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OMNICON, OMNICON Zones of Inhibition
System, OMNICON Zone Reader, OMNICON Image Analysis System, OMNICON Image
Analyzer, Zones Reader, Automated Zone Reader, Automatic Zones Reader,
Zones of Inhibition, Inhibition Zone, Agar Diffusion, Agar Diffusion Assay,
Antibiotic Potency Testing, Antibiotic Testing, Potency Testing, USP 24,
CFR 21, British Pharmacopoeia, BP, European Pharmacopoeia, EP, Large Plate,
Latin Square, Nystatin, Mycostatin, Gentamycin, Erythromycin, Polymixin,
Amoxicillin, Bacitracin, Vancomycin
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Zones of Inhibition
United States Pharmacopoeia / CFR Method
Calculations
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
| 3
Point |
4
Point |
5
Point |
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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
Report

OMNICON is a registered trademark of BioLogics,
Inc.
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