A New Generation Filter Integrity Tester

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The DLE-501 filter integrity tester is a new-generation device signed according to the latest GAMP guidelines. It combines intelligent technology with high-sensitivity performance and features large-capacity accurate data recording, exporting, and printing functions. The tester’s system is designed for greater stability, making it suitable for most cleanroom environments. The device is lightweight, compact, and ergonomic. Its 10-inch high-de.nition truecolor touch screen enhances usability and simpli.es operation. Additionally, the equipment complies with GMP guidelines and meets FDA 21 CFR Part 11 requirements for electronic records, and 21 CFR 820.72 for calibration.

▎ Product Features

Innovation of Hardware Con.guration

1. The new high-performance industrial-grade dual-core design CPU signi.cantly improves the data processing speed and capability to ensure the safety, reliability, and ef.ciency of the instrument during operation.
2. The structure is optimized to achieve front IP65 level dust and splash protection, with superior internal sealing for reliable operation in wet environments, enhancing durability.
3. The device features a 10-inch true-color touch screen design and a user-friendly interface, allowing for simple, quick, and reliable operation.
4. The built-in thermal printer avoids the risk of particle and ink contamination, hardly produces any particles during the printing process, meets the FDA requirements for data recording, can maintain legible writing under the appropriate conditions for more than 10 years, and the printing paper outlet design is ergonomic.
5. The instrument supports various industrial buses and analog control ports, tailored to customer needs. It features a rich data interface, including standard digital and analog interfaces (RS232/USB), and offers a USB disk data export function. This function exports not only the original test data but also source data and con.guration data, enhancing .exibility.
6. The equipment adopts compact and lightweight design, small size, light weight, less energy consumption, easy to carry.

Flexible and Steady Operating System Design

1. Optimize the Linux system, enhance the autonomy of the instrument, its stability has been fully veri.ed, optimize test operation, and reduce the test time.
2. With a perfect boot-up automatic self-check function and comprehensive diagnostic capabilities, the instrument ensures accurate operation.
3. Supports one-click switching between Chinese and English.
4. The scienti.c electronic signature system and user hierarchy management mechanism enhance responsibility division, reduce misoperations, and increase standardization and security in laboratory management.
5. 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 .eld use without affecting the test results.
6. The operation interface displays the test data and process curve in real time, and monitors the test process throughout the process to ensure the accuracy and controllability of the test.
7. Audit trail records can be exportable and be quickly queried record storage ≥5 years.
8. Support database encryption export, which perfectly re.ects the data integrity requirements of the instrument.
9. Implemented an ef.cient calibration process to ensure accurate pressure and .ow measurements within instrument test thresholds.

Comprehensive Testing and Data Processing Capabilities

1. Comprehensive and powerful, it covers all existing test methods for filter integrity, including the integrity testing of ultra.ltration systems.
2. Advanced digital sensor technology is utilized to signi.cantly enhance the accuracy and consistency of test results, ensuring precise evaluation of the performance indicators of the tested filter.
3. Conduct both of.ine (with battery) and online testing using pressure sensors that provide higher accuracy and lower deviation.
4. The tester provides detailed and comprehensive test data, along with complete test curves that accurately re.ect various performance indicators of the filter being tested, delivering precise analytical information to users.
5. Up to 12 20-inch filters can be tested, which greatly improves the user's work ef.ciency.

Secure and Reliable Data Storage Capability

1. Historical records can store up to 300,000 test results, support quick query and generate PDF test reports.
2. "Reservation Solution (programs) " design simpli.es operation, can establish 1000 sets of pre-stored programs, and fully meets multiple filter types and different test conditions in the .eld, which is more intelligent, simpler, and accurate.
3. User-level management allows for the creation of up to 1,000 user accounts, which can be easily queried.
4. The information base can store 5000 fault information and prompt information, and can be quickly queried.

Service and Support

1. Custom Program Design: Our independent R&D team specializes in creating tailored programs based on customer needs. With years of onsite experience and a commitment to professional service, we ensure that customers can use our instruments with con.dence. Additionally, we offer technical support for the design and con.guration of filter systems to meet our customers' speci.c requirements.
2. Quali.cation: High quality tester developed according to the GAMP guidelines, developed in strict accordance with GMP guidelines, electronic records meet the requirements of FDA 21 CFR Part 11, calibration by 21 CFR820.72.
3. Calibration and Service: The Filter Integrity Tester can be calibrated at any Darlly certi.ed service center or directly at the customer's site, and all components used in the tester are carefully selected and quality tested.
4. Training: We can provide professional integrity tester on-site training services. The training content covers instrument veri.cation, filter veri.cation, operation methods, basic principles, relevant regulatory requirements, etc. In addition, we are also happy to customize the training program according to the speci.c needs of customers, to ensure that the training content is accurate to your actual operation and compliance needs.

▎ Parameters

CataLog