Designing Medical Products for Electron Beam Sterilization Part 1
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When selecting a sterilization method for medical products, why would one choose E-beam over other methods?
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Designing Medical Products for Electron Beam Sterilization Part 1
- 1. Designing Medical ProductsDesigning Medical Products forfor Electron Beam SterilizationElectron Beam Sterilization Lu Ann Sidney LNS Consulting Services Part 1 – Why Choose E-Beam?
- 2. Questions a design engineer mightQuestions a design engineer might ask about E-beam sterilization…ask about E-beam sterilization… 1. Why choose E-beam? 2. What is the E-beam process? 3. What are the important steps in qualifying a product for E-beam sterilization? 4. What are the applicable standards and guidelines? 5. Do you have any useful references?
- 3. First Commercial Application:First Commercial Application: Ethicon in Somerville, NJ, sterilized sutures with E-beam Contracted Sterilization – 1994 to 2002Contracted Sterilization – 1994 to 2002 1994 2002 EtO 49% 46% Gamma 44% 44% E-beam 5% 10% Steam 2% --- 1956 -
- 4. E-Beam SterilizationE-Beam Sterilization • 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) Advantages: Disadvantages:
- 5. Comparison of Sterilization MethodsComparison of Sterilization Methods Key Considerations EtO Gamma E-Beam Process Methodology Batch Continuous or batch Continuous Product Release Conventional release (BIs) or parametric Dosimetric Dosimetric Penetration Volumetric – requires gas-permeable packaging Complete Depends on product or material density Materials Compatibility Nearly all materials are satisfactory Most materials are satisfactory* Most materials are satisfactory* Residuals EO, ECH, and EG – requires aeration period following processing None None
- 6. Comparison of Sterilization MethodsComparison of Sterilization Methods Key Considerations EtO Gamma E-Beam Process Methodology Batch Continuous or batch Continuous Product Release Conventional release (BIs) or parametric Dosimetric Dosimetric Penetration Volumetric – requires gas-permeable packaging Complete Depends on product or material density Materials Compatibility Nearly all materials are satisfactory Most materials are satisfactory* Most materials are satisfactory* Residuals EO, ECH, and EG – requires aeration period following processing None None