RTU Glass Vials with Nest and Tub for Aseptic Filling
Tamaños:
2R, 4R, 6R, 8R, 10R, 15R, 20R, 25R, 30R, 50R
Capacidades principales:
Wash-free and ready for filling
Pre-sterilized sterile barrier packaging
Pyrogen-control process support
Nest & Tub format for automated aseptic filling
Reduced glass-to-glass contact during handling and transport
Descripción:
RTU Vials with Nest and Tub are ready-to-use sterile glass vials designed for direct integration into aseptic filling lines. Each system combines borosilicate glass injection vials, PP nest, HIPS tub, Tyvek® sterile barrier components, double sterile bags, and ETO sterilization to help pharmaceutical manufacturers reduce preparation steps before filling.
This product is suitable for pharmaceutical companies, CDMOs, biotech manufacturers, and fill-finish operations that require ready-to-use vials with nest and tub packaging for biologics, vaccines, blood products, and high-value injectable formulations.
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RTU Vial Advantages
Eficiencia de llenado plug-and-play
The Nest & Tub system allows RTU sterile vials to be loaded directly into compatible aseptic filling environments, reducing in-house washing, depyrogenation, and sterilization preparation work.
Sterile Barrier Protection
Tyvek® inlay, Tyvek® seal, double sterile bags, and tub packaging support contamination-controlled transfer into sterile production areas.
LINUO Nest & Tub packaging; shipment configuration must follow the released specification.
Envío de viales estériles listos para su uso: integridad, riesgos durante el transporte y controles de recepción
Match transport and receiving controls to the released vial, nest, tub and sterile-barrier configuration. Protect the pack from dispatch through controlled opening.
Protect and identify the shipment
Confirm nest/tub support, specified protective inserts, bags, seals, cartons and pallet labels against the released pack specification.
Match evidence to the route
Review drop, vibration and stacking risks, sea or air transport, moisture exposure and carrier hand-offs. Request the report and limits for this configuration.
Inspect, hold and record
Check accessible packaging and labels without opening the sterile barrier. Segregate affected material for QA review if bags are torn or wet, seals are damaged or labels conflict.
Request applicable transport simulation, shelf-life and package-integrity evidence by SKU and packaging revision. Use approved storage, expiry and opened-pack use instructions; no universal shelf life or time after opening is stated.
The nest structure keeps each vial individually positioned, helping reduce vial-to-vial collision, scratches, and breakage during transport, handling, and filling preparation.
Compatibilidad con líneas de llenado
Standardized Nest & Tub formats are designed to support automated loading and stable transfer on aseptic filling equipment.
Filling-Line Compatibility, Format Parts and Trial Protocol
Qualify the complete Nest & Tub system against your filling line. Start with the vial drawing and nest/tub interfaces, then confirm format parts, transfer method and performance with a recorded trial.
LINUO Nest & Tub packaging. Confirm the exact configuration against the SKU drawing.
2R, 6R and 10R Nest & Tub reference dimensions
SKU / drawing
Vial dimensions (mm)
Packaging interface
Reference
2R / V002050086A
Body Ø16.00 ±0.15; height 35.00 ±0.50; flange Ø13.00 +0.20/-0.30.
100 positions; nest footprint 230 × 198 mm (nominal). Confirm pitch, locating features, lift height and tub drawing.
These values describe the listed Nest & Tub drawings only. Matching outer dimensions or position counts does not establish interchangeability. Request the current released vial, nest and tub drawings, with all tolerances, before tooling approval; confirm tub dimensions and datum definitions with LINUO.
From interface review to documented trial
Match the OEM and format parts
Record the filling-line OEM, model, software or recipe revision, target speed in vials/min and current format-part IDs. Agree the SKU-specific CAD revision, sample quantity and acceptance criteria before the trial.
Open, de-nest and transfer
Check bag opening, lid peeling, nest orientation, gripper contact, lift clearances and vial hand-off. Compare in-nest processing with de-nesting where required; record interventions, jams, tipping and glass contact.
Fill, stopper and lyophilize
Verify filling-needle alignment, fill accuracy and stopper feeding. For lyophilized products, assess partial stoppering, transfer to the lyophilizer, shelf or carrier interface and final stoppering under the agreed process.
Crimp, inspect and accept
Check cap and stopper fit, crimp settings, inspection and reject handling. Record actual throughput, run duration, sample count, breakage, cosmetic defects and deviations against the pre-agreed limits.
Compatibility is established for the tested vial SKU, packaging revision, closure system, machine configuration and operating range. An equipment trial does not replace aseptic process validation, formulation compatibility studies or container-closure integrity testing of the filled and closed product.
Evaluación de viales listos para su uso (RTU) en aisladores, RABS y líneas de alta velocidad
Assess the complete Nest & Tub transfer route before committing to a filling-line configuration. Mechanical fit alone does not establish aseptic suitability or validated throughput.
Opening and aseptic boundaries
Map outer-bag removal, lid peeling and protected transfer. Identify exposed surfaces and how the isolator or RABS transfer procedure protects them.
De-nesting and contact scope
Confirm gripper access, lift clearance and each hand-off. Define where vials remain separated and where guides or tooling make contact.
Interventions and line performance
Agree how to assess mispicks, jams, breakage, stoppages and inspection/reject handling. Record actual throughput and results against pre-agreed limits.
LINUO’s RTU production workflow includes washing, depyrogenation, optional siliconization, AI inspection, double bagging, ETO sterilization, and sterility testing support.
B2B Supply Stability
Linuo provides integrated pharmaceutical glass packaging capability, supported by in-house glass tubing resources, smart manufacturing, CNAS laboratory testing, and global pharmaceutical packaging experience.
Doble bolsa: polietileno de baja densidad (LDPE)
and Tyvek®
ISO 10993-5
Método de esterilización
ETO
ISO 17665-1
GB 18279.1-2015
GB/T 18279.2-2015
RTU Vial Manufacturing Process
· 01
Automatic feeding
· 02
Ultrasonic Cleaning & WFI Rinsing
· 03
Secado con aire caliente en túnel
· 04
Siliconization Treatment
· 05
Batch Loading Tray Loading System
· 06
Inspección visual mediante IA
· 07
Double-Layer Packaging
· 08
Ethylene Oxide (EtO) Sterilization
· 09
Sterility Testing
Flujo de procesos principales
Programa de lavado de núcleos
Sistema avanzado de limpieza en varias etapas diseñado para envases farmacéuticos de vidrio, que garantiza un alto nivel de limpieza, bajos niveles de partículas y el control de endotoxinas, de conformidad con las normas aplicables a los productos inyectables.
6× Soplado de aire (aire ionizado para la eliminación de partículas grandes)
2 enjuagues con agua purificada (eliminación de residuos químicos)
2 enjuagues con agua para inyección (WFI) (control de endotoxinas y pirógenos)
Cuadro de mando de los puntos críticos de control (PCC) de la esterilización por ETO
Nuestro proceso de esterilización se supervisa rigurosamente para garantizar una seguridad absoluta y una esterilidad 100%:
Temperatura: 30–60 ℃
Concentración de ETO: 250–1200 mg/L
Duración: de 4 a 12 horas
Humedad: 30%–80% HR
Alerta de fugas en el prevacío: un cambio de presión superior a 3 kPa/min activa la parada automática inmediata.
Apertura de seguridad: La puerta solo se abre cuando la presión interna se encuentra dentro de un margen de 5 kPa respecto a la presión atmosférica.
Aplicaciones y casos de uso
Campo de las vacunas
Productos sanguíneos
Sector biofarmacéutico
Medicamentos innovadores de alto valor
Medicina estética
Tecnologías principales
Personalización y servicios OEM/ODM
Dimensiones
Capacidad personalizada (0,1 ml–50 ml+), diámetro, altura y grosor de pared
Impresión y codificación
Serigrafía, impresión HD, codificación láser, estampado en caliente
Siliconización y recubrimiento
Superficie interior hidrófoba; recubrimiento exterior bloqueador de UV o antifricción
Envasado y esterilización
A granel/RTU en nido y bandeja /RFF; esterilización ETO disponible
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