In the pharmaceutical production process, the integrity of the filter is directly related to the quality of the final product. Integrity testing can ensure the effectiveness of the filtration system, thereby ensuring the cleanliness and quality of the drug. The laws and regulations of various countries also have clear requirements for the integrity of the filter. Integrity testing is a necessary means to meet these regulations, and the integrity tester is an important instrument for convenient and fast integrity testing.

Cobetter Certitest 20 Plus Integrity Tester offers a variety of product testing scenarios to meet more testing demands of users. The core hardware is fully upgraded to provide guarantee to your testing and use. At the same time, the RAM is expanded to 16 G, making your operation and data management more smoother, and more compatible with more languages as well as authority management. In addition to the comprehensive upgrade on the hardware and testing functions, the upgraded automation function can cover more scenarios, bringing you a more intelligent integrity testing experience.

Features

The ability to balance pressure control stability and rapid inflation

The Certitest 20 Plus Integrity Tester is equipped with a high-end proportional pressure regulator, which can provide an inflation capacity of 1500mL/min. When testing small samples, such as lab-grade hollow fibers, membranes, etc., it can maintain long-term stable pressure control without being affected by pressure fluctuations, ensuring high accuracy and repeatability of test results. When testing large samples, such as multi-core filter systems, large quantity and area membrane cassette, etc, it can be inflated quickly.

Data integrity

Certitest 20 Plus Integrity Tester has a complete audit trail function, and the data can be signed with electronic signature, which complies with GMP and FDA 21 CFR part11 regulations. 

The device supports the feature for users to create their own authority groups and users (system administrator, administrator, supervisor, technician, QA, operator, etc. up to 20 levels), which can achieve more detailed access permission to ensure data integrity.

More advanced automated network functions

In addition to the basic testing functions, Certitest 20 Plus Integrity Tester integrates advanced automated network functions, which can realize automatic archiving of all data and databases; and synchronize users, settings and multi-device management through the network framework, saving time.

The device also supports Modbus TCP and OPC-UA protocols, and is compatible with other automation network control protocols, such as PLC (programmable logic controller), SCADA system (supervisory control and data acquisition system), HMI (human-machine interface), etc.

Test Principle

Bubble Point Test

Bubble point is the pressure at which gas displaces liquid from the largest set of filter pores

Diffusion Test

Diffusion test is based on measuring the gas flow across a completely wetted membrane at a defined test pressure on the upstream side, diffusive flow of gas is established due to the differential pressure.

Water Flow Test

Water Flow Test:The water flow test is based on measuring the water flow across a hydrophobic membrane completely covered with water at a defined test pressure on the upstream side, a low evaporative water flow is established intrude into the pores due to the pressure.

Pressure Decay Test

The pressure decay test is also called the pressure holding. During the test, the upstream pressure drop caused by gas diffusion or leakage of the filter is monitored.

Connection Reference for the Integrity Tester