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Fill finish solutions

Crystal M1

Small batch aseptic filling station for the AT-Closed Vial®

Application type
Aseptic
Customization level
Standardized

  • Containers

    AT-Closed Vial®

  • Objects per hour

    Up to 150

  • Filling volume

    0.1-45 ml

  • Filling line

    AT

Crystal M1 at a glance

Closed filling process for early-stage applications

  • Closed vial processing

    AT-Closed Vial® enables a functionally closed filling process with minimal product exposure

  • Annex 1 compliance

    Closed system design supports Annex 1 compliant aseptic processing

  • Flexible barrier solution

    The system can be operated in a standard Biosafety Cabinet or an isolator

  • Rapid deployment

    Installation and qualification within one day with minimal setup effort

  • Single-use product path

    Disposable product contact parts eliminate cleaning requirements

  • Versatility

    Supports all vial sizes from 1 ml to 50 ml for different applications

  • Optimized for small batches

    Designed for low-volume production from a few up to several hundred vials

  • Efficiency

    Quick, toolless format change and no additional utilities required

Application

Closed aseptic filling for clinical and small-scale manufacturing

  • For cell and gene therapies

    Designed for personalized and high-value therapies with limited batch sizes.

  • For biologics and ATMPs

    Suitable for sensitive formulations, including next-generation biologics and innovative therapies.

  • For R&D and process development

    Provides a reproducible and validation-ready filling process for laboratory and pilot activities. Enables early definition of container strategy and simplifies future scale-up decisions.

  • Image description

    For GMP compounding and hospital use

    Applicable for specialized compounding activities requiring high aseptic safety within compact and controlled environments.

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

The AT-Closed Vial® is filled in three simple steps

  • 1

    Filling

    The vial is filled through the stopper with a specialized sterile needle. Once the needle is withdrawn, the stopper re-closes mechanically because of its elastic properties.

  • 2

    Laser re-sealing

    The stopper is resealed with a one second laser shot.

  • 3

    Capping

    The sterile snap-fit cap is placed on the vial to maintain stopper protection up to the point of product collection.

Regulatory requirements

Highest regulatory standards

  • 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.

  • Material compliance

    All materials for the vials meet relevant pharmacopoeial requirements (USP/EP) for primary packaging.

Product highlights

Optimized for small ATMP batches

  • 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.

  • Rapid implementation

    The system has a lead time of six weeks and can be installed and qualified within one day. This enables fast deployment in development and clinical environments without requiring additional utilities or complex infrastructure adjustments.

  • 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.

Crystal M1 - The AT-Closed Vial® ecosystem.
Crystal M1 - The AT-Closed Vial® ecosystem.

Technical specifications

  • Cabinet dimensions (recommended)

    180 × 60 cm (6 × 2 ft)

  • Output

    Up to 150 AT-Closed Vial® per hour (with two operators)

  • Filling volume

    0,1 ml to 45 ml

  • Filling accuracy

    ± 2 %

  • Included equipment

    Filling tool, laser housing, capping tool, laser control unit

  • Optional equipment

    Peristaltic dispensing pump, foot switch for the pump, high precision balance

  • Consumables

    Single-use materials for product contact parts

  • Material compatibility

    Resistant to classical cleaning agents

  • Cleanroom requirement

    Adapted for cleanroom and GMP-compliant environments

  • Barrier system

    Biosafety Cabinet (BSC) or isolator

  • Operating temperature

    18 to 22 °C (64,4 to 71,6 °F)

  • Electrical supply

    Standard 110/230 V (to be selected at order), AC earthed

FAQs

  • The system uses the AT-Closed Vial® concept, where the stopper is sealed with the vial body right after molding. The product is injected through the stopper, and the injection site is laser re-sealed immediately afterward. This functionally closed process minimizes product exposure and reduces operator-dependent contamination risks.

  • The Crystal M1 is designed for operation in a standard Biosafety Cabinet (BSC) or within an isolator providing Grade A conditions. This allows integration into existing laboratories or GMP environments without requiring major facility modifications.

  • The system is optimized for small and personalized batches, ranging from a few vials to several hundred units per batch. With a throughput of up to 150 vials per hour, it supports clinical production, process development, and small-scale GMP manufacturing.

  • The Crystal M1 is shipped within 6 weeks and can be installed and qualified within one day. This short implementation time enables rapid deployment in clinical or development settings, reducing project timelines.

  • Yes. The filling concept is designed to be reproducible and validation-ready. Using the same core closed-vial technology facilitates transition from R&D and early clinical batches to larger GMP manufacturing systems without fundamental process redesign.

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