Sartocheck® 5 | 5 Plus Accessories

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The Sartocheck® 5 Plus represents the ideal intersection point of today's most releveant industry requirements for filter intgrity testing within demanding GMP environments. A combination of a unique approach of Quality Risk Management (QRM) as well as optimal data integrity, intuitive usability, and minimized risk factors for Health, Safety, and Environmente (HSE) set a new standard for filter integrity test devices.

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Products (7)

  • Accessory Kit for Cleaning Sartocheck® 5 | 5 Plus
    Accessory Kit for Cleaning Sartocheck® 5 | 5 Plus
  • Accessory Kit for External Venting (AKEV) Sartocheck® 5 | 5 Plus
    Accessory Kit for External Venting (AKEV) Sartocheck® 5 | 5 Plus
    Item no.
    26787---AK---EV
    Operating Conditions - Temperature
    2-40 °C (environmental)2-50 °C (cleaning and rinsing agent depending on chemical compatibility)
    Dimensions WxDxH
    159x147x163 mm
    Total Weight
    2.7 kg
  • Barcode Scanner for Sartocheck® 5 | 5 Plus
    Barcode Scanner for Sartocheck® 5 | 5 Plus
    Item no.
    26787---BS

    Barcode scanner for flawless data entry and test selection for the Sartocheck® 5/ 5 Plus.

  • Test tube 15m Sartocheck® 5 | 5 Plus
    Test tube 15m Sartocheck® 5 | 5 Plus
    Item no.
    26787---TT---15

    15 m test tube for the Sartocheck® 5 / 5 Plus filter tester.

  • Test tube 2m Sartocheck® 5 | 5 Plus
    Test tube 2m Sartocheck® 5 | 5 Plus
    Item no.
    26787---TT---02

    2 m test tube for the Sartocheck® 5 / 5 Plus filter tester.

  • Test tube 5m Sartocheck® 5 | 5 Plus
    Test tube 5m Sartocheck® 5 | 5 Plus
    Item no.
    26787---TT---05

    5 m test tube for the Sartocheck® 5 / 5 Plus filter tester.

    • Reach the Ultimate Level of Data Integrity

    Filter integrity test values are part of the batch protocol and are used to justify the drug release. Long-term reliable data is crucial to avoid quality deviations and potential 483 warning letters.The integrity and security of filter integrity test data must not be seen only as an IT problem, but also as a potential global business risk. Low standards of data integrity and security may not only jeopardize the activities of the drug manufacturing company, but more critically, endanger the health of patients.

    Surpass the Requirements of 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 before or during the test. This prevents time-consuming, costly variations, potential drug recalls, and 483 warning letters.

    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.

    Discover the Simplicity of HSE

    Integrity testing often involves the use of chemicals and hazardous materials, e.g., alcohol. The Sartocheck® 5 Plus is certified for use in explosion-hazardous areas (ATEX) and is compatible with all current cleaning agentsand VHP. This ensures maximum safety for operators and manufacturing facilities.