Precision Primary Packaging by Pharglass | Optimized for Aseptic Filling & NMPA Submissions
Pharglass YBB00292005-2-2015 compliant injection vials feature a tubular shoulder-ended design—the gold standard for modern parenteral packaging—manufactured from neutral Type I borosilicate glass to deliver superior chemical resistance, low extractables, and exceptional dimensional consistency. Fully certified to China’s national pharmaceutical packaging standard YBB00292005-2-2015, these vials are engineered to meet the stringent quality requirements of the NMPA (National Medical Products Administration) while aligning with USP und EP 3.2.1 for global regulatory flexibility.
Die tubular construction—drawn from precision glass tubing rather than molded—ensures uniform wall thickness, smooth internal surfaces, and minimal stress points, making these vials ideal for high-value injectables, including biologics, monoclonal antibodies, vaccines, antibiotics, and oncology drugs. The shoulder-ended geometry provides optimal compatibility with serum stoppers, crimp seals, and automated filling lines, ensuring reliable container closure integrity (CCI) and consistent performance during lyophilization or liquid fill-finish.
Key Features & Benefits
- ✅ Full Compliance with YBB00292005-2-2015 – Mandatory for NMPA drug product registration in China
- ✅ Tubular Shoulder-Ended Design – Superior to molded vials in wall uniformity and break resistance
- ✅ Type I Neutral Borosilicate Glass – Ultra-low leachables; ideal for pH-sensitive formulations
- ✅ Global Harmonization – Meets core requirements of USP <660> and EP 3.2.1
- ✅ Low Particulate Generation – Smooth interior minimizes particle shedding during filling
- ✅ Standard ISO Neck Finishes – Seamless integration with stoppers, caps, and robotic handling systems
Technical Specifications
| Parameter | Spezifikation |
|---|---|
| Produktname | Tubular Shoulder-Ended Injection Vials |
| Brand | Pharglass |
| Glass Type | Type I Neutral Borosilicate (tubular drawn) |
| Design | Shoulder-ended (ISO 8362-1 compliant profile) |
| Primary Standard | YBB00292005-2-2015 (China National Standard for Injection Vials) |
| Aligned With | USP <660>, EP 3.2.1, ISO 8362-1 |
| Hydrolytic Resistance | ≤ 0.10 ml 0.01N HCl/g glass (powdered glass test per YBB) |
| Capacities (Standard ISO Sizes) | 2R (2ml), 5R (5ml), 10R (10ml), 20R (20ml), 30R (30ml), 50R (50ml) |
| Farboptionen | Clear (standard); Amber (UV-protective, on request) |
| Neck Finish | Standard ISO finish (e.g., 13mm, 20mm) for rubber stoppers and aluminum seals |
| Packaging | Bulk in clean, dust-proof cartons or nest trays for automated lines |
| Sterility Options | Non-sterile (standard); sterile (gamma/ETO, SAL 10⁻⁶) available |
| MOQ | 5,000 pieces |
| Applications | Injectable biologics, mRNA vaccines, antibiotics (e.g., ceftriaxone), hormones, oncology drugs, diagnostic reagents |
Why Tubular > Molded for High-Risk Injectables?
While molded vials are cost-effective for low-risk products, tubular vials offer critical advantages for sensitive parenterals:
- Uniform wall thickness → consistent heat transfer during lyophilization
- Lower internal surface roughness → reduced protein adsorption & particle generation
- Higher mechanical strength → lower breakage during transport and processing
- Precise dimensional control → better stopper seating and CCI
These attributes make tubular shoulder-ended vials the preferred choice for FDA-, EMA-, and NMPA-approved biologics.
YBB00292005-2-2015: What It Requires
This Chinese standard mandates rigorous testing for:
- Hydrolytic resistance (glass dealkalization)
- Thermal shock stability
- Internal surface homogeneity
- Dimensional accuracy (neck, body, height)
- Visual defects (bubbles, stones, scratches)
Pharglass performs batch-specific YBB validation and provides full test reports—accelerating your NMPA dossier review.
Customization & Regulatory Support
- Embossed volume markings or client logos
- Pre-sterilized Ready-to-Fill (RTF) configuration in double sterile pouches
- Extractables & Leachables (E&L) data
- Drug Master File (DMF) support for NMPA, FDA, and EMA
Engineered for China. Validated for the world.
When your injectable therapy demands the highest level of container quality and regulatory assurance, choose Pharglass tubular YBB-compliant vials—where precision meets compliance.
📩 Kontaktieren Sie uns heute for samples, YBB test reports, or a quote for your next NMPA or global filing!
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