Standard: | ISO14644-7, 21 CFR Part 11 Compliance | Test Accuracy: | Minimum Aperture 300μm |
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Test Duration: | 3-8min | Pressure Range: | 500-3000Pa |
High Light: | GIT-1000 glove integrity testing machine,Online Glove Integrity Testing System,Sterile glove integrity testing machine |
The Sterile Isolator Wireless Glove Integrity Tester GIT-1000/2000 produced by Bonnintech company, for the positive pressure leak detecting by GB/T 25915.7-2010/ISO 14644-7:2004. It is a special instrument for detecting leakage of gloves. Our company has been engaged in the production and sales of filter integrity testers for many years, and the pressure control technology is very mature.
The device uses a wireless communication mode, built-in air pump and lithium battery, through systematic management, so that multiple detection units can be linked in real time. In addition to complying with the requirements of FDA and GMP and other laws and regulations, four-level authority management and electronic signature design are also set up to comply with 21CFR part 11 electronic records and electronic signature certification requirements; The history record can store more than 12000 groups, and at the same time, it has its own storage FLASH, which can transmit and save the test records in time; the structure design is simple and exquisite, no additional equipment is required, no need to remove gloves, and the glove tray can be replaced, supporting different specifications and sizes of gloves Detection. The high-precision pressure sensor is adopted, and the glove test is fast and accurate.
Application Range:
1.Pharmaceutical industry: sterile inspection and microbial limit inspection of purified water, water for injection, sterile preparations (large infusion, small injection, powder, biological products, blood products, ophthalmic preparations, maintenance solutions, etc.).
2.Medical equipment industry: sterility inspection and microbial limit inspection of purified water, water for injection, syringes, infusion sets, blood transfusion sets, intravenous catheters, etc.
3.Food and beverage industry.
4.Environmental protection industry, etc.
Technical Parameters:
Power supply | DC 12V 20W |
Built-in battery | 12V lithium battery |
Test accuracy | Minimum aperture 300μm |
Test duration | 3-8min |
Pressure range | 500-3000Pa |
Pressure resolution | 0.1Pa |
Noise | ≤50dB(A) |
Communication method | WIFI wireless network |
Gas source | Built-in air pump |
Sealing pressure | ≤ 200 KPa |
History record | 12000 set |
Glove recognition method | RFID/manual input |
Weight | 4.5KG |
Online glove tray | Customizable replacement |
FAQ 1. Are you a factory or trading company?
We are a factory.
FAQ 2. Can you supply OEM?
OEM is available.
FAQ 3. What's the MOQ ?
(1). MOQ is 1 piece. The disposable supplies order usually at least 1 box.
FAQ 4. How about the order processing and lead time?
After order confirmation and receive the advance payment, we will prepare the machines and goods. Usually could ready within 10 working day, when dispatch, will inform client and send the documents for client making import customs clearance.
FAQ 5. What quality will be ensured?
100% new and quality inspection before delivery from factory.
Stable export box for good package.
FAQ 6. Can you guide the working?
The machine will deliver with English display, English manual and video for installation and operation.
FAQ 7. How can your engineer replace parts if they are not beside the machine?
Bonnin’s engineer could provide the solutions by email and video. In warranty period, we can send spare parts for free and life-time technical support for spare supply.