Labthink C660M Positive-Pressure Seal Integrity & Burst Strength Tester

Overview

The Labthink C660M Positive-Pressure Seal Integrity & Burst Strength Tester is an engineered solution for quantitative evaluation of package integrity and mechanical resistance under controlled pressurization. Based on the positive-pressure inflation principle—where regulated compressed air is introduced into a sealed package cavity—the instrument measures critical performance parameters including burst pressure, creep deformation, creep-to-failure time, and seal retention under sustained pressure. It operates in strict accordance with internationally recognized test methodologies defined in ISO 11607-1/-2 (Packaging for terminally sterilized medical devices), ASTM F1140 (Internal Pressurization Failure Resistance of Flexible Packages), and ASTM F2054 (Inflation and Burst Testing of Flexible Packaging). Designed for laboratories requiring regulatory-grade repeatability and traceability, the C660M supports both routine QC verification and development-stage material qualification across food, pharmaceutical, personal care, and medical device packaging sectors.

Key Features

• Multi-mode testing protocol: burst test, creep test, creep-to-burst test, and pressure-hold test—each configurable with user-defined ramp rates, hold durations, and termination criteria
• Dual expansion control: selectable “inhibited expansion” (rigid chamber confinement) and “non-inhibited expansion” (free-volume inflation) modes, enabling compliance with distinct test standards and material response characterization
• Real-time airflow monitoring via proprietary mass-flow sensor technology—ensuring consistent gas delivery across pressure ranges up to 1.6 MPa and 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)
• Embedded data management: automatic timestamped storage of ≥1,200 test records with full audit trail; optional DataShield™ integration for centralized database synchronization and LIMS/ERP compatibility
• GMP-aligned architecture: password-protected multi-tier user roles (operator, supervisor, administrator), electronic signature support, and 21 CFR Part 11–compliant data integrity features (available with validated software package)
• Modular hardware design: standardized Φ8 mm PU tubing interface; optional accessories include miniature thermal printer, PC communication cable, application-specific inflation fixtures (e.g., soft-tube cradles, blister clamps, aerosol valve adapters), and certified air compressor units

Sample Compatibility & Compliance

The C660M accommodates a broad spectrum of flexible and semi-rigid packaging formats without requiring sample modification. Validated applications include three-side-sealed pouches, stand-up pouches, laminated foil bags, aluminum-plastic blisters, collapsible tubes (toothpaste, ointment, cosmetic), aerosol valve assemblies, tamper-evident caps (PET, HDPE, metal), and composite can ends. All test methods align with pharmacopeial and industrial standards governing package validation: USP , ISO 11607 series, ASTM F1140/F2054, GB/T 17876 (caps), BB/T 0025 (soft tubes), and YBB 00252005 (pharmaceutical plastic containers). For GMP-regulated environments, optional IQ/OQ documentation packages and 21 CFR Part 11–validated software modules are available upon request.

Software & Data Management

The embedded operating system provides real-time graphical display of pressure vs. time curves, with dynamic annotation of key inflection points (onset of creep, yield point, burst event). Raw data export is supported via USB 2.0 port in CSV format; optional Labthink Vision™ PC software enables advanced statistical analysis (Weibull distribution fitting, Cp/Cpk calculation), batch report generation, and automated compliance checking against predefined pass/fail thresholds. Audit logs record all operator actions, parameter changes, and calibration events with immutable timestamps. When configured with DataShield™, test records synchronize securely to enterprise servers using TLS 1.2 encryption, supporting ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available).

Applications

• Flexible packaging validation: Quantification of seal strength, channel integrity, and delamination resistance in multilayer laminates used for snacks, instant noodles, dairy, and ready-to-eat meals
• Tube and closure assessment: Measurement of cap torque equivalence, bridge rupture force, and diaphragm sealing performance for squeeze tubes and child-resistant closures
• Blister and strip pack testing: Detection of foil-punch defects, edge seal failure, and thermoform web weakness under simulated transit conditions
• Aerosol system verification: Leak rate quantification at valve-seat interfaces and actuator stem seals across propellant-filled systems
• Non-standard container qualification: Custom fixture-based testing of pouches with irregular geometries, spouted bags, and retort pouches subjected to post-sterilization stress

FAQ

What pressure range options are available for the C660M?
Standard configuration covers 0–600 kPa (0–87 psi); extended-range version supports 0–1.6 MPa (0–232 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 (87–101 psi) via Φ8 mm polyurethane tubing. Labthink offers compatible scroll-type compressors as optional accessories.
Can test data be exported for regulatory submission?
Yes—CSV exports include full metadata (operator ID, timestamp, method ID, raw curve points). With validated software and DataShield™, outputs meet FDA eCTD and EU Annex 11 requirements for electronic records.
Which international standards does the C660M directly support?
ISO 11607-1/-2, ASTM F1140, ASTM F2054, GB/T 10440, GB 18454, YBB 00252005, and USP Annex 2 (deterministic leak testing) are fully implemented in test method templates.
How is measurement traceability ensured?
Each unit ships with NIST-traceable calibration certificate (pressure transducer and flow sensor). Optional annual recalibration service includes uncertainty budget documentation per ISO/IEC 17025.