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Bag Integrity

Bag Integrity Tester BGT-120

Specialized bag integrity testing system based on pressure drop test principle — ASTM F2095-01, GAMP5 & FDA 21 CFR Part 11 compliant with IQ/OQ/PQ validation support and electronic signature

Product Introduction

Hexa Pharma Chem presents the Bag Integrity Tester BGT-120, produced by Beijing Neuronbc Laboratories. The BGT-120 is based on the pressure drop test principle, with the method based on the program of ASTM F2095-01. It is fully compliant with GAMP5 and FDA 21 CFR Part 11 requirements.

The BGT-120 features comprehensive authority management with electronic signature, and comes with full validation support including IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification), and SOP documentation. Its compact, portable design with color touchscreen and built-in printer makes it ideal for pharmaceutical bag integrity testing applications.

Product Features

  • Simple operation with accurate and reliable test results
  • Small amount frequent air inlet mode — uniform inlet velocity prevents bag deformation
  • Color touch screen with humanized interface design
  • Automatic selection and matching of most adaptive test procedure for current parameters
  • Date and time display for complete test documentation
  • Portable and easy to connect for flexible deployment
  • Historical records can be printed, stored and queried
  • ASTM F2095-01 compliant pressure drop test methodology
  • GAMP5 and FDA 21 CFR Part 11 compliant
  • Authority management with electronic signature
  • Full validation support — IQ, OQ, PQ and SOP
  • Built-in printer for immediate test documentation
  • Low noise operation — ≤50 dB(A)
  • Compact design — 250×420×220 mm, 11.7 KG

Application Areas

Pharmaceutical Industry Medical Device Industry Food & Beverage Industry Environmental Protection

The BGT-120 is specifically designed for pharmaceutical bag integrity testing, ensuring container closure integrity for bagged pharmaceutical products. Its ASTM F2095-01 compliant methodology and full IQ/OQ/PQ validation support make it ideal for regulated pharmaceutical manufacturing environments.

Technical Parameters

Power Supply AC 220V, 50Hz, 120W
Rated Power 120W
Pressure Range 0 – 5000 Pa
Resolution 1 Pa
Response Value ≤50 dB(A)
Noise Level ≤50 dB(A)
Working Mode Continuous work
External Gas Source Compressed air, Nitrogen, Inert gas
Print Function Built-in printer
Other Function Audit trail (operational)
Dimensions (mm) 250 × 420 × 220
Weight 11.7 KG

Validation Support

IQ/OQ/PQ

Full Documentation

ASTM F2095-01 · GAMP5 · FDA 21 CFR Pt 11 · Electronic Signature · SOP Included

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