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Vial filling and stoppering: difference between revisions

Diff·revision 4 → 5·18:54, 2 Dec 2024

Difference between revision 4 and revision 5 of Vial filling and stoppering. 3 lines changed; the page grew by 268 bytes.

Revision 4 — 20:43, 20 Nov 2024
FmocFrancis (talk)
add the figure for the lyophilisation cycle and caption it
2,480 bytes +465		Revision 5 — 18:54, 2 Dec 2024
TirzTaxonomist (talk)
state that overlay gas is used and name it
2,748 bytes +268
10Two 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}}10Two 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}}
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+12Neither is visible in a chromatographic determination. A [[Certificate of analysis|certificate]] reporting purity describes the material; it says nothing about how much of it is in the vial or whether the vial is sealed.{{r|usp1503}}
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12== Fill control ==14== Fill control ==
13Filling 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}}15Filling 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}}
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27[[Category:Fill and finish]]29[[Category:Fill and finish]]
28[[Category:Manufacturing and supply]]30[[Category:Manufacturing and supply]]
+31[[Category:Quality and testing]]
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