Vial: difference between revisions
Diff·revision 7 → 8·11:29, 3 Oct 2024
Difference between revision 7 and revision 8 of Vial. 15 lines changed; the page grew by 1,409 bytes.
| Revision 7 — 11:32, 15 Sep 2024 FreightFenna (talk) add the customs-detention point as a logistics fact, sourced 7,798 bytes +1,039 | Revision 8 — 11:29, 3 Oct 2024 ResinRhoswen (talk) expand §Delamination and glass defects 9,207 bytes +1,409 | ||
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| 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}} | 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 | 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. | |
| + | 61 | ||
| 47 | == References == | 62 | == References == |
| 48 | {{reflist}} | 63 | {{reflist}} |