Vial filling and stoppering: difference between revisions
Diff·revision 3 → 4·20:43, 20 Nov 2024
Difference between revision 3 and revision 4 of Vial filling and stoppering. 3 lines changed; the page grew by 465 bytes.
| Revision 3 — 22:47, 6 Nov 2024 StubSorterBot (talk) bot: normalise temperature formatting 2,015 bytes ±0 | Revision 4 — 20:43, 20 Nov 2024 FmocFrancis (talk) add the figure for the lyophilisation cycle and caption it 2,480 bytes +465 | ||
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| 15 | Fill accuracy is specified as a tolerance and monitored during the run, since pump and valve behaviour drifts, and the in-process records are part of the batch documentation.{{r|iso9001}} A deliberate overage above the label claim is ordinary and compensates for losses in reconstitution and withdrawal; it is not a defect. See [[Underfilling]]. | 15 | Fill accuracy is specified as a tolerance and monitored during the run, since pump and valve behaviour drifts, and the in-process records are part of the batch documentation.{{r|iso9001}} A deliberate overage above the label claim is ordinary and compensates for losses in reconstitution and withdrawal; it is not a defect. See [[Underfilling]]. |
| 16 | 16 | ||
| + | 17 | 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}} | |
| + | 18 | ||
| 17 | == References == | 19 | == References == |
| 18 | {{reflist}} | 20 | {{reflist}} |
| 19 | <ref name="ich_q7">International Council for Harmonisation, ''Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients'' (2000).</ref> | 21 | <ref name="ich_q7">International Council for Harmonisation, ''Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients'' (2000).</ref> |
| 20 | <ref name="usp1207">United States Pharmacopeia, General Chapter <1207>, ''Package Integrity Evaluation — Sterile Products''.</ref> | 22 | <ref name="usp1207">United States Pharmacopeia, General Chapter <1207>, ''Package Integrity Evaluation — Sterile Products''.</ref> |
| + | 23 | <ref name="usp1503">United States Pharmacopeia, General Chapter <1503>, ''Quality Attributes of Synthetic Peptide Drug Substances''.</ref> | |
| 21 | <ref name="iso9001">ISO 9001:2015, ''Quality management systems — Requirements''.</ref> | 24 | <ref name="iso9001">ISO 9001:2015, ''Quality management systems — Requirements''.</ref> |
| 22 | 25 |