Vial: difference between revisions
Diff·revision 6 → 7·11:32, 15 Sep 2024
Difference between revision 6 and revision 7 of Vial. 9 lines changed; the page grew by 1,039 bytes.
| Revision 6 — 07:02, 4 Sep 2024 ResinRhoswen (talk) de-duplicate a repeated sentence 6,759 bytes ±0 | Revision 7 — 11:32, 15 Sep 2024 FreightFenna (talk) add the customs-detention point as a logistics fact, sourced 7,798 bytes +1,039 | ||
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| 6 | | Common neck finishes = 13 mm and 20 mm | 6 | | Common neck finishes = 13 mm and 20 mm |
| 7 | | Common sizes for research peptides = 2R and 6R | 7 | | Common sizes for research peptides = 2R and 6R |
| + | 8 | <!-- Glass properties --> | |
| + | 9 | | Hydrolytic class = USP <660> Type I | |
| + | 10 | | Linear expansion coefficient = approximately 32–33 × 10⁻⁷ K⁻¹ | |
| + | 11 | | Forming routes = Drawn from tubing; moulded | |
| + | 12 | | Principal degradation mode = Inner-surface delamination | |
| 8 | }} | 13 | }} |
| 9 | 14 | ||
| ⋮ | ⋮ | ||
| 14 | 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a lyophilised cake over its shelf life; and coring of the stopper by a needle introduces elastomer particles into the withdrawn liquid.{{r|fda2011,ennis2001,iso8362_5}} | 19 | Failures of each duty are documented and distinct.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a lyophilised cake over its shelf life; and coring of the stopper by a needle introduces elastomer particles into the withdrawn liquid.{{r|fda2011,ennis2001,iso8362_5}} |
| 15 | 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 | ||
| 16 | == Construction and materials == | 23 | == Construction and materials == |
| 17 | Pharmaceutical glass vials are produced by two routes with different characteristics. | 24 | Pharmaceutical glass vials are produced by two routes with different characteristics. |
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| 32 | 39 | ||
| 33 | The classification is by measured hydrolytic resistance rather than by nominal composition, and the tests differ between types: powdered glass tests interrogate the bulk composition, whereas the water attack test interrogates the treated inner surface. The European Pharmacopoeia operates a closely comparable scheme through general chapter 3.2.1 and the ISO 719 and ISO 720 grain tests.{{r|usp660,pheur321}} | 40 | The classification is by measured hydrolytic resistance rather than by nominal composition, and the tests differ between types: powdered glass tests interrogate the bulk composition, whereas the water attack test interrogates the treated inner surface. The European Pharmacopoeia operates a closely comparable scheme through general chapter 3.2.1 and the ISO 719 and ISO 720 grain tests.{{r|usp660,pheur321}} |
| + | 41 | ||
| + | 42 | Type I borosilicate is specified for essentially all injectable products. Its low alkali content limits pH shift on storage, and its linear expansion coefficient of roughly 32–33 × 10⁻⁷ K⁻¹ — about a third that of soda-lime glass — gives the thermal shock resistance required for depyrogenation at 250 °C or above and for the thermal cycling of a lyophilisation cycle.{{r|usp660}} | |
| 34 | 43 | ||
| 35 | === Depyrogenation === | 44 | === Depyrogenation === |