MedTech Manufacturing worked example
Process Validation Sample Size at 7.2% sampling rate per run: a worked example
Suppose sampling rate per run falls to 7.2%. This page works the full calculation at that level so you can see exactly which result moves and by how much. Estimate total sample count for process validation from number of PQ runs, sampling rate per run, and minimum per-run requirement.
The inputs for this scenario
- Number of validation runs: 3 runs (held at the documented default)
- Sampling rate per run: 7.2 % (the input this scenario stresses; the baseline uses 10)
- Minimum samples per run: 30 samples (held at the documented default)
Working through the calculation
- The calculation starts from the formula this tool documents: Calculated validation samples = number of validation runs × sampling rate per run.
- Required sample size works out to 30 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 30 samples at these inputs.
How this compares with the baseline
- Against the tool's baseline example, where sampling rate per run sits at 10% and the headline result is 30 samples, this scenario lands almost exactly on the baseline at 30 samples.
- It multiplies the number of validation runs by the per-run sampling rate, then returns the larger of that result and your minimum samples per run. 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: 30 samples (headline result)
- Calculated sample: 1 samples
- Minimum sample size: 30 samples
Run it with your numbers
- To rerun this with your own numbers, open the live Process Validation Sample Size calculator, set sampling rate per run to your actual value, and adjust the remaining inputs to match your operation.
Last reviewed 2026-05-12.