Labthink C660M Positive-Pressure Seal Integrity Tester
| Brand | Labthink |
|---|---|
| Origin | Shandong, China |
| Manufacturer Type | OEM/ODM Producer |
| Country of Origin | China |
| Model | C660M Positive-Pressure |
| Price Range | USD 4,200 – 7,000 |
| Test Range | 0–600 kPa (standard), up to 1.6 MPa (custom) |
| Resolution | 0.1 kPa |
| Pressure Accuracy | ±0.25% FS |
| Inflation Nozzle Diameter | Φ10 mm (standard) |
| Airflow Control Range | 0.01–10 L/min |
| Hold Time | 0.1 s – 999999.9 s |
| Air Supply Requirement | 0.6–0.7 MPa (87–101 psi), Φ8 mm polyurethane tubing |
| Dimensions (H×W×D) | 200 × 334 × 230 mm (main unit) |
| Power | 220 VAC ±10%, 50 Hz or 120 VAC ±10%, 60 Hz |
| Weight | 8 kg (unit), 16 kg (fixture) |
| Compliance | ISO 11607-1/-2, ASTM F1140/F2054, GB/T 10440, GB 17447, YBB 00252005, BB/T 0025, QB/T 1871 |
Overview
The Labthink C660M Positive-Pressure Seal Integrity Tester is an engineered solution for quantitative evaluation of package integrity under controlled pressurization conditions. It operates on the principle of positive-pressure leak detection and burst testing—applying regulated compressed air to the interior of sealed packages while monitoring pressure decay, inflation dynamics, or time-to-failure. This method enables deterministic assessment of seal quality, material strength, and structural resilience across diverse packaging formats including flexible pouches, blister packs, aerosol valve assemblies, plastic bottles with tamper-evident closures, laminated tubes, and three-side-sealed sachets. Unlike vacuum-based systems, the C660M’s positive-pressure architecture eliminates risk of package collapse during test initiation and provides direct correlation between internal stress and failure mode—critical for validating aseptic barrier performance in pharmaceutical, food, and personal care applications.
Key Features
- Multi-Mode Pressure Testing Protocol: Supports rupture testing, creep testing, creep-to-rupture testing, and pressure-hold (leak detection) modes—each configurable via intuitive touch interface with real-time pressure-time curve visualization.
- Dual Expansion Control Architecture: Offers both expansion-suppressed and expansion-unrestricted test configurations; accommodates volumetric compliance of soft packaging through optional fixtures (e.g., restraining plates, custom mandrels).
- Real-Time Mass Flow Monitoring: Implements patented airflow sensing technology enabling precise control and logging of gas inflow rates (0.01–10 L/min) during pressurization—ensuring reproducible boundary conditions critical for inter-laboratory comparability.
- Industrial Touchscreen Interface: 7-inch capacitive display with IP65-rated enclosure, supporting one-touch operation, bilingual (English/Chinese) UI, customizable unit sets (kPa, psi, MPa), and automatic data retention after power loss.
- Regulatory-Ready Data Handling: Built-in non-volatile memory stores up to 1,200 test records with timestamp, operator ID, test parameters, and raw pressure/time traces. Optional DataShield™ integration enables secure audit trails compliant with FDA 21 CFR Part 11 and EU Annex 11 requirements.
- Modular Hardware Design: Standard Φ10 mm inflation nozzle; field-upgradable nozzles (Φ4 mm, Φ1.6 mm) support micro-volume containers and narrow-neck closures. USB port and optional thermal printer facilitate offline reporting.
Sample Compatibility & Compliance
The C660M accommodates a broad spectrum of primary packaging geometries and closure types without requiring destructive sample preparation. Validated use cases include aluminum-plastic blister cavities, PE/AL/PE laminated pouches, HDPE squeeze tubes (toothpaste, ointments), PET carbonated beverage bottles with screw caps, aerosol actuators (insecticide, topical sprays), and three-side-sealed snack pouches. Its test methodology aligns with internationally recognized standards governing package integrity verification—including ISO 11607-1 (materials, sterile barrier systems) and ISO 11607-2 (validation requirements), ASTM F1140 (burst test for flexible packages), ASTM F2054 (creep test), and multiple Chinese pharmacopoeial and industrial standards (YBB 00252005, GB/T 17876, BB/T 0025). The system supports GLP/GMP environments through multi-level user authentication, electronic signature capability (with optional software), and traceable calibration logs.
Software & Data Management
While the C660M operates autonomously via embedded firmware, optional PC-based software extends analytical functionality: statistical process control (SPC) charting, comparative trend analysis across batches, automated report generation (PDF/CSV), and integration with LIMS or MES platforms via TCP/IP or RS232. All stored data includes full metadata—test mode, pressure ramp rate, hold duration, peak pressure, burst pressure, creep slope, and pass/fail status per ISO-defined criteria. The optional DataShield™ module provides role-based access control, encrypted database storage, and change-log auditing—meeting stringent data integrity expectations in regulated pharmaceutical manufacturing and contract packaging operations.
Applications
- Flexible Packaging Validation: Quantitative burst strength measurement of laminated films, peel seal integrity of medical device pouches, and creep resistance of stand-up resealable bags.
- Bottle & Cap Systems: Tamper-evident cap torque-to-leak threshold mapping, PET bottle wall stress distribution analysis, and HDPE container deformation behavior under sustained internal pressure.
- Tubular Packaging: Seam strength evaluation of aluminum collapsible tubes, crimp integrity of laminate toothpaste tubes, and nozzle-to-body bond durability in cosmetic dispensers.
- Aerosol & Valve Assemblies: Leak rate quantification at actuator interfaces, valve seat sealing performance under simulated discharge cycles, and canister body integrity at elevated pressures.
- Specialty Formats: Integrity screening of paperboard cans with foil seals, pouches with zip-lock mechanisms, and pouches fabricated using ultrasonic or impulse sealing technologies.
FAQ
What pressure range options are available for the C660M?
The standard configuration covers 0–600 kPa (0–87 psi); high-pressure variant supports up to 1.6 MPa (232 psi) upon request.
Is an external air supply required?
Yes—the instrument requires a clean, dry, oil-free compressed air source delivering 0.6–0.7 MPa at the Φ8 mm polyurethane inlet port. Air compressor is not included.
Can the C660M be used for quantitative leak rate calculation?
While primarily designed for pass/fail burst and creep evaluation, optional software modules enable derived leak rate estimation based on pressure decay during hold-phase tests per ASTM F2338 principles.
Does the system support IQ/OQ documentation packages?
Yes—Labthink provides vendor-qualified installation qualification (IQ) and operational qualification (OQ) templates aligned with ISO/IEC 17025 and GMP Annex 15 guidelines.
How is calibration maintained over time?
The unit features NIST-traceable pressure transducers with annual recalibration intervals; built-in self-diagnostic routines verify sensor linearity and zero stability prior to each test sequence.
