Los viales de vidrio RTU de LINUO están diseñados para fabricantes farmacéuticos que buscan eficiencia con llenado directo, menos pasos de preparación y una transferencia estéril confiable. Disponibles de 2R a 50R, nuestros viales estériles RTU son compatibles con biofármacos, vacunas, productos sanguíneos, medicina estética y formulaciones inyectables de alto valor.
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LINUO’s RTU glass vials provide a ready-to-use sterile packaging solution for high-end aseptic filling lines. Each vial is supplied washing-free, depyrogenation-free, and pre-sterilized, helping pharmaceutical manufacturers reduce in-house preparation, eliminate the need for additional WFI washing systems and depyrogenation tunnels, and lower CAPEX, floor space, and maintenance requirements.
Available in 2R, 4R, 6R, 8R, 10R, 15R, 20R, 25R, 30R, and 50R sizes, LINUO RTU sterile vials are compatible with mainstream automated filling machinery and support direct loading into sterile production workflows. The standardized RTU Nest & Tub and flexible RTU Tray formats are designed for smooth line integration, reduced machine downtime, and safe Grade A/B transfer.
Viales estériles RTU · Embalaje en nido y bandeja · Aplicaciones para medicamentos inyectables
Cartuchos de vidrio RTU · Llenado directo · Procesamiento aséptico
Vidrio borosilicato de tipo I · Cuello para engarzar · Envases para inyectables · Transparentes/ámbar
Cartuchos de vidrio RTU · Llenado directo · Procesamiento aséptico
Los viales estériles RTU se entregan sin necesidad de lavado ni despirogenización y previamente esterilizados, lo que permite a los clientes reducir los pasos de preparación y avanzar directamente hacia el llenado aséptico.
Al prescindir de los sistemas de lavado con WFI y de los túneles de despirogenización, los viales RTU ayudan a reducir la inversión de capital, el espacio en salas limpias, el mantenimiento de los equipos y la complejidad operativa.
Individual vial support can reduce vial-to-vial contact within the defined packaging configuration. Confirm the contact scope during unloading and line transfer, and record scratches, breakage and handling interventions during the SKU-specific trial.
Vacuum-sealed Tyvek® double breathing bags and clean-peel technology help prevent fibers or particles from entering the sterile zone, supporting clean Grade A/B transfer.
Assess each Nest & Tub or Tray configuration with the selected machine OEM, format parts and transfer method. Establish the acceptable operating range through a documented trial, recording actual throughput, stoppages, interventions and changeover performance.
The ETO sterilization process is controlled through temperature, concentration, time, humidity, pre-vacuum leak alert, and atmospheric pressure safe-release logic to support sterility assurance.
| Parameter | Especificación |
| Product Type | Vial de vidrio RTU / vial estéril listo para usar |
| Size Range | 2R · 4R · 6R · 8R · 10R · 15R · 20R · 25R · 30R · 50R |
| Packaging Formats | RTU Nest & Tub · RTU Tray |
| Production Value | Non-contact handling prevents glass-to-glass contact and scratches |
| Inner Packaging | Tyvek® double breathing bags |
| Embalaje exterior | Reinforced corrugated carton |
| Carton Size | L 800mm × W 245mm × H 250 / 270 / 290mm |
| Logistics Standard | Palletized · Cold-chain ready · Safe Grade A/B transfer |
| Process Flow | Auto-loading · Ultrasonic clean & WFI rinse · Tunnel depyrogenation · Siliconization · Nesting · AI inspection · Double bagging · Terminal ETO sterilization · Sterility testing |
| Washing Program | 6× air blowing for inner/outer wall · 3× WFI rinse for inner/outer wall |
| Sterilization Method | Esterilización terminal con ETO |
| Temperatura de ETO | 30–60°C |
| Concentración de ETO | 250–1200 mg/L |
| ETO Time | 4–12 hours |
| Humidity Range | 30%–80% RH |
| Pre-vacuum Leak Alert | >3KPa/min pressure change triggers immediate auto-stop |
| Safe Release | Door opens only when internal pressure is within 5KPa of atmospheric pressure |
| Quality Control | 100% AI vision inspection · Siemens MES tracking |
| Cumplimiento de normas | USP · EP · JP · ChP |
| Global Certifications | FDA DMF · ISO 15378 · EU CEP · Russian RU |
| Personalización | Vial size · RTU format · Nest & Tub · RTU Tray · sterile barrier packaging · OEM RTU pharmaceutical packaging |
PRE-TRIAL REQUEST CHECKLIST
Before samples or a filling-line trial, confirm the SKU, RTU packaging configuration and document scope below. Public references are shown separately; batch-specific and controlled records are released only for the agreed project stage.
Public reference set: 2026-09-22 | SOP/ZG 241, 242, 243 and 248: A/1, effective 2026-07-02
Confirm the vial SKU, nominal size (for example 2R, 6R or 10R), glass type, neck/finish, drawing revision and required dimensional tolerances.
SKU-specific dimensional drawing, CAD/drawing revision and approved specification boundary. Do not use a Nest drawing as evidence for a Tray SKU.
Select Nest & Tub or Tray, confirm nest/tub/tray interface, bag configuration, carton and pallet requirements, and the intended Grade A/B transfer route.
Packaging configuration record plus the applicable controlled quality standards for the tub, nest, tray and breathing bags.
Confirm sample quantity, destination, Incoterms, importer or consignee requirements, requested supply status and whether the trial is development, qualification or commercial preparation.
A project-specific supply and sample plan. Country or project statements are limited to the confirmed scope and date on the request.
Confirm whether the requested RTU SKU is supplied pre-sterilized, the applicable sterilization summary, storage and transport conditions, shelf-life or retest basis, and release status.
Status-matched sterilization, storage, transport and release documents. These are not substituted by a generic product page statement.
Identify the batch or sample lot and the tests required for release, including appearance, dimensions, particulate, sterility, endotoxin and other agreed attributes.
A batch-linked CoA or agreed release package. A generic sample CoA is not a substitute for the formal batch release record.
Confirm the governing USP, EP, JP, ChP or approved enterprise specification, plus any customer validation, Annex 1 or contamination-control requirements.
The applicable standard and qualification checklist, with revision and effective date where stated in the controlled document.
Confirm stopper, seal and crimp configuration, target fill volume, lyophilization cycle or thermal exposure, and the required container-closure integrity evidence.
An agreed closure and process-interface record for the selected vial SKU. Closure compatibility remains project-specific.
Provide line OEM, machine model, target speed, format parts, loading/unloading method, denesting or transfer steps, filling, partial stoppering, lyophilization, capping and inspection requirements.
A SKU-specific trial protocol and acceptance record covering throughput, stoppages, interventions, changeover and observed defects. No universal speed or OEM validation is implied.
Productos biológicos de alta sensibilidad que requieren niveles ultrabajos de sustancias extraíbles y una resistencia hidrolítica superior. Recomendados: viales de borosilicato Tipo I, cartuchos, jeringas precargadas (PFS).
Los anticuerpos monoclonales y los ADC requieren inercia química y tolerancias dimensionales precisas para las líneas automatizadas de llenado y acabado. Recomendados: viales RTU, PFS y cartuchos.
Producción a gran volumen con calidad de lote constante y pleno cumplimiento de las farmacopeas. Recomendados: viales tubulares, ampollas y viales moldeados.
Líneas de llenado de alta velocidad que requieren precisión dimensional y envases de vidrio sin defectos. Recomendados: ampollas, viales tubulares.
Los ciclos de liofilización requieren resistencia al choque térmico y una integridad segura del cierre. Recomendados: viales tubulares compatibles con tapones de goma.
Presentación prémium combinada con seguridad y esterilidad de grado farmacéutico. Recomendado: viales RTU y PFS, con opciones de impresión y personalización de marca.
Custom RTU vial supply across 2R, 4R, 6R, 8R, 10R, 15R, 20R, 25R, 30R, and 50R formats.
Standard RTU Nest & Tub format or flexible RTU Tray format according to filling-line requirements.
Tyvek® double breathing bags, reinforced corrugated cartons, palletized logistics, and Grade A/B transfer-ready packaging.
AI inspection, Siemens MES lifecycle tracking, batch documentation, and compliance support for validation workflows.
9.6B+ units annual capacity; $694M+ annual sales. 900,000+ m² Smart Factory; 500+ Core Production Machines. 13K+ tons annual glass tubing output, ensuring material security. We have built a full industrial chain spanning glass tubing — to tubular and moulded vials.
Dedicated QA/QC team. CNAS-accredited lab (ICP-MS, SEM-EDS); full testing per ChP/USP/EP/JP.Certified to the full ISO suite (including 15378), FDA DMF, EU CEP, and Russian PJ.
130+ patents; $4.2M+ annual R&D; 20+ standards. Custom solutions across performance, form, ID/printing, capacity, and packaging/sterilization — including PFS & RTU systems.
Modelo de centros globales: I+D en Alemania y sede central en Dubái, con bases de producción en Oriente Medio, el Sudeste Asiático y Sudamérica. Garantiza la resiliencia de la cadena de suministro y el servicio local. Los principios ESG están integrados en las operaciones y en el ciclo de vida de los productos.
100% AI inspection; “Zero Glass Debris” tech. Digital twin (Siemens/Horn/ANSYS); robotics; energy/carbon management.
Sede de la única Base de Formación en Vidrio Farmacéutico de China. Más de 30 años de experiencia; cuenta con la confianza de 1 de cada 3 empresas farmacéuticas del mundo y presta servicio a más de 10.000 clientes en más de 100 países.
Años de experiencia
Atendemos a más de 100 países
A controlled document pathway for pharmaceutical manufacturers qualifying RTU glass vials for United States and European Union markets.
Applicable USP, EP, JP, ChP or approved corporate specification identified for each vial configuration.
View quality and standards support →TDS, CAD drawings, Certificate of Analysis, batch release information and traceability records matched to SKU and project stage.
View approved document downloads →Controlled documentation may include sterilization summary, sterility, endotoxin, particulate and container-closure integrity evidence.
Review validation support →Documentation support for qualification workflows aligned with GMP Annex 1 and the customer contamination control strategy.
Request controlled evidence →
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