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Full view of the Pure2 M1 integrated small batch filling isolator, featuring a large central processing chamber with four glove ports, side pass-throughs, and an integrated control system in a cleanroom facility.
Fill finish solutions

pure² M1

Getting started with isolator technology in the ATMP sector

Application type
Aseptic(-toxic)
Customization level
Modular configuration

  • Containers

    AT-Closed Vial®

  • Objects per hour

    Up to 150

  • Filling volume

    0.1-45 ml

  • Filling line

    AT

pure² M1 at a glance

Your entry into isolator technology

  • Fast decontamination cycles

    Automated skanfog H₂O₂ decontamination provides validated cycles under 30 minutes

  • Easy integration in the cleanroom

    SKAN nanox catalyst breaks down residual H₂O₂, enabling direct exhaust to the room without HVAC connection

  • Low installation requirements

    Plug-and-play equipment requiring only compressed air and power

  • Aseptic fluid transfer

    Integrated AT-Port for safe liquid transfer through the isolator wall while keeping bulk product outside

  • High filling accuracy

    Peristaltic pump with integrated weighing cell ensures precise dosing and easy calibration

  • Single-use materials

    Pre-sterilized AT-Assembly components ensure aseptic integrity while reducing cleaning validation efforts

  • User-friendly and ergonomic design

    Beginner-friendly, compact, and front-accessible design, tool-less format change and two HMIs for process tracking

  • Comprehensive validation

    Delivered with full GMP and FDA 21 CFR Part 11 compliant validation documentation

Application

Aseptic Fill Finish solution for the AT-Closed Vial®

  • For cell and gene therapies

    Adaptable to workflow needs, supporting rapid transfer steps for cell culture processing.

  • image description

    For pharmaceutical manufacturing

    Ideal for small-scale aseptic production, including aseptic-toxic applications (e.g. CMR substances), ensuring GMP-compliance and patient safety.

A precision needle dispensing liquid through the blue stopper of a glass vial at a pharmaceutical filling station.
Fill Finish

The AT-Closed Vial® ecosystem

The AT-Closed Vial® system enables a fully closed aseptic filling process.

At its core is the AT-Closed Vial® as the primary packaging, combined with the AT-Cap as closure, complemented by suitable filling lines and the single-use system AT-Assembly for sterile liquid transfers.

All components are fully aligned, ensuring a consistent, contamination-controlled, and scalable process.

Process

The M1 filling process within the pure2 isolator

  • 1

    Material introduction

    Ready-to-use consumables (AT-Closed Vial®, AT-EasyCap, AT-Assembly) enter through a rapid decontamination airlock.

  • 2

    Liquid transfer

    Bulk product is introduced via the AT-Port, while keeping the product container outside the isolator for cooling and mixing.

  • 3

    Filling, sealing and capping

    In the isolator, vials are semi-automatically filled, laser-resealed, and capped. The peristaltic dosing system ensures accuracy and simple calibration.

  • 4

    Batch monitoring

    Live batch data is displayed on the integrated chamber screen for calibration and tracking.

  • 5

    Continuous product exit

    Filled vials exit through a mousehole with laminar airflow.

Product highlights

Isolator protection for small batches

  • A black-gloved hand holding a small glass vial with a blue stopper inside a sterile isolator workstation.

    Reduced contamination risk through closed filling

    The AT-Closed Vial® remains functionally closed throughout the filling process. The product is not exposed to the surrounding environment, significantly reducing contamination risks compared to conventional open-vial handling and manual filling approaches.

  • Inside view of the main stainless steel chamber of a SKAN isolator Pure2 M1, equipped with a Flexicon peristaltic pump, a filling station, a sealing unit, and an integrated control screen.

    Designed for small batches and scalability

    The reproducible filling principle is structured for validation and enables a smooth transition from Research and Development to GMP manufacturing without fundamental process changes.

  • A blue Pipetman laboratory pipette hanging on a stainless steel wire rack inside a sterile isolator environment next to a box of sample tubes. 2. A white Fresenius Kabi LOVO cell processing system integrated into a stainless steel medical isolator chamber. 3. An empty, high-grade stainless steel incubator or pass-through chamber with adjustable wire shelves, integrated into a sterile isolator system. 4. A close-up of a digital touchscreen showing the system status and workflow for a SKAN Pure2 isolator.

    Efficient decontamination with short cycle times

    skanfog H₂O₂ micro-nebulization enables rapid, reproducible decontamination of the working chamber and airlock within approximately one hour.

Regulatory requirements

Highest regulatory standards with the AT-Closed Vial® Technology

  • Annex 1-compliant process design

    The closed filling approach supports requirements for minimized interventions and reduced contamination risks.

  • Container Closure Integrity (CCI)

    Validated test methods (e.g. dye ingress, CT scan, headspace analysis) provide robust, regulatory- compliant proof of integrity.

  • Reliable validation

    Delivered with a validation master plan and a complete test package for the AT-Closed Vial® process.

Technical specifications

  • Isolator dimensions

    3300 × 955 × 2277 mm (W × H × D)

  • Minimum room height

    2400 mm

  • Weight

    1250 kg (incl. airlock and laminar flow)

  • Output

    Up to 150 AT-Closed Vial® per hour

  • Filling volume

    0.1 ml to 45 ml

  • Cleanroom requirement

    Operation in Grade C/D

  • Working chamber

    Grade A (ISO 5)

  • Decontamination

    35% H₂O₂ stored within isolator

  • Filtration

    Double H14 HEPA filtration with 99.995% efficiency

  • Airflow

    Downflow 0.45 m/s ± 20% (0.25 m/s in standby)

  • HMI

    HMI for isolator, HMI for M1 filling station, additional screen inside the chamber for process tracking

  • Glove testing

    Optional WirelessGT glove test system

  • Chamber

    Stainless steel, AISI 316L (≤ 0,8 µm)

  • Housing

    ABS

  • Window

    Double safety glass

  • Operating status

    Internal lighting shows system status (red/white/blue)

  • Noise level

    ≤ 65 dB(A)

  • Power supply

    220–240 V AC, 50–60 Hz, max. 3800 W

  • Compressed air

    6–10 bar / 7,5–22 Nm³/h, ISO 8573-1:2010 Class 1.3.1

  • Standards and certifications

    IEC 61010-1:2010, DIN 12980:2017-05, 2006/42/EC, 2014/30/EU, EN 12469, ISO 14644-3/7, cTUVus-zertifiziert

FAQs

  • It provides aseptic fill and finish for small batches under GMP, ideal for introducing isolator technology in the production processes.

  • No. The SKAN nanox catalyst neutralizes H₂O₂ exhaust, allowing safe release to the room.

  • The equipment is compatible with all AT-Closed Vial® sizes, with a filling volume range from 0.1 ml to 45 ml, with high accuracy via peristaltic pump and calibrated weighing cell.

  • Its compact, ergonomic design, tool-less changeover, live HMI tracking, and front-access operation make it easy to use.

  • Delivered with validation master plan, cleaning procedures, and full certification file.

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