japanese Pharmacopeia (JP) method for Antibiotic Potency Testing
The OMNICON JP Zones of Inhibition software performs all calculations in accordance to the JP method or sometimes refered to as the 2 + 2 Method. The software calculates the mean and standard deviation values for both the standard and unknown zones and several statistical values.
The Analyst defines the assumed potency, the software then measures the zone diameters and performs all the calculations and presents the data on the "Independent Assay" report.
The software also provides the Analyst with 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 4 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 JP Zones of Inhibition software is compliant, providing three levels of security, audit trails and data encryption.
Assay Layout
4 zones per plate |
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)
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