Labthink C690H Vacuum Decay Leak Tester for Non-Destructive Package Integrity Testing
| Brand | Labthink |
|---|---|
| Origin | Shandong, China |
| Manufacturer Type | OEM Manufacturer |
| Country of Origin | China |
| Model | Labthink C690H |
| Pricing | Upon Request |
| Test Principle | Vacuum Decay Method |
| Standards Compliant | ASTM F2338, YY/T 0681.18, USP <1207> |
| Detection Range | 3–8–Large Leak (USP <1207> Reference Orifice) |
| Detection Limit | ≤3 µm |
| Resolution | 0.1 µm |
| Repeatability | ±1 µm |
| Pressure Range | −100 to 0 to +100 kPa |
| Sample Capacity | 20–120 units per run |
| Max Sample Dimensions | Ø45 mm × 80 mm |
Overview
The Labthink C690H Vacuum Decay Leak Tester is an engineered solution for non-destructive, quantitative package integrity testing of sterile pharmaceutical primary packaging. It operates on the vacuum decay principle—a deterministic, pressure-based method in which a sealed test chamber containing the sample is evacuated to a user-defined target vacuum level; subsequent pressure rise over time is measured via high-stability, NIST-traceable pressure transducers. The resulting pressure-time curve is mathematically modeled to calculate leakage rate and equivalent reference orifice size (in micrometers), directly correlating to defect severity per USP guidance. Unlike probabilistic dye ingress or microbial challenge methods, vacuum decay delivers objective, repeatable, and statistically defensible data—making it suitable for validation, routine QC release testing, and stability studies under ISO 11607-2 and EU Annex 1 requirements.
Key Features
- Dual independent AB-channel architecture enables concurrent testing of two distinct sample formats (e.g., vials and syringes) without cross-contamination or recalibration.
- Automated drop-in sample loader accommodates 20–120 units per batch, minimizing operator intervention and reducing cycle time variability.
- Programmable vacuum setpoint and dwell time allow optimization across diverse container closure systems—including glass and polymer-based vials, ampoules, cartridges, and pre-filled syringes.
- Integrated positive-pressure mode mitigates false negatives caused by temporary pore occlusion (e.g., from residual stopper particles or viscous formulation).
- Micro-flow control system emulates calibrated leak standards (3–8 µm and larger), eliminating manual orifice substitution and supporting method qualification per ASTM F2338 Annex A2.
- Real-time pressure curve visualization, automated pass/fail classification, and on-board statistical summary (mean, SD, CV%) support immediate decision-making during production runs.
- Embedded 15.6-inch industrial touch panel running Windows OS ensures intuitive navigation, localized UI responsiveness, and compatibility with enterprise IT infrastructure.
Sample Compatibility & Compliance
The C690H is validated for use with rigid and semi-rigid parenteral containers up to Ø45 mm × 80 mm, including but not limited to: Type I/II glass vials (2–30 mL), molded glass ampoules (1–10 mL), polymer-based cartridges, infusion bottles, and elastomeric-capped pre-filled syringes. Its design adheres to regulatory expectations outlined in USP , FDA Guidance for Industry (2022), and EMA CHMP Reflection Paper on Container Closure Integrity Testing (2022). All measurement subsystems—including pressure sensors, flow controllers, and timing circuits—are calibrated against NIST-traceable references. Full audit trail functionality—including user login/logout timestamps, parameter changes, result modifications, and electronic signatures—meets 21 CFR Part 11 and EU Annex 11 requirements for computerized systems used in GMP environments.
Software & Data Management
The embedded software provides full lifecycle data governance: secure multi-level user roles (administrator, analyst, reviewer), configurable permission sets, and tamper-evident audit logs recording every action with operator ID, timestamp, and contextual metadata. Raw pressure vs. time datasets are stored in proprietary binary format with embedded checksums; export options include CSV, PDF reports, and XML for LIMS integration. System updates are delivered remotely via encrypted HTTPS channel. Optional GMP-compliant computer system validation packages include IQ/OQ documentation, risk assessments (FMEA), and change control templates aligned with PIC/S TR 57 and WHO TRS 996 Annex 11.
Applications
- Batch release testing of lyophilized and liquid-filled vials prior to distribution.
- Container closure system (CCS) development and qualification studies.
- Stability protocol execution at accelerated and real-time conditions.
- Root cause analysis of seal failure during process transfer or line changeovers.
- Supporting comparability protocols following CCS component or manufacturing site changes.
- Verification of sterilization process impact on seal integrity (e.g., after steam or gamma exposure).
FAQ
What standards does the C690H comply with?
ASTM F2338–22, YY/T 0681.18–2022, USP , ISO 11607–2:2019, and relevant sections of EU GMP Annex 1 and FDA Guidance for Industry (2022).
Can the system be qualified for GMP use?
Yes—the platform supports full IQ/OQ/PQ execution with vendor-supplied protocols, traceable calibration certificates, and 21 CFR Part 11–compliant electronic signature implementation.
Is compressed air required on-site?
Yes; external compressed air (≥500 kPa / 72.5 psi) is needed for positive-pressure mode and actuation of pneumatic components. An optional integrated oil-free air compressor is available as an accessory.
How is measurement traceability ensured?
All pressure and flow sensors are factory-calibrated against NIST-traceable standards, with calibration certificates provided. In-use verification is supported via certified reference leaks and daily system suitability checks.
Does the system support remote monitoring or integration with MES/LIMS?
Yes—Ethernet and USB interfaces enable secure data export, API-based status polling, and scheduled report generation compatible with common laboratory informatics platforms.
