Zhongke Instrument LSSD-01H Leak and Seal Strength Tester

Overview

The Zhongke Instrument LSSD-01H Leak and Seal Strength Tester is an industrial-grade positive-pressure integrity testing system engineered for quantitative evaluation of package seal integrity, burst resistance, and mechanical strength in flexible and semi-rigid packaging systems. It operates on the principle of controlled internal pressurization—introducing regulated compressed air into sealed specimens while continuously monitoring pressure decay or structural failure via high-fidelity piezoresistive transducers. This method enables direct measurement of leakage rate (via pressure drop over time), seal rupture pressure, creep deformation behavior under sustained load, and ultimate burst strength. Designed for laboratories engaged in packaging validation, quality assurance, and regulatory compliance, the LSSD-01H supports deterministic assessment aligned with internationally recognized sterility assurance frameworks, particularly for medical device packaging, pharmaceutical primary containers, and aseptic food packaging.

Key Features

• Positive-pressure testing architecture compliant with ASTM F1140 (burst test) and ASTM F2054 (creep test) methodologies
• Industrial 7-inch capacitive touchscreen with intuitive menu-driven interface; fully configurable test protocols executed via single-touch initiation
• Dual-mode inflation control: expansion-inhibited mode for rigid containment and expansion-permitted mode for flexible pouch characterization
• Four standardized test modes: burst pressure, creep-to-failure, creep hold (constant-pressure dwell), and pressure-hold (leak quantification)
• High-reliability pneumatic components sourced from globally certified suppliers, ensuring long-term repeatability and minimal maintenance
• Modular test fixture support—including constraint plates, open-package adapters, tube sealing fixtures, aerosol valve testers, and blister pack leak modules
• Bilingual (English/Chinese) GUI with real-time unit switching across kPa, MPa, psi, bar, and kgf/cm²
• Automated data logging with timestamped records, power-loss recovery, and non-volatile memory storing up to 2000 test results
• User-level access control (administrator/operator/guest) with optional audit trail functionality meeting FDA 21 CFR Part 11 and EU Annex 11 requirements

Sample Compatibility & Compliance

The LSSD-01H accommodates a broad spectrum of packaging formats: heat-sealed pouches (PE, PET/AL/PE, Tyvek®-based sterile barriers), blow-molded bottles (HDPE, PP), aluminum screw caps, laminated tubes (collapsible aluminum, plastic laminate), blister cavities (PVC/PVDC, cold-form foil), and aerosol actuator assemblies. Its design adheres to critical regulatory benchmarks—including ISO 11607-1 and -2 for packaging validation in healthcare applications, USP <1207> guidance on container closure integrity testing (CCIT), and Chinese pharmacopoeial standards YBB00252005 and YBB 00162002. The system supports both qualitative pass/fail screening and quantitative reporting required for GMP documentation, stability studies, and process validation protocols.

Software & Data Management

Embedded firmware provides real-time graphical display of pressure vs. time curves, automatic detection of inflection points (e.g., onset of creep, burst event), and export-ready CSV reports. Data files include operator ID, test date/time, sample ID, parameter set, raw sensor output, and pass/fail status per user-defined limits. Optional PC-based software enables advanced statistical analysis (Cpk, capability indices), SPC charting, and integration with LIMS or MES platforms via RS232 or USB virtual COM port. All electronic records maintain full traceability—including modification history, login timestamps, and digital signature support when configured for 21 CFR Part 11 compliance.

Applications

• Quantitative seal strength verification of medical device pouches and trays prior to sterilization
• Validation of hot-fill and retort pouch integrity under thermal stress conditions
• Evaluation of cap torque retention and gasket compression performance in pharmaceutical bottles
• Creep resistance assessment of laminated tubes used for ointments and gels
• Leak rate determination for cold-form foil blisters containing moisture-sensitive APIs
• Structural endurance testing of aerosol can valves under cyclic pressure loading
• Material-specific burst pressure profiling for film thickness optimization studies

FAQ

What pressure ranges does the LSSD-01H support?

Standard configuration covers 0.00–600.00 kPa; extended range up to 1.60 MPa is available as a factory-configured option.

Is an external air supply required?

Yes—the instrument requires a clean, oil-free, and dried compressed air source at 0.4–0.9 MPa, delivered via Φ6 mm polyurethane tubing.

Can the system be integrated into a validated laboratory environment?

Yes—when equipped with optional audit trail and electronic signature modules, it satisfies FDA 21 CFR Part 11, EU GMP Annex 11, and ISO/IEC 17025 documentation requirements.

Are custom fixtures available for non-standard packaging geometries?

Yes—Zhongke Instrument offers engineering consultation and mechanical design services for application-specific test fixtures, including ISO-compliant mounting interfaces.

How is calibration maintained over time?

The system supports periodic verification using NIST-traceable pressure calibrators; built-in zero-point auto-compensation ensures baseline stability between tests.