Vial: difference between revisions
Diff·revision 44 → 45·18:21, 21 May 2025
Difference between revision 44 and revision 45 of Vial. 2 lines changed; the page grew by 187 bytes.
| Revision 44 — 18:48, 13 May 2025 ArchiveBot (talk) bot: add stub category 19,742 bytes ±0 | Revision 45 — 18:21, 21 May 2025 CrudePeptidePearl (talk) expand §Delamination and glass defects 19,929 bytes +187 | ||
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| 122 | Two consequences bear on handling. Once a flip-off button is removed, the exposed stopper surface is no longer protected, and its disinfection before each penetration is the compendially expected practice for multiple-dose containers. And the crimp is not intended to be removed and replaced; a vial whose ferrule shows evidence of having been decapped and recrimped has an unknown seal history, which is a recognised indicator in the examination of suspected [[Repackaging|repackaged]] or [[Counterfeit peptide|counterfeit]] material.{{r|usp1207}} | 122 | Two consequences bear on handling. Once a flip-off button is removed, the exposed stopper surface is no longer protected, and its disinfection before each penetration is the compendially expected practice for multiple-dose containers. And the crimp is not intended to be removed and replaced; a vial whose ferrule shows evidence of having been decapped and recrimped has an unknown seal history, which is a recognised indicator in the examination of suspected [[Repackaging|repackaged]] or [[Counterfeit peptide|counterfeit]] material.{{r|usp1207}} |
| 123 | 123 | ||
| + | 124 | {{figure|coa-sheet|A certificate of analysis identifies the lot but not the container. Where a lot number appears only on a peelable label, the link between document and vial is weak.}} | |
| + | 125 | ||
| 124 | == Container closure integrity == | 126 | == Container closure integrity == |
| 125 | Integrity is the ability of the container closure system to prevent ingress of micro-organisms and, where required, to maintain headspace composition. USP <1207> is the governing informational chapter and it reorganised thinking on the subject by classifying methods as ''deterministic'' or ''probabilistic''.{{r|usp1207}} | 127 | Integrity is the ability of the container closure system to prevent ingress of micro-organisms and, where required, to maintain headspace composition. USP <1207> is the governing informational chapter and it reorganised thinking on the subject by classifying methods as ''deterministic'' or ''probabilistic''.{{r|usp1207}} |