Vial: difference between revisions
Diff·revision 52 → 53·06:26, 12 Aug 2025
Difference between revision 52 and revision 53 of Vial. 2 lines changed; the page grew by 522 bytes.
| Revision 52 — 06:47, 31 Jul 2025 CrudePeptidePearl (talk) merge two short sections 22,444 bytes ±0 | Revision 53 — 06:26, 12 Aug 2025 Chromatokid (talk) consistent en dashes in ranges 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}} |