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 Vidro borossilicato neutro 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, e 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.
Principais recursos e benefícios
- ✅ Full Size Range: 2ml to 50ml – Supports everything from pediatric doses to bulk drug substance
- ✅ Vidro 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
- ✅ Baixo teor de partículas e qualidade de superfície controlada – Minimizes nucleation defects and cake heterogeneity
- ✅ Acabamentos padrão ISO para colares – Compatível com tampas para soro, selos de crimpagem e tampas flip-off
Especificações técnicas
| Parâmetro | Especificação |
|---|---|
| Nome do produto | Lyophilization Vials for Freeze-Dried Powders |
| Marca | Pharglass |
| Capacidades (tamanhos ISO) | 2R (2 ml), 5R (5 ml), 10R (10 ml), 20R (20 ml), 30R (30 ml), 50R (50 ml) |
| Tipo de vidro | Vidro de borosilicato neutro tipo I |
| Conformidade | USP <660>, EP 3.2.1, YBB00292005-2-2015, ISO 8362-1 |
| Opções de cores | Clear (standard) or Amber (UV-protective, on request) |
| Bottom Design | Flat-bottom (optimized for lyophilizer trays) |
| Acabamento do braço | Acabamento padrão ISO (por exemplo, 13 mm, 20 mm) para rolhas de borracha |
| Thermal Resistance | Validated from -40°C to +70°C (suitable for aggressive lyo cycles) |
| Embalagem | Bulk in cleanroom-washed cartons or nest trays for automated handling |
| Opções de esterilidade | Non-sterile (standard); gamma or ETO sterilized (SAL 10⁻⁶) available |
| MOQ | 5.000 unidades |
| Aplicativos | 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)
- Inspeção visual automatizada 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.
Personalização e Suporte Regulatório
- Marcações de volume em relevo ou logotipos de clientes
- Pré-esterilizado Pronto para encher (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.
📩 Entre em contato conosco hoje mesmo for samples, validation reports, or a quote tailored to your lyo program!
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