Multi Plate Bio Assay - 100mm dishes - Antibiotic Potency Testing

Measuring zone diameters has never been easier. Using the OMNICON Zone Reader you can get fast reproducible, quantitative antibiotic
potency results while automating one of the most time-consuming, tedious tasks in your lab.

Software
The OMNICON Zones of Inhibition software enables automatic zone diameter measuring, applies the USP Outlier Test or Gap Test,
performs all calculation based on percent label claim or weight and dilution. Regardless of the agar diffusion method being used, Peni
Cylinders, cut wells or paper disc, the OMNICON Zone Reader analyzes them all effortlessly. The Zones of Inhibition system software
is 21 CFR Part 11 Electronic Records and Signature compliant, and provides three levels of security, encrypted data files and
comprehensive audit trails.

The reader can confirm and determine potencies of twelve antibiotics in the time it takes to read only one using the Fisher-Lilly Antibiotic
Zone Reader or caliper. The OMNICON Zone Reader can read an entire USP / CFR Standard Curve, perform all calculations, generate and
print the Standard Report, Standard Curve and Sample Report in less than two minutes. The system can easily be modified specifically
conform to a wide range of requirements and procedures.

Pharmacopeia Specific Software

The OMNICON Zone Reader integrates image analysis, comparison and reporting to provide accurate results in record time. The software
can perform antibiotic potency (bio-assays) testing conforming to:
- United States Pharmacopeia (USP), Code of Federal Regulations (CFR), and Association of Analytical Communities (AOAC
International) on 100mm round petri dishes
- European Pharmacopeia (EP) and British Pharmacopeia (BP) on 100mm round petri dishes
- Society of Japanese Pharmacopeia (JP) on 100mm round petri dishes

References
United States Pharmacopeia (USP)
US-FDA Code of Federal Regulations (CFR)
Association of Analytical Communities (AOAC International)
British Pharmacopeia (BP)
European Pharmacopoeia (EP)
Society of Japanese Pharmacopeia (JP)
UNITED STATES PHARMACOPEIA (USP), CODE OF FEDERAL REGULATIONS (CFR) AND AOAC INTERNATIONAL
METHODS FOR ANTIBIOTIC POTENCY TESTING

The OMNICON USP Zones of Inhibition software 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). 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 with 6 zones in less than 3/10th of a second, measuring the diameter and
shape of the zone. The shape value can be 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 Assay 4 Point Assay

3 Concentrations - S1, S2 & S3 4 Concentrations - S1, S2, S3 & S4

3 Plates per set - User can define up to 9 plates per set 3 Plates per set - User can define up to 9 plates per set

User defined Concentration Levels User defined Concentration Levels

EUROPEAN PHARMACOPEIA (EP), BRITISH PHARMACOPEIA (BP) METHODS FOR ANTIBIOTIC POTENCY TESTING

The OMNICON EP/BP Zones of Inhibition software performs all calculations in accordance to the procedures defined in the EP / BP
Methods, sometime referred to as the 3+3 Method. The software allows the Analyst to specify a minimum of 4 plates and maximum of
10 plates per assay, defines the concentration of the standards and preparations, and the assumed potency.

Once the zone diameters are measured, all the calculations are performed and the data presented in the "Independent Assay" report.
The Analyst also has the ability to generate a "Combination Analysis" report by selecting Independent assay previously analyzed.

Plate Reading
The OMNICON Zones Reader reads each 100 mm petri dish with 6 zones in less than 3/10th of a second, 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 EP/BP Zones of Inhibition software is compliant, providing three levels of security, audit trails and data encryption.
Assay Layout

6 zones per plate

Standard Concentrations
S1, S2 and S3

Preparations / Samples
P1, P2 and P3

Replicates
4 to 6 Plates

5 Point Assay
5 Concentrations - S1, S2, S3, S4 & S5

3 Plates per set - User can define up to 9 plates per set

User defined Concentration Levels

Assay Reports
Standard Curve Report

Standard Curve Graph

 Trial (Sample) Report

References
United States Pharmacopeia (USP)
US-FDA Code of Federal Regulations (CFR)
Association of Analytical Communities (AOAC International)
British Pharmacopeia (BP)
European Pharmacopoeia (EP)
Society of Japanese Pharmacopeia (JP)