Choosing the Sterilization Method
Your choice for method will be based on
compatibility, price and turn time requirements.
Some general guidelines are as follows.
Ethylene Oxide Sterilization:
Advantages
- Used when irradiation can damage medical device or packaging
- Can be used effectively to sterilize products cheaply
Disadvantages
- Can be problematic when sterilizing products with non-porous
cavities or products with torturous paths
- Requires extensive validation
- May have long turn time
- Vacuum rates and set points can damage product or product packaging
- Unless you undergo extensive validation allowing for parametric
release, you will require Biological
Indicators (BIs) to monitor process.
Biological Indicators can add to processing
fees
- May require other tests: residual testing, pyrogenicity testing…
Gamma Sterilization:
Advantages
- Fast turn time
- Easily validated (cheaper that EO)
- Recently cleared by USDA to sterilize food products
- Quantitatively measured (no Bis)
Disadvantages
- Irradiation can degrade product or product packaging
E-Beam Sterilization:
- Same as Gamma