Sartocheck® 5 Plus Filter Tester

Surpass the Requirements of Quality Risk Management (QRM)

The regulatory focus on QRM (cf. ICHQ9 and the new Annex 1 written by EMA in cooperation with the US-FDA, WHO and PICs) also applies to filter integrity testing, as a fundamental element of sterility assurance. The Sartocheck® 5 Plus Filter Tester uses program specific parameters allowing the automatic identification of testing anomalies in advance or during the test.

Integrity testing often involves the use of chemicals and hazardous materials. The Sartocheck® 5 Plus is certified for use in explosion hazardous areas (ATEX) and is compatible with all current cleaning agents and VHP. This ensures maximum safety for operators and manufacturing facilities. The combination of a unique approach to quality risk management (QRM) as well as optimal data integrity, intuitiveness and minimized risk factors for health, safety and the environment (HSE) has set a new standard for filter integrity testing devices.

Main Features

Quality Risk Management

• Automatic detection of incorrect test setups
• Automatic detection of abnormal test conditions
• Self-test at booting and before each test

Data Integrity

• Custom Linux-based Operating System
• Four eyes principle with electronic signature
• C10- Internal Double Data Backup
• Encrypted Data
• Time Zone synchronization - NTP
• Audit Trail with time stamped events
• User Matrix to generate individual user roles
• Mandatory fields for Operator entries
• Data entry by Barcode Scanner
• Long-life printouts and sticker function from optional printer

Health, Safety and Environment

• Splash-proof (IP64)
• Explosion proof (ATEX IECEx & FM certified
• Safe testing and re-testing of alcohol wetted filters
• Continuous and clear visualization of pressure status
• Resistant to all current cleaning agents
• H2O2-vapor resistant (VHP)
• PFA tubes (FDA 21 CFR 177 and USP Class VI compliant)
• Prepared for automated cleaning of all pneumatics with up to 0.5 M NaOH

Optional Accessory

• 21 CFR part 11
• GAMP 5
• Ex proof (ATEX | IECEx | FM)
• CE
• FCC