Sartocheck® 5 Plus Universal

Sartocheck® 5 Plus Universal: Advanced Filter and Bag Testing

The Sartocheck® 5 Plus Universal is a cutting-edge solution for combined filter integrity testing and bag testing, designed to meet the stringent demands of GMP environments. With the latest software and hardware enhancements, it offers unparalleled performance in sterility assurance, ensuring optimal data integrity, usability, and safety.

Data Integrity and Security

• Robust Data Management: Ensures long-term reliable data storage, crucial for batch protocol and drug release justification.
• Advanced Security Features: Includes encrypted double data backup, redundant data storage, and electronic signatures to safeguard data integrity.
• Comprehensive Audit Trail: Provides a detailed, easy-to-read audit trail with time zone-synchronized events, ensuring compliance with 21CFR Part 11.

Intuitive Usability

• User-Friendly Interface: Features a high-quality 12.1” touchscreen with a large digital keypad for easy operation.
• Customizable Settings: Offers program-specific parameters for automatic detection of testing anomalies, enhancing user experience and reducing errors.
• Multi-Language Support: Available in 10 languages, facilitating global usability.

Health, Safety, and Environment

• Certified Safety Standards: Compatible with all current cleaning agents and certified for use in explosion-hazardous areas (ATEX).
• Minimized Risk Factors: Designed to ensure maximum safety for operators, with features like splash-proof and ex-proof certifications.
• Environmentally Friendly: Resistant to vaporized hydrogen peroxide (VHP) and other cleaning agents, promoting a safe testing environment.

Compliance and Quality Assurance

• Regulatory Alignment: Supports Quality Risk Management (QRM) as outlined in ICH Q9 and the new Annex 1, ensuring compliance with global standards.
• Automatic Anomaly Detection: Prevents costly variations and potential drug recalls by identifying incorrect test setups and abnormal test conditions.
• Comprehensive Failure Analysis: Includes a failure mode and effects analysis (FMEA) for thorough risk assessment.

Supplies and Accessories

• Versatile Accessory Kits: Includes kits for bag testing and external venting, enhancing testing capabilities.
• Comprehensive Installation Packages: Offers installation and validation documentation, ensuring seamless integration into existing systems.
• Optional Cleaning Kits: Provides accessory kits for cleaning pneumatics, ensuring maintenance and operational efficiency.

Advantages at a Glance

• Combined Testing Capabilities: Integrates filter and bag testing in one device, streamlining processes.
• Enhanced Data Security: Protects data integrity with advanced security features.
• User-Friendly Design: Simplifies operation with intuitive interface and customizable settings.
• Certified Safety: Ensures operator safety with compliance to ATEX and other standards.
• Regulatory Compliance: Aligns with global quality risk management standards for sterility assurance.

The Sartocheck® 5 Plus Universal sets a new benchmark in filter integrity and single-use systems testing, offering a comprehensive solution for modern pharmaceutical manufacturing needs.