Vial: difference between revisions
Diff·revision 6 → 7·16:07, 8 Aug 2024
Difference between revision 6 and revision 7 of Vial. 12 lines changed; the page grew by 1,230 bytes.
| Revision 6 — 22:56, 4 Aug 2024 RepackRadek (talk) fix hyphenation per PP:MOS 4,911 bytes +988 | Revision 7 — 16:07, 8 Aug 2024 Ref_Desk_Ron (talk) correct molar mass 6,141 bytes +1,230 | ||
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| 23 | Polymer vials of cyclic olefin polymer or copolymer are established for products incompatible with glass or requiring extreme resistance to breakage. They eliminate delamination and alkali leaching, and they permit lower moisture-vapour barrier performance and different extractable profiles — trade-offs rather than improvements. Requirements for plastic packaging systems are set out in USP <661> and its subsidiary chapters.{{r|usp661}} | 23 | Polymer vials of cyclic olefin polymer or copolymer are established for products incompatible with glass or requiring extreme resistance to breakage. They eliminate delamination and alkali leaching, and they permit lower moisture-vapour barrier performance and different extractable profiles — trade-offs rather than improvements. Requirements for plastic packaging systems are set out in USP <661> and its subsidiary chapters.{{r|usp661}} |
| 24 | 24 | ||
| + | 25 | |+ Glass container types, USP <660> | |
| + | 26 | | !Type | Composition | Determined by | Typical use | | |
| + | 27 | |---|---|---|---| | |
| + | 28 | | I | Borosilicate | Powdered glass test | Parenterals, including all lyophilised products | | |
| + | 29 | | II | Soda-lime, inner surface treated | Water attack at 121 °C | Aqueous parenterals of suitable pH | | |
| + | 30 | | III | Soda-lime | Powdered glass test | Non-parenteral, and dry powders where permitted | | |
| + | 31 | | NP | Soda-lime, general purpose | Powdered glass test | Non-parenteral only | | |
| + | 32 | ||
| + | 33 | === Depyrogenation === | |
| + | 34 | 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}} | |
| + | 35 | ||
| 25 | == References == | 36 | == References == |
| 26 | {{reflist}} | 37 | {{reflist}} |
| + | 38 | <ref name="usp660">United States Pharmacopeia, General Chapter <660>, "Containers — Glass". USP–NF, current revision.</ref> | |
| 27 | <ref name="usp661">United States Pharmacopeia, General Chapter <661>, "Plastic Packaging Systems and Their Materials of Construction". USP–NF, current revision.</ref> | 39 | <ref name="usp661">United States Pharmacopeia, General Chapter <661>, "Plastic Packaging Systems and Their Materials of Construction". USP–NF, current revision.</ref> |
| 28 | <ref name="usp381">United States Pharmacopeia, General Chapter <381>, "Elastomeric Closures for Injections". USP–NF, current revision.</ref> | 40 | <ref name="usp381">United States Pharmacopeia, General Chapter <381>, "Elastomeric Closures for Injections". USP–NF, current revision.</ref> |