Single-Use Bioprocess Assemblies worked example

Packaging Integrity Yield at 68% target sterile-barrier pass rate: a worked example in single-use bioprocess assemblies

Here is what the math looks like when conditions slip. We hold every other input steady and drop target sterile-barrier pass rate to 68%, then walk the calculation through step by step. Estimate packaging integrity yield for single-use bioprocess assemblies using production-ready inputs so teams can track KPI performance and decide whether corrective action is needed.

The inputs for this scenario

  • Assemblies passing sterile-barrier integrity test: 8 count (held at the documented default)
  • Assemblies inspected in the lot: 250 count (held at the documented default)
  • Target sterile-barrier pass rate: 68 % (the input this scenario stresses; the baseline uses 95)

Working through the calculation

  • The calculation starts from the formula this tool documents: Packaging integrity yield rate = packaging integrity yield count ÷ total packaging integrity yield population × 100.
  • Packaging integrity yield rate works out to 3.2 % at these inputs, and this is the headline figure for the scenario.
  • Packaging integrity yield gap to target works out to 64.8 points at these inputs.
  • Packaging integrity yield count works out to 8 count at these inputs.
  • Total packaging integrity yield population works out to 250 count at these inputs.

How this compares with the baseline

  • Against the tool's baseline example, where target sterile-barrier pass rate sits at 95% and the headline result is 3.2 %, this scenario lands almost exactly on the baseline at 3.2 %.
  • The practical read: the gap between this scenario and the baseline is entirely attributable to target sterile-barrier pass rate, so recovering it is worth quantifying in dollars before considering equipment or staffing changes. It uses whatever count you enter as passing units; if you accidentally enter the failure count instead, the rate inverts. Confirm the numerator is passes, not defects, before reading the gap.

Results at a glance

  • Packaging integrity yield rate: 3.2 % (headline result)
  • Packaging integrity yield gap to target: 64.8 points
  • Packaging integrity yield count: 8 count
  • Total packaging integrity yield population: 250 count

Run it with your numbers

  • To rerun this with your own numbers, open the live Packaging Integrity Yield calculator, set target sterile-barrier pass rate to your actual value, and adjust the remaining inputs to match your operation.

Last reviewed 2026-05-12.