High-Performance Primary Packaging by Pharglass | Optimized for Stability, Integrity & Scalability
Pharglass lyophilization vials are precision-engineered for the reliable freeze-drying of sensitive therapeutics—from small-molecule antibiotics to complex mRNA vaccines, monoclonal antibodies, peptides, and viral vectors. Available in a full range of standard capacities (2ml, 5ml, 10ml, 20ml, 30ml, and 50ml), these vials are manufactured from Vidrio de borosilicato neutro de tipo I, ensuring exceptional chemical resistance, low extractables, and long-term stability of freeze-dried cakes.
Fully compliant with USP, European Pharmacopoeia (EP) 3.2.1, y Chinese YBB00292005-2-2015 standards, Pharglass lyo vials meet the stringent quality requirements of global regulatory agencies (FDA, EMA, NMPA). Their consistent wall thickness, flat-bottom design, and precise dimensional tolerances ensure uniform heat transfer during primary and secondary drying—minimizing collapse, melt-back, and batch failure.
Ideal for both clinical and commercial-scale lyophilization, our vials integrate seamlessly with leading freeze-dryer systems from SP Industries, GEA, Telstar, and IMA.
Principales características y ventajas
- ✅ Full Size Range: 2ml to 50ml – Supports everything from pediatric doses to bulk drug substance
- ✅ Vidrio de borosilicato tipo I – Highest pharmaceutical grade; ideal for parenterals and biologics
- ✅ Triple Pharmacopeial Compliance – USP, EP, and YBB certified for global market access
- ✅ Optimized Geometry – Flat bottom + uniform walls = consistent thermal conduction & low breakage
- ✅ Low Particulates & Controlled Surface Quality – Minimizes nucleation defects and cake heterogeneity
- ✅ Standard ISO Neck Finishes – Compatible with serum stoppers, crimp seals, and flip-off caps
Especificaciones técnicas
| Parámetro | Especificación |
|---|---|
| Nombre del producto | Lyophilization Vials for Freeze-Dried Powders |
| Marca | Pharglass |
| Capacidades (tamaños ISO) | 2R (2ml), 5R (5ml), 10R (10ml), 20R (20ml), 30R (30ml), 50R (50ml) |
| Tipo de vidrio | Vidrio de borosilicato neutro de tipo I |
| Conformidad | USP <660>, EP 3.2.1, YBB00292005-2-2015, ISO 8362-1 |
| Opciones de color | Clear (standard) or Amber (UV-protective, on request) |
| Bottom Design | Flat-bottom (optimized for lyophilizer trays) |
| Acabado del cuello | Standard ISO finish (e.g., 13mm, 20mm) for rubber stoppers |
| Thermal Resistance | Validated from -40°C to +70°C (suitable for aggressive lyo cycles) |
| Packaging | Bulk in cleanroom-washed cartons or nest trays for automated handling |
| Opciones de esterilidad | Non-sterile (standard); gamma or ETO sterilized (SAL 10⁻⁶) available |
| MOQ | 5,000 pieces |
| Aplicaciones | Lyophilized vaccines, mAbs, enzymes, antibiotics, mRNA-LNPs, diagnostic reagents, cell & gene therapies |
Why Glass Quality Matters in Lyophilization
The success of a freeze-drying cycle depends not just on formulation—but on container performance:
- Poor glass → alkali leaching → pH shift → protein aggregation
- Inconsistent walls → uneven drying → collapsed cake or residual moisture
- Surface defects → uncontrolled nucleation → variable reconstitution time
Pharglass mitigates these risks through:
- Advanced melting & forming control to eliminate cords and stones
- Strict hydrolytic resistance testing (powdered glass test per USP)
- Automated visual inspection for cracks, chips, and particulates
- Batch-specific CoA with dimensions, weight, and compliance data
Our vials are used in commercialized lyophilized drugs across North America, Europe, and Asia.
Customization & Regulatory Support
- Embossed volume markings or client logos
- Pre-sterilized Ready-to-Fill (RTF) configuration in double sterile pouches
- Compatibility testing with your specific lyo cycle
- Full regulatory documentation: CoA, CoC, DMF support, E&L data
From lab to launch—freeze-dry with confidence.
Pharglass lyophilization vials combine pharmaceutical excellence, global compliance, and scalable supply to support your most critical freeze-dried products.
📩 Póngase en contacto con nosotros for samples, validation reports, or a quote tailored to your lyo program!
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