Beyond-use date: difference between revisions
Diff·revision 20 → 21·03:14, 9 Jan 2025
Difference between revision 20 and revision 21 of Beyond-use date. 2 lines changed; the page grew by 646 bytes.
| Revision 20 — 18:32, 4 Jan 2025 SubQ_Solveig (talk) rv unexplained removal of sourced content 7,749 bytes ±0 | Revision 21 — 03:14, 9 Jan 2025 Retention_Time_Rae (talk) consistent en dashes in ranges 8,395 bytes +646 | ||
|---|---|---|---|
| 57 | Periods are those tabulated in the 2023 revision of the chapter, which differs from earlier revisions; the earlier low-, medium- and high-risk classification has been replaced by the category scheme.{{r|usp797}} | 57 | Periods are those tabulated in the 2023 revision of the chapter, which differs from earlier revisions; the earlier low-, medium- and high-risk classification has been replaced by the category scheme.{{r|usp797}} |
| 58 | 58 | ||
| + | 59 | Three structural features of the table repay attention. Sterility testing buys a large extension — from 4 days to 30 at room temperature for an aseptically processed preparation from sterile components — which reflects that the untested default is a bound on the probability of undetected contamination rather than an estimate of when contamination occurs. Introducing a nonsterile starting component shortens the dating sharply, because the bioburden and endotoxin history of that component is unknown. And frozen storage flattens the differences, because microbial growth is suppressed and the residual limit becomes chemical.{{r|usp797}} | |
| + | 60 | ||
| 59 | == References == | 61 | == References == |
| 60 | {{reflist}} | 62 | {{reflist}} |