Current
Location:
+86 17853698681
WhatsApp
Product Details
Product Description
The HM-GL filter integrity tester is a fully automated instrument that complies with the requirements of the 2020 edition of the Pharmacopoeia. It provides user permission management, audit trail functionality, and electronic signature capability. An optional proprietary database expert management system is available for centralized data administration.
Product Features
High Intelligence: Fully automated test process control with no manual intervention required.
High Reliability: High detection accuracy with excellent reproducibility.
User-Friendly Design: Touchscreen input with an intuitive operating interface.
Multi-Functionality: Capable of testing single cartridges, multi-cartridge housings, and multiple test modes.
Highly Integrated: Portable design with compact dimensions for convenient use.
Advanced Technology: ARM11 processor with Windows CE 6.0 operating system.
Practical Operation: Data storage and real-time result printing in compliance with GMP requirements.
Scope of Application
The HM-GL filter integrity tester is applicable to the following filter types:
Disc membranes: Φ25 mm to Φ300 mm (all types)
Standard pleated cartridges: 2.5″ to 40″, single to 9-element configurations
Capsule filters
Mini cartridges
Air filter testing: 2.5″ to 40″
Other specification filter elements
Technical Specifications
Power & Dimensions
| Parameter | Specification |
|---|---|
| Power Supply / Power Rating | 170–240 VAC, 50/60 Hz; 100 W |
| Dimensions (W × D × H) | 40 cm × 30 cm × 25 cm |
Pressure Parameters
| Parameter | Specification |
|---|---|
| Maximum Operating Pressure | 6000 mbar |
| Minimum Inlet Pressure | 200 mbar |
Test Range & Accuracy
| Parameter | Specification |
|---|---|
| Forward Flow Test Range | 0.1–200 ml/min |
| Water Intrusion Test Range | 0.05–50 ml/min |
| Bubble Point Test Range | 700–6000 mbar |
| Test Accuracy | ±3% or ±5‰ F.S., whichever is greater |
| Sensitivity (Forward Flow) | 0.1 ml/min |
| Sensitivity (Water Intrusion) | 0.01 ml/min |
| Sensitivity (Bubble Point) | 50 mbar |
| Repeatability Error | ≤3% |
Operating Conditions
| Parameter | Specification |
|---|---|
| Ambient Temperature | 0°C to 50°C |
| Relative Humidity | 10%–80% |
Test Duration
| Parameter | Specification |
|---|---|
| Bubble Point Test | 2 min ± 2 min |
| Diffusion Flow Test | 7 ± 2 min |
| Water Intrusion Flow Test | 7 ± 2 min |
| System Leak Test | 3 ± 1 min |
Data & Display
| Parameter | Specification |
|---|---|
| Print Function | Prints test conditions, test results, and test curves |
| Data Storage | 32 GB storage capacity; stores over 1,000,000 records |
| Display | 5.7-inch, 256-color touchscreen |
Frequently Asked Questions (FAQ)
Q1: What integrity test methods does the HM-GL support?
A: The HM-GL supports three standard integrity test methods: bubble point testing, forward flow (diffusion flow) testing, and water intrusion testing. It also performs automated system leak tests to verify connection integrity before each measurement.
Q2: Is the HM-GL compliant with pharmaceutical GMP data integrity requirements?
A: Yes. The instrument includes built-in audit trail functionality, electronic signature capability, and multi-level user permission management. These features are designed to meet the data integrity requirements specified in 21 CFR Part 11 and EU Annex 11, as well as the 2020 Pharmacopoeia standards.
Q3: What filter sizes and types can be tested with this instrument?
A: The HM-GL accommodates disc membranes from Φ25 mm to Φ300 mm, standard pleated cartridges from 2.5″ to 40″ (single to 9-element housings), capsule filters, mini cartridges, and air filters. This covers virtually all common filter formats used in pharmaceutical and biotech processing.
Q4: How long does a typical filter integrity test take?
A: Test duration depends on the method selected. A bubble point test typically completes in approximately 2 minutes, while diffusion flow and water intrusion tests require approximately 7 minutes each. The system leak check takes about 3 minutes. All processes are fully automated once initiated.
Q5: Can test data be exported or managed through external software?
A: The instrument stores over 1,000,000 test records internally on 32 GB of built-in storage. Results can be printed in real time, including test conditions, measured values, and test curves. An optional proprietary database expert management system is available for centralized data export, review, and long-term archiving across multiple instruments.
- Previous: no more
- Next: no more
Related Products
