Sterility testing: difference between revisions
Diff·revision 4 → 5·00:25, 6 Nov 2024
Difference between revision 4 and revision 5 of Sterility testing. 4 lines changed; the page grew by 388 bytes.
| Revision 4 — 02:34, 23 Oct 2024 CategoryBot (talk) bot: repair redlinked category 2,226 bytes +318 | Revision 5 — 00:25, 6 Nov 2024 CiteBot (talk) bot: normalise unit spacing 2,614 bytes +388 | ||
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| 11 | This limitation is intrinsic and well recognised. Testing a small number of units from a large batch has limited power to detect low-level contamination, and for this reason sterility assurance in manufacture rests on process validation and environmental control rather than on end-product testing.{{r|usp1211}} | 11 | This limitation is intrinsic and well recognised. Testing a small number of units from a large batch has limited power to detect low-level contamination, and for this reason sterility assurance in manufacture rests on process validation and environmental control rather than on end-product testing.{{r|usp1211}} |
| 12 | 12 | ||
| + | 13 | Sterility is distinct from freedom from pyrogens. A sterile preparation may contain [[Bacterial endotoxin test|bacterial endotoxin]] from organisms killed during processing, and the two determinations are not substitutes for one another.{{r|usp85}} | |
| + | 14 | ||
| 13 | == Method == | 15 | == Method == |
| 14 | Two methods are recognised. Membrane filtration passes the sample through a 0.45 μm filter that retains organisms, washes away any inhibitory substance, and incubates the membrane in growth media; it is preferred where the sample can be filtered. Direct inoculation adds the sample to media directly and is used where filtration is impractical.{{r|usp71}} | 16 | Two methods are recognised. Membrane filtration passes the sample through a 0.45 μm filter that retains organisms, washes away any inhibitory substance, and incubates the membrane in growth media; it is preferred where the sample can be filtered. Direct inoculation adds the sample to media directly and is used where filtration is impractical.{{r|usp71}} |
| ⋮ | ⋮ | ||
| 22 | <ref name="usp71">United States Pharmacopeia, General Chapter <71>, ''Sterility Tests''.</ref> | 24 | <ref name="usp71">United States Pharmacopeia, General Chapter <71>, ''Sterility Tests''.</ref> |
| 23 | <ref name="usp1211">United States Pharmacopeia, General Chapter <1211>, ''Sterility Assurance''.</ref> | 25 | <ref name="usp1211">United States Pharmacopeia, General Chapter <1211>, ''Sterility Assurance''.</ref> |
| + | 26 | <ref name="usp85">United States Pharmacopeia, General Chapter <85>, ''Bacterial Endotoxins Test''.</ref> | |
| 24 | 27 | ||
| 25 | {{DEFAULTSORT:Sterility testing}} | 28 | {{DEFAULTSORT:Sterility testing}} |
| 26 | [[Category:Compendial testing]] | 29 | [[Category:Compendial testing]] |
| 27 | [[Category:Analytical methods]] | 30 | [[Category:Analytical methods]] |
| + | 31 | [[Category:Quality and testing]] | |
| 28 | 32 |