Vial: difference between revisions
Diff·revision 23 → 24·08:24, 10 Aug 2025
Difference between revision 23 and revision 24 of Vial. 2 lines changed; the page grew by 522 bytes.
| Revision 23 — 14:42, 15 Jul 2025 SPPS_Sorrel (talk) rm the vendor-specific packaging detail; not general enough for the article 22,444 bytes +732 | Revision 24 — 08:24, 10 Aug 2025 PrepHPLC_Pia (talk) add the crimp-seal step to the fill-and-finish description 22,966 bytes +522 | ||
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| 133 | For a lyophilised product, headspace analysis is a particularly informative method because it is non-destructive and answers two questions at once. Headspace pressure and oxygen concentration measured by laser absorption reveal both loss of integrity and gradual moisture or oxygen ingress, and the same measurement can be repeated on the same vial over time to give a rate rather than a single value.{{r|usp1207}} | 133 | For a lyophilised product, headspace analysis is a particularly informative method because it is non-destructive and answers two questions at once. Headspace pressure and oxygen concentration measured by laser absorption reveal both loss of integrity and gradual moisture or oxygen ingress, and the same measurement can be repeated on the same vial over time to give a rate rather than a single value.{{r|usp1207}} |
| 134 | 134 | ||
| + | 135 | Integrity is not preserved indefinitely by an intact crimp. Elastomer compression set, thermal cycling, and mechanical shock during transport all degrade the seal, and integrity testing at the end of shelf life — rather than only at release — is the expectation for products where sterility is a claim. This is one respect in which the position for material distributed outside regulated channels is simply unknown: no integrity data exist, and an intact-looking crimp is not evidence of an intact seal.{{r|usp1207}} | |
| + | 136 | ||
| 135 | == Delamination and glass defects == | 137 | == Delamination and glass defects == |
| 136 | Inner-surface delamination is the detachment of thin glass flakes, conventionally called lamellae, from the interior wall of a vial. It came to prominence in 2010 and 2011 when several injectable products were recalled after lamellae were observed, and the Food and Drug Administration issued an advisory to manufacturers describing the phenomenon and its risk factors.{{r|fda2011}} | 138 | Inner-surface delamination is the detachment of thin glass flakes, conventionally called lamellae, from the interior wall of a vial. It came to prominence in 2010 and 2011 when several injectable products were recalled after lamellae were observed, and the Food and Drug Administration issued an advisory to manufacturers describing the phenomenon and its risk factors.{{r|fda2011}} |