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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.
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Sartocheck® 5 | 5 Plus AccessoriesProduct FamilyThe 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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Measuring Ranges - Test pressure: 10 – 300 mbar
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PLC port, FTP, RS232, RS485, RJ45
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Sartocheck®
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460 × 390 × 245 mm
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Measuring Ranges - Test pressure: 10 – 300 mbar
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8798977884768, 8798978671200, 8798978146912
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8798951473760
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460 × 390 × 150 mm
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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%
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CE Mark, ATEX Certified, IECEx Compliant, FM Approved
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Sartocheck®, Sartocheck® 5
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GAMP 5; 21 CFR p11
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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%
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CE Mark, ATEX Certified, IECEx Compliant, FM Approved
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Sartocheck®, Sartocheck® 5, Sartocheck® 5 plus
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GAMP 5; 21 CFR p11
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159x147x163 mm
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2.7 kg
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2-40 °C (environmental)2-50 °C (cleaning and rinsing agent depending on chemical compatibility)
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Barcode scanner for flawless data entry and test selection for the Sartocheck® 5/ 5 Plus.
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Sterilization and cleaning of air, gases and venting
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Minisart® PES
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Venting, Moisture barrier
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≥ 0.95 bar (14 psi) with ethanol
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