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Transfer systems

mini ebeam

Small footprint, big impact

Transfer type
RTU tubs
Configuration level
Modular configurable
mini ebeam at a glance

Leading solution for the transfer and surface sterilization of RTU tubs

  • Maximum safety

    12-log surface sterilization with continuously ensured tub integrity

  • Annex 1-compliant

    Inline surface sterilization supports a Contamination Control Strategy (CCS) in accordance with Annex 1

  • Regulatory acceptance

    High acceptance by FDA, EMA, Swiss Medic, and other supervisory authorities

  • High efficiency

    Robust technology with high reliability and low maintenance effort and cost

  • Low operating costs

    Single-bag packaging eliminates the cost for outer bags; low energy consumption (approx. 6 kWh)

  • Sustainability

    Single-bag packaging of tubs reduces several tons of plastic and CO₂ emissions annually

  • High throughput with a small footprint

    Continuous transfer with max. 3 tubs/min and minimal footprint (1.5 × 1.2 m)

  • Reproducible, fast validation

    According to ISO 11137 method 2: min. 25 kGy dose on all sides

Application

Safe transfer of pre-sterilized RTU tubs into isolator filling lines

  • Pharmaceutical manufacturers pictogram.

    For pharmaceutical manufacturers

    The mini ebeam transfer and surface sterilization system is designed for small- to medium-scale production of sterile pharmaceuticals.

  • RTU tub pictogram.

    For C(D)MOs

    mini ebeam is ideal for contract manufacturers looking for a flexible transfer solution for varying tub suppliers and sizes.

  • eBeam pictogram.

    For upgrading existing systems

    mini ebeam is not only available for new isolator filling lines but can also be integrated into existing systems to ensure long-term regulatory compliance.

Interior view of a SKAN e-beam sterilization system with stainless steel housing and a Ready-to-Use (RTU) tub positioned for processing.
Process

Safe RTU transfer into isolator filling lines

  • 1

    Cleanroom preparation

    The tub is removed from its single-bag packaging by a debagger machine in a Grade C/D cleanroom and inserted into the mini ebeam. Tyvek remains on the tub.

  • 2

    Insertion into the tunnel

    The tub is introduced into the tunnel via a transport system. The emitters are active only when both shutters at the tunnel entrance and exit are closed. This, in combination with the lead lining, ensures continuous and complete radiation shielding (<1 µSv/h).

  • 3

    Surface sterilization

    Two emitters irradiate the tubs from all sides with ≥25 kGy. Accelerated electrons (beta radiation) reliably destroy the DNA of all pathogens, such as bacteria, fungi, yeasts, spores, parasites, and viruses on the tub surface.

  • 4

    Exhaust air

    The exhaust works in negative pressure to ensure no particles can enter the cleanroom or the isolator. By-products such as ozone are removed from the building through the exhaust air system.

  • 5

    Airflow

    The mini ebeam system features an advanced air handling system with unidirectional airflow and a defined pressure cascade between the tunnel, cleanroom, and isolator. Supply air is double HEPA filtered to prevent particles or contaminated air from entering the mini ebeam.

  • 6

    Transfer into the filling line

    After sterilization, the tub is transferred directly into the isolator filling line. A direct transfer takes place from cleanroom grade C to the grade A isolator chamber.

Product benefits

Efficient, safe, durable – technological benefits that pay off in operation

  • Close-up of a SKAN e-beam lamp emitting a bright purple light in a dark environment.

    Residue-free sterilization

    Electron beam radiation penetrates only a few micrometers into surfaces. It reliably destroys DNA-containing contaminants without leaving residues such as ozone in the tub. No thermal stress is generated; Tyvek, the tub, and RTU objects remain intact.

  • Two SKAN e-beam emitters with circular white covers integrated into a complex stainless steel industrial assembly with cables and sensors.

    Long-lasting emitters, low maintenance

    The ebeam emitters are highly robust, with an expected service life of >6000 hours. Thanks to the “light bulb philosophy,” they can be replaced independently within a few minutes – without long downtimes or complex interventions. This reduces maintenance costs and increases line availability.

  • Full-service package

    SKAN supports you throughout the entire lifecycle of your system. Our comprehensive range of services include cycle development, microbiological validation, and dosimetry testing.
    Maintenance processes for both the ebeam system and the isolator are combined and carried out in a single step, including spare parts supply, operator training and personal contact.

Regulatory requirements

How the mini ebeam meets central Annex 1 requirements

  • Inline surface sterilization

    “Wherever possible, sterilization should take place at the point of transfer.” (Annex 1, 4.11) The tub surface is sterilized immediately before entering the isolator, in a closed system without intermediate steps, validated, and documented.

  • Part of your CCS

    Annex 1 requires a comprehensive Contamination Control Strategy (CCS), including safe, controlled transfer. mini ebeam supports the CCS with a reproducible, validated ISO 11137 process, inline monitoring, and SCADA integration.

  • High regulatory acceptance

    The ebeam technology has proven itself in numerous FDA, EMA, and GMP inspections. Its closed design, validated surface sterilization, and documented radiation protection make it a solution recognized by authorities.

Wide-angle view of a large pharmaceutical cleanroom featuring multiple stainless steel isolator systems and glass-walled processing units by SKAN.
flexfill + ebeam: The fastest route to validated aseptic RTU filling.
flexfill + ebeam: The fastest route to validated aseptic RTU filling.

Technical specifications

  • Tub sizes

    3″, 4″, 5″ already qualified and validated

  • New formats

    Can be validated with minimal adjustments

  • Dimensions

    Approx. 1,5 × 1,2 m footprint

  • Height

    2804 mm (adjustable depending on line integration)

  • Weight

    Approx. 3200 kg

  • Floor load

    Max. 1800 kg/m² (can be reduced)

  • Material

    GMP-compliant stainless steel construction

  • Protective design

    Shielding via a lead layer between two stainless steel plates

  • Certification

    Certified radiation integrity testing

  • Integrated control systems

    Detection of tub position and speed control

  • Integrated sensors

    Leak testing, differential pressure, and humidity sensors

  • Options

    Particle, temperature, and ozone sensors for extended monitoring

  • Automation system

    PLC-based, validated in accordance with GAMP 5

  • User interface

    SCADA with batch reporting

  • Control

    Via Factory Talk or Zenon

  • Integration

    Standardized interfaces for integration into existing systems

  • Air intake surrounding room / air exhaust

    800 – 1’100 m³/h

  • Compressed air

    35 Nm³/h at 6-8 bar, dewpoint −20 °C

  • Power supply

    400 VAC / 50 – 60 Hz

  • Average power consumption

    6 kWh in production

FAQs

  • No. Electrons do not penetrate Tyvek or the tub, so no ozone or other residues form inside the tub.

  • Using vaporized H₂O₂, synchronized or independent from the isolator. Duration: <2 hours.

  • None. The system is fully shielded, reducing radiation exposure to <1 µSv/h, far below legal limits. Employees can operate it without a dosimeter or time restrictions. Depending on the local laws, a radiation safety officer should be present during its use.

  • The system automatically detects out-of-spec emitters. In this case, the transfer stops, batch data is logged, and the tub is not forwarded to the isolator. There is no risk of contamination of the isolator.
    The emitter can be replaced by yourself and the dosimetry confirmed immediately. After successful H₂O₂ decontamination of the mini ebeam, production can be resumed immediately.

  • Validation according to ISO 11137 Method 2 eliminates the need for biological indicators. Instead, measurements take place with film dosimeters. As a result, new product or format validations can be mapped much more quickly and in a manner that complies with regulatory requirements.

  • No. Emitters do not emit radiation when they are not in operation; there are no radioactive residues.

  • No. Because the emitters do not carry radioactive residues, no special disposal is necessary.

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