Lethal-Rate (Bioburden-Based) Product Release
A gentler, lower-cost cycle designed around your product's actual bioburden — ideal for sensitive materials and exposure-conscious programs.
The lethal-rate, bioburden-based method designs the sterilization cycle around the microbial population actually present on your product. By characterizing real bioburden and demonstrating the cycle's lethality against it, we can validate a less aggressive process that still meets the required sterility assurance level — typically 10⁻⁶ — while reducing exposure and cost per lot.
This pathway rewards a clean, well-controlled manufacturing environment. Because our biological testing is in-house, the bioburden characterization and routine monitoring this method depends on happen on the same campus as your sterilization — no shipping samples to an outside lab and waiting on results.
When bioburden-based is the right call
- Materials are sensitive to the aggressive exposure of an overkill cycle
- Minimizing cost, exposure, or cycle time per lot is a priority
- Your environment produces a low, consistent, well-characterized bioburden
- You have the quality infrastructure to support routine bioburden monitoring
Prefer the simplest, most robust logic with minimal routine testing? The overkill method may be the better fit. We scope both against your device during cycle development.
Lethal-Rate Method FAQ
What is the lethal-rate (bioburden-based) method?
The bioburden-based or lethal-rate method uses the actual microbial population on your product to define the sterilization cycle. By measuring real bioburden and demonstrating the cycle’s lethality against it, we validate a less aggressive process that still achieves the required sterility assurance level (typically 10⁻⁶).
How is it different from the overkill method?
Overkill assumes a worst-case bioburden and applies a large margin with minimal routine testing. The lethal-rate method instead characterizes and monitors your true bioburden, allowing a gentler, lower-cost cycle — at the cost of routine bioburden testing and tighter process control.
When should I use a bioburden-based release?
It is the right choice when materials are sensitive to aggressive cycles, when minimizing exposure or cost per lot matters, or when your manufacturing environment produces a low, well-controlled, and consistently characterized bioburden. We confirm your bioburden profile during cycle development before committing to this pathway.
Want a bioburden-based release scoped?
Tell us about your device, materials, and manufacturing environment. We will recommend the right release pathway within one business day.