The RiboPrinter® Microbial Characterization System is an automated tool for characterizing and identifying unknown bacterial isolates at or below the species level. Quality control labs in the pharmaceutical, personal care products and food industries use the RiboPrinter® system to track and trend microbial contamination. Microbial isolates may be obtained from sources such as raw materials, in-process samples, the processing environment and finished products.
Patented Process Samples are prepared in batches and loaded into the characterization unit for processing in about eight hours. The RiboPrinter® system uses a patented technology to process bacterial samples and extract data derived from the gene fragments that encode their ribosomal RNA. That data is used to generate RiboPrint™ patterns, which are genetic fingerprints of individual samples. The system then compares these patterns against others in the database to characterize (group) samples at the subspecies level. The patterns can also be used to identify genus and species.
DuPont Identification Libraries The RiboPrinter® system includes identification libraries with over 6900 RiboPrint™ patterns, representing 219 bacterial genera and more than 1440 species and serotypes that are critical to the food and pharmaceutical industries. You can also create Custom identification libraries to meet the unique needs of your business.
Data security and audit trails The RiboPrinter® software includes features that are important to pharmaceutical, biotechnical and other industries regulated by the U.S. Food and Drug Administration. The Windows®-based application provides data security and audit trails to support compliance with regulatory requirements for electronic records, as described in FDA 21 CFR Part 11.
Two convenient RiboPrinter® System Validation Packages are also available for purchase. The main Validation Package includes comprehensive test protocols for qualifying installation (IQ), performance (PQ) and operation (OQ - operator interface, data analysis and batch processing), along with compliance documents and a test plan. The Validation Package Supplement provides complete descriptions of user requirement specifications and functional design specifications.
The optional remote client software, available for RiboPrinter® system software version 2.0, allows you to perform many RiboPrinter® system tasks from another computer on a local or wide area network. You can run the user interface side by side with word processing, spreadsheet and presentation applications. This is very convenient when exporting data from the RiboPrinter® system and importing it into other types of documents.
The RiboPrinter® Data Merging workstation is an option available with RiboPrinter® system software version 2.1, which allows you to combine the records from many RiboPrinter® systems over a local network into one integrated database for characterization and identification. This is very valuable to service labs and other customers with several RiboPrinter® systems behind the same firewall. You control which data is merged, along with the frequency of uploads (automated and/or manual) and the processes that are performed on the data. The Data Merging Workstation includes a Windows® -based computer, monitor, printer and software that supports data merging.
For regulated industries, a Data Merging Workstation Validation Package is also available for purchase. This package includes test protocols for qualifying installation (IQ), performance (PQ) and operation (OQ), along with a test plan, user requirement specifications and functional design specifications.