Quality risk management is a critical component to any aseptic manufacturing process, making it necessary for pharmaceutical and medical device manufacturers to leverage processes that deliver the highest possible levels of sterility assurance. While offline technologies such as gamma radiation, high voltage (MeV) electron beam, and ethylene oxide can provide effective microbiological kill rates, cost, size and safety concerns prohibit in-line production application.

Several alternatives have been explored for in-line production use. Manual isopropyl alcohol wipedown lacks the consistency of automation and has low kill rates. Ultraviolet light tunnels suffer from heat, shadowing and kill rate concerns. Steam is slow and energy inefficient. Vaporized hydrogen peroxide (VHP) has been a favored approach but has lengthy cycle times and can result in residual contamination of the product.

Advanced Electron Beams (AEB) has emerged with a viable alternative to these limited options with a compact, low-voltage, in-line electron beam technology. The AEB Emitter offers distinct advantages for use in sterilization processes, including:

• High kill rate: capable of >6 log count reduction on Bacillus pumilus and other bacterial spores
• Fast cycle time: kills microbes in milliseconds
• Product friendly: energy is delivered on the surface only, limiting the effects on the product or package, and the process is room temperature (<1°C temp increase)
• No residue
• In-line integration: the electron beam source can be integrated in-line at flexible angles, enabling effective dose delivery to all sample surfaces and lending themselves to use in existing processes.

Advanced Electron Beams' compact, cost-effective electron beams can be readily integrated into in-line production systems for surface sterilization. This approach enables fully automated production with the highest possible sterility assurance levels, helping manufacturers reduce their risk. As a result, AEB Emitters can be leveraged in high-value applications such as:

• Sterile syringe filling: Advanced Electron Beam's emitters sterilize syringe tubs at the entrance to a barrier isolator filling line. OEM partners have integrated AEB emitters into fully automated systems for easy validation.
• Sterile device assembly: The electron beam creates a sterile zone for joining medical device components. Advanced Electron Beam emitters have been successfully integrated into highly automated manufacturing lines by end customers.
• Sterile packaging material: AEB sterilizes pouches, bags, and other containers prior to filling.

AEB-Enabled Solutions for Aseptic Drug Manufacturing

 Download Medical Device Sterilization Brochure