Sterility testing: difference between revisions
Diff·revision 11 → 12·13:21, 24 Mar 2025
Difference between revision 11 and revision 12 of Sterility testing. 2 lines changed; the page grew by 401 bytes.
| Revision 11 — 08:51, 3 Mar 2025 ChromCleanupCass (talk) add the detection wavelength 3,235 bytes ±0 | Revision 12 — 13:21, 24 Mar 2025 SourceHunterSile (talk) add the repeatability figure with the number of injections 3,636 bytes +401 | ||
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| 31 | | 50% | High | | 31 | | 50% | High | |
| 32 | 32 | ||
| + | 33 | The figures are illustrative of the shape of the relationship rather than exact, and the exact values follow from the binomial distribution and the sampling plan. The point is that end-product sterility testing detects gross failure reliably and low-level failure poorly, which is why it functions as a final check on a validated process rather than as the basis for release on its own.{{r|usp1211}} | |
| + | 34 | ||
| 33 | == References == | 35 | == References == |
| 34 | {{reflist}} | 36 | {{reflist}} |