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Fill finish solutions

spectra M1

Isolated fill and finish unit for small GMP batches

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

spectra M1 at a glance

Safest fill finish with the AT-Closed Vial®

  • Efficiency for small batches

    Semi-automated processes, short cycles, and streamlined operations

  • Highest sterility conditions

    Leading solator technology with skanfog H₂O₂ decontamination and nanox catalyst

  • GMP and regulatory compliance

    21 CFR Part 11-compliant

  • Operator and product protection

    Through safe-change filters and isolator design

  • AT-Closed Vial® technology

    Validated AT-Closed Vial® filling process

  • High filling accuracy

    Peristaltic pump combined with integrated weighing cell

  • Quick format changeovers

    Tool-less format changes for different vial sizes

  • Reduced downtime

    Automated skanfog system for rapid decontamination

Application

Closed aseptic filling for clinical and small-scale manufacturing

  • For small-batch filling and industrial preparation

    Suited for aseptic filling of injectable drugs in small-scale GMP production.

  • For cell and gene therapies

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

  • For research and development

    Offers flexibility and safety for R&D with customizable configurations for specific project needs.

A gloved hand operating a manual filling station for small vials inside a sterile stainless steel isolator (spectra M1 from SKAN), with a precise needle mechanism for liquid dispensing.
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

Simplified fill and finish with the AT-Closed Vial® technology

  • 1

    Material introduction

    Ready-to-use components are introduced via rapid decontamination airlock.

  • 2

    Product connection

    Bulk product is connected through the AT-Port, enabling cooling and mixing outside the isolator.

  • 3

    Filling

    Vials are placed on supporting bases, pierced, and filled using a peristaltic pump. An integrated weighing cell allows for simple calibration.

  • 4

    Laser resealing

    Resealing is achieved by a 1-second laser shot onto the stopper to restore container integrity.

  • 5

    Capping and monitoring

    Snap-fit AT-Cap closures are applied. Batch data is monitored via the built-in screen.

  • 6

    Exit

    Filled vials are continuously removed through a controlled laminar airflow exit.

Product highlights

Isolator protection for small batches

  • A close-up of an automated filling needle piercing the blue stopper of a 1ml vial.

    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.

  • A stainless steel laser sealing or capping machine for pharmaceutical vials, situated within a sterile isolator next to a tray of prepared glass vials - by SKAN AG.

    Designed for small batches and scalability

    The system supports filling volumes from 0.1 ml to 45 ml with a throughput of up to 150 vials per hour. 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 modular stainless steel isolator for small-batch filling, featuring a pass-through chamber with shelving and a main workspace equipped with glove ports and various processing equipment - spectra M1 by SKAN AG Switzerland.

    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

  • 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

    Integrated skanfog decontamination system and nanox catalyst for validated decontamination and exhaust management

  • Aseptic liquid transfer

    AT-Port System

  • Material transfer

    Rapid airlock with integrated H₂O₂ decontamination

  • Consumables

    Single-use fluid path components

  • SCADA

    Includes batch tracking, decontamination and batch reports, audit trail, electronic records, and signatures

  • Compliance

    21 CFR Part 11- and Annex 1-compliant

FAQ

  • The spectra M1 is designed for aseptic filling of injectable drugs in small GMP batches.

  • AT-Closed Vial® technology plays an essential role in the process. It enables secure filling, laser resealing, and capping, ensuring reliable Container Closure Integrity (CCI).

  • The system complies with GMP and 21 CFR Part 11. It is suitable for Grade C environments and incorporates GAMP-compliant automation features.

  • Yes. The isolator is configurable for aseptic and aseptic-toxic applications, protecting both operators and products in processes such as oncology drug preparation.

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