MedTech Manufacturing worked example

Bioburden Sampling Cost at 3.6% sampling rate per lot: a worked example

Suppose sampling rate per lot falls to 3.6%. This page works the full calculation at that level so you can see exactly which result moves and by how much. Estimate bioburden testing sample requirements from production lots, sampling rate, and minimum sample count per ISO 11737.

The inputs for this scenario

  • Production lots in scope: 12 lots (held at the documented default)
  • Sampling rate per lot: 3.6 % (the input this scenario stresses; the baseline uses 5)
  • Minimum samples per lot: 10 samples (held at the documented default)

Working through the calculation

  • The calculation starts from the formula this tool documents: Calculated bioburden sample count = production lots in scope × sampling rate per lot.
  • Required sample size works out to 10 samples at these inputs, and this is the headline figure for the scenario.
  • Calculated sample works out to 1 samples at these inputs.
  • Minimum sample size works out to 10 samples at these inputs.

How this compares with the baseline

  • Against the tool's baseline example, where sampling rate per lot sits at 5% and the headline result is 10 samples, this scenario lands almost exactly on the baseline at 10 samples.
  • It computes a percentage-based sample count across lots in scope and then takes the larger of that count and a minimum-per-lot floor. When the numbers land here, the stressed input is the lever to work; the walkthrough above shows exactly how much each output recovers as it climbs back toward the baseline.

Results at a glance

  • Required sample size: 10 samples (headline result)
  • Calculated sample: 1 samples
  • Minimum sample size: 10 samples

Run it with your numbers

  • To rerun this with your own numbers, open the live Bioburden Sampling Cost calculator, set sampling rate per lot to your actual value, and adjust the remaining inputs to match your operation.

Last reviewed 2026-05-12.