Simplifying Microbiological Testing

A personal computer with a Windows®-based program controls the operation of the instrument(s) and provides the user with tools to analyze and manage the information. The system has traditional Windows® menu functionality and is easy-to-operate without extensive training. The software contains an audit trail and full data management system, allowing the user to comply with a variety of regulations. The data collected from the instrument is automatically archived and processed by the computer with various reports and connectivity to LIMS (laboratory information management systems). Results can be communicated over any IP network in real-time.

Any out-of-spec samples are indicated in red. The greater the contamination level, the faster the result, ensuring rapid corrective action. Borderline samples appear next, indicated in yellow, while acceptable samples appear in green. The longer the test has progressed with no detection of growth, the more confident one can be about the product quality. The software is GMP, HACCP, 21 CFR part 11 and ISO 9000 compliant, provides an audit trail, trend analysis, and multiple, customizable report formats. The system is barcode capable.

Each time a new data point is obtained, an on-line mathematical algorithm determines, for each vial, whether "detection" conditions are met. If a detection condition is indicated, the software calculates the corresponding microbiological measurement, such as counts of organisms or shelf life of the product. In addition, the software stores all generated sample information in the hard drive, allowing for its retrieval and display during the test and in subsequent analyses.

The results of the assays are presented as soon as detections occur with no need for involvement of an operator. Any out-of-spec samples are "flagged" in red, demanding attention. The greater the contamination level, the faster the result, ensuring rapid warning of poor-quality raw material, finished product or line swab. Borderline samples are next to appear, "flagged" in yellow, while acceptable samples appear in green. The longer the test has progressed with no detection of growth, the more confident one can be about the product quality. Sterile samples do not “detect” since no growth occurs.

The software package has easy to use, menu-driven functionality. The data from the instrument(s) is collected every six minutes and automatically stored in the computer. This data provides automated detection time, automated alerts for contaminated samples, and such results can be automatically transferred over networks.

The system generates automated reports in a variety of formats. Reports can be customized to fit a user’s needs. The system supports bar code entry of data, has connectivity to LIMS systems, and data is evaluated in real time to release products in a timely manner.