Product nameTILE-X — Aseptic fill-finish machine with magnetic levitation for RTU vials, syringes and cartridges
Machine overviewTILE-X is an aseptic fill‑finish machine developed for high-value biopharmaceuticals including ATMPs and cell & gene therapies. The system uses magnetic levitation floating shuttles for frictionless, particle‑free transport of single containers or RTU nests within gloveless isolator modules. The modular architecture assigns one production phase per sealed module to minimise contamination risk and simplify qualification.
Key features- Magnetic levitation floating shuttles for particle‑free transport of single vials or RTU nests.
- Gloveless, closed isolator modules (each module functions as a Grade A gloveless isolated chamber).
- Modular architecture: dedicated modules for RTU component introduction, de‑lidding/de‑nesting, filling with 100% check‑weighing, capping, crimping, etc.
- Fully automatic machine set‑up with automated positioning and loading of size parts and product‑contact components.
- Automatic handling and replacement of viable particle (EM) plates without manual intervention.
- Integration options for No‑Touch‑Transfer or compact RTU decontamination solutions for component feeding.
- Flexible dosing: peristaltic, volumetric or time‑pressure dosing systems depending on product formulation (including suspensions, cold filling).
- Throughput up to 40 pieces per minute for RTU syringes, vials and pre‑capped cartridges (glass or polymer), depending on configuration.
- Capability to run multiple compounding recipes and mixed formulations within single fill runs.
- Compact design reduces footprint and cleanroom class requirements to facilitate rapid scale‑out.
Machine concept and processTILE‑X applies a gloveless, modular concept where magnetic transport allows freely programmable trajectories for single containers or nests. Each module is individually sealed with automatic airtight doors and supports pressure cascade management to maintain first‑air protection and limit cross‑contamination. Loading of autoclaved stoppering and capping parts is performed via RTP port and canister inside a dedicated preparation module, avoiding complex bag‑in/bag‑out procedures.
ApplicationsDesigned for small‑batch, high‑value aseptic production: ATMPs, cell & gene therapies and advanced biologics where sterility assurance, particle control and process flexibility are critical.
Highlights- Particle‑free magnetic levitation transport.
- Gloveless isolator concept enabling Grade D installation with Grade A modular chambers.
- Automatic EM plate handling and full machine auto‑set‑up.
- Compact modular layout for fast production scale‑out.
- Up to 40 pcs/min throughput for RTU formats (dependent on format and configuration).
Technical specifications- Model name: TILE‑X.
- Processing mode: Aseptic fill‑finish with magnetic levitation transport.
- Formats handled: RTU vials, RTU syringes, pre‑capped cartridges (glass or polymers).
- Maximum nominal throughput: up to 40 pieces per minute (format and configuration dependent).
- Isolator concept: multiple independent Grade A gloveless isolated chambers with automatic airtight doors and pressure cascade management.
- Transport: floating shuttles via magnetic levitation for frictionless, particle‑free movement; programmable trajectories.
- Set‑up: automatic machine set‑up and automatic positioning/loading of size parts (filling needles, stoppers, caps).
- EM plate handling: automatic change without manual intervention; compatible with real‑time viable monitoring.
- Feeding options: RTP port & canister; compatible with No‑Touch‑Transfer or compact RTU decontamination technologies.
- Filling/dosing options: peristaltic, volumetric, or time‑pressure dosing systems.
- Quality controls: 100% check‑weighing during filling (inspection integration configurable).
- Suitable for: ATMPs, cell & gene therapies, high‑value advanced biologics and small‑batch production.
- Design goal: minimal product loss and configurable filling circuit to match product‑specific requirements (e.g., suspensions, cold filling).