ویال‌های تزریقی مطابق YBB00292005-2-2015 – شانهٔ لوله‌ای انتهایی، شیشه نوع I

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

فَرگلاس YBB00292005-2-2015 compliant injection vials feature a tubular shoulder-ended design—the gold standard for modern parenteral packaging—manufactured from شیشهٔ بوروسیلیکات نوع I خنثی 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 فصل ۳.۲.۱ for global regulatory flexibility.

آن 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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ویژگی‌ها و مزایای کلیدی

• ✅ 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
• ✅ شیشهٔ بوروسیلیکات خنثی نوع I – 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

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مشخصات فنی

پارامتر	مشخصات
نام محصول	Tubular Shoulder-Ended Injection Vials
برند	فَرگلاس
نوع شیشه	Type I Neutral Borosilicate (tubular drawn)
طراحی	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)	۲R (۲ میلی‌لیتر)، ۵R (۵ میلی‌لیتر)، ۱۰R (۱۰ میلی‌لیتر)، ۲۰R (۲۰ میلی‌لیتر)، ۳۰R (۳۰ میلی‌لیتر)، ۵۰R (۵۰ میلی‌لیتر)
گزینه‌های رنگ	Clear (standard); Amber (UV-protective, on request)
Neck Finish	Standard ISO finish (e.g., 13mm, 20mm) for rubber stoppers and aluminum seals
بسته‌بندی	Bulk in clean, dust-proof cartons or nest trays for automated lines
Sterility Options	Non-sterile (standard); sterile (gamma/ETO, SAL 10⁻⁶) available
حداقل سفارش	۵۰۰۰ تکه
کاربردها	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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سفارشی‌سازی و پشتیبانی نظارتی

• Embossed volume markings or client logos
• Pre-sterilized آماده پر کردن (RTF) configuration in double sterile pouches
• 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.

📩 امروز با ما تماس بگیرید for samples, YBB test reports, or a quote for your next NMPA or global filing!