UNISTAT bioassay analysis software, by Synbiosis, manufacturer of automated microbiological systems, has been integrated for use with ProtoCOL 3 colony counting and inhibition zone measuring system.
UNISTAT’s Analysis of Bioassays module will allow scientists a fast method of analysing their ProtoCOL 3 data to generate accurate antibiotic and vaccine potency results.
With one click of the ProtoCOL 3 system, microbiologists can export inhibition zone measurement and colony count data directly to UNISTAT.
The UNISTAT software supports calculations including Parallel Line Method and Slope Ratio Method, to produce potencies with confidence limits and analysis of variance compliant with United States Pharmacopoeia and European Pharmacopoeia. The software also uses powerful tools to detect, omit or replace outliers.
The package is the perfect combination for antibiotic or vaccine manufacturing facilities that need to increase testing accuracy.
The UNISTAT software generates results in graphs and tables, thus saving time and preventing transcribing errors when transferring data.
The module also offers tools to produce publication quality reports that will comply with 21 CFR Part 11 and Synbiosis can supply documentation to allow the UNISTAT software to be integrated with ProtoCOL 3 in a Good Manufacturing Practice (GMP) compliant environment.
“The integrated ProtoCOL 3 and UNISTAT package is the perfect combination for antibiotic or vaccine manufacturing facilities that need to increase testing accuracy, as well as securely store their results for on-demand review by any major regulatory authority,” said Kate George, Senior Divisional Manager at Synbiosis.