Rapid sterility testing is essential to ensure patient safety for both personalized, time-sensitive therapies and products with longer manufacturing cycles. The solutions described aim to accelerate detection, improve operational efficiency, reduce risks, and support regulatory compliance across quality control activities.
Improve Operational Efficiency
BACT/ALERT® 3D, combined with its data management platform CODEX™, enhances automation, traceability, and workflow management in sterility testing.
- Full Traceability
- CODEX™ captures raw data and growth curves generated by BACT/ALERT® 3D.
- Bottle History provides complete visibility over all bottle-related events.
- An advanced audit trail allows easy access to instrument history and supports robust data retention.
- Easy Report Generation
- Real-time and on-demand report creation for products, samples, or bottles.
- Customizable work lists and print/extraction options streamline documentation.
- Compliance Protection
- Electronic signatures for bottle and sample approval.
- Designed to support high-level international standards, including 21 CFR Part 11 (ALCOA+).
- Centralized storage of system events with no storage limits, plus backup and archiving capabilities to facilitate audits.
Increase Productivity
CODEX™ supports better asset utilization and optimized laboratory workflows, offering broader insight into sterility testing operations.
- Data at a Glance
- Customizable dashboards enhance visibility of instrument status and sample progress.
- Advanced search functions improve workflow monitoring.
- Data Digitalization
- Streamlined sample creation and bottle loading through an improved order entry module.
- Traceability of manual operations, including GRAM staining and microbial identification.
- Connectivity & Data Optimization
- Seamless integration with commercial LIMS for end-to-end sample traceability.
- Flexible installation on PC, virtual machine, or server, with full integration into networks, LDAP, and domains.
- Built-in web application enables access to results anytime, anywhere.
- Cybersecurity by Design
- High-level data integrity and protection support confident decision-making through secure, reliable insights.
Receive Expert Support
- Dedicated teams provide ongoing support for BACT/ALERT® and CODEX™.
- Assistance is available for new system implementations, upgrades from MYLA® or OBSERVA®, and continuous operation.
Find out more information on how to equip your BACT/ALERT® 3D with CODEX™
