SKAN ebeam

Are you looking for an Annex 1 compliant way to transfer your pre-sterilised tubs with RTU components into your isolator filling line? Then look no further than the ebeam technology. With an ever-increasing number of standards and regulatory requirements in pharmaceutical manufacturing, ebeam is the safest transfer and surface sterilization solution on the market, and carries the most approvals from relevant authorities.

Who should consider the ebeam technology?

SKAN ebeam is a safe transfer and surface sterilization system for high-speed sterile pharma production, but also for C(D)MOs who seek a flexible and efficient transfer solution for different products and container sizes. 2”, 3”, and 4” tubs can be processed with only minor adjustments.

The ebeam tunnel is not only available as part of new installations but can be integrated into existing isolator filling lines. This does not only offer you state-of-the-art technology with a small footprint, but also decreases your operational expenditure (OPEX) in the long run.

Why ebeam?

• Efficient, continuous transfer embedded in a compact design
• High-speed production with up to 6 tubs/min
• Assured tub integrity during the whole transfer process (from grade C to grade A)
• >6-log tub surface sterilization
• Widespread acceptance by FDA and other inspection authorities
• «No-risk transfer» for full Annex 1 compliance
• Simple qualification and validation
• Maximum Overall Equipment Effectiveness (OEE)
• Low maintenance requirements and costs
• Significant reduction in operating costs

How does it work?

The SKAN ebeam is designed for transferring pre-sterilised tubs with RTU components such as syringes, vials and cartridges into an isolator filling line. The process is divided into three parts: infeed, surface sterilization and outfeed into the filling line. The air handling is approached from an overarching perspective and in conjunction with the isolator.

• Infeed

  The process is configured for tubs in single-bag packaging. First, the tub is de-bagged in a grade C room. It is then placed on a conveyor system which acts as an interface to the ebeam tunnel.

  The Tyvek lid remains in place when the tub is moved into the entry section. Once the tub has entered the first airlock, the outer door closes automatically, while the inner door opens. This parallel shutter system guarantees full radiation shielding.

• Surface sterilization

  During the main process, the tub is exposed to a radiation dosage of at least 25 kGy on all sides, which is necessary for safe surface sterilization. The emitters are arranged in a way that the accelerated electrons (beta radiation) can reach all surfaces.

  This process destroys the DNA of all pathogens such as bacteria, fungi, yeast, spores, parasites, and viruses on the tub surface. While killing all living cells, there is no adverse effects on the tub or the RTU components.

• Outfeed

  After surface sterilization, the tub leaves the tunnel through the second airlock into the isolator. This represents a direct transfer from cleanroom class C to class A.

• Air handling

  The ebeam system has an integrated, advanced air handling system with unidirectional airflows at the inlet points and a defined pressure cascade between the ebeam tunnel, the cleanroom, and the isolator.

  Both inlet and outlet air are HEPA-filtered. This guarantees that no particles or contaminated air enter the isolator and surrounding room.

More safety for your production

With the ebeam you are on the safe side – in many respects. Not only does the ebeam ensure reliable results at process level, but the operators are fully protected.

• Maximum reliability & OEE

  The proven long-life emitters are the centerpieces of the ebeam technology. With a lifetime expectancy of >6000 hours, ebeam does not only offer you an extremely reliable and maintenance-friendly transfer method, but it also increases your OEE significantly.

  Due to good accessibility, you can replace the emitters easily on your own (“light bulb philosophy”). Only few operators are needed to run the system. Like this, you keep your independence and flexibility, and at the same time ensure low downtimes and maximum OEE.

  As the tubs only need a single-bag packaging, the OPEX is low, while sustainability and process reliability are higher in comparison to double-bag packaging.

• Maximum product and operator safety

  With the in-line >6-log sterilization of all tub surfaces, the safety of the ebeam exceeds all other transfer technologies. No human intervention is needed for de-bagging, which decreases the contamination risk additionally.

  The ebeam tunnel itself is designed with maximum operator safety in mind. It is manufactured 100 % in Switzerland, with highest quality and safety standards. The use of dosimeters is not required as the fully shielded system has a certified radiation integrity test by the Swiss authorities.

  The emitters are placed in a chamber with sandwich technology shielding, which consists of a 6 mm layer of lead in between two stainless steel plates. In combination with the parallel shutter system, this guarantees perfect radiation shielding.

• Maximum process safety

  The conveyor system is positioned on the same level as the filling line, which leads to a smooth transport without particle emission. Control systems like tub position tracking and speed monitoring ensure a reliable transport.

  Above that, there are multiple safety systems integrated per standard: leak test, differential pressure and humidity sensors, which you can complement with more optional sensors and controls.

Authorities love the ebeam

The transfer process of containers and materials into the A-zone is a critical process with risks – but not with the SKAN ebeam. Approval authorities recognize this.

• Easy validation process

  The ebeam technology is currently one of the most recognized transfer methods by inspection authorities such as the FDA. The surface sterilization process is reliable and reproducible, which facilitates and speeds up qualification and validation.

  There are two ways to validate the ebeam process according to ISO 11137 “Sterilization of health care products – Radiation”:

  • Calibrated film dosimeters are used to confirm that the correct dose (> 25 kGy) has been applied.
  • Bioindicators are used to determine the correct radiation dose (not required in this case).

  With decades of experience in validation and qualification procedures, SKAN supports you during the whole process, as we test and certify the system for you.

• Full Annex 1 compliance

  Annex 1 (4.10) states: “The transfer of equipment and materials into and out of the cleanrooms and critical zones is one of the greatest potential sources of contamination.” This risk can be minimized by the ebeam system.

  Annex 1 (8.47) defines sterilization upon transfer as the preferred method of introducing material to grade A areas: “Where materials, equipment, components and ancillary items are sterilized in sealed packaging and then transferred into grade A, this should be done using appropriate validated methods (for example, airlocks or pass-through hatches) with accompanying disinfection of the exterior of the sealed packaging.”

  With these requirements given, the in-line surface sterilization management of the ebeam simplifies your holistic contamination control strategy significantly.

• Certified according to current standards

  SKAN‘s experts are the knowledge center for a successful qualification. All steps are according to current standards like:

  • (European Union) EudraLex – Volume 4 – Good Manufacturing Practice (GMP)
  • (European Union) GMP – Annex 1 (8.48)
  • (European Union) CE Certification
  • (European Pharmacopoeia) Ph. Eur. Chapter 4.1.3. “Ionization Radiation Sterilisation”
  • (United States Pharmacopeia) USP <1211> “Sterilization and Sterility Assurance of Compendial Articles”
  • (Federal Drug Association) FDA CFR 21 part 11 (Electronic records; electronic signatures)
  • (International Society for Pharmaceutical Engineering) ISPE GAMP guidelines
  • (International Organization for Standardization) ISO 11137 “Sterilization of health care products – Radiation” (part 1-3)

Comprehensive service package

SKAN stays at your side during the whole lifecycle of the system and guarantees the reliable supply of spare parts and emitters. We provide you with the full-service package to keep the equipment reliable and the use comfortable. As SKAN offers you the ebeam transfer system and isolator from one hand, the technology is optimally integrated into your filling line and can be serviced together.

• Testing and qualification / validation
  • Installation and Operational Qualification (IQ/OQ)
  • Cycle Development (CD)
  • Microbiological Qualification and Validation (MBQ) for H₂O₂
  • Dosimetry test (radiation measurement) on tub surface and below the Tyvek lid / liner
  • Site Acceptance Test (SAT)
  • O₃ residual testing
• Spare parts supply

  SKAN reliably supplies you with consumables, replacement emitters and everything else you need for your ebeam. You have a central contact person who takes care of you.

• Additional services
  • Professional training of operators and service personnel
  • Technical services with support tools tailored to the ebeam
  • Scheduled preventive maintenance

FAQ

• How does the decontamination of the ebeam tunnel work?

  Before the tub transfer process starts, the ebeam tunnel gets decontaminated by vaporized H₂O₂. This process works independently or can be synchronized with the isolator. The average decontamination time is <2 hours.

• Are byproducts generated during the process?

  During the ebeam process, byproducts such as Ozone and NO_X are generated. The contaminated air is kept away from the isolator and surrounding room by controlled airflow. A pressure cascade within the ebeam tunnel and attached isolator guarantees that no byproducts leave the emitter section. The contaminated air with Ozone and NO_X is sucked into the exhaust air system.

• Are there residuals within the tub?

  The radiation dosage is calculated to ensure safe surface sterilization while avoiding residuals of by-products inside the tub. The electrons are stopped by the tub surface and the Tyvek, so there is no deep penetration or residuals within the tub. SKAN experts are at your disposal to perform the required tests and validate the process.

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