Neuronbc BGT‑200 Bag Integrity Tester – Safeguarding Flexible Bioprocess Packaging Safety

In the full‑flow biopharmaceutical manufacturing workflow, flexible packaging components such as single‑use liquid storage bags, mixing‑stirring bags and culture medium bags serve as core carriers for the storage and transfer of buffer solutions, culture media and drug solutions. Flexible bags feature soft material and are highly prone to deformation and wrinkling. During integrity testing, improper air‑inlet control may cause bag expansion and deformation, which readily generates false leak signals and leads to misjudgment. Conventional testing methods struggle to balance detection sensitivity and sample protection, posing multiple challenges for enterprises in incoming‑material inspection, method validation and GMP audits.

The Neuronbc BGT‑200 Bag Integrity Tester from Beijing Neuronbc is purpose‑built for flexible pharmaceutical packaging. Adopting the pressure‑decay method and with full‑unit optimization tailored to the physical properties of flexible bags, it delivers an offline non‑destructive packaging integrity testing solution for biopharmaceutical manufacturers.

Purpose‑built for flexible bags: addressing inherent challenges of flexible‑package testing

The BGT‑200 is developed for various bioprocess flexible packaging types, compatible with single‑use bioprocess storage bags, mixing‑stirring bags, culture medium bags, large‑volume pharmaceutical film bags, infusion soft bags and other flexible samples. The instrument adopts direct‑line sample connection: the test bag is directly connected to the tester via an air‑inlet tube, while an external air supply is connected to complete the test. It accommodates testing requirements for flexible bags of diverse models and specifications.

The major interference in flexible‑bag testing originates from bag deformation caused by pressurization. The BGT‑200 implements low‑volume, frequent air‑inlet logic with uniform and gentle air‑feeding velocity, avoiding violent pressurization of the bag. It minimizes interferences induced by excessive bag expansion, effectively distinguishes bag‑derived deformation artefacts from genuine micro‑leakage signals, reduces false‑positive rates, and ensures excellent repeatability across repeated tests.

Performance Parameters: balancing sensitivity and laboratory practicality

Compact and lightweight, the tester measures 292 × 480 × 115 mm (Height 1) / 190 mm (Height 2), and weighs merely 10.7 kg. It enables flexible placement and relocation within laboratories with simple and fast wiring.

The unit supports global‑range power supply: AC 110 V / 220 V, 50 Hz / 60 Hz, with rated power of 100 W. A full test cycle can be completed within minutes; test duration can be customized according to sample characteristics and test methods.

Test pressure range: 0‑5000 Pa (customizable upon request); pressure resolution reaches 0.1 Pa with pressure deviation ＜ 30 Pa, enabling high‑sensitivity capture of micro‑leakage signals.

The instrument supports independent offline operation without mandatory upper‑computer dependency. It locally stores up to 300 000 historical test records, and supports audit‑trail logging for up to 1 000 000 entries. Mass‑volume local storage fully satisfies data‑retention requirements for high‑volume laboratory sample testing. The embedded Linux 3.2.0 armv7l operating system guarantees stable and reliable operation.

Strong compliance capability for pharmaceutical‑industry audit requirements

Besides testing performance, data traceability constitutes a core audit focus under GMP for pharmaceutical testing instruments. The BGT‑200 strictly complies with ALCOA+ data‑integrity principles.

Four‑level permission management enables graded operator access control. Comprehensive audit‑trail functionality records every operation, parameter modification and test activity. Raw test data is automatically stored locally in non‑alterable format, supporting query, export and printout. Complete preservation of all original records facilitates responses to GMP unannounced inspections and customer‑site audits.

Performance confirmation and periodic calibration can be performed with certified reference leak orifices to achieve controllable and traceable detection capability. IQ/OQ/PQ validation documentation is available to support customers in efficient full‑lifecycle equipment validation and hand‑over.

User‑friendly design for easy operation

Equipped with a color touch‑screen and graphical HMI, the instrument features intuitive operation logic to reduce operator learning costs. Multiple test methods can be pre‑configured and saved inside the device. Operators can directly call pre‑saved methods for different flexible‑bag types instead of repeated parameter setup, significantly improving testing efficiency.

Thanks to its lightweight mechanical design, no complex peripheral accessories are required. The instrument can be deployed for routine laboratory use after installation and commissioning.

Key Application Scenarios

Biopharmaceuticals ‑ Incoming‑material inspection for single‑use‑process consumables

For monoclonal‑antibody, vaccine and cell‑and‑gene‑therapy production lines: offline sampling inspection upon incoming of large‑volume single‑use storage bags, mixing‑stirring bags, liquid‑preparation bags and culture‑medium preparation bags. Integrity screening prior to material feeding intercepts incoming micropores and weld‑seam defects in advance, eliminating risks of full‑batch product scrapping caused by consumable leakage.

Pharmaceutical‑formulation industry ‑ Quality evaluation of pharmaceutical flexible packaging

Applied to quality assessment of infusion soft bags and pharmaceutical film‑pack products. It evaluates whether micro‑leakages occur at bag weld‑seams and ports after packaging sealing, production and transportation vibration, supporting product‑stability studies and iterative optimization of packaging processes.

Supply‑chain‑risk assessment ‑ Reliability verification of consumables post‑transport and process handling

Evaluate whether hidden micropore damages emerge at weld‑seams and tube connections of single‑use bags after cold‑chain transportation, handling, filling and sterilization. Used for supply‑chain‑risk assessment and consumable‑compatibility verification.

Consumable R&D ‑ Performance testing of novel flexible packaging

For packaging‑consumable manufacturers: perform integrity‑performance evaluation for newly‑developed bioprocess bags and culture‑medium bags. Support optimization of bag‑welding and joint‑assembly processes, and complete performance verification during product‑development phases.

The bottleneck in flexible‑bag integrity testing seldom lies in testing principles, but in hardware and control‑algorithm adaptation to the physical characteristics of flexible bags. The Neuronbc BGT‑200 Bag Integrity Tester from Beijing Neuronbc is purpose‑engineered for large‑format flexible packaging across air‑inlet control, pipeline‑connection design, data governance and large‑capacity storage. It delivers a stable, sensitive and regulatory‑compliant integrity‑testing solution for flexible bags in the biopharmaceutical industry.