Designing Medical Products for Electron Beam Sterilization

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Presentation transcript:

Designing Medical Products for Electron Beam Sterilization Lu Ann Sidney LNS Consulting Services Part 1 – Why Choose E-Beam?

Questions a design engineer might ask about E-beam sterilization… Why choose E-beam? What is the E-beam process? What are the important steps in qualifying a product for E-beam sterilization? What are the applicable standards and guidelines? Do you have any useful references?

First Commercial Application: Contracted Sterilization – 1994 to 2002 1956 - Ethicon in Somerville, NJ, sterilized sutures with E-beam Contracted Sterilization – 1994 to 2002 1994 2002 EtO 49% 46% Gamma 44% 44% E-beam 5% 10% Steam 2% ---

E-Beam Sterilization Advantages: Disadvantages: High dose rates One product in process at one time Adjustable processing rate JIT processing Good processing efficiencies (depends on product) Capital cost increases slowly with capacity Can turn it off Low penetration Reliability (complex technology) High capital cost (accelerator & shielding)

Comparison of Sterilization Methods