BactoSense PURE

BactoSense® PURE is a high-performance, fully automated flow cytometer designed for rapid and precise microbiological monitoring of purified water, delivering near real-time results within approximately 20 minutes to support immediate operational decision-making . Based on advanced fluorescence detection and laser technology (488 nm), it directly quantifies microbial parameters such as Intact Cell Count (ICC), HNA/LNA populations, and activity indicators, providing a comprehensive understanding of microbial dynamics across water systems .

The system supports both online and manual sampling, with flexible measurement intervals ranging from 30 minutes to 6 hours, and is engineered to operate across a wide range of water conditions, ensuring reliability in diverse industrial and pharmaceutical environments . Designed for seamless integration, it offers extensive connectivity options including Modbus TCP, Ethernet, and digital/analogue I/O, enabling direct communication with SCADA and control systems for automated monitoring and response .

Additionally, BactoSense PURE ensures high data integrity and regulatory compliance through features such as audit trails, role-based access control, electronic signatures, and primary validation aligned with pharmacopeial standards, making it suitable for GMP-regulated applications . Its cartridge-based system allows up to 1,000 automated measurements with minimal maintenance, providing a robust, scalable, and cost-efficient solution for continuous microbiological control.

Key advantages:

• Intact Cell Count results in approximately 20 minutes
• Primary validated against the compendial membrane-filtration benchmark
• Validation approach based on Ph. Eur. 5.1.6, USP <1223> and PDA Technical Report No. 33
• Audit trail and role-based access control
• Electronic-signature functionality
• Technical controls supporting FDA 21 CFR Part 11-compliant implementation
• IQ/OQ documentation and qualification support
• Performance Qualification support
• Online and manual operation
• Supports Contamination Control Strategy (CCS)
• Proven Technology

Best suited for:

• Pharmaceutical manufacturing
• Biotechnology and biopharmaceutical facilities
• Purified water systems
• Water for injection systems
• Cosmetics and personal-care manufacturing
• Low-bioburden production environments
• Storage tanks, distribution loops and points of use
• Sanitisation verification and microbial investigation