The Sartocheck® 5 Plus Filter Tester is an automatic filter integrity tester designed to cover the complete range of integrity testing from small syringe filters up to large multiround housings and tangential flow cassettes.
The Sartocheck® 5 Plus can perform the following filter integrity tests:
- Bubble Point Test
- Diffusion Test / Forward flow Test
- Combined Diffusion and Bubble Point Test
- Water Intrusion Test (WIT)
- Pressure Drop Test / Leak Test
Quality Risk Management
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 before or during the test. This prevents time-consuming, costly deviations, potential drug recalls and 483 warning letters.
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
Usability
- Intuitive iF-Design rewarded Human Machine Interface (HMI)
- 1"" bright touchscreen with a +-88° viewing angle
- Large digital keypad - no need for a pen – compatible with glove use
- 10 system languages
- LDAP - Log on with network user credentials
- Automatic test time for faster testing
- Data transfer
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 kit for backflow protection Compliance
- 21 CFR part 11
- GAMP 5
- Ex proof (ATEX | IECEx | FM)
- CE
- FCC
Supplies
- Sartocheck® 5 Plus Filter Tester
- Inlet and outlet tubes
- Country specific power cable
- Instruction manual
- QRM documentation - FMEA
- Network cable 2m
- USB- Cable for the optional printer
- T20 screw driver
