Vial: difference between revisions
Diff·revision 59 → 60·03:47, 28 Oct 2025
Difference between revision 59 and revision 60 of Vial. 2 lines changed; the page grew by 442 bytes.
| Revision 59 — 13:22, 17 Oct 2025 CustomsClarke (talk) add citation 25,024 bytes ±0 | Revision 60 — 03:47, 28 Oct 2025 CDMO_Caradoc (talk) move unsourced paragraph to talk 25,466 bytes +442 | ||
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| 144 | Other glass defects are more mundane and more common: chips at the sealing land, which prevent sealing; stones and cords, which are inclusions and inhomogeneities weakening the wall; and scratches from handling, which initiate breakage. Inspection for these is a fill-finish activity and is treated at [[Vial filling and stoppering]]. | 144 | Other glass defects are more mundane and more common: chips at the sealing land, which prevent sealing; stones and cords, which are inclusions and inhomogeneities weakening the wall; and scratches from handling, which initiate breakage. Inspection for these is a fill-finish activity and is treated at [[Vial filling and stoppering]]. |
| 145 | 145 | ||
| + | 146 | For lyophilised peptides the delamination risk is lower than for aqueous products in the same containers, because the material is dry throughout its storage life and the reconstituted solution is in contact with the glass for minutes rather than years. The risk is not nil where the reconstituted solution is stored in the original container, which is the ordinary practice for a [[Multi-dose vial|multiple-dose]] presentation.{{r|usp1660}} | |
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| 146 | == Vials in unregulated distribution == | 148 | == Vials in unregulated distribution == |
| 147 | Vials of research peptides are physically ordinary — commonly 2R or 6R tubing vials with butyl closures and flip-off ferrules, sourced from the same suppliers that serve pharmaceutical manufacturers. What differs is the documentation attached to them and the inspection they have undergone. | 149 | Vials of research peptides are physically ordinary — commonly 2R or 6R tubing vials with butyl closures and flip-off ferrules, sourced from the same suppliers that serve pharmaceutical manufacturers. What differs is the documentation attached to them and the inspection they have undergone. |