ready-to-Use (RTU), ETO sterilized, washed, and depyrogenated—ideal for injectable drugs, biologics, vaccines, and sterile liquid formulations intended for export to North America, Europe, Asia, and beyond.

Manufactured under GMP-compliant facilities in Henan, China, our vials are engineered to ensure chemical stability, sterility, and compatibility with sensitive pharmaceutical products—making them a trusted choice for manufacturers seeking reliable packaging solutions that pass stringent international inspections.

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✅ Why Choose PharGlass ISO & USP Compliant Vials?

• Regulatory Compliance: Meets USP <660>, USP <85>, EP 3.2.1, y ISO 15884 standards for pharmaceutical glassware.
• High Purity & Inertness: Hecho de Vidrio de borosilicato de tipo I, resistant to leaching and pH changes—critical for long-term stability.
• Sterile & Ready-to-Use: Pre-sterilized via Ethylene Oxide (ETO), thoroughly washed, and validated for use without additional processing.
• Depyrogenated: Endotoxin levels below 0.25 EU/mL, ensuring safe use in injectable applications.
• Sealed with Rubber Stopper: Ensures leak-proof containment and prevents microbial ingress.
• Hot Stamping Compatible: Enables permanent marking of batch numbers, expiry dates, and barcodes.
• Customizable Branding: Accepts custom logos, cap colors, and labeling for OEM/ODM clients.

💡 According to the U.S. Pharmacopeia (USP), glass containers must be free from defects and contaminants that could affect drug safety or efficacy. Our vials undergo rigorous testing to ensure full compliance with USP Chapter <660> for glass containers.

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🔬 Key Product Specifications

Atributo	Especificación
Tipo de sellado	Tapón
Forma	Cilindro redondo
Con difusor Reed	No
Manipulación de superficies	Estampación en caliente
Número de modelo	RTU
Marca	PharGlass
Material del cuerpo	Vidrio (borosilicato)
Material del cuello	Vidrio
Nombre del producto	2R 2ml 3ml Clear RTU Washed Sterile Glass Bottle Vial
Capacidad	10ml
Material	Vidrio
Color de la tapa	Colores personalizados disponibles
Utilización	Liquid Pharmaceuticals, Injectables, Biologics
Manipulación de la impresión	Etiquetas, Estampación en caliente
Lugar de origen	Henan, China
Uso industrial	Pharmaceutical Packaging
MOQ	5000 unidades
OEM/ODM	Aceptable
Logotipo	Logotipo personalizado aceptable
Embalaje	Cartón

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🌐 Applications in Global Pharmaceutical Markets

These vials are widely used by manufacturers exporting to:

• North America: FDA-regulated markets requiring strict adherence to USP standards.
• Europe: CE-marked products compliant with EU pharmacopoeia (EP).
• Asia-Pacific: Countries like Japan, South Korea, and India with high-quality requirements.
• Middle East & Africa: Growing demand for sterile injectables and vaccines.

Ideal for:

• Injectable medications (antibiotics, analgesics)
• Vacunas (mRNA, subunit, live attenuated)
• Biológicos (monoclonal antibodies, recombinant proteins)
• Generic drugs requiring cost-effective, compliant packaging

📊 The global pharmaceutical packaging market is projected to exceed $150 billion by 2030, driven by demand for compliant, sustainable, and smart packaging solutions (Source: Statista).

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🌍 Manufacturing Excellence & Quality Assurance

Fabricado en Henan, China, bajo GMP-compliant facilities, each vial undergoes:

• Automated inspection for defects (cracks, bubbles, surface flaws)
• Sterilization via ETO gas (residual levels <10 ppm)
• Depyrogenation process to remove endotoxins
• Leak testing under vacuum pressure
• Visual and dimensional quality checks
• Compliance testing against USP, EP, and ISO standards

All products are ISO 9001, ISO 13485, and FDA registered, ensuring alignment with global regulatory expectations.

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🎯 Opciones de personalización

PharGlass supports full branding and functional customization:

• Hot-stamped labels (batch codes, expiry dates, lot numbers)
• Colores de gorra personalizados for product differentiation (e.g., blue for antibiotics, red for emergency use)
• Etiquetado privado y impresión de logotipos personalizados
• Envases de cartón a granel optimized for warehouse handling and shipping

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📦 Packaging & Logistics

• Embalaje: Standard export cartons (customizable per order)
• Shipping Terms: FOB, CIF, DDP disponible
• Plazos de entrega: 15-30 días después de la confirmación del pedido
• Certificaciones: ISO 9001, ISO 13485, CE, FDA Fabricante registrado

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✅ Trusted by Global Pharmaceutical Manufacturers

PharGlass ha suministrado high-compliance packaging solutions to leading pharmaceutical companies across North America, Europe, and Asia. Our vials are trusted for their consistency, clarity, and regulatory readiness in global supply chains.

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📞 Póngase en contacto con nosotros
Need samples? Want to discuss custom labeling or regulatory support? Our technical team is ready to assist with product specifications, MOQ negotiation, and bulk orders. Let’s build compliant, globally accepted packaging together.

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PharGlass – Engineering Trust for Global Pharmaceutical Markets.