Designing Medical Products Designing Medical Products forfor

Electron Beam SterilizationElectron Beam Sterilization

Lu Ann Sidney

LNS Consulting ServicesPart 1 – Why Choose E-Beam?

Questions a design engineer might Questions 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?

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 -

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:

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