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 verre borosilicaté neutre de type 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.
Disponibles dans des capacités standard de 2ml à 50ml (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 et Pharmacopée européenne 3.2.1, enabling dual-track regulatory submissions for global commercialization.
Principales caractéristiques et avantages
- ✅ Conformité totale avec YBB00292005-2-2015 – Mandatory for NMPA drug registration in China
- ✅ Neutral Type I Borosilicate Glass – Highest pharmaceutical grade; minimal ion leaching
- ✅ Capacité : 2ml-50ml - Prise en charge de tous les produits, des doses pédiatriques aux formulations en vrac
- ✅ Harmonisation mondiale – Meets key requirements of USP & EP for international filings
- ✅ Low Particulates & Controlled Surface Quality – Reduces risk of visible/invisible particles in solution
- ✅ Finitions standard du col ISO – Compatible with serum stoppers, crimp seals, and flip-off caps
Spécifications techniques
| Paramètres | Spécifications |
|---|---|
| Nom du produit | YBB-Compliant Pharmaceutical Glass Vials |
| Marque | Pharglass |
| Capacités (tailles ISO) | 2R (2ml), 5R (5ml), 10R (10ml), 20R (20ml), 30R (30ml), 50R (50ml) |
| Type de verre | Neutral Type I Borosilicate Glass |
| Norme primaire | YBB00292005-2-2015 (China National Standard) |
| Aligné sur | USP , EP 3.2.1, ISO 8362-1 |
| Résistance à l'hydrolyse | ≤ 0,10 ml 0,01N HCl/g de verre (essai sur verre pulvérulent selon YBB) |
| Options de couleur | Transparent (standard) ; Ambre (protection UV, sur demande) |
| Finition du manche | Standard ISO finish (e.g., 13mm, 20mm) for rubber stoppers |
| Emballage | Bulk in clean, dust-proof cartons or nest trays for automated handling |
| Options de stérilité | Non stérile (standard) ; stérile (gamma/ETO, SAL 10-⁶) disponible |
| MOQ | 5 000 pièces |
| Applications | 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:
- Résistance à l'hydrolyse (désalcalinisation du verre)
- Thermal shock resistance
- Internal surface uniformity
- Précision dimensionnelle
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
Nos flacons sont déjà utilisés dans 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.
Personnalisation et soutien réglementaire
- Marques de volume en relief ou logos de clients
- Pré-stérilisé Prêt à remplir (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.
📩 Contactez-nous dès aujourd'hui for samples, YBB test reports, or a quote tailored to your fill-finish operation!
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