Vial: difference between revisions
Diff·revision 15 → 16·15:42, 28 Sep 2024
Difference between revision 15 and revision 16 of Vial. 17 lines changed; the page grew by 1,809 bytes.
| Revision 15 — 04:50, 20 Sep 2024 ThymosinTamsin (talk) clarify whether figure is gross or net mass 7,398 bytes +242 | Revision 16 — 15:42, 28 Sep 2024 SPPS_Sorrel (talk) replace primary source with the review 9,207 bytes +1,809 | ||
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| 19 | Failures of each duty are documented and distinct. Leaching of glass constituents alters solution pH and can catalyse degradation; inner-surface delamination sheds glass flakes and was the subject of regulatory advisories and recalls in 2010 and 2011; incomplete sealing permits microbial ingress and moisture gain, the latter raising the residual moisture of a lyophilised cake over its shelf life; and coring of the stopper by a needle introduces elastomer particles into the withdrawn liquid.{{r|fda2011,ennis2001,iso8362_5}} | 19 | Failures of each duty are documented and distinct. Leaching of glass constituents alters solution pH and can catalyse degradation; inner-surface delamination sheds glass flakes and was the subject of regulatory advisories and recalls in 2010 and 2011; incomplete sealing permits microbial ingress and moisture gain, the latter raising the residual moisture of a lyophilised cake over its shelf life; and coring of the stopper by a needle introduces elastomer particles into the withdrawn liquid.{{r|fda2011,ennis2001,iso8362_5}} |
| 20 | 20 | ||
| + | 21 | For material distributed outside pharmaceutical channels, the vial is also the principal carrier of identity. A label, a crimp colour and a stamped lot number are frequently the only evidence linking a solid to a [[certificate of analysis]], and the ease with which all three can be reproduced is the structural reason that [[Lot traceability|lot traceability]] in that sector is weak.{{r|usp1207}} | |
| + | 22 | ||
| 21 | == Construction and materials == | 23 | == Construction and materials == |
| 22 | Pharmaceutical glass vials are produced by two routes with different characteristics. | 24 | Pharmaceutical glass vials are produced by two routes with different characteristics. |
| ⋮ | ⋮ | ||
| 42 | === Depyrogenation === | 44 | === Depyrogenation === |
| 43 | Glass vials are rendered free of endotoxin by dry heat, conventionally at 250 °C or above for a validated period, with the requirement expressed as a demonstrated reduction of at least three logarithms in a challenge of bacterial endotoxin rather than as a time and temperature alone. The process is destructive to endotoxin rather than merely sterilising, which is why it is specified separately from sterilisation and why autoclaving does not substitute for it. Verification of the result is by the [[Bacterial endotoxin test|bacterial endotoxin test]] described in USP <85>.{{r|usp660,usp1207}} | 45 | Glass vials are rendered free of endotoxin by dry heat, conventionally at 250 °C or above for a validated period, with the requirement expressed as a demonstrated reduction of at least three logarithms in a challenge of bacterial endotoxin rather than as a time and temperature alone. The process is destructive to endotoxin rather than merely sterilising, which is why it is specified separately from sterilisation and why autoclaving does not substitute for it. Verification of the result is by the [[Bacterial endotoxin test|bacterial endotoxin test]] described in USP <85>.{{r|usp660,usp1207}} |
| + | 46 | ||
| + | 47 | == Dimensions and nominal capacity == | |
| + | 48 | Vial sizes are standardised by ISO 8362-1 in a series designated by a number and the letter R, the number being the nominal capacity in millilitres. The nominal capacity is not the volume the vial holds: the brimful or overflow capacity is substantially larger, because headspace is required for stoppering, for the expansion of a lyophilisation cake and for withdrawal. | |
| + | 49 | ||
| + | 50 | |+ Nominal dimensions of the ISO 8362-1 R series, selected sizes | |
| + | 51 | | !Designation | Outside diameter | Height | Overflow capacity | Neck finish | | |
| + | 52 | |---|---|---|---|---| | |
| + | 53 | | 2R | 16 mm | 35 mm | approximately 4 mL | 13 mm | | |
| + | 54 | | 4R | 16 mm | 45 mm | approximately 6 mL | 13 mm | | |
| + | 55 | | 6R | 22 mm | 40 mm | approximately 10 mL | 20 mm | | |
| + | 56 | | 8R | 22 mm | 45 mm | approximately 11.5 mL | 20 mm | | |
| + | 57 | | 10R | 24 mm | 45 mm | approximately 13.5 mL | 20 mm | | |
| + | 58 | | 20R | 30 mm | 55 mm | approximately 26 mL | 20 mm | | |
| + | 59 | ||
| + | 60 | Dimensions are nominal and subject to the tolerances in the standard.{{r|iso8362_1}} Two consequences follow for reading a label. A vial described as a 2 mL vial holds about 4 mL brimful, so a 2R vial containing 1 mL of liquid looks nearly empty and a 2R vial containing a 5 mg lyophilised cake may appear to contain nothing at all. And the neck finish, not the nominal capacity, determines which closure fits — 13 mm and 20 mm are not interchangeable, and a 20 mm stopper on a 13 mm vial cannot be sealed. | |
| 44 | 61 | ||
| 45 | == References == | 62 | == References == |