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FT-8.0 Laboratory Filter Integrity Tester 100 - 10000 Mbar
| Adedi: | 1 Takım |
| Fiyat: | Pazarlık edilebilir |
| Standart paketleme: | Ahşap Kutu |
| Teslim süresi: | 5~8 iş günü |
| Ödeme yöntemi: | T/T,L/C |
| Tedarik Kapasitesi: | 500 takım/ay |
Filter Integrity Test Machine 100 Mbar
,Filter Integrity Test Machine 10000 Mbar
,Laboratory Filter Integrity Test Machine
FT-8.0 Filter Integrity Tester
SHUOBODA Filter Integrity Testers 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.
◎Solutions
Connection diagram of online test
◎Applied range
1. Disc Membrane:Φ25mm-Φ300mm; 2. Standard Cartridge:2.5″- 40″
3. Capsule & Mini Cartridge 4. Air filter test :2.5″- 40″
5. Ultrafiltration membrane
Specifications
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Model |
FT-8.0 |
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Power Supply |
100–240 VAC, 50HZ, 120W |
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Operation Pressure |
100-10000 mbar (150psi) |
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Unit |
Mbar, kpa, psi, kgf/cm2 |
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Operation Condition |
Ambient Temperature:+5℃ ~ +40℃；Relative Humidity:10-80% |
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Dimension(mm) |
480(Depth) ×300 (Width) × 210(Height1) |
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Function |
Manual Bubble point Test；Basic Bubble Point Test；Extensive Bubble Point Test； Pressure Holding Test；Diffusion Flow Test；Water Immersion Test；Ultrafiltration Membrane Test |
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Test Accuracy |
Upstream Volume Test:± 4%；Bubble Point Test:± 50mbar ； Diffusion Flow Test:± 4% ；Water Immersion:± 0.01ml |
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Test Scope |
BP:100-8000mbar DF:1-900ml/min WI:0.01-100ml/min |
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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 |
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Audit Trial |
Audit trail records can exportable and irreversible |
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Authority Management |
User Name and Password to Login ,4 Authority Grades,meeting the FDA 21CFR PART 11requirements |
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Reservation Solution(programs) |
1000sets |
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Audit trail record storage |
≥5 years storage |
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Anti-backflow(liquid) device |
Customization |
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Number of users |
1000sets |
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Operating System |
Linux system |
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Operation Interface |
Chinese and English bilingual operation interface |
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Dust and splash level |
IP54, Front is IP65 |
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Print Function |
Built-in printer,can control on PC；choose subject |
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Historical Record |
300000 sets records storage |
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Records Copy |
Support USB disk to export (include test curve)； |
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Display Screen |
High definition 10-inch, color touch screen; |
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Serial Connection |
RS232/USB/Support wireless connection; |
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Language |
Chinese/English |
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Work Mode |
Online/Offline |
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Applicable Environment |
Above D level |
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Weight |
10KG |
Features:
Ÿ Powerful, covers all existing test methods regarding the integrity of the filter;
Ÿ Adopt optimized Linux system;
Ÿ Optimized test operation and shortened test time;
Ÿ 10-inch true-color touch screen design, friendly human-machine interface, simple, fast and reliable operation;
Ÿ To meet offline online testing, using pressure sensors with higher accuracy and lower deviation bands to improve the test accuracy of the instrument;
Ÿ Automatic self-test function, self-test of multiple performance functions of the instrument itself, after turning on the instrument has instrument self-test function, report faults in time.
Ÿ The first domestic company to implement the integrity test of an ultrafiltration system.
Ÿ 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;
Ÿ The instrument comes with an audit trail function, truly meets the requirements of data integrity;
Ÿ Can establish 1000 sets of pre-stored programs, which can fully meet multiple filter types and different test conditions in the field, and the instrument is more simple and intelligent;
Ÿ Increased the display curve of diffusion flow-pressure, realized the display and printing function of three curves, optimized the air intake control unit, and greatly increased the air intake speed and stability;
Ÿ Support USB disk data export function, which can not only export the original test data, but also the source data and configuration data, so that the data integrity requirements are perfectly reflected in the instrument; if single data can export PDF style directly;
Ÿ Can expand data communication and network interface requirements according to customer requirements, and support wireless communication functions;
Ÿ Optimize the structure of the instrument so that its dustproof and splashproof level reaches IP54, and use quick connectors (Staubli connectors can be used) to avoid incorrect connection of the inlet and outlet pipes
Ÿ Test records and audit trails of the instrument both can be queried and exported；
Ÿ 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;
Ÿ 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;
Ÿ External interfaces can be customized according to customer requirements, which is convenient for customers' automated control and management;
Ÿ Using Chinese and English bilingual interface;
Ÿ Multiple pressure units can be switched flexibly(mbar,kpa,psi,kgf/cm2)；
Ÿ 1000 user accounts, four level of user management, and each user's authority can be determined by default or customized methods, more flexible to meet the needs of on-site production and laboratory management, and perfect user information and authority configuration;
Ÿ Can test most up to 12-core 20-inch filter cartridges, which greatly improves the user's work efficiency;
Ÿ Rich data interface, the instrument not only includes standard digital and analog interfaces (RS232 / USB), but also can customize a variety of industrial buses and analog control ports according to customer needs to prepare for intelligent upgrade of the system, such as online full automation supporting bacteria control system;
Ÿ The independent R & D team can design specific solutions according to the needs of customers. Many years of field experience and strong professional services not only ensure that customers can use the instrument at ease, but also provide technical support for the design and configuration of customer filtration systems.
