Pharmaceutical Primary Packaging by Pharglass | USP/EP Aligned | Trusted for Parenteral Formulations in China & Global Markets
فارغلاس 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.
Available in standard capacities from 2ml to 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 و European Pharmacopoeia 3.2.1, enabling dual-track regulatory submissions for global commercialization.
الميزات والفوائد الرئيسية
- ✅ Full Compliance with YBB00292005-2-2015 – Mandatory for NMPA drug registration in China
- ✅ Neutral Type I Borosilicate Glass – 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
- ✅ جسيمات منخفضة وجودة سطح مضبوطة – Reduces risk of visible/invisible particles in solution
- ✅ تشطيبات العنق القياسية ISO - متوافق مع سدادات المصل، وأختام التجعيد، والأغطية القابلة للقلب
المواصفات الفنية
| المعلمة | المواصفات |
|---|---|
| اسم المنتج | YBB-Compliant Pharmaceutical Glass Vials |
| العلامة التجارية | فارغلاس |
| السعات (مقاسات ISO) | 2 ر (2 مل)، 5 ر (5 مل)، 10 ر (10 مل)، 20 ر (20 مل)، 30 ر (30 مل)، 50 ر (50 مل) |
| نوع الزجاج | Neutral Type I Borosilicate Glass |
| 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) |
| خيارات الألوان | Clear (standard); Amber (UV protection, on request) |
| تشطيب الرقبة | تشطيبات ISO القياسية (على سبيل المثال، 13 مم، 20 مم) للسدادات المطاطية |
| التعبئة والتغليف | Bulk in clean, dust-proof cartons or nest trays for automated handling |
| خيارات العقم | Non-sterile (standard); sterile (gamma/ETO, SAL 10⁻⁶) available |
| موك | 5,000 قطعة |
| التطبيقات | 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
- الفحص البصري الآلي
- 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.
التخصيص والدعم التنظيمي
- علامات حجم منقوشة أو شعارات العميل
- معقمة مسبقاً جاهز للتعبئة (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.
📩 اتصل بنا اليوم for samples, YBB test reports, or a quote tailored to your fill-finish operation!
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