Pharmaceutical Primary Packaging by Pharglass | USP/EP Aligned | Trusted for Parenteral Formulations in China & Global Markets
Pharglass YBB00292005-2-2015 compliant glass vials are precision-manufactured to meet China’s stringent national standard for pharmaceutical glass containers—ensuring full compatibility with NMPA (National Medical Products Administration) registration requirements. Made from vidrio de borosilicato neutro de tipo I, these vials offer exceptional chemical durability, low extractables, and superior hydrolytic resistance, making them ideal for a wide range of injectable drugs, including antibiotics, biologics, vaccines, hormones, and small-molecule therapeutics.
Disponible en capacidades estándar desde De 2 ml a 50 ml (2R-50R), our vials feature consistent wall thickness, smooth internal surfaces, and precise dimensional tolerances to support automated filling lines, reliable stopper seating, and long-term drug stability. While fully compliant with China YBB00292005-2-2015, they also align with USP y Farmacopea Europea 3.2.1, enabling dual-track regulatory submissions for global commercialization.
Principales características y ventajas
- ✅ Full Compliance with YBB00292005-2-2015 – Mandatory for NMPA drug registration in China
- ✅ Vidrio de borosilicato neutro de tipo I – Highest pharmaceutical grade; minimal ion leaching
- ✅ Rango de capacidad: 2ml-50ml – Supports everything from pediatric doses to bulk formulations
- ✅ Armonización mundial – Meets key requirements of USP & EP for international filings
- ✅ Low Particulates & Controlled Surface Quality – Reduces risk of visible/invisible particles in solution
- ✅ Standard ISO Neck Finishes – Compatible with serum stoppers, crimp seals, and flip-off caps
Especificaciones técnicas
| Parámetro | Especificación |
|---|---|
| Nombre del producto | YBB-Compliant Pharmaceutical Glass Vials |
| 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 |
| Norma primaria | YBB00292005-2-2015 (China National Standard) |
| Alineado con | USP <660>, EP 3.2.1, ISO 8362-1 |
| Resistencia hidrolítica | ≤ 0.10 ml 0.01N HCl/g glass (powdered glass test per YBB) |
| Opciones de color | Transparente (estándar); Ámbar (protección UV, bajo pedido) |
| Acabado del cuello | Standard ISO finish (e.g., 13mm, 20mm) for rubber stoppers |
| Embalaje | Bulk in clean, dust-proof cartons or nest trays for automated handling |
| Opciones de esterilidad | Non-sterile (standard); sterile (gamma/ETO, SAL 10⁻⁶) available |
| MOQ | 5,000 pieces |
| Aplicaciones | Injectable antibiotics, monoclonal antibodies, vaccines, insulin, oncology drugs, diagnostic reagents |
Why YBB Compliance Matters for Market Access in China
Since 2015, the YBB00292005-2-2015 standard has been a cornerstone of China’s pharmaceutical packaging regulations. It mandates rigorous testing for:
- Resistencia a la hidrólisis (glass dealkalization)
- Thermal shock resistance
- Internal surface uniformity
- Precisión dimensional
Non-compliant vials can lead to NMPA rejection, batch recalls, or post-market quality issues. Pharglass ensures every batch undergoes:
- Batch-specific YBB testing
- Automated visual inspection
- Full traceability from raw material to finished goods
Nuestros viales ya se utilizan en NMPA-approved injectable products across therapeutic areas.
Global Compatibility Without Compromise
While designed for the Chinese market, Pharglass YBB-compliant vials are engineered to exceed baseline global expectations:
- Lower alkali content than many “Type I” alternatives
- Tighter dimensional control vs. general-purpose vials
- Cleanroom washing to reduce particulate load
This makes them an excellent choice for multi-market drug launches where one container must satisfy both NMPA and FDA/EMA requirements.
Customization & Regulatory Support
- Embossed volume markings or client logos
- Pre-sterilized Ready-to-Fill (RTF) configuration
- Full documentation package: CoA, CoC, YBB test reports, DMF support
- Compatibility testing with your specific formulation
One vial. Dual compliance. Global confidence.
Whether you’re launching in Shanghai or shipping worldwide, Pharglass YBB00292005-2-2015 compliant glass vials deliver the quality, consistency, and regulatory readiness your injectable drug deserves.
📩 Póngase en contacto con nosotros for samples, YBB test reports, or a quote tailored to your fill-finish operation!
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