SARTORIUS – Filter Tester – Sartocheck® 5 Plus
The Sartocheck® 5 Plus perfectly meets today’s key industry requirements for filter integrity testing in demanding GMP environments. 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), it sets a new standard for filter integrity testing devices.
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. This avoids time-consuming and costly deviations, potential drug recalls and 483 warning letters.
Key Features
• Large touch screen (12.1”) (± 88° viewing angle)
• High ingress protection IP64
• Automatic Detection of Abnormal Test Conditions from a Pressure Increase
• Self-test at Booting and Before Each Test
• Internal Double-Data Backup
• Electronic Signatures | 4 Eyes Principle
Technical Specifications
| Test Methods | Diffusion / Bubble point / Combined diffusion and bubble point / Water intrusion test / Pressure drop | leak test |
| Power Supply | 100 – 240 V AC at 50 | 60 Hz |
| Max power input | 74 W |
| Power consumption in standby mode | 14.8 W |
| Max inlet pressure | 8,000 mbar | 116 psi |
| Overpressure protection | Max inlet pressure + 4,000 mbar |
| Dimensions (W × D × H) | 348 × 379 × 286 mm |
| Weight | 16.8 kg |
SARTORIUS – Sartocheck®5 Plus Filter Tester
The Sartocheck®5 Plus represents the ideal intersection point of today’s most relevant industry requirements for filter integrity testing within demanding GMP environments. A combination of a unique approach to Quality Risk Management (QRM) as well as optimal data integrity, intuitive usability, and minimized risk factors for Health, Safety, and Environment (HSE) set a new standard for filter integrity test devices.
Key Industries
- Pharmaceutical
- Food & Beverage
The Sartorius Group is a leading international partner of the biopharmaceutical industry and the research sector. We are helping biotech…
