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 neutral Type I borosilicate glass, 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
- ✅ Neutral Type I Borosilicate Glass – 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 | Neutral Type I Borosilicate Glass |
| 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 |
| Packaging | 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:
- Hydrolytic resistance (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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