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Electron beam radiation therapy linear particle accelerator mini ebeam

Electron beam radiation therapy linear particle accelerator - mini ebeam - Skan - image - 2

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Characteristics

Type of therapy: electron beam radiation therapy

Description

Overview

Leading solution for the transfer and surface sterilization of RTU tubs according to Annex 1 requirements.
Small footprint, big impact — inline surface sterilization immediately before entry into an isolator supports a Contamination Control Strategy (CCS).
Transfer type: RTU tubs. Configuration level: Modular configurable.

Key features

Maximum safety: 12-log surface sterilization with continuously ensured tub integrity.
Annex 1-compliant: inline surface sterilization supporting CCS in accordance with Annex 1.
Regulatory acceptance: proven high acceptance by FDA, EMA, Swiss Medic and other authorities.
High efficiency and low maintenance: robust ebeam technology, long-lasting emitters, low maintenance effort and cost.
Low operating costs: single-bag packaging eliminates outer bag costs; low energy consumption (~6 kWh in production).
Sustainability: single-bag packaging reduces plastic use and CO₂ emissions.
High throughput with a small footprint: continuous transfer up to max. 3 tubs/min; minimal footprint approx. 1.5 × 1.2 m.
Reproducible, fast validation: ISO 11137 method 2 — minimum 25 kGy dose on all sides.

Applications

For pharmaceutical manufacturers: designed for small- to medium-scale production of sterile pharmaceuticals.
For C(D)MOs: flexible transfer solution suitable for varying tub suppliers and sizes.
For upgrading existing systems: integrable into existing isolator filling lines to ensure regulatory compliance.

Process (main steps)

1. Cleanroom preparation: tub removed from single-bag packaging in Grade C/D and inserted into mini ebeam; Tyvek remains on the tub.
2. Insertion into the tunnel: tub introduced via transport system; emitters active only when both shutters are closed; lead lining and closed shutters ensure radiation shielding (<1 µSv/h).
3. Surface sterilization: two emitters irradiate tubs from all sides with ≥25 kGy; accelerated electrons (beta radiation) destroy DNA of pathogens on the tub surface.
4. Exhaust air: exhaust operates at negative pressure to prevent particle entry; by-products such as ozone are removed via the exhaust system.
5. Airflow: advanced air handling with unidirectional airflow and a defined pressure cascade; supply air double HEPA filtered.
6. Transfer into the filling line: after sterilization, the tub is transferred directly into the isolator filling line (direct transfer from cleanroom grade C to grade A isolator chamber).

Product benefits

Residue-free sterilization: electron beam penetrates only a few micrometers; destroys DNA-containing contaminants without leaving residues or generating thermal stress; Tyvek and tub contents remain intact.
Long-lasting emitters and low maintenance: emitters expected service life >6000 hours; replaceable quickly to minimize downtime.
Full-service support available: services include cycle development, microbiological validation and dosimetry testing along lifecycle and combined maintenance procedures.

Regulatory and validation

Inline surface sterilization performed immediately before transfer into the isolator, in a closed and validated system.
Supports a comprehensive Contamination Control Strategy (CCS) with reproducible validated ISO 11137 process, inline monitoring and SCADA integration.
Technology proven in FDA, EMA and GMP inspections; closed design and documented radiation protection.

FAQs — selected

Are there residues in the tub or on the product? No. Electrons do not penetrate Tyvek or the tub interior, so no ozone or other residues form inside the tub.
How is the mini ebeam tunnel decontaminated? Using vaporized H₂O₂, synchronized or independent from the isolator; typical duration < 2 hours.
What are the radiation protection requirements? The system is fully shielded reducing radiation exposure to <1 µSv/h; operators can work without dosimeters or time restrictions in normal operation (local regulations may require a radiation safety officer presence).
What happens if an emitter fails? The system detects out-of-spec emitters automatically; transfer stops, batch data is logged, and the tub is not forwarded to the isolator. The emitter can be replaced and dosimetry confirmed before resuming production.
How quickly can the system be validated for a new product? Validation according to ISO 11137 Method 2 uses film dosimeters instead of biological indicators, enabling faster format validations in line with regulatory requirements.
Are ebeam emitters radioactive or do they require special disposal? No. Emitters are not radioactive when not in operation and do not carry radioactive residues; no special disposal is necessary.

caractéristiques / spécifications techniques

Tub sizes: 3", 4", 5" already qualified and validated; new formats can be validated with minimal adjustments.
Throughput: continuous transfer up to max. 3 tubs/min.
Footprint (approx.): 1.5 × 1.2 m.
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; certified radiation integrity testing.
Sterilization dose: according to ISO 11137 method 2 — min. 25 kGy on all sides.
Emitters: accelerated electron (beta) emitters; expected service life >6000 hours; replaceable quickly.
Air intake / 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.
Control & automation: PLC-based automation validated in accordance with GAMP 5; SCADA with batch reporting; control via Factory Talk or Zenon; standardized interfaces for integration.
Integrated control systems & sensors: detection of tub position and speed control; leak testing, differential pressure and humidity sensors; optional particle, temperature and ozone sensors for extended monitoring.
Certification / regulatory: high acceptance by FDA/EMA/Swiss Medic; validated processes and documented radiation protection.
Packaging & sustainability: supports single-bag packaging of tubs, eliminating outer bags and reducing plastic and CO₂ emissions.