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Front view of a closed SKAN e-beam transfer system with multiple stainless steel compartments and a status indicator light.
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Transfer systems

ebeam

Your Annex 1-compliant RTU transfer with surface sterilization

Transfer type
RTU tubs
Customization level
Modular configuration
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 and OEE

    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 (7 kWh for entire ebeam, approx. 3 kWh for emitter)

  • Sustainability

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

  • High throughput with a small footprint

    Continuous transfer with max. 6 tubs/min and minimal footprint (2.4 × 1.2 m)

  • Reproducible, fast validation

    Validation according to ISO 11137 Method 2 – minimum 25 kGy dose on all sides

Application

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

  • For pharmaceutical manufacturers

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

  • For C(D)MOs

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

  • For upgrading existing systems

    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 in isolator filling systems

  • 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 ebeam. Tyvek remains on the tub.

  • 2

    Insertion into the tunnel

    The tub enters the first airlock. The stainless steel–lead–stainless steel sandwich structure and parallel shutter system (inner and outer shutters) ensure full shielding (<1 µSv/h).

  • 3

    Surface sterilization

    Three emitters irradiate the tub 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 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 ebeam

  • 6

    Transfer into the filling isolator

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

Product highlights

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 includes 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 SKAN 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. ebeam supports the CCS with a reproducible, validated ISO 11137 process, inline monitoring, and SCADA integration.

  • High regulatory acceptance

    ebeam 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

    2″, 3″, 4″, 5″ already qualified and validated

  • New formats

    Can be validated with minimal adjustments

  • Dimensions

    Approx. 2.4 m × 1.2 m footprint

  • Height

    Adjustable depending on line integration

  • Weight

    Approx. 5,225 kg

  • Floor load

    max. 1800 kg/m²

  • 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 oder 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

  • Super supply

    400 VAC / 50 – 60 Hz

  • Average power consumption

    7 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 ebeam, production can be resumed immediately.

  • Validation according to ISO 11137 Method 2 eliminates the need for biological indicators. Instead, dose measurement takes place with film dosimeters. This makes new product or format validations significantly faster and easier to document in a regulatorily compliant manner.

  • 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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