ebeam – innovative electron beam technology

The ebeam (Electron Beam Tunnel) uses electron energy for continuous surface decontamination in high-speed aseptic filling lines, providing the highest standards of hygiene.

The safe and compact ebeam system is equipped with a multi-part transport system that safely transports ready-to-use containers and trays through a tunnel with three long-life electron emitters. The integrated decontamination system guarantees a safe and short cycle. Therefore, the ebeam corresponds to the state of the art pharmaceutical production facility and enables the next step in the automation and digitalisation of aseptic processes.

The advantages of the ebeam decontamination system

• Reliable decontamination of all external surfaces of individually packaged, pre-sterilised tubs with nested syringes
• Continuous aseptic transfer of pre-sterilised tubs into high-speed filling lines.
• Fast, safe and fully monitored pouch transfer increases product and operator protection.
• Compact and stable system with low maintenance requirements. 
• Easy qualification and validation of the complete system even for customised isolators. 
• High acceptance by FDA and other inspection agencies.

• Functionalities of the ebeam

  The advanced air handling system controls a defined pressure cascade from the filling point to the emitters and the suction system for safe filling. Easy integration, ergonomic design and reliable cleaning and maintenance make it the perfect complement for cleanroom processes and workplaces.

  Easy accessibility through opening possibilities on both sides as well as the independent quick exchange of the emitters in less than 20 minutes by your own personnel creates independence and flexibility.

  The ebeam is a space-saver that allows use in small laboratories  (2,4 x 1,2m) and fits into any cleanroom.

  Highly effective shielding with stainless steel encased lead in sandwich technology provides maximum product and the operator protection.

• Electron beam decontamination process with ebeam

  ebeam takes over the trays directly and at the same height of the filling line. Both the tub position and the transport speed are continuously monitored and controlled. The β-beam system guarantees a dose of > 25 kGy radiation energy on each surface of the RTU tubs for safe transfer to the aseptic filling isolator. Transport of the trays is smooth with extremely low particle generation.

  The occurrence of an arc is directly detected by the system. Reverse transport is possible via the “jog function”, which can manually control the furnace transport forwards and backwards.

• What makes ebeam exceptional

  The ebeam decontamination technology for isolators and filling lines enables a continuous and powerful flow of up to six cups per minute. This results in a significant cost reduction for individually packaged cups.

  The technology is based on long-life low-electron beams, which ensure complete decontamination of all external surfaces and containers with a duration of over 8,000 hours.

  The stainless material transport system guarantees smooth and fast transport of containers in the aseptic process. The unique closure system enables straight cup transfer and symmetrises high-speed filling production.

  In addition, the integrated and independent H₂O₂ decontamination system shortens the qualified cycle time to less than two hours.

• Operation areas for the Electron Beam Tunnel

  SKAN offers with ebeam a continuous and validatable transfer solution for decontamination of vats and cups in isolators and for aseptic manufacturing processes using electron energy.

  Here, the electron beam is connected to the filling isolators and can be installed directly in Class D or C environments. Inlet and outlet are completely covered with HEPA H14 filters and harmful gases are discharged directly to the outside.

  The use of dosimeters is not required as the fully shielded system has a certified radiation integrity test by the Swiss authorities.

• Automation

  SKANs automated solutions are developed according to the current GAMP guidelines and comply with all regulatory requirements.

  • GMP guidelines, CFR 21 part11, EndraLex volume 4
  • Supervisory Control and Data Acquisition (SCADA)
  • PLC Siemens or Allen Bradley
  • HMI Beckhoff industrial PC
  • Beckhoff touch screen monitor
  • Active directory
  • Decontamination report
  • Batch report
  • Audit trail functionalities
  • Electronic logs
  • Electronic signature
  • OPC interface
  • Thin client technology with customer server
  • H₂O₂ TLV sensor for room monitoring (operator safety)
  • O₃ TLV sensor for inlet section (operator safety)
  • Air velocity sensor at the exit section
  • X-ray sensor (operator safety)
  • Fully automatic and alarmed particle counter (non-viable)
• Options and accessories
  • H₂O₂ TLV sensor for room monitoring (operator safety)
  • O₃ TLV sensor for entry section (operator safety)
  • Air velocity sensor at the exit section
  • X-ray sensor (operator safety)
  • Fully automated and alarmed particle counter (non-viable)