Integrity tester 3Q audit

Integrity tester 3Q auditDue to the use of advanced algorithms and filtering methods, the instrument has achieved stability and reliability comparable to foreign detectors, solving the common problem of instrument instability in China. The air intake unit of the instrument adopts fully automatic digital control, greatly increasing the stability of the detection process and eliminating the original method of requiring professional personnel from domestic manufacturers to adjust the air intake knob to control the air intake speed.

Operating conditions: Environmental temperature:+5 ℃~+35 ℃; Relative humidity: 10-80%

Integrity tester 3Q audit(1) User Management

Integration of system and identity authentication system. Use password to confirm the user's identity and perform identity authentication.

(2) Re identification

The system provides a setting function for idle operation time. When the idle operation time exceeds the specified value (usually 2 hours), it is necessary to

The user needs to re authenticate their identity.

(3) Login Failure Audit

When the number of failed attempts at user authentication reaches 5, the system locks the user and can only be restored by the administrator,

Simultaneously generate audit events and issue alerts.

2、 Data Audit

(1) Audit scope

The system should provide audit functionality to audit the addition and deletion of users within the system, changes in user permissions, and the actions of system administrators and users

The operation of application.

(2) Audit record content

Audit records should include the following information: time, location, type, subject, object, and outcome (success or failure) of the event

To be audited regularly by the audit administrator. 3、 Audit tracking

1) Log recording

1) Log recording: Automatically record the operation records of system users, including login name, machine name (as much as possible), login time

Exit time, operation content, and other information can be summarized.

2) Log query

2) Log query: Log queries can be performed based on information such as login name, machine name, login time, exit time, and operation content.

3) Log viewing

3) Log viewing: Depending on the different permissions of the account, different accounts can only view log files within their scope of permissions

The person in charge checks the logs of department employees, and the dean checks all logs.

Wonderful historical articles

working environment

Environmental temperature: 15 ℃ to 40 ℃;

Environmental humidity: ≤ 80% RH;

Power requirements: AC220V ± 22V, 50Hz ± 1Hz;

Usage environment: Clean environment, no corrosive gases;

Bubble point method

Bubble point testing is a method based on the surface tension and capillary phenomenon of liquids in the pores of filtration membranes

Non destructive testing methods; It is the most important method to check whether the filter membrane is complete and meets the requirements.

After the filter membrane is fully immersed, the gas in the gas phase should be adsorbed and blocked in the capillary wall

The extraction of liquid requires overcoming a certain surface tension of the liquid, which is related to the physical properties of capillary pores, the wetting angle of liquid membrane materials, and gas pressure. The formula is:

R = 2k ·δ ·cos θ/Δp

among which

R —— δ—— θ—— ∆p——

K - Micro pore radius;

Liquid surface tension coefficient;

The infiltration angle of liquid filter membrane material;

The net pressure exerted by gas on capillary pores;

Hole type correction coefficient.

The above expression indicates that the smaller the pore size, the higher the pressure required for the first bubble generated by compressed air to pass through, and the minimum pressure value required to pass through the largest pore is called the bubble point of the membrane. Based on this, the maximum pore size values of flat filter membranes and column filter membranes can be analyzed.

Pressure maintenance method

The pressure holding method is also known as the pressure decay test. During the testing process, a high-precision pressure gauge or high-precision pressure sensor is used to monitor the pressure changes upstream caused by leaks or gas diffusion through the filter. This test has two main purposes:

1. Used to measure the sealing performance of the filtration system;

2. Check the integrity of the filter.

On earlier versions of the machine, there was no device or program specifically designed to measure the upstream volume, which made it impossible to achieve real-time and accurate measurement of the absolute upstream volume of the filter, thus making it impossible to directly calculate the diffusion flow value.

Generally, measuring the pressure attenuation of the filter can also be used as an approximate alternative to the diffusion flow testing method. After a certain amount of

Time, measuring this attenuation value can determine the integrity of the filter. The calculation formula is as follows: ∆ p=D · T · Pa/V

However, due to limitations in basic theory and sensor hardware, as well as the removal of functions such as temperature compensation and volume calibration compensation, there is a significant loss in the reliability and sensitivity of the test data.

Enhanced Bubble Point Method

The enhanced bubble point method combines diffusion flow testing and bubble point testing to detect the integrity of the filtration membrane. Enhanced bubble point testing is not suitable for situations where the filtration membrane area is small or large multiple filtration systems make it impossible to measure the bubble point. Basic bubble point test: 2 minutes ± 2 minutes; Diffusion flow test for 7 ± 2 minutes; Water immersion
Flow test for 7 ± 2 minutes; System airtightness: 3 ± 1min;
Printing function in Chinese/English, printing test conditions, test results, and test curves;
History recording function with 32GB storage space, saving 1 million pieces of data
Display screen size: 5.7-7 inches; 256 colors; touch screen
Language selection: Chinese/English Disc membrane: Various types of membranes ranging from 25mm to 300mm in diameter
Standard cartridge: 2.5 "to 40", 1 core to 9 cores
Capsule filter cartridge
Mini cartridge filter
The 2.5 "to 40" integrity tester for air filters has the following characteristics compared to other domestic brands of instruments:
1. Automatic intake control
The integrity tester adopts the fully automatic digital intake control subsystem commonly used abroad, abandoning the domestic one
The later mechanical semi-automatic intake method (i.e. using manual adjustment of one-way throttle valve to change gas flow)
Speed, so that the tester can work stably and reliably under different gas source pressures and testing conditions, especially when
When the pressure fluctuation of the gas source used by the customer is relatively large, the instrument itself has automatic stabilization and digital control technology,
Ensuring the accuracy and precision of the test results.
2. Filter qualified, automatic exit function
As a consumable, filter membrane/folding filter cartridge has its own service life, but proper use can lead to
Their lifecycle is greatly extended. To protect the customer's filter membrane and improve the efficiency of production use (i.e
Shorten testing time), specifically added the function of "automatic exit after passing the test", this
The instrument that implements this function.
3. Automatic printing
Some users may have other things to deal with during integrity testing and need to leave the testing site
However, he hopes to receive the printed test results when he returns. Not because after the testing is completed,
Other unforeseeable reasons may cause the loss of test results. The tester started automatic printing when the user activated it
After selecting the option, the function of automatically printing the test results after the test is completed can be realized, which is also the implementation
This type of instrument has this function.
4. User Rating Control
As a precision testing instrument, there are many parameters that need to be set in the complete tester
Changes may affect the accuracy and reliability of test results. At the same time, in order to meet the management requirements of GMP
Please note that regular operators and managers should have their own distinct operational permissions. All versions of the series
There is a user grading management function, and I V4.0 has made it more user-friendly, allowing users to use it according to their usage situation
Changing the login password of the instrument is also the instrument that implements this function.
5. Larger data storage capacity
The integrity tester currently has the largest storage capacity for test results in China, with a standard configuration of 500 sets
We can also customize the historical records (including testing conditions, test results, and test curves) according to customer requirements
Create larger storage capacity. It is possible to copy all historical data from the instrument to the computer, thus achieving
Unrestricted preservation of historical records.
6. Wide testing scope
The measurement range of the integrity tester is very wide, from flat filters to multi-core bucket filters, ranging from
Both bag filters and respirators can be tested. And the instrument itself has a high-resolution signal analysis section
The logic module ensures that errors can be minimized when measuring the integrity of large filtering area filters. With the same
When some brands conduct comparative tests with third parties, the testing instruments repeatedly measure 5-core 20 inch PES filters
When it comes to the integrity of the chip, its testing speed and consistency of test results are far superior to those of the other instrument.
7. Testing is more convenient and the human-machine interface is more user-friendly
A lot of work has been done in the aspect of human-computer interface. Firstly, there are prominent operation prompts at the bottom of each work interface
Users can complete all operation items according to the prompt content. Secondly, the instrument was designed with "final testing conditions
The 'auto save' function allows users to use 'one' if they test filters of the same specifications every time
Press and hold the 'OK' button on the instrument panel after selecting a testing function, and the instrument will
Being able to perform filter integrity testing based on the parameters input during the last test greatly simplifies the process
Operating procedures for personnel.
8. It is the earliest instrument in China to achieve diffusion flow and water intrusion testing functions, and the water immersion testing function is no longer available
Chang has matured and its test results have high reliability.
9. Security
Safety production is the most important indicator for all enterprises, and the safe operation of instruments and equipment is also the key to safety production
From the beginning of the design, the safety of the instrument has been considered as the fundamental performance, whether it is under pressure or not
During the testing process, security measures were taken even in standby mode. For example, the instrument is in standby mode after being powered on
In fact, it has been conducting safety self checks on the system. When it is found that the pressure inside the instrument is greater than the safety pressure, it
The air release function will automatically activate to prevent workers from operating the filter under pressure and eliminate safety hazards.

This product meets the requirements of the Pharmacopoeia issued in 2020,

Implement instrument permission management, audit tracking, and electronic signature.

And an optional database expert management system can be developed.

Product Features

High intelligence: The testing process is fully automated and does not require manual intervention;

High reliability: high detection accuracy and good reproducibility;

High humanization: touch screen input, user-friendly operation interface;

Multifunctional: Can be used to test single core filters, multi-core filters, and multiple testing functions;

High integration: The instrument adopts a portable design, small size, and easy to use;

High tech: using ARM11 controller and Windows CE 6.0 system;

High practicality: data storage, real-time printing of test results, in compliance with GMP requirements.

Application scope

Disc membrane: various types of membranes ranging from 25mm to 300mm in diameter

Standard cartridge: 2.5 "to 40", 1 core to 9 cores

Capsule filter cartridge

Mini cartridge filter

Air filter detection from 2.5 inches to 40 inches

Other parameter filter audit tracking is an audit behavior that tracks and analyzes system activity and user activity flow records, where flow records refer to events from power requirements/power 100-240V AC, 50/60Hz; 120W
Maximum operating pressure 10000 mbar (150psi)
Inlet pressure 100 mbar (1.5psi)
Dimensions (mm) 400 (length) × 240 (width) × 270 (height 1) × 220 (height 2)
Test range Bubble point 100-8000mbar Diffusion flow rate 1-600ml/min Water immersion: 0.01-100ml/min
Test function
Manual bubble point test, basic bubble point test, enhanced bubble point test, pressure holding test, diffusion flow test, water immersion test;
Ultrafiltration membrane package testing
Scope of application: Symmetric/Asymmetric Membrane, Needle Filter, Capsule Filter, Flat Plate Filter, Cartridge Filter, Ultrafiltration Membrane Pack, Ultrafiltration Column
Audit tracking of multiple event logs (optional)
Permission management username and password login, with four levels of permissions, meeting FDA21 CFR PARTII requirements
120 sets of pre stored solutions
Test accuracy net volume test: ± 4%; Bubble point: ± 50mbar; Diffusion flow: ± 4%; Water immersion: ± 0.01%
Operating conditions: Environmental temperature:+5 ℃~+40 ℃; Relative humidity: 10-80%
Printing function comes with a micro printer, online PC
Record storage with no quantity limit for over 15000 sets of historical records
Record backup supports exporting data from USB flash drive
Dustproof and waterproof rating: IP65 on the front
High definition 7-inch color touchscreen display
Serial port connection method RS232; USB port
Usage: Online/Offline
Language Selection/Chinese
Weight 8KG
Suitable for environments above level D
Signal output (4-20) mA, RS485, 12V alarm output

The sequential inspection, review, and verification of the environment and activities of each event carried out through the end-to-end approach, including system activities such as operating systems and applications

The activity of program processes, including user activities within the operating system and applications.

Audit tracking provides written evidence of the activities of responsible personnel to support the implementation of audit functions, through the use of appropriate tools

By implementing regulations and procedures, audit tracking can provide early warning and prevent potential disruptors from infringing on the security of audit activities.