Filter integrity tester Integtest V6.5
Short Description:
Filter Integrity Tester —— Integtest series
Dongguan Puno Filter Integrity Tester Integtest series are special instruments of integrity
testing for sterile filtration membrane and filter system, where the testing method and instrument
design fully meet the requirements for relevant laws and regulations in GMP, EP, FDA and USP.
◎ Regulatory requirements
1. Chinese GMP and EU EP have made specific provision for the integrity testing of sterile
filter on the test method, where the commonly used methods include bubble point test, diffusion
flow test or pressure holding test. GMP regulates that the test is required after the use of sterile
filtration. EP regulates that the test is required before and after the use, and at the same time EP
regulates that the critical gas and air filter must be confirmed after use, while other filters must be
tested on a regular basis.
2. According to Drug Manufacturing Quality Management Standard (revised in 2010) Article
310, two appendices of Computerized System and Confirmation and Validation are now issued,
as the supportive documents for Drug Manufacturing Quality Management Standard (revised in
2010), effective as of December 1, 2015.
3. The requirements for electronic records and electronic signatures as specified in 21 CFR
Part 11.
※ Covering all the existing test methods for the filter integrity testing
※ High-definition, large-size color touch screen input more abundant test information, and
can automatically select and match suitable for the current filter detection program
※ Digital sensor makes the test results more accuracy and consistence
※ The CPU of the instrument, adopts industrial grade dual core high speed and high stability
ensure the safety, reliability and rapidity of the instrument in the use process, and solve the
problems of instability and system vulnerability caused by the operating system
※ “pre-program” improves the integrity of the test parameters, greatly simplifies the user’s
operation procedures, and truly realizes “one key completion”
※ With detailed test data and complete test curve, users can comprehensively and accurately
analyze a variety of performance indicators of the filter under test, and provide objective analysis
report for users
※ Friendly Interface and prompt information make the operation simple and convenient, A
variety of input methods: Chinese, English, numbers and punctuation
※ Scientific electronic signature and user management for division of responsibilities and
prevent misoperation
※ With digital and analog interface (RS232/USB), also customize a variety of industrial bus
and simulation control port according to customer’s need
※ Carrying out the design of specific solutions according to the needs of customers; Many
years of experiences and strong professional services provide the technical support for the design
and configuration of the filter system for customers
◎ Parameters
| Power Supply | 100–260 VAC, 50HZ, 120W |
| Operation Pressure | 100-10000 mbar (145psi) |
| Unit | Mbar |
| Operation Condition | Ambient Temperature：+5℃ ~ +40℃；Relative Humidity：10-80% |
| Dimension(mm) | 400(Depth) ×260(Width) × 240(Height1)x220(Height2) |
| Function | Manual Bubble point Test；Basic Bubble Point Test；Extensive Bubble Point Test； Pressure Holding Test；Diffusion FLow Test；Water Immersion Test；Ultrafitration Membrane Test |
| Test Accuracy | Net Volume Test：≤ ± 4%；Bubble Point Test：≤ ± 50mbar ； Diffusion Flow Test：≤ ± 4% ；Water Immersion：≤ ± 0.01ml |
| Test Scope | BP：100-8000mbar DF：1-600ml/min WI：0.01-100ml/min |
| Applied Range | Symmetric and asymmetric membrane test, syrine filters, capsule filters, plate filters, cartridge filters ;ultrafiltration membrane packages, ultrafiltration columns, various irregular filters |
| Audit Trial | Audit trail records can exportable and ireeversible |
| Authority Management | 4 level User Name and Password to Login ,electronic signature to meet the FDA 21 CFR PART 11 requirements |
| Reservation Solution(programs) | 120sets |
| Audit Trial (customization) |
More subject logs |
| Print Function | Built-in printer |
| Applicable Environment | Above D level |
| Weight | 8KG |
| Historical Record | More than 5000 sets unlimited sets records |
| Records Copy | Support USB disk to export （include test curve）； |
| Display Screen | High definition 7 inch ,color touch screen; |
| Serial Connection | RS232/USB |
| Language | Chinese/English |
| Work Mode | Online/Offline |
| Dust and splash level | IP54 |
| Signal output | （4-20）mA, RS485,12V Alarm output |
