YBB0000292005-2-2015 قوارير الحقن المتوافقة - أنبوبي أنبوبي الكتف، زجاج من النوع I

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Precision Primary Packaging by Pharglass | Optimized for Aseptic Filling & NMPA Submissions

فارغلاس 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 و EP 3.2.1 for global regulatory flexibility.

إن 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.

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الميزات والفوائد الرئيسية

• ✅ 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
• ✅ النوع I زجاج البورسليكات المحايد من النوع الأول – 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
• ✅ تشطيبات العنق القياسية ISO – Seamless integration with stoppers, caps, and robotic handling systems

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المواصفات الفنية

المعلمة	المواصفات
اسم المنتج	Tubular Shoulder-Ended Injection Vials
العلامة التجارية	فارغلاس
نوع الزجاج	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)	2 ر (2 مل)، 5 ر (5 مل)، 10 ر (10 مل)، 20 ر (20 مل)، 30 ر (30 مل)، 50 ر (50 مل)
خيارات الألوان	Clear (standard); Amber (UV-protective, on request)
تشطيب الرقبة	Standard ISO finish (e.g., 13mm, 20mm) for rubber stoppers and aluminum seals
التعبئة والتغليف	Bulk in clean, dust-proof cartons or nest trays for automated lines
خيارات العقم	Non-sterile (standard); sterile (gamma/ETO, SAL 10⁻⁶) available
موك	5,000 قطعة
التطبيقات	Injectable biologics, mRNA vaccines, antibiotics (e.g., ceftriaxone), hormones, oncology drugs, diagnostic reagents

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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.

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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.

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التخصيص والدعم التنظيمي

• علامات حجم منقوشة أو شعارات العميل
• معقمة مسبقاً جاهز للتعبئة (RTF) التكوين في أكياس معقمة مزدوجة
• Extractables & Leachables (E&L) data
• Drug Master File (DMF) support for NMPA, FDA, and EMA

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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.

📩 اتصل بنا اليوم for samples, YBB test reports, or a quote for your next NMPA or global filing!