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Integrity Testing (14)

Built-in Integrity Control Strategy All Along the SUS Life CycleWith the growing implementation of single-use bags into commercial production and critical process steps, SUS Integrity (SUSI) has become a critical quality attribute for both end-users, regulatory authorities, and suppliers of SUS, as an integrity failure can significantly impact drug safety, availability, and costs. The ASTM E3244-20 standard practice on SUSI assurance recommends Quality Risk Management (QRM) and life-cycle approach. This is in-line with the EU GMP Annex 1 for manufacturing sterile medicinal products, proposing a risk assessment for QRM and Contamination Control Strategy (CCS). Thus, depending on customer application and criticality of a SUSI breach, specific integrity and leak tests may be needed.

  • Sartocheck® 5 | 5 Plus Accessories

    Product Family

    Sartocheck® 5 | 5 Plus Accessories

    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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  • Sartocheck® 4 plus Bag Tester
    Sartocheck® 4 plus Bag Tester
    Item no.
    26288---BT
    Additional Product Specifications
    Measuring Ranges - Test pressure: 10 – 300 mbar
    Brand
    8798951473760
    Data Interface
    8798977884768, 8798977262176, 8798978671200, 8798978146912, 8798977983072
    Dimensions WxDxH
    460 × 390 × 245 mm
  • Sartocheck® 4 plus Bag Tester MultiUnit
    Sartocheck® 4 plus Bag Tester MultiUnit
    Item no.
    26288---BM
    Additional Product Specifications
    Measuring Ranges - Test pressure: 10 – 300 mbar
    Brand
    8798951473760
    Data Interface
    8798977884768, 8798978671200, 8798978146912
    Dimensions WxDxH
    460 × 390 × 150 mm
  • Sartocheck® 5 Filter Tester
    Sartocheck® 5 Filter Tester
    Item no.
    26787---FT
    Additional Product Specifications
    BP: 250-6550 mbar acc. ± 50 mbar, Diffusion: 0.01-24000 mL/min acc. ± 5%, Water Intr: 0.005-300 mL/min acc. ± 5%, Net volume: 10 mL - 150 L acc. ± 4%
    Brand
    Sartocheck®, Sartocheck® 5
    Certification
    CE Mark, ATEX Certified, IECEx Compliant, FM Approved
    Compliance
    GAMP 5; 21 CFR p11
  • Sartocheck® 5 Plus Filter Tester
    Sartocheck® 5 Plus Filter Tester
    Item no.
    26787---FT---P
    Additional Product Specifications
    BP: 250-6550 mbar acc. ± 50 mbar, Diffusion: 0.01-24000 mL/min acc. ± 5%, Water Intr: 0.005-300 mL/min acc. ± 5%, Net volume: 10 mL - 150 L acc. ± 4%
    Brand
    Sartocheck®, Sartocheck® 5, Sartocheck® 5 plus
    Certification
    CE Mark, ATEX Certified, IECEx Compliant, FM Approved
    Compliance
    GAMP 5; 21 CFR p11
  • 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
    Dimensions WxDxH
    159x147x163 mm
    Operating Conditions - Temperature
    2-40 °C (environmental)2-50 °C (cleaning and rinsing agent depending on chemical compatibility)
    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 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.

  • Minisart® PES- Venting Filter 1757H----------Q, 0.2 µm hydrophobic PES
    Minisart® PES- Venting Filter 1757H----------Q, 0.2 µm hydrophobic PES
    Item no.
    1757H----------Q
    Application
    Sterilization and cleaning of air, gases and venting
    Application Area
    Venting, Moisture barrier
    Brand
    Minisart® PES
    Bubble Point
    ≥ 0.95 bar (14 psi) with ethanol
  • Pressure Safety Device MR
    Pressure Safety Device MR
    Item no.
    26787---PS

    Pressure Safety Device for Maxicaps® MR

  • SoloHill Hillex® II ACF 10 gramm
    SoloHill Hillex® II ACF 10 gramm
    Item no.
    H-170-020
    Area/gram (cm²/g)
    515 cm²/g
    Brand
    SoloHill®
    Protein Coated (yes/no)
    No
    Purity
    Non-sterile
  • SoloHill® Collagen-coated APC 500g
    SoloHill® Collagen-coated APC 500g
    Item no.
    C-215-070
    Area/gram (cm²/g)
    480 cm²/g
    Brand
    SoloHill®
    Protein Coated (yes/no)
    Yes
    Purity
    Non-sterile