GIFSQ Tools · Module 4 — Microbiology Methods & Laboratory Operations · Tool 76 of 500
Record a sterility test under USP <71>: units tested, growth observed, incubation days and temperature, with a pass, fail or incomplete verdict.
Try sample values — fills the form with the worked example below.
Sterility test record
Saved on this device only. Calculate a result first, then add it to the log.
| Date / time | Units | Growth | Days | Temp (°C) | Result |
|---|
–
Sterility result
–
Units showing growth (%)
–
Days remaining (of 14)
Equation: Growth % = units showing growth ÷ units tested × 100. Days remaining = 14 − days completed (never below zero). Pass only when growth = 0 and at least 14 days of incubation are complete.
Method: USP <71> Sterility Tests and ISO 11737-2 (tests of sterility): direct inoculation or membrane filtration, incubation for not less than 14 days at 20–25 °C and 30–35 °C, with the test repeated if growth appears.
Assumptions: the sample units are representative of the batch; the media support growth of the test organisms; the incubation temperature stayed in range for the whole period.
Limitations: a sterility test samples only part of a batch, so a pass does not prove every unit is sterile. Growth in one unit fails the test for the batch and triggers investigation, not a retest by default.
Rounding: growth percentage to 1 decimal place. Days are whole numbers.
This is a calculation aid, not a laboratory report — confirm against your accredited method before citing a value.
Method: USP <71> Sterility Tests and ISO 11737-2 (tests of sterility): direct inoculation or membrane filtration, incubation for not less than 14 days at 20–25 °C and 30–35 °C, with the test repeated if growth appears.
Assumptions: the sample units are representative of the batch; the media support growth of the test organisms; the incubation temperature stayed in range for the whole period.
Limitations: a sterility test samples only part of a batch, so a pass does not prove every unit is sterile. Growth in one unit fails the test for the batch and triggers investigation, not a retest by default.
Rounding: growth percentage to 1 decimal place. Days are whole numbers.
This is a calculation aid, not a laboratory report — confirm against your accredited method before citing a value.
Worked example: 20 units tested, 0 showing growth, 14 days at 22.5 °C. Growth is 0.0 % and the full 14 days are complete, so the test passes with 0 days remaining.
Enter values above to see results.
USP <71> requires not less than 14 days of incubation. Do not report a pass early — a test at 7 days with no growth is incomplete, not passed. Tool 76 of 500 — GIFSQ
