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
Brand
The Sartorius Group is a leading international partner of the biopharmaceutical industry and the research sector. We are helping biotech scientists and engineers across the entire globe to develop and manufacture medications from the first idea to production. So more people will have access to better medicine.