Easy, Windows-Based Operation
A personal computer with a Windows®-based program controls the operation of the BioLumix 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 is 21 CFR Part 11, cGMP, HACCP, and ISO 9000 compliant, provides an audit trail, operator identification, trend analysis, and multiple, customizable report formats. The system is barcode capable.
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.
Real-Time Results: Color-Coded Alerts
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 any equipment line issues.
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. 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.
Each time a new data point is obtained, an on-line mathematical algorithm determines whether “detection” conditions are met. This happens for each individual vial. If a detection condition is indicated, the software calculates the corresponding microbiological measurement, such as organism count or shelf-life of the product.
Automated Reports in Your Choice of Format
The BioLumix system generates automated reports in a variety of formats. Reports can be customized to fit your 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.
BioLumix Software Capabilities
- Log in and log out for security
- Operator Identification
- Audit Trail
- Random Access in sample entry
- Easy-to-interpret screens with overview of sample status
- Effective display of relevant information for each vial with a single click
- Information transfer over the network
- Real-time contamination alerts