Vial: difference between revisions
Diff·revision 18 → 19·08:32, 16 Apr 2025
Difference between revision 18 and revision 19 of Vial. 5 lines changed; the page grew by 957 bytes.
| Revision 18 — 02:22, 30 Mar 2025 StopperingSteff (talk) add the reconstitution-stability sentence with its storage condition 18,279 bytes +550 | Revision 19 — 08:32, 16 Apr 2025 DrTitration (talk) expand §Sealing and capping 19,236 bytes +957 | ||
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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 | == 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}} | |
| + | 126 | ||
| + | 127 | Deterministic methods measure a physical quantity related to leakage, give quantitative results, and are reproducible: helium mass-spectrometric leak detection, vacuum decay, pressure decay, laser-based headspace analysis, and high-voltage leak detection. Probabilistic methods depend on a chain of stochastic events and give a pass or fail: microbial immersion challenge, dye ingress, and bubble tests. The chapter's position is that deterministic methods are preferred wherever available, and that probabilistic methods are appropriate mainly as qualitative confirmation.{{r|usp1207,kirsch1997}} | |
| + | 128 | ||
| 124 | == References == | 129 | == References == |
| 125 | {{reflist}} | 130 | {{reflist}} |