Sartocheck® 5 Plus
Sartocheck® 5 Plus perfectly meets today’s essential industry requirements for filter integrity testing in demanding GMP environments. It sets a new standard for filter integrity test devices by combining a unique approach to Quality Risk Management with optimal data integrity, intuitive usability, and minimized risk factors for Health, Safety, and Environment (HSE).
- Categories: Process-Scale Filtration | Filter Integrity Test |
The Sartocheck® 5 Plus Filter Test Device uses program-specific parameters that allow automatic identification of test abnormalities before or during testing. This helps prevent time-consuming and costly deviations, potential drug recalls, and warnings.
Exceed Quality Risk Management (QRM) Requirements:
- Automatic detection of improper test setups
- Automatic detection of abnormal test conditions
- Comprehensive FMEA documentation available
- Calculation tool for improbable pressure reading deviations
- Data Integrity Statement | ALCOA+ Principles
- Data security
- Electronic signatures | Four-eyes principle
- Encrypted data and encrypted LDAP
- Traceability | Audit trail
- Traceability | Audit
- Consistent file names and compliant time displays
- User matrix for creating individual user roles
- Internal dual data backup
- Mandatory fields for operator entries