Vial: difference between revisions
Diff·revision 19 → 20·18:08, 22 Oct 2024
Difference between revision 19 and revision 20 of Vial. 2 lines changed; the page grew by 279 bytes.
| Revision 19 — 05:18, 16 Oct 2024 CouplingCillian (talk) attribute claim in-text 10,898 bytes +1,691 | Revision 20 — 18:08, 22 Oct 2024 SPPS_Sorrel (talk) expand §Container closure integrity 11,177 bytes +279 | ||
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| 62 | 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. | 62 | 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. |
| 63 | 63 | ||
| + | 64 | The label declaration for an injectable is the volume or mass withdrawable, and vials are therefore filled with a small excess. USP <697> requires that the volume obtainable be not less than the labelled volume, and USP <1151> gives recommended excess volumes for that purpose. | |
| + | 65 | ||
| 64 | == Elastomeric closures == | 66 | == Elastomeric closures == |
| 65 | The stopper performs three functions: it seals, it is penetrable by a needle and reseals afterwards, and it must not contribute leachables to the product. No single elastomer optimises all three, and formulation is a compromise. | 67 | The stopper performs three functions: it seals, it is penetrable by a needle and reseals afterwards, and it must not contribute leachables to the product. No single elastomer optimises all three, and formulation is a compromise. |