Sterilizer for the pharmaceutical industry ebeam

production environmentfor sterilization servicesby irradiation

Short description
Inline electron-beam surface sterilizer for transfer of Ready‑to‑Use (RTU) containers into isolator filling lines. Provides ≥25 kGy surface dose with continuous container integrity monitoring, enabling Annex 1-compliant transfer and supporting a Contamination Control Strategy (CCS).

At a glance

• Validated surface sterilization: ≥25 kGy minimum on all sides (ISO 11137 Method 2).
• Radiation shielding: Stainless steel–lead–stainless steel sandwich and parallel shutter system (operator exposure <1 µSv/h).
• High throughput with compact footprint: Continuous transfer up to 6 tubs/min; footprint ≈ 2.4 × 1.2 m.
• Low operating costs: Single-bag packaging eliminates outer bag; average energy ~7 kWh (≈3 kWh emitter).
• Regulatory acceptance: Demonstrated in FDA, EMA and SwissMedic inspections.

Applications

• Pharmaceutical manufacturers: Medium- to large-scale sterile product filling lines requiring inline transfer sterilization.
• C(D)MOs: Flexible for multiple RTU container suppliers and formats.
• Upgrades and retrofits: Integrates into existing isolator filling lines to meet Annex 1 CCS expectations.

Process (safe RTU transfer in isolator filling systems)

• 1. Cleanroom preparation: Debagger removes single-bag packaging in Grade C/D; Tyvek remains on container.
• 2. Insertion into the tunnel: Container enters first airlock; sandwich shielding and shutter system ensure full protection (<1 µSv/h).
• 3. Surface sterilization: Three emitters irradiate all sides with accelerated electrons (beta radiation) to deliver ≥25 kGy and destroy DNA on surfaces.
• 4. Exhaust air: Negative-pressure exhaust removes reaction by-products such as ozone.
• 5. Airflow: Unidirectional airflow, defined pressure cascade and double HEPA-filtered supply air.
• 6. Transfer into the filling isolator: Sterilized container passes through second airlock directly into isolator (direct transfer from Grade C to A).

Product highlights

• Residue-free sterilization: Electron beam affects only surface micrometers; no residues or thermal stress—Tyvek and RTU containers remain intact.
• Long emitter life: Expected >6000 hours; user-replaceable emitters to reduce downtime.
• Lifecycle support: Cycle development, microbiological validation, dosimetry, maintenance, spare parts and operator training available.

Regulatory and safety

• Supports Annex 1 recommendation to sterilize at point of transfer within a documented CCS.
• ISO 11137 Method 2 validation, inline monitoring and SCADA integration for batch reporting.
• Closed, shielded design with documented radiation protection and proven performance in regulatory inspections.

FAQs (selected)

• Are there residues inside the container? No. Electrons do not penetrate Tyvek or the container interior; no residues form inside the container.
• How is the ebeam tunnel decontaminated? Vaporized H2O2 is used (synchronized or independent from isolator); typical duration <2 hours.
• What are radiation protection requirements? None for operators—system fully shielded to <1 µSv/h; local regulations may require a radiation safety officer.
• What if an emitter fails? System detects out-of-spec emitters, stops transfer, logs batch data and prevents contaminated containers entering the isolator; emitters are user-replaceable and dosimetry can be confirmed immediately.

Technical specifications

• Model name: ebeam
• Brand: SKAN
• Tub/container sizes: 2", 3", 4", 5" (qualified and validated)
• New formats: Can be validated with minimal adjustments
• Footprint (approx.): 2.4 m × 1.2 m
• 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: Stainless steel–lead–stainless steel sandwich shielding
• Certification: Certified radiation integrity testing
• Sterilization dose: ≥25 kGy minimum on all sides; validation per ISO 11137 Method 2
• Emitters: 3 emitters; service life >6000 hours; non-radioactive when off
• Throughput: Continuous transfer up to max. 6 tubs/min
• Packaging: Single-bag packaging to eliminate outer bag costs
• Energy / utilities: Avg. power consumption ~7 kWh in production (≈3 kWh for emitter); supply 400 VAC / 50–60 Hz
• Air handling: Exhaust 800–1,100 m3/h; supply air double HEPA filtered; unidirectional airflow and defined pressure cascade
• Compressed air: 35 Nm3/h at 6–8 bar, dewpoint -20°C
• Control systems: PLC-based automation validated per GAMP 5
• User interface: SCADA with batch reporting; supports Factory Talk and Zenon
• Integrated sensors: Leak test, differential pressure and humidity; optional particle, temperature and ozone sensors
• Validation support: Dosimetry testing, inline monitoring, SCADA integration and batch data logging