Bag integrity tester BGT-120 meet the requirements of audit tracking and data integrity

Bag integrity tester BGT-120 meet the requirements of audit tracking and data integrity

Bag integrity tester description:

The bag integrity tester produced by Beijing Neuronbc,:BGT-120 is based on the pressure drop test principle. The method is based on the program of ASTM F2095-01, which compliance with GAMPs and FDA 21 CFR Part 11. with authority management and electronic signature, value support, including IQ, OQ, PQ and SOP.

Bag integrity tester applications:

Test the integrity of all sterilization solution bags, breathing bags, disposable dispensing bags, storage bags, transfer bags, etc. before and after use to ensure the sterility requirements of the product.

Bag integrity tester features:

- A simple and user-friendly operating interface.

- Simple and fast operation process.

- Accurate and reliable test results.

- Mature pressure control technology; Simultaneously adding permission management and electronic signature design to comply with the requirements of 21CFR Part 11 for electronic records and electronic signature authentication.

- History records can store over 10000 sets, and come with a built-in printer that can print and save test records in a timely manner; Simple design, no need for additional equipment, fast detection speed, high testing accuracy.

- The instrument adopts a small amount of frequent air intake method, with a uniform air intake speed to avoid bag deformation.

- Color touch screen, user-friendly interface design, and the ability to automatically select and match the most suitable detection program according to different testing parameters, displaying date and time.

- Convenient to move, easy to carry, and fast to connect.

Bag integrity tester technical parameter:

- power supply: AC 220V 50Hz 120W

- Rated power: 120W

- Pressure range: 0-5000Pa

- Response value: ≤50dB(A)

- Noise: ≤50dB(A)

- Working mode: Continuous work

-  External gas source: Compressed air, nitrogen, inert gas

- Resolution: 1pa

- Print Function: Built-in Printer

- Dimensions(mm): 370*220*210mm

- Weight: 7.5KG

- Other function: Audit trail(operational)

Bag integrity tester test method:

1. This method is a recognized pressure decay testing method by the American Society for Testing and Materials (ASTM F2095-01).

2. Compliant with GAMPS and FDA21 CFR Part 11.

3. Complete client validation support, including IQ, 0Q, PQ, and SOP.

4. The pressure control technology is very mature: adding permission management, electronic signature design, and complying with the requirements of FDA 21 CFR Part 11 for electronic records and electronic signature authentication; Historical records can store over 10000 sets, with a built-in printer that can print and save test records in a timely manner; Simple design, no need for additional equipment for testing, fast speed, and high testing accuracy.

Partial products categories: Bioprocess single-use bags, Single use sampling system, Manual crimping tool, Single use frozen storage bags, Single use sampling bags, Liquid storage bags, Single use liquid mixing Bags, Atomic absorption spectrometer(AAS), Ultraviolet and Visible spectrophotometer(UV-VIS Spectrophotometer) , Sterilized tube sealer& tube welder, Life science instruments, Heating instruments, etc.

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