Product Description
· Function
Integrity testing of single-use bags before or after use
Support custom pressure parameters within 300 mbar
Two-stage inflation control, free combination of fast charging and fine-tuning
Support custom stabilization time and testing tests, and flexibly adapt to various testing scenarios
Equipped with high-precision sensors, real-time display of pressure drop curve
Confirmation when to start and stop the test, safe and controllable test operation
Features
· Fully Compliant with Data Integrity Requirements
Developed in accordance with GAMP5, fully compliant with 21 CFR Part 11
Multi-level permission settings, supporting customer customization of user groups, assigning user permissions, and fully compliant with quality management system requirements
Multi-level password policy, supporting customized password policies for users, meeting the verification requirements of computerized system
Complete audit trail function, supporting PDF file export of data and logs, easy traceability, and traceable operation
One-click backup and restore, easily cope with disaster recovery
Support Electronic Signatures, with first/second level audit function, release compliance
· Easy to Operate
Application software developed based on Windows 10 operating system, user-friendly for operators
Easy to switch between Chinese and English, and can customize other languages according to needs
Support USB updates, client can update independently without returning to the factory, saving costs
Support power-on self test, automatically determine whether internal communication, air source pressure, and control detection functions are normal
Quick inlet/outlet connectors, plug and test
· Accessory & Hardware
Computer memory capacity 16G, smoothly-operation
Configure 128G solid-state drive with large storage capacity and fast read and write capabilities
Equipped with piezoelectric control components, accurate and fast pressure control, support temperature control
Integrated valve terminal design, with few interfaces, high sealing performance, stable system and low leakage risk
· Services
Support 3Q documents drafting and validation, and provide comprehensive application technology training services
Provide remote/on-site technical support
.
