Lifecube SAP PUPSIT Semi-Automatic System

Lifecube SAP PUPSIT Semi-Automatic System. Sold in the configuration options listed below; specifications are as published by the manufacturer.

Specifications

• Functional Module: Test Step
• Leak Test: Leaking test of the tubing assembly
• Bag Integrity Test: Pre-filtration integrity test of top wash bags and waste liquid bags
• Sterile Filter Wetting: Wetting the sterile filters in preparation for pre-filtrationintegrity testing (diffusion flow)
• Sterile Filter Integrity Test Before Filtration: Diffusion flow testing for sterile filter integrity
• Gas Filter Integrity Test: Pre-filtration gas filter integrity test (water intrusion)
• Liquid Top Washing: Cleaning the tubing and draining WFI
• Liquid Filtration: Sterility filtration the product solution
• Final Integrity Test: Perform integrity test after final sterile filtration
• Manual Mode: All components can be operated individually, and a single process step can be operated manually
• Single Module Formula: All process modules can be run individually, each process module can set parameters individually
• Semi-automatic Formula: The formulas runs in sequence, with parameters and steps that can be set according to actual needs
• Authority Management: Custom permissions, user management, password management, audit trail, electronic signature
• Other Functions: Flow calibration, weight calibration, data backup, data recovery
• Regularoty Compliance: Complies with FDA 21 CFR part11
• Item: Specifications
• Gas Filter: Cobetter Bricap C01, C02, C03 capsule filter
• Sterile Filter: Cobetter Bricap L02 - L10 capsule filter
• Single-use 2D Bag: Cobetter Lifecube Single-use 2D Storage Bag (100 mL-50 L)
• Single-use Pressure Sensor: Cobetter Lifemeta SPC single-use pressure sensorBody Material: PSFPressure Range: 0-30 PSIAccuracy: 0-6 psi ±2% | 6-30 psi ±3%
• Reinforced Silicone Tubing: Cobetter Lifemeta ST9B reinforced silicone tubing, with max. pressure 5 bar
• Silicone Tubing: Lifemeta STT platinum-cured silicone tubing, with max. pressure 2 bar
• Tube Fitting: Straight tube fitting, Cross fitting, Tee Fitting, Y-Fitting
• Main Pump: Speed range: 0-650 rpm; Accuracy: ± 0.1%Flow range: ≤13 L/min; Accuracy: < 3% FSSuitable for 73# and 82# tubing
• Auxiliary Pump: Speed range: 0-600 rpm; Accuracy: ± 0.1%Flow range: ≤13 L/min; Accuracy: < 5% FSSuitable for 73# and 82# tubing
• Electrically Controlled Pinch Valves: Suitable for reinforced silicone tubing, with maximum pressure 5 bar
• Weighing Module: Max. weighing: 60 kg; Accuracy: ≤ 5 gMax. weighing: 11 kg; Accuracy: ≤ 1 g
• Filter Integrity Tester: Cobetter Certitest 20 Plus Filter Integrity TesterPressure range: 100-8000 mbar; diffusion accuracy: 4% or 2 mL/min whichever is greater
• Bag Integrity Tester: Cobetter Certitest Bag Integrity TesterPressure range: 0-300 mbar; Accuracy: Max±0.3 mbar
• Control Cabinet: Siemens PLC control system
• HMI: Siemens SIMATIC IPC477E 15" touchscreenWindows 10 IoT Enterprise 2019 LTSC, 64-bit