Advanced Bag Integrity Testing System for Pharmaceutical & Packaging Applications – BGT-120
Equipment Name: Bag Integrity Tester
Equipment application: Testing all sterilization solution bags and respirators.
After use, the bags, disposable solution bags, and transfer bags are completely cleaned.
Integrity testing ensures the product meets sterility requirements.
- This method is the pressure decay test method recognized by ASTM F2095-01 of the American Society for Testing and Materials;
- Complies with GAMPS and FDA 21 CFR Part 11
- Comprehensive client-side authentication support, including IQ, OQ, PQ, and SOP.
- The pressure control technology is very mature; it incorporates access control and electronic signature design, meeting the FDA 21 CFR Part 11 electronic record and electronic signature certification requirements; it can store more than 10,000 historical records, has a built-in printer, and can print and save test records in a timely manner; it has a simple design, requires no additional equipment for testing, is fast, and has high testing accuracy.
- The instrument uses a small, frequent air intake mode, ensuring a uniform air intake speed and preventing bag deformation.
- The color touchscreen features a user-friendly interface and can automatically select and match the most suitable testing program, date, and time display based on different test parameters.
- Easy to move, portable, and connects quickly.
- Historical records can be printed, stored, and retrieved.
Testing all sterilization solution bags and respirators.
After use, the bags, disposable solution bags, and transfer bags are completely cleaned.
Integrity testing ensures the product meets sterility requirements.
| Main parameters |
Parameter range |
| Working power supply |
AC 220V 50Hz |
| Built-in battery |
Lithium-ion batteries |
| Rated power |
120W |
| Test duration |
2-8min |
| Pressure range |
0-5000Pa |
| Response value |
≤50Pa |
| Noise |
≤50dB(A) |
| working methods |
Continuous operation |
| External gas source |
Compressed air, nitrogen, inert gas |
| Historical records |
≥15000 groups |
| Accuracy |
0.1pa |
| External dimensions |
420*330*180 (width*depth*height) |
| weight |
5kg |
| Audit trail function |
≥3 years |