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Molecular Microbiology

Sector: Industrial

DuPont Qualicon RiboPrinter® microbial characterization system supports data security and audit trails for 21 CFR Part 11 compliance

DuPont Qualicon RiboPrinter ®

The RiboPrinter® system uses powerful genetic information to provide an automated genetic snapshot, or RiboPrint™ pattern, of any bacterium in less than eight hours. RiboPrint™ patterns can be used to identify and characterize environmental isolates, pathogens, spoilage organisms, control strains, beneficial organisms or any bacterium that is important to the pharmaceutical, personal care and food safety industries.

RiboPrinter® microbial characterization system

The RiboPrinter® microbial characterisation system provides the speed, accuracy and resolution needed to identify micro-organisms and characterize them efficiently and consistently. These determinations can be applied to virtually all bacteria.

Using powerful genetic information, the RiboPrinter® system provides an automated genetic snapshot, or RiboPrint ® pattern, of any bacterium in less than eight hours. 

RiboPrint® patterns characterize environmental isolates, pathogens, spoilage organisms, control strains, beneficial organisms or any bacterium that is important to the pharmaceutical, personal care and food safety industries.

Until now, the methods for genetic characterization of bacteria required highly skilled technicians and lacked standardisation and consistency. The RiboPrinter® system provides the speed, accuracy, reproducibility and confidence never before possible.

From start to finish, the RiboPrinter® system process is automated, simplifying operator training and minimising errors due to technique. Loading and operating the characterization unit are easy and intuitive. The workstation software is user-friendly, providing sophisticated data analysis that eliminates the need for subjective interpretation of results.

Only the RiboPrinter® system combines automation and the power of DNA to go beyond identifying and documenting a problem. The RiboPrinter® system produces an exact genetic snapshot of organisms, delivering the unparalleled power to track sources of contamination and gain control of any microbial environment.

Advantages


The flexibility to match any situation
With the RiboPrinter® system restriction enzyme flexibility, ribotyping bacteria can be performed with either a prepackaged restriction enzyme or a custom configuration, while retaining the advantage s of full automation.

Greater speed and confidence throughout the day
Up to eight bacterial isolates can be tested at one time, with results available eight hours from sample input. Because the system can accept new batches every two hours, up to 32 samples can be loaded in a normal workday. This provides rapid, accurate results for great confidence in any product tested.

Control any microbial environment
The RiboPrinter® system provides rapid, standardised identification and characterization of bacteria. The power to track and identify bacteria increases every time a sample is run. With a comprehensive, dynamic picture of any microbial environment, technicians can track and manage data at the strain level, letting them pinpoint contamination with more speed, ease and precision than ever before possible.

How it works

After you prepare your samples, the automated process begins by lysing cells and cutting the released DNA into fragments via a restriction enzyme. These fragments are separated by size through gel electrophoresis and then transferred to a membrane, where they are hybridized with a DNA probe and mixed with a chemiluminescent agent. A digitizing camera captures the light emission as image data, from which the system extracts a RiboPrint® pattern. This pattern is compared to others in the database for characterization and identification, and the results are automatically printed in a report for your review.

How it works

 

Data security and audit trails

Version 2.0 of the RiboPrinter® software includes features that are important to pharmaceutical, biotechnical and other industries regulated by the U.S. Food and Drug Administration. This release is a Windows® 2000-based application that provides data security and audit trails to support compliance with regulatory requirements for electronic records, as described in FDA 21 CFR Part 11.

Validation packages

A convenient Validation package is also available for purchase. The package includes comprehensive test protocols for qualifying installation (IQ), performance (PQ) and operation (OQ - three volumes for operator interface, data analysis and batch processing) , along with compliance documents and a test plan. Complete descriptions of user requirements and functional specifications are also included in the validation package.

Remote client software

The 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.

Ordering information

QR0021H

Windows® 2000 RiboPrinter® microbial characterization system

Characterization unit
Windows® PC
Flat screen LCD monitor
RiboExplorer software/Microsoft® Windows based
Laser printer
Heat treatment station
Handheld mixer
Sample preparation rack

 
QR0533CECO RI kit48 samples
QR0601C PVUII RiboPrinter kit48 samples
QR0641CNo Enzyme RiboPrinter kit48 samples
QR0002A

Windows® 2000 RiboPrinter® Validation package

Qualification Protocol ( IQP )
Operational Qualification Protocol ( OQP )Vol. 1
Operational Qualification Protocol ( OQP ) Vol. 2
Operational Qualification Protocol ( OQP ) Vol. 3
Batch protocol ( OQP )
Performance Qualification Protocol ( PQP )
Part 11 White paper
User Requirements specification
Functional Requirement Specification
Readme file

 


Product related literature

For further information about Riboprinter® microbial characterization systems, please download the DuPont Qualicon Riboprinter system update (2.66MB) in PDF format.

 
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