Single-Use Bioprocess Assemblies worked example

Packaging Integrity Yield at 99% target sterile-barrier pass rate: a worked example in single-use bioprocess assemblies

What does the result look like when target sterile-barrier pass rate reaches 99%? The full calculation is worked below with real intermediate numbers. Use it when packaging integrity yield in single-use bioprocess assemblies needs a clean rate and gap-to-target you can put on a tier board.

The inputs for this scenario

  • Assemblies passing sterile-barrier integrity test: 8 count (unchanged)
  • Assemblies inspected in the lot: 250 count (unchanged)
  • Target sterile-barrier pass rate: 99 % (raised for this scenario; the documented default is 95)

Working through the calculation

  • Applying the documented formula (Packaging integrity yield rate = packaging integrity yield count ÷ total packaging integrity yield population × 100) to the inputs above produces each figure below.
  • At this operating point the engine returns 3.2 % for packaging integrity yield rate, the number this scenario is built around.
  • At this operating point the engine returns 95.8 points for packaging integrity yield gap to target.
  • At this operating point the engine returns 8 count for packaging integrity yield count.
  • At this operating point the engine returns 250 count for total packaging integrity yield population.

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 %.
  • A figure at this level is achievable when target sterile-barrier pass rate is genuinely sustained, not just peaked for a shift. 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: 95.8 points
  • Packaging integrity yield count: 8 count
  • Total packaging integrity yield population: 250 count

Run it with your numbers

  • Every input above is editable in the live Packaging Integrity Yield calculator, which recalculates instantly and can be shared with the inputs intact.

Last reviewed 2026-05-12.