ISO Standard & USP Compliant Pharmaceutical Glass Vials for Global Markets
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.
✅ Why Choose PharGlass ISO & USP Compliant Vials?
- Regulatory Compliance: Meets USP <660>, USP <85>, EP 3.2.1, and ISO 15884 standards for pharmaceutical glassware.
- High Purity & Inertness: Fabriqué en Verre borosilicaté de type 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.
🔬 Key Product Specifications
| Attribut | Spécifications |
|---|---|
| Type d'étanchéité | Bouchon |
| Forme | Cylindre rond |
| Avec diffuseur à roseau | Non |
| Manipulation de surface | Marquage à chaud |
| Numéro de modèle | RTU |
| Nom de la marque | PharGlass |
| Matériau du corps | Verre (Borosilicate) |
| Matière du col | Verre |
| Nom du produit | 2R 2ml 3ml Clear RTU Washed Sterile Glass Bottle Vial |
| Capacité | 10ml |
| Matériau | Verre |
| Couleur du bouchon | Couleurs personnalisées disponibles |
| Utilisation | Liquid Pharmaceuticals, Injectables, Biologics |
| Manipulation de l'impression | Étiquettes, Hot Stamping |
| Lieu d'origine | Henan, Chine |
| Utilisation industrielle | Pharmaceutical Packaging |
| MOQ | 5000 pièces |
| OEM/ODM | Acceptable |
| Logo | Logo personnalisé acceptable |
| Emballage | Carton |
🌐 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)
- Vaccines (mRNA, subunit, live attenuated)
- Biologics (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).
🌍 Manufacturing Excellence & Quality Assurance
Fabriqué en Henan, Chine, under 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.
🎯 Options de personnalisation
PharGlass supports full branding and functional customization:
- Hot-stamped labels (batch codes, expiry dates, lot numbers)
- Couleurs de capuchon personnalisées for product differentiation (e.g., blue for antibiotics, red for emergency use)
- Étiquetage privé et impression de logos personnalisés
- Emballage en carton en vrac optimized for warehouse handling and shipping
📦 Emballage et logistique
- Emballage: Standard export cartons (customizable per order)
- Shipping Terms: FOB, CIF, DDP disponibles
- Délai d'exécution: 15-30 jours après la confirmation de la commande
- Certifications: ISO 9001, ISO 13485, CE, FDA Fabricant enregistré
✅ Trusted by Global Pharmaceutical Manufacturers
PharGlass a fourni 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.
📞 Contactez-nous dès aujourd'hui
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.
PharGlass – Engineering Trust for Global Pharmaceutical Markets.
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