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Fill finish solutions

robocell

Where humans step back, robocell steps forward

Application type
Aseptic(-toxic)
Customization level
Modular configuration

  • Primary packaging

    RTU

  • Units per hour

    Up to 1,200

  • Filling volume

    0.1-50 ml

  • Partner

    groninger

robocell at a glance

Fully automated processes for lights out manufacturing

  • Elimination of human interventions

    Robots perform all aseptic core processes, ensuring maximum product safety

  • Maximum sterility assurance

    Eliminating human intervention in Grade A areas significantly reduces contamination risks

  • Annex 1 compliant

    Engineered from the ground up according to the revised Annex 1, providing future-proof regulatory compliance

  • Reproducible results

    Standardized, robotized operations ensure maximum process reliability and batch-to-batch consistency

  • Maximum flexibility

    Processing of all common RTU containers and closures

  • Maximum OEE

    Fastest changeover times through recipe-based setup and tool-free format changes

  • Product loss minimization

    100% IPC with re-dosing, loss-free start-up and run-down

  • Fast project execution

    Standardized, modular machine design by groninger + SKAN

Application

Flexible automation for demanding and high-value products

  • For clinical trials

    Designed for the safe filling of small batches, particularly suitable for orphan drugs and personalized therapies due to maximum flexibility.

  • For commercial production

    Suitable for scaling up from clinical development to commercial manufacturing. Consistent processes on a single platform and reduced technology transfer effort.

  • For ATMP and biologics manufacturers

    Especially suited for Advanced Therapy Medicinal Products (ATMPs), including gene therapies.

  • For high-potent and complex products

    Compliance with the highest safety standards enables the handling of toxic products.

RTU vial filling line inside isolator with accumulated stoppered vials on conveyor.
Fill Finish

Partnership with groninger

The best of two worlds: SKAN and groninger combine their strengths to set new standards in aseptic filling. Discover how isolator technology, filling expertise and a shared vision come together to create an integrated end-to-end system.

Learn more
Process

Automation and in-process control from start to finish

  • 1

    Aseptic transfer

    RTU materials are transferred via the skanfog FTC (Fast Transfer Chamber) with validated H₂O₂ decontamination.

  • 2

    Tub opening and singulation

    Low-particle tub opening using a vacuum roller. A robot arm singulates the RTU components and transports them in pairs.

  • 3

    Filling and in-process control (IPC)

    Two-head filling station with 100% IPC. Start-up and run-down modes minimize product loss.

  • 4

    Stoppering

    Stopper supply via RTP bags. Robotic sorting (pick and place). Stopper re-seating function. Optional: purge and closure gassing for oxygen-sensitive products.

  • 5

    Lyophilization (optional)

    Seamless connection to (Martin Christ) lyophilizers. Robotic loading without glass-to-glass contact. Full traceability and breakage control through visual inspection of the vials.

  • 6

    Crimping module (optional)

    100% IPC for stopper gap, crimping quality, and color. Defective objects are safely rejected.

  • 7

    Outfeed

    Optional magazine loading or renesting.

Product highlights

Driving innovation for the medicines of tomorrow

  • Robotic handling of RTU vials inside isolator with precise tray transfer system.

    Faster time to market through platform strategy

    robocell supports consistent processes from development to commercialization on a single platform. This reduces technology transfer times and accelerates market approval – especially valuable for orphan drugs and high-cost products.

  • Operator interacting with Robocell filling line in cleanroom isolator environment (groninger and skan).

    Highly automated – highly efficient

    robocell achieves increased overall equipment effectiveness (OEE) through end-to-end automation and short changeover times. Loss-free batch start-up and integrated IPC minimize product loss – a decisive advantage for high-value products and small batches.

  • Open isolator interior of Robocell filling line with integrated glove ports and material handling area.

    Safe handling of toxic substances

    The system provides maximum protection for both personnel and product. Especially for highly potent substances, robocell offers a robust and reproducible solution.

Regulatory requirements

Setting benchmarks in Annex 1 implementation

  • Consistent first-air principle

    robocell ensures a vertical, unidirectional and laminar airflow throughout the entire aseptic core area. The airflow concept strictly follows the first-air principle and was designed based on evidence using CFD analyses and qualified by smoke studies.

  • Automated environmental monitoring

    Environmental monitoring is fully automated. Transfer, placement, and return of agar plates as well as handling of active and passive microbial monitoring are implemented without manual intervention.

  • Aseptic installation of product-critical components

    All components that come into direct or indirect contact with the product are installed automatically after decontamination. This includes the single-use filling path and stopper-contacting parts such as the sorting plate.

Precision handling of open vials during filling inside aseptic isolator.

Technical specifications

  • Footprint

    Compact footprint enabled by modular design

  • Height

    System height approx. 2.6–3.0 m

  • Weight

    Dependent on configuration

  • Layout 1 – Fill finish

    H₂O₂ transfer chamber, infeed module for tub opening and singulation, filling and closing module

  • Layout 2 – Fill finish with crimping

    H₂O₂ transfer chamber, infeed module for tub opening and singulation, filling and closing module, crimping module

  • Layout 3 – Fill finish with freeze-dryer connection

    H₂O₂ transfer chamber, infeed module for tub opening and singulation, filling and closing module, lyophilization loading module, crimping module

  • Throughput

    Up to 1,200 units/hour

  • Tubs / Nests

    2″ – 4″

  • Plastic and glass formats

    RTU vials (2R–30R), syringes (0.5–10 ml*), cartridges (up to 10 ml*) *up to AD 17.05 mm

  • Filling volume

    0.1 – 50 ml

  • Closures

    Coated and uncoated rubber serum and lyophilization stoppers (for vials, syringes, cartridges), plungers, aluminum caps, snap-on caps, flip-off caps

  • Work chamber

    EU GMP Grade A (ISO 5)

  • Decontamination

    >6-log decontamination via skanfog H₂O₂ micro-nebulization with short cycle times (<1 h to 1 ppm)

  • Filters

    H14 HEPA filters covering entire process area

  • Airflow

    Unidirectional First-Air airflow with CFD-optimized design

  • Exhaust

    Direct to room via SKAN nanox catalytic converter for rapid H₂O₂ decomposition (one-pass reduction <0.1 ppm)

  • Pressure zone concept

    Defined pressure cascades and controlled airflow to prevent product carryover, ensuring safe separation between critical areas

  • Filling systems

    Two-head peristaltic pump

  • In-Process Controls (IPC)

    100 % IPC, such as dosage, stopper, and cap inspection

  • Vacuum stopper placement / gas flushing

    Optional for oxygen-sensitive polymer containers and cartridges

  • Format change system

    Recipe-based changeover, tool-free format switching

  • Stopper/cap feeding

    Via single-use RTP bags

  • Crimping station (optional)

    Camera-based crimping control, particle-minimized process with single-disc crimping

  • User interface

    Intuitive HMI for operation and monitoring

  • Data interfaces

    Integrated data connections with remote access capability

  • System integration

    Seamless connection to existing PI systems

FAQs

  • robocell goes beyond conventional automation: robots not only handle object transport, but also critical steps such as environmental monitoring, aseptic set-up, and handover to peripheral equipment like lyophilizers or the crimping station.

  • robocell generates automated, complete process data – including IPC results, environmental monitoring measurements, and robot movements. These data can be directly integrated into digital QMS or MES systems, significantly simplifying GMP-compliant documentation, audit preparation, and root-cause analysis.

  • robocell is more than hardware – it is part of a digital production strategy. With comprehensive sensor technology, digital batch reporting, and interfaces to Manufacturing Execution Systems (MES), it provides a scalable foundation for Pharma 4.0 environments and data-driven decision-making.

  • Changeover times vary depending on machine layout and individual processes, but can be less than 2.5 hours, including decontamination cycle, fully automated aseptic set-up, and environmental monitoring configuration.

  • 24/7 hotline, remote support, requalification services, global spare parts supply, and training ensure maximum system availability.

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