ویال‌های چنددوز آماده مصرف ۵۰ میلی‌لیتری – شیشه بوریسیلیکات نوع I، استریل‌شده با ETO برای محصولات بیولوژیک و واکسن‌ها

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50ml Multi-Dose Ready-to-Use (RTU) Vials – Type I Borosilicate Glass for Biologics & Vaccines

Manufactured by Pharglass | Sterile | ETO-Sterilized | USP/EP/YBB Compliant

Pharglass 50ml multi-dose Ready-to-Use (RTU) vials are engineered for the safe, reliable, and efficient packaging of high-value biologics, monoclonal antibodies, recombinant proteins, and large-volume vaccines. Made from premium شیشهٔ بوروسیلیکات خنثی نوع I, these vials offer exceptional chemical resistance, low extractables, and outstanding thermal stability—critical for sensitive parenteral formulations.

Designed for seamless integration into aseptic fill-finish lines, each vial is pre-washed, depyrogenated, and sterilized via Ethylene Oxide (ETO) to a sterility assurance level (SAL) of یک ده به توان منفی شش, eliminating the need for in-house cleaning and sterilization. This significantly reduces contamination risk, operational complexity, and time-to-market for drug developers and CDMOs.

Ideal for multi-dose applications, these vials support repeated withdrawal while maintaining container closure integrity—ensuring patient safety and regulatory compliance throughout the product lifecycle.

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ویژگی‌ها و مزایای کلیدی

• ✅ شیشهٔ بوروسیلیکات نوع I – Compliant with USP <660>, EP 3.2.1, and YBB00292005-2-2015
• ✅ آماده مصرف (RTU) – Pre-sterilized and pre-assembled with stopper and cap
• ✅ Multi-Dose Compatible – Supports multiple entries with standard needles
• ✅ Low Particulate & Low Leachables – Minimizes interaction with sensitive biologics
• ✅ Thermal Shock Resistant – Stable from -70°C to +100°C, suitable for cold-chain logistics
• ✅ Global Regulatory Alignment – Meets FDA, EMA, and NMPA packaging requirements

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مشخصات فنی

پارامتر	مشخصات
نام محصول	50ml Multi-Dose RTU Vial
برند	فَرگلاس
ظرفیت	50ml (Nominal)
نوع شیشه	شیشهٔ بوروسیلیکات خنثی نوع I
انطباق	USP , EP 3.2.1, YBB00292005-2-2015, ISO 8362-1
روش استریل‌سازی	اکسید اتیلن (ETO)
سطح تضمین استریلیته (SAL)	یک ده به توان منفی شش
سطح اندوتوکسین	<0.25 EU/ml (as per compendial methods)
سیستم بسته‌شدن	Bromobutyl rubber stopper + aluminum crimp seal (or flip-off cap, optional)
قالب بسته‌بندی	Nest-in-tray within double-layer sterile pouches, packed in export cartons
حداقل سفارش	۵۰۰۰ واحد
کاربردها	Monoclonal antibodies, mRNA vaccines (large-volume), insulin, IVIG, biosimilars

Note: Stopper and cap materials can be customized per client requirements (e.g., coated vs. uncoated, colored flip-off).

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Why Choose Pharglass RTU Vials?

As a trusted global supplier of pharmaceutical primary packaging, فَرگلاس combines advanced manufacturing with rigorous quality control (ISO 15378 & ISO 13485 certified facilities) to deliver vials that meet the highest standards of safety and performance.

Our 50ml multi-dose RTU vials are produced in a Class 10,000 (ISO 7) cleanroom environment, with full traceability from raw material to finished goods. Every batch undergoes comprehensive testing for:

• Hydrolytic resistance
• Particulate matter
• Dimensional accuracy
• Container closure integrity (CCI)

We support خدمات OEM/ODM, including custom labeling, unique serialization, and tailored packaging configurations for clinical trials or commercial launch.

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Typical Use Cases

• Large-volume vaccine formulations (e.g., pandemic response stockpiles)
• Hospital pharmacy multi-dose reconstitution
• Biopharma bulk fill of therapeutic proteins
• Global health programs requiring cost-effective, high-integrity packaging

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Trusted by innovators. Engineered for life-saving medicines.
Contact Pharglass today for samples, regulatory documentation (DMF support available), and volume pricing for your next biologic or vaccine project.

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