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.

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Overview

Features

Specifications

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.