Pharmaceutical Primary Packaging by Pharglass | USP/EP Aligned | Trusted for Parenteral Formulations in China & Global Markets
Pharglass 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 Нейтральное боросиликатное стекло типа I, 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 и European Pharmacopoeia 3.2.1, enabling dual-track regulatory submissions for global commercialization.
Ключевые особенности и преимущества
- ✅ Полное соответствие стандарту 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
- ✅ Глобальная гармонизация – Meets key requirements of USP & EP for international filings
- ✅ Low Particulates & Controlled Surface Quality – Reduces risk of visible/invisible particles in solution
- ✅ Стандартная отделка горловины ISO – Compatible with serum stoppers, crimp seals, and flip-off caps
Технические характеристики
| Параметр | Технические характеристики |
|---|---|
| Название продукта | YBB-Compliant Pharmaceutical Glass Vials |
| Бренд | Pharglass |
| Capacities (ISO Sizes) | 2R (2 мл), 5R (5 мл), 10R (10 мл), 20R (20 мл), 30R (30 мл), 50R (50 мл) |
| Тип стекла | Neutral Type I Borosilicate Glass |
| Основной стандарт | YBB00292005-2-2015 (China National Standard) |
| В соответствии с | USP , EP 3.2.1, ISO 8362-1 |
| Устойчивость к гидролизу | ≤ 0,10 мл 0,01N HCl/г стекла (испытание на порошкообразное стекло согласно YBB) |
| Варианты цвета | Clear (standard); Amber (UV protection, on request) |
| Отделка шеи | Standard ISO finish (e.g., 13mm, 20mm) for rubber stoppers |
| Упаковка | Bulk in clean, dust-proof cartons or nest trays for automated handling |
| Варианты стерильности | Нестерильные (стандартные); стерильные (гамма/ЭТО, SAL 10-⁶). |
| MOQ | 5,000 шт. |
| Приложения | 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:
- Гидролитическая стойкость (деалкализация стекла)
- Thermal shock resistance
- Internal surface uniformity
- Точность размеров
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.
Настройка и нормативная поддержка
- Тисненая маркировка объема или логотипы клиентов
- Предварительно простерилизованный Готовые к заполнению (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.
📩 Свяжитесь с нами сегодня for samples, YBB test reports, or a quote tailored to your fill-finish operation!
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