Hengmei HM-MF2A Negative Pressure Seal Integrity Tester

Overview

The Hengmei HM-MF2A Negative Pressure Seal Integrity Tester is an engineered solution for deterministic leak detection and seal performance evaluation of flexible and semi-rigid packaging across regulated and non-regulated industries. It operates on the principle of vacuum decay-based seal integrity assessment—applying controlled negative pressure within a sealed chamber to induce differential stress across package seals. Two primary evaluation modes are supported: (1) submerged bubble emission observation, where packages immersed in water are subjected to vacuum; visible gas leakage indicates seal failure; and (2) non-submerged deformation analysis, where vacuum-induced expansion and post-vacuum shape recovery of the package are monitored to infer structural integrity and seal resilience. This dual-mode methodology aligns with fundamental physical principles of pressure differentials and material elasticity, enabling objective pass/fail determination without subjective interpretation.

Key Features

• Embedded Linux-based operating system with intuitive 7-inch HD capacitive touchscreen interface—designed for one-touch workflow execution including vacuum draw, pressure hold, auto-compensation, timing control, venting, data logging, and printout.
• Automated pressure maintenance via SMC (Japan) pneumatic components—ensuring stable vacuum levels throughout the hold phase with real-time digital feedback control.
• Dual-test mode support: standard single-step vacuum test and programmable gradient vacuum profile testing—enabling method development for complex packaging geometries or multi-layer barrier systems.
• Configurable display and interface language (English/Chinese) with globally recognized pressure units (kPa/mbar) selectable per user preference.
• Real-time vacuum curve visualization on screen—displaying pressure vs. time trace during draw-down, hold, and release phases for immediate qualitative assessment.
• Digital presetting of target vacuum level (0 to –90 kPa) and hold duration (0–9999 s)—minimizing operator variability and enhancing inter-laboratory reproducibility.
• Four-tier role-based access control with password authentication—supporting distinct permissions for operator, supervisor, QA, and administrator roles.
• Audit trail functionality compliant with China’s GMP Annex 13 requirements—recording timestamps, user IDs, parameter changes, test executions, and result modifications—all exportable in printable format.
• Local data persistence: up to 100,000 test records stored internally with dual-indexed retrieval by timestamp and operator ID.
• Integrated thermal printer and USB 2.0 port for Excel-formatted data export—facilitating integration into LIMS or QA documentation systems.
• WiFi connectivity enabling secure over-the-air (OTA) firmware updates and remote diagnostic support—reducing downtime and service dependency.
• Modular lightweight chassis design—optimized for benchtop deployment and portable use across QC labs, production lines, and validation environments.

Sample Compatibility & Compliance

The HM-MF2A accommodates a broad range of soft and semi-rigid packaging formats including pouches, blister cards, sachets, tubes, bottles, trays, and composite cans—regardless of material composition (e.g., PET/AL/PE, PP, LDPE, Tyvek®-based laminates). Its standardized vacuum chamber (Φ270 × 210 mm H) supports common commercial packaging dimensions; custom chamber configurations are available upon request. The instrument conforms to multiple national and international standards governing package integrity verification, including GB/T 15171 (China), ASTM D3078 (U.S.), GB/T 27728 (China), and key Chinese pharmaceutical packaging standards YBB00112002–2015 through YBB00392003–2015. While not inherently 21 CFR Part 11–compliant out-of-the-box, its audit trail, electronic signature readiness, and immutable record storage provide a foundational architecture for Part 11 validation when deployed within a documented GxP quality system.

Software & Data Management

The embedded Linux OS delivers deterministic real-time control and deterministic data capture. All test parameters—including vacuum setpoint, hold time, gradient steps, operator ID, and timestamp—are digitally recorded at acquisition. Data integrity is preserved via write-once internal memory architecture; records cannot be edited or deleted without explicit administrative override and full audit log generation. Exported Excel files contain raw pressure-time series, metadata headers, and pass/fail flags. Optional integration with enterprise LIMS or MES platforms is achievable via configurable CSV/Excel templates and network-accessible file shares over WiFi or USB-hosted storage.

Applications

• Pre-release seal validation for sterile medical device pouches (ISO 11607–1/–2)
• Post-sterilization integrity verification of terminally sterilized drug product containers
• QC screening of food packaging under accelerated aging or post-distribution stress conditions (e.g., drop test, compression)
• Process validation support for heat-seal, RF seal, and cold-form foil lamination operations
• Comparative evaluation of sealant formulations, film structures, or sealing equipment parameters
• Regulatory submission support for FDA 510(k), CE marking, or NMPA registration dossiers

FAQ

What vacuum accuracy class does the HM-MF2A meet?
The instrument meets Class 1 accuracy per JJG 52–2013 (Chinese national metrological verification regulation) across its full 0 to –90 kPa operating range.
Is external compressed air required?
Yes—a clean, dry, oil-free air supply at 0.7 MPa is mandatory; users must provide compatible filtration and pressure regulation upstream of the Φ6 mm polyurethane inlet.
Can test methods be validated per ISO 13485 or ICH Q5C?
The HM-MF2A provides the measurement capability and data fidelity required for method validation; full validation requires user-defined protocols covering specificity, repeatability, intermediate precision, and robustness per ISO/IEC 17025 guidelines.
Does the device support GLP-compliant electronic signatures?
Electronic signature functionality is not built-in but can be implemented via external software layers integrated through the USB or WiFi interface, subject to organizational SOPs and risk assessment.
How is calibration performed?
Calibration is performed using traceable reference pressure sensors at three points (–20 kPa, –50 kPa, –80 kPa); certificate of calibration is issued annually or after any impact event affecting sensor integrity.