Vial filling and stoppering: difference between revisions
Diff·revision 7 → 8·00:47, 22 Jan 2025
Difference between revision 7 and revision 8 of Vial filling and stoppering. 5 lines changed; the page grew by 582 bytes.
| Revision 7 — 20:49, 4 Jan 2025 LiraLotte (talk) serial comma per PP:MOS 2,773 bytes +25 | Revision 8 — 00:47, 22 Jan 2025 StopperingSteff (talk) state that a phase-change pack and a gel pack behave differently 3,355 bytes +582 | ||
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| 20 | For a peptide the mass of interest is peptide mass, which is fill mass multiplied by [[Peptide content|content]]. A fill process controlled to a tight tolerance on solid mass still delivers a variable peptide mass if content varies between lots, which is why content belongs on the certificate alongside purity.{{r|usp1503}} | 20 | For a peptide the mass of interest is peptide mass, which is fill mass multiplied by [[Peptide content|content]]. A fill process controlled to a tight tolerance on solid mass still delivers a variable peptide mass if content varies between lots, which is why content belongs on the certificate alongside purity.{{r|usp1503}} |
| 21 | 21 | ||
| + | 22 | == Stoppering and seal integrity == | |
| + | 23 | The stopper is an elastomeric closure that must reseal after needle penetration, not shed particles, and not interact with the contents. For lyophilised products it is seated in two stages, since the partially seated position is what allows water vapour to leave during drying.{{r|ich_q7}} | |
| + | 24 | ||
| + | 25 | An aluminium seal is crimped over the stopper to hold it in place. A loose crimp, a stopper that has lifted, or a cracked flange are the visible defects; container closure integrity is formally established by test rather than by inspection.{{r|usp1207}} | |
| + | 26 | ||
| 22 | == References == | 27 | == References == |
| 23 | {{reflist}} | 28 | {{reflist}} |