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: Made from Type I borosilicate glass, 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
| Attribute | Specification |
|---|---|
| Sealing Type | Stopper |
| Shape | Round Cylinder |
| With Reed Diffuser | No |
| Surface Handling | Hot Stamping |
| Model Number | RTU |
| Brand Name | PharGlass |
| Body Material | Glass (Borosilicate) |
| Collar Material | Glass |
| Product Name | 2R 2ml 3ml Clear RTU Washed Sterile Glass Bottle Vial |
| Capacity | 10ml |
| Material | Glass |
| Cap Color | Customized Colors Available |
| Usage | Liquid Pharmaceuticals, Injectables, Biologics |
| Printing Handling | Labels, Hot Stamping |
| Place of Origin | Henan, China |
| Industrial Use | Pharmaceutical Packaging |
| MOQ | 5000 pcs |
| OEM/ODM | Acceptable |
| Logo | Customized Logo Acceptable |
| Packing | 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)
- 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).
🌍 Manufacturing Excellence & Quality Assurance
Manufactured in Henan, China, 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.
🎯 Customization Options
PharGlass supports full branding and functional customization:
- Hot-stamped labels (batch codes, expiry dates, lot numbers)
- Custom cap colors for product differentiation (e.g., blue for antibiotics, red for emergency use)
- Private labeling y custom logo printing
- Bulk carton packaging optimized for warehouse handling and shipping
📦 Packaging & Logistics
- Packing: Standard export cartons (customizable per order)
- Shipping Terms: FOB, CIF, DDP available
- Lead Time: 15–30 days after order confirmation
- Certifications: ISO 9001, ISO 13485, CE, FDA Registered Manufacturer
✅ Trusted by Global Pharmaceutical Manufacturers
PharGlass has supplied 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.
📞 Contact Us Today
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.
ES 
EN 
FR 
AR 
DE 
PT 
FA 
RU