Vial filling and stoppering (revision 1)
Old revision·11:01, 31 Oct 2024·MolarMassMaeve
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| Vial filling and stoppering | |
|---|---|
| Determines | Fill mass, headspace, container integrity |
| Sequence for lyophilisate | Fill, partially stopper, dry, seat, cap |
| Failure mode of interest | Underfill; seal defects |
| Analytical method infobox · conventions | |
Vial filling and stoppering is the operation that transfers material into its final container and closes it. For a lyophilised product the sequence is distinctive: solution is filled, stoppers are seated only partially so that vapour can escape, the vials are dried in the chamber, and the stoppers are then pressed home before the vials leave it.[1]
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.[2]
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