Implantable Electronics & Neurodevices worked example

Sterilization Validation Load with sterilization validation lots or configurations of 1.5 lots: a worked example

This worked example runs the sterilization validation load numbers for a tougher week than the baseline: sterilization validation lots or configurations of 1.5 lots instead of the typical 3 lots. Estimate the number of sterilization validation samples needed across implantable device lots, runs, and sample points.

The inputs for this scenario

  • Sterilization validation lots or configurations: 1.5 lots (the input this scenario stresses; the baseline uses 3)
  • Validation runs per lot: 3 runs / lot (held at the documented default)
  • Samples per validation run: 28 samples / run (held at the documented default)

Working through the calculation

  • The calculation starts from the formula this tool documents: Total sterilization validation samples = sterilization validation lots or configurations × validation runs per lot × samples per validation run.
  • Total sterilization validation samples works out to 126 samples at these inputs, and this is the headline figure for the scenario.
  • Estimated sample handling hours works out to 6.3 hr at these inputs.
  • Sterilization validation lots or configurations works out to 3 count at these inputs.
  • Samples per validation run works out to 28 samples at these inputs.

How this compares with the baseline

  • Against the tool's baseline example, where sterilization validation lots or configurations sits at 3 lots and the headline result is 252 samples, this scenario comes in 50% below the baseline at 126 samples.
  • Use it during validation protocol drafting (per ISO 11135 for EO or ISO 11137 for radiation) when you need to reserve build quantity and lab capacity before the first run. A result at this level usually justifies acting on the stressed input before touching anything else, because every other figure in the table is downstream of it.

Results at a glance

  • Total sterilization validation samples: 126 samples (headline result)
  • Estimated sample handling hours: 6.3 hr
  • Sterilization validation lots or configurations: 3 count
  • Samples per validation run: 28 samples

Run it with your numbers

  • To rerun this with your own numbers, open the live Sterilization Validation Load calculator, set sterilization validation lots or configurations to your actual value, and adjust the remaining inputs to match your operation.

Last reviewed 2026-05-12.