NeuronBC BGT-120 Single-Use Bag Integrity Tester

Overview

The NeuronBC BGT-120 Single-Use Bag Integrity Tester is an engineered solution for non-destructive, quantitative integrity verification of single-use bioprocessing containers—including stirred-tank bags, mixing bags, and storage bags—used across upstream and downstream biomanufacturing workflows. It implements the pressure decay method in strict accordance with ASTM F2095-01, a globally recognized standard for leak detection in flexible packaging and fluid containment systems. This principle relies on monitoring the rate of pressure loss within a sealed bag after pressurization under controlled conditions; deviations exceeding predefined thresholds indicate defects such as micro-punctures, weld seam failures, or connector interface leaks. Designed specifically for GMP-regulated environments, the BGT-120 supports full validation lifecycle management—including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Standard Operating Procedure (SOP) integration—ensuring compliance with ICH Q5A, EU Annex 1, and USP <1207> guidance on package integrity evaluation.

Key Features

• Pressure decay methodology validated per ASTM F2095-01, enabling traceable, repeatable, and operator-independent pass/fail determinations;
• High-resolution pressure sensing with 0.1 Pa resolution and ≤50 Pa system response threshold, ensuring sensitivity to sub-micron-level leaks;
• Intelligent gas delivery architecture using low-flow, pulsed inflation to prevent bag deformation or stress-induced false positives;
• 7-inch color touchscreen interface with intuitive navigation, real-time parameter visualization, and automatic test protocol selection based on bag volume and material characteristics;
• Integrated thermal printer for immediate hard-copy output of test reports—including date/time stamp, operator ID, test parameters, raw pressure curve, and final verdict (“Pass” or “Fail”);
• Built-in rechargeable lithium-ion battery supporting portable operation in cleanroom corridors, isolators, or mobile QC labs without fixed power access;
• User role-based access control with electronic signature capability, aligned with FDA 21 CFR Part 11 requirements for electronic records and signatures;
• Compact footprint (370 × 220 × 210 mm) and lightweight design (4.5 kg) facilitate rapid deployment across multiple manufacturing suites or satellite testing stations.

Sample Compatibility & Compliance

The BGT-120 accommodates single-use bags ranging from 5 L to 2000 L capacity, including those manufactured from multi-layer ethylene vinyl acetate (EVA), polyolefin, or thermoplastic polyurethane (TPU) films. It interfaces seamlessly with common bag port configurations (e.g., sterile connectors, diaphragm valves, and aseptic sampling ports) without requiring custom fixtures. All firmware and software modules are developed under a documented configuration management system, supporting GxP-aligned change control procedures. The instrument meets electromagnetic compatibility (EMC) standards per IEC 61326-1 and operates within Class A noise limits (≤50 dB[A]) suitable for ISO Class 5–8 cleanrooms. Optional audit trail functionality provides time-stamped, immutable logs of all user actions, parameter modifications, and test executions—fully auditable during regulatory inspections.

Software & Data Management

Data handling follows ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available). Each test record stores pressure vs. time profiles, environmental temperature/humidity metadata (if external sensors are connected), operator credentials, and digital signatures. Local storage retains ≥10,000 complete test histories with search-by-date, batch ID, or operator filter. Export options include CSV and PDF formats compatible with LIMS integration. For enterprise deployments, optional Ethernet/Wi-Fi connectivity enables remote data aggregation via secure HTTPS APIs. Software validation documentation—including risk assessments, requirement specifications, and test scripts—is provided as part of the IQ/OQ package.

Applications

• Pre-use integrity verification of single-use bioreactor bags prior to cell culture inoculation;
• Post-sterilization (gamma/e-beam) integrity confirmation of filled buffer or media bags;
• Leak screening of transfer bags before aseptic connection to chromatography columns or filtration skids;
• Periodic in-process checks during extended storage of purified drug substances;
• Supporting root cause analysis during deviation investigations involving container closure integrity;
• Qualification of new bag suppliers or alternative film formulations under change control protocols.

FAQ

What gas sources are compatible with the BGT-120?
Compressed air, nitrogen, or other inert gases may be used, provided inlet pressure does not exceed 0.5 MPa and dew point is maintained below −40 °C to prevent condensation in internal manifolds.
Is calibration required before each test?
No routine recalibration is needed between tests; however, annual traceable calibration against NIST-traceable pressure standards is recommended and supported by certified service partners.
Can test data be exported to our LIMS?
Yes—CSV exports are natively supported; API-based integration with major LIMS platforms (e.g., LabVantage, STARLIMS) is available through optional middleware licensing.
Does the BGT-120 support automated test sequencing for multiple bags?
While designed for individual bag testing, batch reporting and sequential manual execution are enabled via customizable test templates and barcode-assisted sample ID entry.
Is the audit trail module pre-installed or field-upgradable?
The audit trail function is offered as a factory-configured optional module and can be activated via secure license key; no hardware modification is required.