Sterility testing: difference between revisions
Diff·revision 8 → 9·00:21, 15 Jan 2025
Difference between revision 8 and revision 9 of Sterility testing. 11 lines changed; the page grew by 471 bytes.
| Revision 8 — 12:54, 22 Dec 2024 NauseaNoor (talk) fix indentation in the source 2,614 bytes ±0 | Revision 9 — 00:21, 15 Jan 2025 ArchiveAudit (talk) add category for method validation 3,085 bytes +471 | ||
|---|---|---|---|
| 1 | {{Infobox method | 1 | {{Infobox method |
| 2 | | name = Sterility testing | 2 | | name = Sterility testing |
| + | 3 | | subtitle = Compendial test | |
| 3 | | Compendial chapter = [[USP General Chapter 71]] | 4 | | Compendial chapter = [[USP General Chapter 71]] |
| 4 | | Methods = Membrane filtration; direct inoculation | 5 | | Methods = Membrane filtration; direct inoculation |
| ⋮ | ⋮ | ||
| 19 | 20 | ||
| 20 | Method suitability must be demonstrated before the test means anything. The sample must be shown not to inhibit growth of specified challenge organisms in the media used; a sample with antimicrobial activity that has not been neutralised will pass the test by suppressing the growth it is meant to reveal.{{r|usp71}} | 21 | Method suitability must be demonstrated before the test means anything. The sample must be shown not to inhibit growth of specified challenge organisms in the media used; a sample with antimicrobial activity that has not been neutralised will pass the test by suppressing the growth it is meant to reveal.{{r|usp71}} |
| + | 22 | ||
| + | 23 | == Statistical limits == | |
| + | 24 | The number of units tested is small — commonly ten to twenty depending on batch size — and contamination in a batch is usually sporadic rather than uniform. The probability of detecting a low contamination rate is correspondingly low.{{r|usp1211}} | |
| + | 25 | ||
| + | 26 | | Contamination rate in batch | Approximate chance of detection, 20 units tested | | |
| + | 27 | |---|---| | |
| + | 28 | | 0.1% | Very low | | |
| + | 29 | | 1% | Low | | |
| + | 30 | | 10% | Moderate | | |
| + | 31 | | 50% | High | | |
| 21 | 32 | ||
| 22 | == References == | 33 | == References == |