Sartocheck® 5 Plus Filter Tester
Keeps Your Risk Factors Under Complete Control
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.
Surpass the Requirements of Quality Risk Management (QRM)
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.
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Reach the Ultimate Level of Data Integrity
Devastating malware incidents and the continuing threat of computer-related virus infections have created an urgent need for data protection and security. The completeness, consistency and accuracy of data during its entire life-cycle are critical aspects of regulatory compliance in all systems that generate, store and retrieve it. The customized Linux Operating System and write protected root file system of the Sartocheck® 5 Plus, along with the unalterable data formats associated with test results and audit trail, protect against malware and virus infections, ensuring data integrity is always preserved.
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Experience the Comfort of Intuitive Usability
An optimal user experience speeds up process workflows due to intuitive guidance and ease of use. The high quality touchscreen of the Sartocheck® 5 Plus Filter Tester provides a unique viewing angle, an intuitive user interface, a logical menu structure, and simple data entry options. This allows straightforward programming of tests and QRM enhancement features, as well as error-free operation in GMP production environments.
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Discover the Simplicity of Health, Safety, and Environment (HSE)
Integrity testing often involves the use of chemicals and hazardous materials. The Sartocheck® 5 Plus is certified for use in explosion hazardous areas (ATEX) and is compatible with all current cleaning agents and VHP. This ensures maximum safety for operators and manufacturing facilities.
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