Features
- Capable of testing high-flow membrane cassettes
- Diffusion flow detection range is 10 times higher than other products on the market
- Optional buffer tank and reference tank available
- Self-developed software, independently controllable, easy to operate
Application
- Wide range of applications: vaccines, antibodies, recombinant proteins, blood products, mRNA production processes, and CGT large virus projects
Advantage
- Enhanced buffer system: In automatic integrity testing of high-flow membrane cassettes, an appropriately sized buffer system is added to shorten test time, achieve high efficiency and stability, and improve data consistency and reproducibility
- Expanded test types: With the addition of enhanced membrane cassettes, the types of filter tests become more diverse, enabling ‘one machine for multiple filtration tests
- Risk reduction and compliance assurance: From testing to data storage and report output, the entire process for high-flow membrane cassettes is automated, facilitating compliance auditing and traceability
- One housing with multiple cartridges: Capable of testing the overall bubble point value of one housing containing multiple cartridges, compatible with integrity testing for most filters and cartridges on the marke
Specification
- Features a four-level permission management system. Seven types of automatic record files, including audit trails and operation logs, can be exported as encrypted files, fully complying with GMP requirements
- Two-level electronic signature (handwriting capable) complies with 21 CFR Part 11 requirements for electronic data integrity
- CE certified, the product meets EU regulations
