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

2. 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?

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

4. 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)

5. Comparison of Sterilization Methods