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United States Pharmacopoeia (USP)
Method
Performs all calculations in accordance to the
procedures defined in the Code of Federal Regulations Standard
(CFR) 436.105 as well as in the Section of Design and Analysis
of Biological Assays <111>, Chapter of Biological Tests,
United States Pharmacopoeia (USP) XXIV. The software calculates
the mean and standard deviation values, excludes zones based
on the USP Outlier Test and draws the Zones of Inhibition
potency line graph for the Standard Analysis. It also calculates
the differences between the reference assay and the sample
test assay; obtain the mean and standard deviation of these
differences, calculate the label claim percentage and the
determined potency value for the Trial Analysis, or the Trial
analysis results based on weight and dilution.
Plate Reading
The OMNICON Zones Reader reads each 100 mm petri
dish in less than 2 seconds, measuring the diameter and shape
of the zone. The shape value is used to exclude zones which
are oval due to spills or irregular growth.
21 CFR, Part 11, Electronic Records
and Signatures
The OMNICON Zones Reader is compliant, providing
three levels of security, audit trails and data encryption.
Assay Layout
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3 Concentrations - A,B & C
3 Plates per set - User can define up
to 9 plates per set
User defined Concentration Levels
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4 Concentrations - A,B,C & D
3 Plates per set - User can define up
to 9 plates per set
User defined Concentration Levels
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5 Concentrations - A,B,C,D & E
3 Plates per set - User can define up
to 9 plates per set
User defined Concentration Levels
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Assay
Reports
Standard Report
Standard Curve
Trial (Sample) Report
References
United States Pharmacopoeia (USP)
US-FDA Code of Federal Regulations (CFR)
British Pharmacopoeia (BP)
European Pharmacopoeia (EP)
OMNICON is a registered trademark
of BioLogics, Inc.
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OMNICON
ZONE READER
