Viales de vidrio RTU con envase en bandeja para llenado aséptico
Tamaños:
2R, 4R, 6R, 8R, 10R, 15R, 20R, 25R, 30R, 50R
Capacidades principales:
Formato de bandeja listo para usar para una integración flexible en líneas de llenado
Manipulación sin contacto para ayudar a evitar arañazos entre vidrios
Bolsas dobles de respiración Tyvek® para la protección de la barrera estéril
Esterilización terminal con ETO y monitorización controlada del proceso
Descripción:
RTU Vials with Tray Packaging are designed for pharmaceutical manufacturers, CDMOs, and fill-finish facilities that need ready-to-use sterile vials for direct integration into aseptic filling lines.
Los viales RTU en bandeja de Linuo se suministran sin necesidad de lavado ni despirogenización y preesterilizados, lo que ayuda a reducir los pasos de preparación interna, disminuir la carga de trabajo de la sala limpia y favorecer una producción estéril estable.
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Ventajas de los viales RTU en bandeja
Plug-and-Play RTU Efficiency:
RTU tray supply can reduce preparation steps before filling. Confirm the required packaging removal, tray unloading, format parts and transfer sequence on the selected equipment before assigning a production speed.
Sterility Assurance Improvement:
Pre-sterilized vial + tray system reduces human contact exposure. Supports GMP Annex 1 compliant aseptic manufacturing environments.
LINUO Tray packaging; protective components and limits are specific to the selected configuration.
Envío de viales estériles listos para su uso: integridad, riesgos durante el transporte y controles de recepción
Assess the released tray configuration and its own protective packaging. Nest & Tub transport results and handling limits do not automatically apply to Tray.
Protect and identify the shipment
Confirm tray supports, specified protective inserts, sterile-barrier layers, cartons and pallet labels against the selected SKU's 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.
Tray support and a matched unloading sequence can help reduce unintended glass contact. Assess positioning, pickup/release, transfers and handling damage on the selected line; record breakage and interventions against agreed trial criteria.
Diseño del sistema libre de contaminación:
Assess the opening and peeling sequence for particle-generation and transfer risks. Confirm packaging removal, exposed surfaces and protective handling within the site’s contamination control strategy.
Filling-Line Compatibility, Format Parts and Trial Protocol
Qualify the tray and vial as one configuration. Tray loading, release and downstream transfer need their own machine review and trial; Nest & Tub interface data do not establish tray compatibility.
LINUO tray packaging. Tray dimensions, cavity pattern and handling method are SKU-specific.
Tray SKU review: information required before tooling approval
Requested vial format
Vial drawing
Tray interface to confirm
Qualification basis
2R tray configuration
Confirm the tray-supplied vial SKU, body diameter, height, flange and tolerances against its released drawing.
Confirm tray L × W × H, cavity count and pitch, support/contact areas, locating datums, stack separation and pickup/release clearance.
Request the configuration-specific tray drawing and sample plan. Nest dimensions and position counts are not applicable.
6R tray configuration
Confirm the tray-supplied vial SKU, body diameter, height, flange and tolerances against its released drawing.
Confirm tray L × W × H, cavity count and pitch, support/contact areas, locating datums, stack separation and pickup/release clearance.
Request the configuration-specific tray drawing and sample plan. Nest dimensions and position counts are not applicable.
10R tray configuration
Confirm the tray-supplied vial SKU, body diameter, height, flange and tolerances against its released drawing.
Confirm tray L × W × H, cavity count and pitch, support/contact areas, locating datums, stack separation and pickup/release clearance.
Request the configuration-specific tray drawing and sample plan. Nest dimensions and position counts are not applicable.
The available 2R/6R/10R source documents describe Nest & Tub supply. No tray dimensions, cavity counts or rated line speed are inferred from them. Confirm the tray SKU and released interface drawing before ordering format parts.
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, unload and transfer
Confirm bag opening, tray separation, vial pickup or release, support surfaces and transfer into the line. Assess de-nesting only if the selected system includes a nest; otherwise validate the actual tray-unloading method. Record tipping, jams, glass contact and interventions.
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
Evaluate the selected tray, unloading method and downstream transfer on the intended line. A successful Nest & Tub trial does not qualify a tray configuration.
Opening and aseptic boundaries
Map bag opening, tray entry and waste removal. Review exposed surfaces and protection under the site's isolator or RABS transfer procedure.
Unloading and positioning
Assess tray separation, pickup or release, support points and downstream guides. Describe the actual contact scope; do not assume all operations are non-contact.
Interventions and line performance
Record tipping, jams, handling damage, restarts and inspection/reject performance at the intended speeds. Retain configuration details and acceptance records.
Eliminates washing, depyrogenation, and sorting processes. Reduces CAPEX, cleanroom footprint, and operational maintenance cost.
GMP / ISO Compliance Advantage:
Manufactured under ISO 15378 pharmaceutical packaging standards. Fully suitable for global regulated pharmaceutical markets.
RTU Tray Vial Technical Specifications
Componentes
Descripción del material
Cumplimiento de normativas y estándares
Glass injection vials
Vidrio de borosilicato
ISO 8362-1、YBB00292005-2-2015
Bandeja
Polypropylene (PP)
ISO 10993
USP
Tyvek® inlay
Tyvek®: fibra de PE-HD
ISO 10993-5
Tyvek® seal
Tyvek®： PE-HD fiber and hot melt adhesive
ISO 10993-5
Sterilized bags
Doble bolsa: polietileno de baja densidad (LDPE)
ang Tyvek®
ISO 10993-5
Método de esterilización
ETO
ISO 17665-1
GB 18279.1-2015
GB/T 18279.2-2015
RTU Tray 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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