YBB00292005-2-2015 Frascos para injeção em conformidade - Vidro tubular com extremidade de ombro, tipo I

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

Pharglass YBB00292005-2-2015 compliant injection vials apresentar um tubular shoulder-ended design—the gold standard for modern parenteral packaging—manufactured from vidro borossilicato neutro tipo I 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 e EP 3.2.1 for global regulatory flexibility.

O 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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Principais recursos e benefícios

• ✅ Conformidade total com a norma 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
• ✅ Vidro de borosilicato neutro tipo I – Ultra-low leachables; ideal for pH-sensitive formulations
• ✅ Harmonização Global – Meets core requirements of USP <660> and EP 3.2.1
• ✅ Low Particulate Generation – Smooth interior minimizes particle shedding during filling
• ✅ Acabamentos padrão ISO para colares – Seamless integration with stoppers, caps, and robotic handling systems

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Especificações técnicas

Parâmetro	Especificação
Nome do produto	Tubular Shoulder-Ended Injection Vials
Marca	Pharglass
Tipo de vidro	Type I Neutral Borosilicate (tubular drawn)
Design	Shoulder-ended (ISO 8362-1 compliant profile)
Nível Fundamental	YBB00292005-2-2015 (China National Standard for Injection Vials)
Em consonância com	USP , EP 3.2.1, ISO 8362-1
Resistência à hidrólise	≤ 0,10 ml de HCl 0,01 N/g de vidro (teste do vidro em pó conforme YBB)
Capacities (Standard ISO Sizes)	2R (2 ml), 5R (5 ml), 10R (10 ml), 20R (20 ml), 30R (30 ml), 50R (50 ml)
Opções de cores	Clear (standard); Amber (UV-protective, on request)
Acabamento do braço	Standard ISO finish (e.g., 13mm, 20mm) for rubber stoppers and aluminum seals
Embalagem	Bulk in clean, dust-proof cartons or nest trays for automated lines
Opções de esterilidade	Disponível na versão não estéril (padrão) e estéril (gama/ETO, SAL 10⁻⁶)
MOQ	5.000 unidades
Aplicativos	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:

• Resistência à hidrólise (desalcalinização do vidro)
• Thermal shock stability
• Internal surface homogeneity
• Precisão dimensional (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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Personalização e Suporte Regulatório

• Marcações de volume em relevo ou logotipos de clientes
• Pré-esterilizado Pronto para encher (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.

📩 Entre em contato conosco hoje mesmo for samples, YBB test reports, or a quote for your next NMPA or global filing!