Sartocheck® 5 Plus Filter Integrity Tester, manufactured in 2022.

Like-new Sartocheck® 5 Plus Filter Integrity Tester, manufactured in 2022.

The Sartocheck® 5 Plus Filter Tester is an automatic filter integrity tester with automatic Quality Risk Management (QRM) that covers the entire range of integrity tests. It can handle everything from small syringe filters to large multi-round housings and tangential flow cassettes.

Catalog Number: 26787---FT---P

The Sartocheck® 5 Plus can perform the following filter integrity tests:

• Bubble Point Test
• Diffusion Test / Forward Flow Test
• Combination of Diffusion and Bubble Point Test
• Water Intrusion Test (WIT)
• Pressure Drop Test / Leak Test

Quality Risk Management:

Regulations emphasize Quality Risk Management (QRM) (e.g., ICH Q9 and the new Annex 1 drafted by the EMA in collaboration with the US FDA, WHO, and PICs) for filter integrity tests as a fundamental element of ensuring sterility. The Sartocheck® 5 Plus Filter Tester utilizes specific program parameters that allow automatic identification of anomalies before and during testing. This helps prevent time-consuming and costly deviations, potential drug recalls, and 483 Warning Letters.

Key Features:

Quality Risk Management:

• Automatic detection of incorrect or improper test setups
• Automatic detection of abnormal test conditions
• Self-testing during boot-up and before each test

Data Integrity:

• Personalized Linux-based operating system
• Four-eye principle with electronic signature
• Internal double data backup
• Encrypted data
• Time zone synchronization – NTP
• Audit mode with timestamps for events
• User matrix for creating individual roles
• Mandatory fields for operator inputs
• Easy data entry with optional barcode scanner
• Durable prints with optional USB printer

User-Friendly:

• Intuitive user interface, awarded the iF Design Prize
• Bright and 12.1" large touchscreen with +-88° viewing angle
• Large digital keypad - usable without a stylus and even with gloves
• 10 system languages
• LDAP - Lightweight Directory Access Protocol
• Automatic test time for faster testing
• Data transfer

Health, Safety, and Environment:

• Splash-proof (IP64)
• Explosion-proof (ATEX IECEx & FM certified)
• Safe testing of alcohol-moistened 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 automatic cleaning for all pneumatics with up to 0.5 M NaOH at 50°C/122°F
• Optional accessory kit to protect against backflow

Compliance:

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

Package Contents:

• Sartocheck® 5 Plus Filter Tester
• Inlet and outlet hoses
• Country-specific power cable
• User manual