Pharmaceutical Primary Packaging by Pharglass | USP/EP Aligned | Trusted for Parenteral Formulations in China & Global Markets
فَرگلاس 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 شیشهٔ بوروسیلیکات نوع I خنثی, 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.
Available in standard capacities from ۲ میلیلیتر تا ۵۰ میلیلیتر (۲R–۵۰R), 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 و European Pharmacopoeia 3.2.1, enabling dual-track regulatory submissions for global commercialization.
ویژگیها و مزایای کلیدی
- ✅ Full Compliance with YBB00292005-2-2015 – Mandatory for NMPA drug registration in China
- ✅ شیشهٔ بوروسیلیکات نوع I خنثی – Highest pharmaceutical grade; minimal ion leaching
- ✅ Capacity Range: 2ml–50ml – Supports everything from pediatric doses to bulk formulations
- ✅ Global Harmonization – Meets key requirements of USP & EP for international filings
- ✅ ذرات معلق کم و کیفیت سطح کنترلشده – Reduces risk of visible/invisible particles in solution
- ✅ Standard ISO Neck Finishes – Compatible with serum stoppers, crimp seals, and flip-off caps
مشخصات فنی
| پارامتر | مشخصات |
|---|---|
| نام محصول | YBB-Compliant Pharmaceutical Glass Vials |
| برند | فَرگلاس |
| ظرفیتها (ابعاد ISO) | ۲R (۲ میلیلیتر)، ۵R (۵ میلیلیتر)، ۱۰R (۱۰ میلیلیتر)، ۲۰R (۲۰ میلیلیتر)، ۳۰R (۳۰ میلیلیتر)، ۵۰R (۵۰ میلیلیتر) |
| نوع شیشه | شیشهٔ بوروسیلیکات نوع I خنثی |
| Primary Standard | YBB00292005-2-2015 (China National Standard) |
| 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) |
| گزینههای رنگ | Clear (standard); Amber (UV protection, on request) |
| Neck Finish | Standard ISO finish (e.g., 13mm, 20mm) for rubber stoppers |
| بستهبندی | Bulk in clean, dust-proof cartons or nest trays for automated handling |
| Sterility Options | Non-sterile (standard); sterile (gamma/ETO, SAL 10⁻⁶) available |
| حداقل سفارش | ۵۰۰۰ تکه |
| کاربردها | 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
- Dimensional accuracy
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
Our vials are already used in 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.
سفارشیسازی و پشتیبانی نظارتی
- Embossed volume markings or client logos
- Pre-sterilized آماده پر کردن (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.
📩 امروز با ما تماس بگیرید for samples, YBB test reports, or a quote tailored to your fill-finish operation!
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