Statements (43)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
pharmaceutical standard
|
| gptkbp:alternativeMethodsAllowed |
rapid microbiological methods
|
| gptkbp:appliesTo |
pharmaceutical products
|
| gptkbp:compatibleWith |
gptkb:FDA
gptkb:EMA |
| gptkbp:harmonizedWith |
European Pharmacopoeia 2.6.1
Japanese Pharmacopoeia 4.06 |
| https://www.w3.org/2000/01/rdf-schema#label |
USP <71> Sterility Tests
|
| gptkbp:incubationTemperature |
20-25°C
30-35°C |
| gptkbp:incubationTime |
14 days
|
| gptkbp:latestReleaseVersion |
USP 43-NF 38 (2020)
|
| gptkbp:medium |
Fluid Thioglycollate Medium
Soybean-Casein Digest Medium |
| gptkbp:method |
membrane filtration
direct inoculation |
| gptkbp:partOf |
gptkb:United_States_Pharmacopeia
|
| gptkbp:publishedBy |
gptkb:United_States_Pharmacopeial_Convention
|
| gptkbp:purpose |
detect presence of viable microorganisms
|
| gptkbp:regulates |
sterility testing procedures
|
| gptkbp:requires |
parenteral preparations
ophthalmic preparations medical devices labeled as sterile |
| gptkbp:result |
growth indicates contamination
no growth indicates sterility |
| gptkbp:riskOfFalseNegative |
inadequate sample size
|
| gptkbp:riskOfFalsePositive |
contamination during testing
|
| gptkbp:samplePreparation |
aseptic technique required
|
| gptkbp:standardizedBy |
gptkb:USP-NF
|
| gptkbp:testedBy |
14 days
|
| gptkbp:testLimitation |
long incubation period
cannot detect non-culturable organisms not suitable for all product types |
| gptkbp:testOrganisms |
fungi
yeasts anaerobic bacteria aerobic bacteria |
| gptkbp:testVolume |
varies by product type
|
| gptkbp:type |
compendial test
|
| gptkbp:usedBy |
pharmaceutical manufacturers
quality control laboratories |
| gptkbp:bfsParent |
gptkb:USP_Microbiology_Standards
|
| gptkbp:bfsLayer |
7
|