ISO Standard & USP Compliant Pharmaceutical Glass Vials for Global Markets


ISO Standard & USP Compliant Pharmaceutical Glass Vials for Global Markets

PharGlass delivers ISO and USP-compliant pharmaceutical glass vials designed to meet the highest global standards in quality, safety, and regulatory compliance. These 10ml clear borosilicate glass vials are Ready-to-Use (RTU), ETO sterilized, washed, and depyrogenated—ideal for injectable drugs, biologics, vaccines, and sterile liquid formulations intended for export to North America, Europe, Asia, and beyond.

Manufactured under GMP-compliant facilities in Henan, China, our vials are engineered to ensure chemical stability, sterility, and compatibility with sensitive pharmaceutical products—making them a trusted choice for manufacturers seeking reliable packaging solutions that pass stringent international inspections.


✅ Why Choose PharGlass ISO & USP Compliant Vials?

  • Regulatory Compliance: Meets USP <660>, USP <85>, EP 3.2.1, و ISO 15884 standards for pharmaceutical glassware.
  • High Purity & Inertness: مصنوعة من زجاج البورسليكات من النوع I, resistant to leaching and pH changes—critical for long-term stability.
  • Sterile & Ready-to-Use: Pre-sterilized via Ethylene Oxide (ETO), thoroughly washed, and validated for use without additional processing.
  • Depyrogenated: Endotoxin levels below 0.25 EU/mL, ensuring safe use in injectable applications.
  • Sealed with Rubber Stopper: Ensures leak-proof containment and prevents microbial ingress.
  • Hot Stamping Compatible: Enables permanent marking of batch numbers, expiry dates, and barcodes.
  • Customizable Branding: Accepts custom logos, cap colors, and labeling for OEM/ODM clients.

💡 According to the U.S. Pharmacopeia (USP), glass containers must be free from defects and contaminants that could affect drug safety or efficacy. Our vials undergo rigorous testing to ensure full compliance with USP Chapter <660> for glass containers.


🔬 Key Product Specifications

السمةالمواصفات
نوع الختمسدادة
الشكلأسطوانة مستديرة
مع ناشر ريدلا يوجد
مناولة السطحالختم الساخن
رقم الموديلوحدة إعادة التدوير
اسم العلامة التجاريةفار جلاس
مادة الجسمزجاج (بوروسيليكات)
مادة الياقةزجاج
اسم المنتج2R 2ml 3ml Clear RTU Washed Sterile Glass Bottle Vial
السعة10ml
الموادزجاج
لون الغطاءتتوفر ألوان مخصصة حسب الطلب
الاستخدامLiquid Pharmaceuticals, Injectables, Biologics
معالجة الطباعةملصقات، ختم ساخن
مكان المنشأخنان، الصين
الاستخدام الصناعيPharmaceutical Packaging
موك5000 قطعة
تصنيع المعدات الأصلية/التصنيع حسب الطلبمقبولة
الشعارالشعار المخصص مقبول
التعبئةكرتون

🌐 Applications in Global Pharmaceutical Markets

These vials are widely used by manufacturers exporting to:

  • North America: FDA-regulated markets requiring strict adherence to USP standards.
  • Europe: CE-marked products compliant with EU pharmacopoeia (EP).
  • Asia-Pacific: Countries like Japan, South Korea, and India with high-quality requirements.
  • Middle East & Africa: Growing demand for sterile injectables and vaccines.

Ideal for:

  • Injectable medications (antibiotics, analgesics)
  • اللقاحات (mRNA, subunit, live attenuated)
  • البيولوجيا (monoclonal antibodies, recombinant proteins)
  • Generic drugs requiring cost-effective, compliant packaging

📊 The global pharmaceutical packaging market is projected to exceed $150 billion by 2030, driven by demand for compliant, sustainable, and smart packaging solutions (Source: Statista).


🌍 Manufacturing Excellence & Quality Assurance

صُنع في خنان، الصين, under GMP-compliant facilities, each vial undergoes:

  • Automated inspection for defects (cracks, bubbles, surface flaws)
  • Sterilization via ETO gas (residual levels <10 ppm)
  • Depyrogenation process to remove endotoxins
  • Leak testing under vacuum pressure
  • Visual and dimensional quality checks
  • Compliance testing against USP, EP, and ISO standards

All products are ISO 9001, ISO 13485, and FDA registered, ensuring alignment with global regulatory expectations.


🎯 خيارات التخصيص

PharGlass supports full branding and functional customization:

  • Hot-stamped labels (batch codes, expiry dates, lot numbers)
  • ألوان الغطاء المخصص for product differentiation (e.g., blue for antibiotics, red for emergency use)
  • وضع العلامات الخاصة و طباعة الشعار المخصص
  • العبوات الكرتونية السائبة optimized for warehouse handling and shipping

📦 Packaging & Logistics

  • التعبئة: Standard export cartons (customizable per order)
  • Shipping Terms: FOB، CIF، DDP متاح
  • المهلة الزمنية: من 15 إلى 30 يومًا بعد تأكيد الطلب
  • الشهادات: ISO 9001، ISO 13485، ISO 13485، CE، الشركة المصنعة المسجلة لدى إدارة الغذاء والدواء الأمريكية

✅ Trusted by Global Pharmaceutical Manufacturers

قامت شركة PharGlass بتوريد high-compliance packaging solutions to leading pharmaceutical companies across North America, Europe, and Asia. Our vials are trusted for their consistency, clarity, and regulatory readiness in global supply chains.


📞 اتصل بنا اليوم
Need samples? Want to discuss custom labeling or regulatory support? Our technical team is ready to assist with product specifications, MOQ negotiation, and bulk orders. Let’s build compliant, globally accepted packaging together.


PharGlass – Engineering Trust for Global Pharmaceutical Markets.

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