Filter integrity tester Integtest V8.0
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.
The latest model V8.0 Filter Integrity Tester take the lead in completing the system upgrade
of the audit trail function to meet the latest requirements for data integrity. We believe our quality products and service, will be your most correct choice
◎Features
1. Powerful, covers all existing test methods regarding the integrity of the filter;
2. To meet offline /online testing, using pressure sensors with higher accuracy and lower
deviation bands to improve the test accuracy of the instrument;
3. After turning on ,the instrument self-test automatically, report faults in time.
4. Scientific user management, password login, user classification, electronic signature, etc.,
in compliance with GMP and FDA CFR 21 part 11, support multi-level user access permission
settings, ensure data integrity, have comprehensive audit trail functions, and support manual or
electronic signature;
5.The instrument comes with an audit trail function, truly meets the requirements of data
integrity;
6.Establish 1000 sets of pre-stored programs, convinent for more filter types and different
test conditions;
7.Increased the display curve of diffusion flow-pressure, realized the display and printing
function of three curves, optimized the air inlet control unit, and greatly increased the air inlet
speed and stability;
8.Support USB disk data export, not only export the original test data, but also the source
data and configuration data; single data export in PDF style directly;
9.Can expand data communication and network interface requirements according to
customer requirements, and support wireless communication functions;
10.Staubli connectors be used to avoid incorrect connection of the inlet and outlet pipes;
11.Test records and audit trails of the instrument both can be queried and exported
12.High-precision sensors and optimized algorithms can extend the gas path to 100m, make
the upstream volume test more accurate, and the instrument can better meet the conditions of
field use without affecting the test results;
13.The built-in thermal printer avoids the risk of particle and ink contamination, and can keep
the handwriting clear for more than 10 years under appropriate conditions;
Company profile: Beijing Neuronbc was established in 2004. After more than ten years of
development, the filter integrity tester produced by our company has become the first domestic
brand, and the test accuracy has reached the level of imported instruments. At present, we have
accumulated for thousands of pharmaceutical enterprise customers, the latest model V8.0 take the
lead in completing the system upgrade of the audit trail function to meet the latest requirements
for data integrity. We believe our quality products and service, will be your most correct choice.
14.Multiple pressure units can be switched flexibly (mbar,kpa,psi,kgf/cm2 )
15.Can test most up to 12-core 20-inch filter cartridges, which greatly improves the user’s
work efficiency;
16. The instrument has passed the CE certification.
◎ Parameters
| Power Supply | 100–240 VAC, 50HZ, 120W Spare battery（Operational） |
| Operation Pressure | 100-10000 mbar (150psi) |
| Unit | Mbar ,kpa, psi, kgf/cm2 |
| Operation Condition | Ambient Temperature：+5℃ ~ +40℃；Relative Humidity：10-80% |
| Dimension(mm) | 480(Depth) ×300 (Width) × 210(Height1) |
| 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 | Upstream Volume Test：± 4%；Bubble Point Test：± 50mbar ； Diffusion Flow Test：± 4% ；Water Immersion：± 0.01ml |
| Test Scope | BP：100-8000mbar DF：1-900ml/min WI：0.01-100ml/min |
| Applied Range | Symmetric and asymmetric membrane test, needle filters, capsule filters, flat filters, cartridge filters (within 12 cores and 20 inches), ultrafiltration membrane packages, ultrafiltration columns, various irregular filters |
| Audit Trial | Audit trail records can exportable and ireeversible |
| Authority Management | User Name and Password to Login ,4 Authority Grades |
| Reservation Solution(programs) | 1000sets |
| Audit trail record storage | ≥5 years storage |
| Anti-backflow(liquid) device | Customization |
| Number of users | 1000sets |
| Operating System | Linux system |
| Operation Interface | Chinese and English bilingual operation interface |
| Dust and splash level | IP54 |
| Print Function | Built-in printer，can control on PC；choose subject |
| Historical Record | 300000 sets records storage |
| Records Copy | Support USB disk to export （include test curve）； |
| Display Screen | High definition 10 inch ,color touch screen; |
| Serial Connection | RS232/USB/Support wireless connection; |
| Language | Chinese/English |
| Work Mode | Online/Offline |
| Applicable Environment | Above D level |
| Weight | 10KG |
