Labthink C660M Leak and Seal Strength Tester for Gas Sampling Bag Interfaces

Overview

The Labthink C660M Leak and Seal Strength Tester is an engineered solution for quantitative evaluation of package integrity under controlled pressurization. Based on the positive-pressure inflation method, it applies regulated compressed air to sealed packages—such as gas sampling bags, blister packs, pouches, tubes, and capped containers—to assess structural failure thresholds, creep behavior, and hermetic seal performance. The instrument operates on fundamental principles of pneumatic pressure–deformation response analysis, where real-time monitoring of internal pressure, airflow rate, and time-dependent deformation enables precise determination of burst pressure, creep-to-failure duration, and leak rate under constant or ramped pressure profiles. Designed specifically for quality control laboratories in pharmaceutical, medical device, food packaging, and chemical sampling industries, the C660M supports regulatory-driven validation protocols requiring traceable, auditable, and repeatable mechanical integrity data.

Key Features

• Multi-mode pressurization testing: burst test, creep test, creep-to-burst test, and pressure-hold test—each configurable with either restrained or unrestrained expansion conditions (requires optional fixtures)
• Real-time mass airflow monitoring: proprietary flow-sensing technology ensures consistent volumetric delivery across pressure ranges up to 1.6 MPa, eliminating drift-induced variability in high-pressure regimes
• Industrial-grade 7-inch capacitive touchscreen interface with intuitive icon-driven navigation, firmware-over-the-air (FOTA) capability, and dual-language support (English/Chinese)
• Full data governance architecture: automatic timestamped storage of ≥1,200 test records; password-protected multi-level user access (admin/operator/auditor); audit trail compliant with FDA 21 CFR Part 11 and EU Annex 11 requirements when configured with DataShield™
• Modular hardware design: interchangeable nozzles (Φ1.6 mm, Φ4 mm, Φ10 mm) and customizable test fixtures accommodate diverse geometries—from micro-volume gas sampling bags to large-format composite pouches and aerosol valve assemblies
• Integrated environmental safeguards: built-in pressure relief valve, overpressure cutoff, and fail-safe interlock prevent uncontrolled rupture during high-stress testing

Sample Compatibility & Compliance

The C660M accommodates a broad spectrum of flexible and semi-rigid packaging formats, including but not limited to: laminated plastic/aluminum/paper pouches; extruded or laminated tubes (toothpaste, ointment, cosmetic); thermoformed blisters; crimp-sealed vials; child-resistant and tamper-evident closures; and welded gas sampling bag interfaces per ISO 15195 and ASTM D3475. All test methods align with internationally recognized standards for package integrity verification—including ISO 11607-1 (materials/process validation) and ISO 11607-2 (sterile barrier system validation), ASTM F1140 (burst test), ASTM F2054 (creep test), and Chinese pharmacopoeial standards YBB 00252005 and YBB 00162002. When deployed with GMP-compliant software modules and electronic signature functionality, the system meets GLP/GMP documentation requirements for regulated environments.

Software & Data Management

The C660M’s embedded operating system includes native data logging with automatic metadata capture (operator ID, sample ID, test mode, environmental temperature, pressure curve timestamps). Optional Labthink SmartTest™ software enables advanced statistical analysis (Weibull distribution fitting, trend charting, SPC control limits), report generation in PDF/XLSX formats, and direct integration into LIMS or MES platforms via TCP/IP or USB. DataShield™—a validated data centralization module—supports role-based remote access, encrypted cloud backup, and automated synchronization with enterprise document management systems. All digital records maintain full ALCOA+ attributes (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available) for regulatory inspection readiness.

Applications

• Gas sampling bag interface weld strength validation per EPA Method TO-15 and ISO 15195
• Creep resistance assessment of heat-sealed pouches used in sterile medical device packaging
• Burst pressure evaluation of aluminum-plastic blister cavities under accelerated aging conditions
• Seal integrity screening of aerosol valve assemblies (e.g., metered-dose inhalers, topical sprays)
• Mechanical robustness testing of three-side-sealed stand-up pouches subjected to transport vibration and stacking loads
• Quantitative comparison of cap torque vs. seal retention performance across HDPE/PET bottle closure systems
• Stress–strain profiling of laminated tube bodies and shoulder seals under simulated dispensing cycles

FAQ

What pressure range options are available for the C660M?
Standard configuration covers 0–600 kPa (0–87 psi); extended-range version supports up to 1.6 MPa (232 psi) with reinforced pressure vessel and calibrated transducer.
Is an air compressor included with the system?
No—the C660M requires an external clean, dry, oil-free air source delivering 0.6–0.7 MPa at ≥10 L/min. Labthink offers compatible silent compressors as optional accessories.
Can the C660M be integrated into a networked QA/QC lab environment?
Yes—via Ethernet or USB, the instrument supports bidirectional communication with Labthink SmartTest™ software, LIMS, and ERP systems using standard MODBUS TCP or CSV export protocols.
Does the system meet FDA 21 CFR Part 11 requirements?
When equipped with optional GMP-compliant software, electronic signatures, and DataShield™, the C660M fulfills Part 11 criteria for electronic records and signatures—including audit trails, access controls, and record retention.
What certifications does the C660M hold?
CE marked; ISO 9001-certified manufacturing; compliant with EMC Directive 2014/30/EU and Low Voltage Directive 2014/35/EU; factory-calibrated per ISO/IEC 17025 traceable to NIM (China National Institute of Metrology).