RTU Glass Vials with Tray Packaging for Aseptic Filling
Afmetingen:
2R, 4R, 6R, 8R, 10R, 15R, 20R, 25R, 30R, 50R
Kernmogelijkheden:
Ready-to-use tray format for flexible filling line integration
Non-contact handling to help prevent glass-to-glass scratches
Tyvek® double breathing bags for sterile barrier protection
ETO terminal sterilization with controlled process monitoring
Beschrijving:
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.
Linuo RTU tray vials are supplied washing-free, depyrogenation-free, and pre-sterilized to help reduce in-house preparation steps, lower cleanroom workload, and support stable sterile production.
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RTU Tray Vial Advantages
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.
Verzending van steriele, gebruiksklare flacons: integriteit, transportrisico’s en controles bij ontvangst
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.
Contamination-Free System Design:
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.
Beoordeling van RTU-flacons op isolatoren, RABS en hogesnelheidslijnen
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
Components
Material Description
Regulations and Standards Compliance
Glass injection vials
Borosilicate glass
ISO 8362-1、YBB00292005-2-2015
Tray
Polypropylene (PP)
ISO 10993
USP
Tyvek® inlay
Tyvek®： PE-HD fiber
ISO 10993-5
Tyvek® seal
Tyvek®： PE-HD fiber and hot melt adhesive
ISO 10993-5
Sterilized bags
Double bag:low-density polyethylene (LDPE)
ang Tyvek®
ISO10993-5
Sterilisatiemethode
ETO
ISO17665-1
GB 18279.1-2015
GB/T 18279.2-2015
RTU Tray Vial Manufacturing Process
· 01
Automatic feeding
· 02
Ultrasonic Cleaning & WFI Rinsing
· 03
Tunnel Hot Air Drying
· 04
Siliconization Treatment
· 05
Batch Loading Tray Loading System
· 06
AI Vision Inspection
· 07
Double-Layer Packaging
· 08
Ethylene Oxide (EtO) Sterilization
· 09
Sterility Testing
Kernprocesstroom
Programma voor het reinigen van de kern
Geavanceerd meerfasig reinigingssysteem, speciaal ontworpen voor farmaceutische glazen verpakkingen, dat een hoge mate van reinheid, een laag deeltjesgehalte en endotoxinebeheersing garandeert, in overeenstemming met de normen voor injecteerbare producten.
6× Luchtstroom (geïoniseerde lucht voor het verwijderen van grote deeltjes)
2× spoelen met gezuiverd water (verwijdering van chemische resten)
2× WFI-spoeling (controle op endotoxinen en pyrogenen)
ETO-sterilisatie CCP-dashboard
Ons sterilisatieproces wordt streng gecontroleerd om absolute veiligheid en 100%-steriliteit te garanderen:
Temperatuur: 30–60 ℃
ETO-concentratie: 250–1200 mg/l
Duur: 4–12 uur
Luchtvochtigheid: 30%–80% RH
Waarschuwing bij lek in het voorvacuüm: een drukverandering van meer dan 3 kPa per minuut leidt tot onmiddellijke automatische uitschakeling.
Veilige ontgrendeling: De deur gaat alleen open wanneer de interne druk binnen 5 kPa van de atmosferische druk ligt.
Toepassingen en scenario's
Vaccinatiegebied
Bloedproducten
De biofarmaceutische sector
Innovatieve geneesmiddelen met een hoge waarde
Esthetische geneeskunde
Luxe cosmetica
Maatwerk en OEM/ODM-diensten
Afmetingen
Aangepaste inhoud (0,1 ml – 50 ml+), diameter, hoogte, wanddikte
Bedrukken en coderen
Zeefdruk, HD-druk, lasermarkering, warmdruk
Siliconisatie en coating
Hydrofobe binnenkant; UV-werende of wrijvingsverminderende buitenlaag
Verpakking en sterilisatie
Bulk/RTU nest-and-tub /RFF; ETO-sterilisatie mogelijk
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