High-Purity Primary Packaging by Pharglass | USP/EP/YBB Compliant | Ideal for Injectables, Vaccines & Diagnostics
Pharglass empty pharmaceutical glass ampoules offer a trusted, single-dose solution for the safe containment of sterile liquids, lyophilized powders, and sensitive parenteral formulations. Available in clear (for visual inspection) or amber (for UV protection) variants, with capacities ranging from 1ml to 25ml, our ampoules are manufactured from Vidrio de borosilicato neutro de tipo I—ensuring exceptional chemical resistance, low extractables, and long-term drug stability.
Designed for both sterile (SAL 10⁻⁶) and non-sterile applications, these ampoules meet USP, Farmacopea Europea 3.2.1, y Chinese YBB00332005-2015 standards, making them suitable for global regulatory submissions (FDA, EMA, NMPA). Whether you’re filling antibiotics, vaccines, hormones, contrast media, or diagnostic reagents, Pharglass ampoules deliver consistent break performance, minimal particulates, and reliable hermetic sealing after flame closure.
Principales características y ventajas
- ✅ Capacity Range: 1ml–25ml – Supports everything from emergency meds to bulk diagnostics
- ✅ Clear or Amber Glass – Choose based on light sensitivity of your formulation
- ✅ Vidrio de borosilicato tipo I – Highest pharmaceutical grade; ideal for pH-critical drugs
- ✅ Opciones estériles (SAL 10-⁶) o no estériles – Flexibility for in-house sterilization or direct use
- ✅ Consistent Break Ring Design – Ensures clean, safe opening with minimal glass shards
- ✅ Triple Pharmacopeial Compliance – USP, EP, and YBB certified for global market access
Especificaciones técnicas
| Parámetro | Especificación |
|---|---|
| Nombre del producto | Empty Pharmaceutical Glass Ampoules |
| Marca | Pharglass |
| Capacidades | 1ml, 2ml, 5ml, 10ml, 20ml, 25ml (standard sizes) |
| Tipo de vidrio | Vidrio de borosilicato neutro de tipo I |
| Opciones de color | Clear (transparent) or Amber (brown, UV-blocking) |
| Conformidad | USP <660>, EP 3.2.1, YBB00332005-2015, ISO 9706 |
| Sterility | |
| • No estéril: Standard option for terminal sterilization | |
| • Estéril: Gamma or ETO sterilized to SAL 10⁻⁶ (with CoS) | |
| Nivel de endotoxinas | <0.25 EU/ml (for sterile versions, per LAL test) |
| Sealing Method | Open-ended; designed for flame or laser sealing during filling |
| Break Feature | Scored neck with color-coded dot (optional) for easy identification |
| Packaging | Bulk in dust-proof cartons; sterile versions in double pouches |
| MOQ | 10,000 pieces |
| Aplicaciones | Injectable antibiotics, vaccines, anesthetics, radiopharmaceuticals, ophthalmic solutions, diagnostic enzymes, veterinary drugs |
Why Choose Ampoules Over Vials?
Ampoules remain the gold standard for single-dose, oxygen/moisture-sensitive drugs due to their:
- Hermetic seal – No rubber stopper = zero permeability to gases or moisture
- Zero coring risk – No needle puncture required
- Superior stability – Ideal for drugs with short shelf life or high oxidation potential
- Cost-effective for small volumes – Lower material and packaging costs vs. vials
Commonly used for emergency medications (e.g., epinephrine, atropine), radiopharmaceuticals, y light-sensitive compounds (e.g., nitroprusside, riboflavin).
Quality Assurance & Regulatory Support
- Manufactured under ISO 9001 y ISO 15378 (GMP for primary packaging)
- Automated visual inspection for cracks, bubbles, and dimensional defects
- Full documentation: Certificate of Analysis (CoA), Certificate of Sterilization (CoS), YBB/USP test reports
- DMF support available for regulatory filings
Customization Options
- Color-coded break dots (e.g., red for 1ml, blue for 5ml)
- Laser marking for serialization or batch coding
- Custom neck geometry for specialized filling lines
- Pre-sterilized Ready-to-Fill (RTF) configuration in trays
Pure. Sealed. Trusted.
For uncompromised drug integrity in a single-dose format, Pharglass pharmaceutical ampoules combine global compliance, material excellence, and decades of glass expertise.
📩 Póngase en contacto con nosotros for samples, sterility validation data, or a volume quote for your injectable or diagnostic program!
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