Vial filling and stoppering: difference between revisions
Diff·revision 1 → 2·04:14, 1 Nov 2024
Difference between revision 1 and revision 2 of Vial filling and stoppering. 6 lines changed; the page grew by 696 bytes.
| Revision 1 — 11:01, 31 Oct 2024 MolarMassMaeve (talk) create article — process stub 1,319 bytes +1,319 | Revision 2 — 04:14, 1 Nov 2024 SortKeySascha (talk) state the difference between a validated shipper and an insulated box 2,015 bytes +696 | ||
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| 10 | Two attributes are set here and nowhere else. Fill mass determines how much material a purchaser receives — see [[Underfilling]] — and container closure integrity determines whether the contents stay dry and uncontaminated for the shelf life.{{r|usp1207}} | 10 | Two attributes are set here and nowhere else. Fill mass determines how much material a purchaser receives — see [[Underfilling]] — and container closure integrity determines whether the contents stay dry and uncontaminated for the shelf life.{{r|usp1207}} |
| 11 | 11 | ||
| + | 12 | == Fill control == | |
| + | 13 | Filling is volumetric or gravimetric. Volumetric filling meters a volume and relies on solution density; gravimetric filling weighs, in-process or in a sampling plan, and is more directly connected to the quantity of interest.{{r|ich_q7}} | |
| + | 14 | ||
| + | 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 | ||
| 12 | == References == | 17 | == References == |
| 13 | {{reflist}} | 18 | {{reflist}} |
| 14 | <ref name="ich_q7">International Council for Harmonisation, ''Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients'' (2000).</ref> | 19 | <ref name="ich_q7">International Council for Harmonisation, ''Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients'' (2000).</ref> |
| 15 | <ref name="usp1207">United States Pharmacopeia, General Chapter <1207>, ''Package Integrity Evaluation — Sterile Products''.</ref> | 20 | <ref name="usp1207">United States Pharmacopeia, General Chapter <1207>, ''Package Integrity Evaluation — Sterile Products''.</ref> |
| + | 21 | <ref name="iso9001">ISO 9001:2015, ''Quality management systems — Requirements''.</ref> | |
| 16 | 22 | ||
| 17 | {{DEFAULTSORT:Vial filling and stoppering}} | 23 | {{DEFAULTSORT:Vial filling and stoppering}} |