Vial filling and stoppering: difference between revisions
Diff·revision 16 → 17·18:14, 25 Jul 2025
Difference between revision 16 and revision 17 of Vial filling and stoppering. 6 lines changed; the page grew by 545 bytes.
| Revision 16 — 12:25, 28 Jun 2025 PrepHPLC_Pia (talk) add the shelf temperature and the primary drying step to the cycle description 4,012 bytes ±0 | Revision 17 — 18:14, 25 Jul 2025 StyleSheetSybil (talk) correct the eutectic temperature — source gives a range 4,557 bytes +545 | ||
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| 35 | These are handling observations, not determinations. None establishes that contents are compromised, and their absence does not establish integrity — which is the general shape of every visual check on this wiki.{{r|usp1207}} | 35 | These are handling observations, not determinations. None establishes that contents are compromised, and their absence does not establish integrity — which is the general shape of every visual check on this wiki.{{r|usp1207}} |
| 36 | 36 | ||
| + | 37 | == Headspace == | |
| + | 38 | Lyophilised products are commonly stoppered under partial vacuum or under an inert gas. Vacuum stoppering gives a check that is available to a purchaser — a vial under vacuum draws air in audibly when first vented — while inert-gas stoppering does not.{{r|ich_q7}} | |
| + | 39 | ||
| + | 40 | Headspace composition affects oxidative degradation. A vial stoppered under nitrogen exposes its contents to far less oxygen than one stoppered under air, which matters for sequences containing methionine. See [[Methionine oxidation]]. | |
| + | 41 | ||
| 37 | == References == | 42 | == References == |
| 38 | {{reflist}} | 43 | {{reflist}} |
| ⋮ | ⋮ | ||
| 48 | * [[Lyophilisation]] | 53 | * [[Lyophilisation]] |
| 49 | * [[Methionine oxidation]] | 54 | * [[Methionine oxidation]] |
| + | 55 | * [[Peptide content]] | |
| 50 | 56 | ||
| 51 | {{DEFAULTSORT:Vial filling and stoppering}} | 57 | {{DEFAULTSORT:Vial filling and stoppering}} |